79C3C34C52B45572883A05D425EB0F82
Standard operating Procedures for the Ethical Evaluation of Health Research
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| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / criminal
Searching for indicator criminal:
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p.(None): according to the specified format.
p.(None): The content of the report should include information regarding the start date of the evaluation, general information
p.(None): of the object to be evaluated (product or institution), reason for the evaluation, description of the evaluation carried out,
p.(None): recommendations, date of completion of the evaluation (expected and actual), name and signature of the Experts
p.(None): External
p.(None): The final report must be approved by the CNEIS, which will accept or deny, based on the fulfillment of the objectives
p.(None): provided, the decision leaving it in writing in the minutes.
p.(None): The Committee of External Experts will report to the CNEIS on the work done in the period of time of
p.(None): operation, through a written report.
p.(None): FINAL REPORTS
p.(None): The report of the Committee of External Experts should be annulled, if it is detected that your declaration of
p.(None): absence of conflict of interest. This implies reconsidering or annulling the decision in whose trial you had
p.(None): Participation a member of the Committee.
p.(None): VIOLATIONS AND SANCTIONS
p.(None): Page 160 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): RESPONSIBLE DESCRIPTION
p.(None): The condition of External Expert should be temporarily or permanently suspended if:
p.(None): - Failure to comply with the working conditions previously accepted by the External Expert in a manner
p.(None): repeated (non-attendance at meetings, delivery of their reports as planned, among others)
p.(None): - Non-compliance is detected in relation to what is established in your confidentiality statement on the
p.(None): documentation and information in charge.
p.(None): The penalties will be criminal if the violation classifies the crimes of the current penal code.
p.(None): Page 161 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 19 FORMAT OF PRESENTATION OF RESEARCH PROTOCOLS
p.(None): DOCUMENT FORMAT
p.(None): - The documents must be prepared in letter size paper, with exceptions described.
p.(None): - Typeface and size for the text of the entire content of the document: Times New Roma 12. The text in the
p.(None): Document content does not have a “bold”, “italic” or “underlined” format, unless indicated
p.(None): On the contrary, as in titles, headings, words to be defined or words that precede two points.
p.(None): - Paragraph spacing for the entire document is: 1.5 (except for tables or tools, use the
p.(None): ideal spacing).
p.(None): - The margins of the document should be: normal style (Sup .: 2.5 cm, Inf .: 2.5 cm, Left .: 3cm, Right .: 3 cm).
p.(None): - The titles of the sections begin with a correlative number starting from 1. The title of the section is
p.(None): aligned to the left and written in capital letters and in “bold” format, with no end point, since this is a Title.
p.(None): - The titles of the sub sections and their derivatives begin with the correlative number of the title that they come from,
p.(None): followed by a period and then starting from 1. The titles of the sub sections and their derivatives are
p.(None): aligned its beginning to the left, below the first letter of the section that precedes it and they are written in
p.(None): uppercase and in “bold” format, with no end point.
p.(None): - Text that is not a title of sections or subsections is justified, and aligned at the beginning of the first
p.(None): title letter or sub title, as appropriate.
p.(None): - For explanatory footnotes, consecutive numbers are used in superscript format at the end
...
Political / nomad
Searching for indicator nomads:
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p.(None): 75. Subject of the Study: Individual who participates in a health study, either as a recipient of the
p.(None): product (s) under investigation or as a control. In this document, "subject", "individual" and "person" are used
p.(None): With the same meaning.
p.(None): 76. Vulnerable (or Vulnerated) Subjects: Individuals whose desire to participate in a health study may be
p.(None): influenced by the expectation, justified or not, of the benefits associated with your participation, or of a
p.(None): revenge on the part of the superior members of a hierarchy in case of refusing to participate. By
p.(None): For example, the members of a group with a hierarchical structure, such as that made up of medical students,
p.(None): dentistry, chemical-drug-biological and nursing, subordinate hospital and laboratory personnel,
p.(None): employees of the pharmaceutical industry, members of the armed forces and people who are
p.(None): detained / detained Other vulnerable (or violated) subjects include patients with diseases
p.(None): incurable, people in nursing homes, unemployed or homeless, patients in emergency situations,
p.(None): ethnic minority groups, homeless people, nomads, refugees, minors and those who cannot give their
p.(None): consent.
p.(None): 77. Impartial Witness: A person independent of the study, who cannot be influenced in bad faith
p.(None): by the personnel involved in the study, who is present in the process of obtaining the
p.(None): informed consent if the subject or the representative of the legally accepted subject does not know how to read, and who reads the
p.(None): "Informed Consent Form" and any other written information provided to the subject.
p.(None): to. Research Unit / Research Center: In-hospital entity responsible for: Promoting and
p.(None): develop research in the hospital Train hospital staff who request it in methodology
p.(None): of research, to develop research with internal validity, technically evaluate, support the
p.(None): Page 73 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): logistics, register, monitor and monitor the development of studies carried out in the institution.
p.(None): 78. Compliance Monitoring of the BPC: Periodic Audit of any of the parties involved in the
p.(None): conducting a health study (for example, the CNEIS of researchers, sponsors, etc.), for the purpose
p.(None): to verify compliance with the PCBs and the corresponding regulations.
p.(None): Page 74 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): 11. ANNEXES
p.(None): ANNEX 1. GUIDE TO DEVELOP THE LETTER OF INTENTIONS OF A RESEARCHER / RESEARCH TEAM
p.(None): ON THE LETTER OF INTENTION:
p.(None): You must enter:
...
Political / person in detention center
Searching for indicator detained:
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p.(None): Conducting health studies of research products.
p.(None): 73. Site Where the Study is Performed: The place (s) where the related activities are carried out
p.(None): With the study.
p.(None): Page 72 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): 74. Sub-researcher: Any individual member of the health study group, appointed and supervised by the
p.(None): researcher to perform critical procedures related to the study and / or make important decisions
p.(None): related to it (for example, associates, residents, research fellow).
p.(None): 75. Subject of the Study: Individual who participates in a health study, either as a recipient of the
p.(None): product (s) under investigation or as a control. In this document, "subject", "individual" and "person" are used
p.(None): With the same meaning.
p.(None): 76. Vulnerable (or Vulnerated) Subjects: Individuals whose desire to participate in a health study may be
p.(None): influenced by the expectation, justified or not, of the benefits associated with your participation, or of a
p.(None): revenge on the part of the superior members of a hierarchy in case of refusing to participate. By
p.(None): For example, the members of a group with a hierarchical structure, such as that made up of medical students,
p.(None): dentistry, chemical-drug-biological and nursing, subordinate hospital and laboratory personnel,
p.(None): employees of the pharmaceutical industry, members of the armed forces and people who are
p.(None): detained / detained Other vulnerable (or violated) subjects include patients with diseases
p.(None): incurable, people in nursing homes, unemployed or homeless, patients in emergency situations,
p.(None): ethnic minority groups, homeless people, nomads, refugees, minors and those who cannot give their
p.(None): consent.
p.(None): 77. Impartial Witness: A person independent of the study, who cannot be influenced in bad faith
p.(None): by the personnel involved in the study, who is present in the process of obtaining the
p.(None): informed consent if the subject or the representative of the legally accepted subject does not know how to read, and who reads the
p.(None): "Informed Consent Form" and any other written information provided to the subject.
p.(None): to. Research Unit / Research Center: In-hospital entity responsible for: Promoting and
p.(None): develop research in the hospital Train hospital staff who request it in methodology
p.(None): of research, to develop research with internal validity, technically evaluate, support the
p.(None): Page 73 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): logistics, register, monitor and monitor the development of studies carried out in the institution.
...
Political / political affiliation
Searching for indicator party:
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p.(None): established in this Confidentiality Agreement.
p.(None): First: The National Committee for Health Research Ethics makes available to the Expert the information
p.(None): required for the performance of its work.
p.(None): Second: During his work he will have access to information with character
p.(None): confidential that should not be used for outside purposes.
p.(None): The parties that sign this agreement must comply with it in full and comply with the provisions of this
p.(None): Confidentiality Agreement sign two copies of it with the same tenor and equal validity in legal force.
p.(None): Given in San Salvador on the 20th day of the month of XXX of the XXXX year.
p.(None): PRESIDENT NAME
p.(None): Page 151 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 17. DECLARATION OF ABSENCE OF CONFLICTS OF INTEREST
p.(None): Declaration of Absence of Conflicts of Interest
p.(None): In the course of performing your duties as under this agreement, you will have
p.(None): access to information owned by the National Committee for Health Research Ethics. You agree to try
p.(None): this information as confidential (hereinafter as "information")
p.(None): I,
p.(None): I compromise to:
p.(None): a) Not to use the information for any other purpose than to fulfill my obligations under this agreement; Y
p.(None): b) Not disclose or provide the information to any third party who does not have a working relationship and
p.(None): Confidentiality in it and to use the information properly.
p.(None): It will not relate to any obligation of confidentiality and will not use it until you are clearly not
p.(None): able to demonstrate that any part of the information:
p.(None): a) It was known by you before any disclosure or discovery by the National Ethics Committee of
p.(None): Health Research, or:
p.(None): b) It was public domain at the time of discovery by the National Committee for Health Research Ethics,
p.(None): or:
p.(None): c) It has become part of the public domain, or:
p.(None): d) It has been available to you by a third party without abuse of trust or of the obligations of
p.(None): Confidentiality to the National Committee for Health Research Ethics.
p.(None): I promise not to communicate the deliberations and results of the team of
p.(None): Page 152 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): in which it participates, as well as the resulting recommendations
p.(None): and / or the decisions of the National Committee for Health Research Ethics to third parties, except as
p.(None): explicitly agreed the National Committee for Health Research Ethics.
p.(None): You will perform your responsibilities exclusively in your capacity as a
p.(None): of the National Committee of Ethics of Health Research. Signing this
p.(None): agreement, you confirm that you have no financial interest and / or other relationship with the parties, which:
p.(None): a) They could have a commercial interest created by obtaining access to any part of the referred information
p.(None): previously and / or:
p.(None): b) You may have an interest created in the result of the appreciation of the products, in which you will participate
p.(None): but it will not limit parties such as the producer that has been evaluated or from competent producers.
p.(None): I accept the provisions and conditions contained in this document and for the record, I sign this document:
p.(None): Name:
p.(None): Entity:
p.(None): Date:
p.(None): Firm:
p.(None): Page 153 of 164
...
Political / vulnerable
Searching for indicator vulnerable:
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p.(None): 5 Information delivery times:
p.(None): ✓ Serious Adverse Events, EAS: first 24 hours.
p.(None): ✓ Serious unrelated adverse events: one week.
p.(None): ✓ Non-serious internal adverse events associated and not associated with the study: three weeks.
p.(None): ✓ Safety and continuity reports: quarterly, semi-annually and annually.
p.(None): Validity of approval of the research protocol: one year.
p.(None): CNEIS administrative assistant
p.(None): CNEIS administrative assistant
p.(None): CNEIS Reviewers
p.(None): Page 26 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): PROCEDURE 6. EVALUATION MEETING WITH THE INVESTIGATOR
p.(None): OBJECTIVE: Standardize the development of meetings convened with researchers, in order to
p.(None): obtain more technical, methodological and ethical information on the protocols presented, in those investigations in
p.(None): which are necessary opinions of external consultants and those in which it is necessary to deepen in
p.(None): aspects of the protocol.
p.(None): RESPONSIBLE:
p.(None): - National Committee for Health Research Ethics
p.(None): - National Directorate of Medicines
p.(None): - Principal investigator
p.(None): MATERIALS:
p.(None): - Notice of call to principal investigators
p.(None): - Power Point presentation
p.(None): - Written protocol
p.(None): DESCRIPTION OF THE PROCEDURE 6
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): Define if it is necessary to invite the principal investigator, if the study meets one or more of the following
p.(None): terms:
p.(None): ✓ Research that poses a high security risk
p.(None): ✓ Research involving vulnerable populations
p.(None): one
p.(None): ✓ Investigations that are related to the field of
p.(None): genetics.
p.(None): ✓ Research involving little known or complex methodologies
p.(None): CNEIS full reviewers
p.(None): Page 27 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): ✓ That during the appeal process it is considered to listen to the principal investigator.
p.(None): Send invitation to the principal investigator, requesting to make a presentation of the project to the committee and
p.(None): answer your
p.(None): 2 questions. The invitation must be made within a maximum period of 21 business days, from the receipt of
p.(None): the request for evaluation of the study protocol.
p.(None): Make the presentation to the Committee in full and answer the
p.(None): 3 questions that arise from committee members and / or experts invited by the Committee.
p.(None): The Committee will deliberate and resolve according to the arguments and
p.(None): 4
p.(None): analysis.
p.(None): Send the approval or rejection report within 7 days
p.(None): 5 business, counting from the day of the presentation made by the researcher.
p.(None): CNEIS administrative assistant
p.(None): Principal investigator
p.(None): CNEIS and DNM in
p.(None): full
p.(None): CNEIS administrative assistant
p.(None): Page 28 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): PROCEDURE 7. APPEAL REVIEW
p.(None): OBJECTIVE: Standardize the processing of appeal letters of rejected resolutions.
p.(None): MATERIALS:
p.(None): - Letter of appeal, in which the necessary technical or scientific arguments are described.
p.(None): - Document that includes changes.
p.(None): RESPONSIBLE:
...
p.(None): consistent with the applicable product information (for example, that contained in the Researcher's Brochure
p.(None): for an unapproved research product, or packaging insert / summary of product characteristics
p.(None): approved) (see the Guide to the International Harmonization Conference for Data Management of
p.(None): Clinical Safety: Definitions and Standards of an Immediate Report).
p.(None): 70. Original Medical Record: See source documents. In this document, "subject", "individual" and "person" are
p.(None): They use with the same meaning.
p.(None): 71. Legally Accepted Representative: Individual, legal representative or other body authorized under the laws
p.(None): applicable to accept, on behalf of a probable candidate, his participation in the health study.
p.(None): 72. Applicable Regulatory Requirement (s): Any law (s) and regulation (s) that govern
p.(None): Conducting health studies of research products.
p.(None): 73. Site Where the Study is Performed: The place (s) where the related activities are carried out
p.(None): With the study.
p.(None): Page 72 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): 74. Sub-researcher: Any individual member of the health study group, appointed and supervised by the
p.(None): researcher to perform critical procedures related to the study and / or make important decisions
p.(None): related to it (for example, associates, residents, research fellow).
p.(None): 75. Subject of the Study: Individual who participates in a health study, either as a recipient of the
p.(None): product (s) under investigation or as a control. In this document, "subject", "individual" and "person" are used
p.(None): With the same meaning.
p.(None): 76. Vulnerable (or Vulnerated) Subjects: Individuals whose desire to participate in a health study may be
p.(None): influenced by the expectation, justified or not, of the benefits associated with your participation, or of a
p.(None): revenge on the part of the superior members of a hierarchy in case of refusing to participate. By
p.(None): For example, the members of a group with a hierarchical structure, such as that made up of medical students,
p.(None): dentistry, chemical-drug-biological and nursing, subordinate hospital and laboratory personnel,
p.(None): employees of the pharmaceutical industry, members of the armed forces and people who are
p.(None): detained / detained Other vulnerable (or violated) subjects include patients with diseases
p.(None): incurable, people in nursing homes, unemployed or homeless, patients in emergency situations,
p.(None): ethnic minority groups, homeless people, nomads, refugees, minors and those who cannot give their
p.(None): consent.
p.(None): 77. Impartial Witness: A person independent of the study, who cannot be influenced in bad faith
p.(None): by the personnel involved in the study, who is present in the process of obtaining the
p.(None): informed consent if the subject or the representative of the legally accepted subject does not know how to read, and who reads the
p.(None): "Informed Consent Form" and any other written information provided to the subject.
p.(None): to. Research Unit / Research Center: In-hospital entity responsible for: Promoting and
p.(None): develop research in the hospital Train hospital staff who request it in methodology
p.(None): of research, to develop research with internal validity, technically evaluate, support the
p.(None): Page 73 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): logistics, register, monitor and monitor the development of studies carried out in the institution.
p.(None): 78. Compliance Monitoring of the BPC: Periodic Audit of any of the parties involved in the
...
p.(None): 16. Plan to provide the best proven treatment to the community, at the end of the investigation
p.(None): 17. Compensation and compensation provisions for damages
p.(None): 18. Investigator's liability insurance
p.(None): 19. Confidentiality requirements
p.(None): Maximum score 57 points.
p.(None): Page 91 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 4B ETHICAL EVALUATION GUIDE FOR RESEARCH PROTOCOLS DIFFERENT FROM CLINICAL TRIALS
p.(None): Principle analysis Adequate Not applicable
p.(None): Inadequate AUTONOMY
p.(None): Protection of confidentiality Obtaining
p.(None): consent / assent, voluntariness, information, understanding
p.(None): Substitution decisions (legal representative) BENEFIT
p.(None): Risk / benefit ratio Risk not exceeding the minimum NO MALEFICENCE
p.(None): Correct methodology: plausible hypothesis, justification and objectives, sample size
p.(None): Clinical equiponderance: interventions are considered equal in efficacy and safety Suitability
p.(None): of the researcher (training experience, sufficient time for the study) Safety clauses
p.(None): Suitability of research site / facilities JUSTIFICIA
p.(None): Equitable selection of subjects Compensation for damages
p.(None): Social utility
p.(None): Access to interventions
p.(None): VULNERABILITY
p.(None): Vulnerable, discriminated populations have been identified,
p.(None): Page 92 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Principle analysis Adequate Not applicable
p.(None): Inadequate
p.(None): which?
p.(None): Individual guarantees of vulnerability protection are completed
p.(None): The expected results suppose a direct benefit for the participants
p.(None): CONSEQUENCES ANALYSIS
p.(None): For the study subjects
p.(None): For society (responds to the health needs and problems of the country)
p.(None): Page 93 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 4C GUIDE FOR FINAL RESOLUTION
p.(None): At this stage, the important thing is that there is sufficient deliberation for each of the criteria. It's not about
p.(None): Mark the number of people who agree or disagree with the criteria. Only in particular cases, should
p.(None): record if one of the members did not agree with the opinion of the rest and the discussion was exhausted. In case of no
p.(None): If there is agreement, it will be convenient to suspend the discussion and resume it in an upcoming session.
p.(None): Definitions of the numbers in this guide:
p.(None): 1. Evaluate a treatment, intervention or theory that will improve health and well-being, or knowledge.
p.(None): The justification is the scarcity of resources and avoid exploitation. Scientific knowledge is evaluated, the
p.(None): citizen level understanding of social values.
...
Searching for indicator vulnerability:
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p.(None): Page 45 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): of results.
p.(None): Send to the DNM all periodic reports of research progress or continuity.
p.(None): Analyze and update information in Logs of
p.(None): 5
p.(None): tracing.
p.(None): Send notification to principal investigator and CSSP supervisory team. A copy of the notification must be
p.(None): 6
p.(None): filed next to the project information of
p.(None): investigation
p.(None): Technician in charge of Monitoring Clinical Trials.
p.(None): Administrative and Technical Assistant in charge of Monitoring Clinical Trials
p.(None): Administrative assistant
p.(None): Page 46 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): PROCEDURE 13: AUDIT OF GOOD CLINICAL PRACTICES TO RESEARCH CENTERS
p.(None): OBJECTIVES: Define the mechanism and criteria for carrying out the audits of PCBs to all parties
p.(None): involved in clinical research with the purpose of monitoring compliance with them.
p.(None): RESPONSIBLE:
p.(None): - Sponsor
p.(None): - Principal investigator
p.(None): - National Committee for Health Research Ethics
p.(None): - CSSP CSSP Audit Team
p.(None): MATERIALS:
p.(None): - Checklist of requirements for compliance with good clinical practices. (annex 14).
p.(None): DESCRIPTION OF THE PROCEDURE 13
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): Identify the studies that will be inspected according to the following criteria:
p.(None): The importance of proof for decision making
p.(None): 1 regulatory
p.(None): - The nature of the study
p.(None): - The vulnerability of the subjects
p.(None): - The irregularities of the data
p.(None): - The complaints
p.(None): National Committee for Health Research Ethics and National Directorate of Medicines
p.(None): Page 47 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): Request in writing to the CSSP the Audit of one or more research centers, attaching information
p.(None): about him
p.(None): protocol, the modifications, the form of the
p.(None): two
p.(None): authorization with knowledge of the cause, samples of
p.(None): data collection notebooks (FRC), study reports, reports of serious adverse events, etc.
p.(None): Prepare the audit plan for the center and the study to be audited, in agreement with the CNEIS,
p.(None): specifying specific source documents and centers to visit.
p.(None): Note: When planning the Audit, the supervisor must understand the scientific objectives, the
p.(None): criteria of
p.(None): 3
p.(None): inclusion and exclusion, concomitant medications
p.(None): allowed and not allowed, visits and analytical procedures required, any special requirements
p.(None): for handling or storage of the test article, and known information about the medication
p.(None): of the essay, as well as its profile of adverse events.
p.(None): Request information from the CNEIS about irregularities of data or special matters of interest that the
p.(None): DNM,
p.(None): 4
p.(None): during the internal examination of the marketing application
p.(None): (or presentation of the protocol).
p.(None): Inform the clinical investigator in advance, the date of the
p.(None): visit, to ensure that it is present and can access the study records in the
p.(None): moment of
...
p.(None): 15. Plan to provide the best treatment tested to the subjects, at the end of the investigation
p.(None): 16. Plan to provide the best proven treatment to the community, at the end of the investigation
p.(None): 17. Compensation and compensation provisions for damages
p.(None): 18. Investigator's liability insurance
p.(None): 19. Confidentiality requirements
p.(None): Maximum score 57 points.
p.(None): Page 91 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 4B ETHICAL EVALUATION GUIDE FOR RESEARCH PROTOCOLS DIFFERENT FROM CLINICAL TRIALS
p.(None): Principle analysis Adequate Not applicable
p.(None): Inadequate AUTONOMY
p.(None): Protection of confidentiality Obtaining
p.(None): consent / assent, voluntariness, information, understanding
p.(None): Substitution decisions (legal representative) BENEFIT
p.(None): Risk / benefit ratio Risk not exceeding the minimum NO MALEFICENCE
p.(None): Correct methodology: plausible hypothesis, justification and objectives, sample size
p.(None): Clinical equiponderance: interventions are considered equal in efficacy and safety Suitability
p.(None): of the researcher (training experience, sufficient time for the study) Safety clauses
p.(None): Suitability of research site / facilities JUSTIFICIA
p.(None): Equitable selection of subjects Compensation for damages
p.(None): Social utility
p.(None): Access to interventions
p.(None): VULNERABILITY
p.(None): Vulnerable, discriminated populations have been identified,
p.(None): Page 92 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Principle analysis Adequate Not applicable
p.(None): Inadequate
p.(None): which?
p.(None): Individual guarantees of vulnerability protection are completed
p.(None): The expected results suppose a direct benefit for the participants
p.(None): CONSEQUENCES ANALYSIS
p.(None): For the study subjects
p.(None): For society (responds to the health needs and problems of the country)
p.(None): Page 93 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 4C GUIDE FOR FINAL RESOLUTION
p.(None): At this stage, the important thing is that there is sufficient deliberation for each of the criteria. It's not about
p.(None): Mark the number of people who agree or disagree with the criteria. Only in particular cases, should
p.(None): record if one of the members did not agree with the opinion of the rest and the discussion was exhausted. In case of no
p.(None): If there is agreement, it will be convenient to suspend the discussion and resume it in an upcoming session.
p.(None): Definitions of the numbers in this guide:
p.(None): 1. Evaluate a treatment, intervention or theory that will improve health and well-being, or knowledge.
p.(None): The justification is the scarcity of resources and avoid exploitation. Scientific knowledge is evaluated, the
p.(None): citizen level understanding of social values.
p.(None): 2. The study has a clear hypothesis, uses accepted scientific principles and methods - which
p.(None): they include statistical techniques— to produce reliable and valid data.
p.(None): 3. In the selection of subjects or participants, people or populations are not selected
p.(None): stigmatized, or violated for risky investigations, while the most favored are offered
...
Health / Cognitive Impairment
Searching for indicator cognitive:
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p.(None): 45. Audit / supervision: The action of the regulatory authority (s) to carry out an official review of the
p.(None): documents, facilities, records and any other resource that the authority (ies) considers to be related
p.(None): with the study in health and that can be located in the place where the study is carried out, in the facilities of the
p.(None): sponsor and / or contract research organization (ICO) or other sites than the authority (s)
p.(None): Regulatory (s) considered appropriate.
p.(None): 46. Inspector / supervisor: A person conducting inspections of the study on behalf of the Authority of
p.(None): (National) Surveillance of Compliance with the BPC.
p.(None): 47. Institution (medical): Any public or private entity, agency or dental medical facility where they are conducted
p.(None): Health studies
p.(None): 48. Basic, pre-clinical or fundamental research: It is the experimental or technical work that is carried out
p.(None): primarily to acquire new knowledge of the underlying phenomenon and observable facts, without an application
p.(None): particular or use established. It can be divided into pure basic research and oriented basic research. In
p.(None): This type of research study subjects are cells, tissues, molecules and / or experimental animals. East
p.(None): type of research is carried out mainly within a specialized laboratory
p.(None): 49. Clinical Research: Patient oriented research. Research conducted with subjects
p.(None): humans (or with material of human origin, such as tissues, specimens, and cognitive phenomena) to
p.(None): which the researcher interacts directly with human subjects. It also includes studies
p.(None): epidemiological and behavioral studies and results research and research in services of
p.(None): Health.
p.(None): 50. Process research or evaluation of health systems (or research in health services or
p.(None): operational research): Field of research that examines the impact of the organization, financing and
p.(None): administration of health care services in the delivery, quality, costs, access and results of these
p.(None): services. In this type of research the subject of study are the processes or relationships within the
p.(None): health institutions.
p.(None): Page 69 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): 51. Public health research: Whose subject of research are the communities.
p.(None): 52. Health research: “Process of obtaining systematic knowledge and technologies that can be
p.(None): used to improve the health of individuals and groups. Provides basic information about health status
p.(None): and population disease; seeks to develop instruments for the prevention, cure and relief of the effects of
p.(None): diseases; and strives to plan better approaches for individual and community health services. ”
p.(None): 53. Researcher: Person responsible for conducting a health study at the site where the
p.(None): study. If a study is conducted by a group of individuals, the researcher is the responsible leader.
p.(None): of the group and will be called principal investigator.
p.(None): 54. Coordinating Investigator: A researcher, in a Multicenter study, who is assigned the responsibility of
p.(None): coordinate the researchers in the different participating centers.
...
Health / Drug Usage
Searching for indicator drug:
(return to top)
p.(None): Local Committee for Health Research (CLEIS) of El Salvador, to guarantee quality in the
p.(None): Documentary and administrative operation, and comply with international guidelines and Good Practice Guide
p.(None): Clinics
p.(None): 2.2 SPECIFIC
p.(None): - Standardize the procedures for the review of ethical considerations of health research.
p.(None): - Establish a guide for an appropriate induction of the new members of the Committees.
p.(None): - Optimize processes for decision making.
p.(None): - Establish inter-institutional procedures for the integral evaluation of Clinical Trials.
p.(None): 3. SCOPE
p.(None): This manual applies to the entire Regulation of Clinical Trials that are carried out in El
p.(None): Salvador and is evaluated inter-institutionally between the National Directorate of Medicines, National Committee
p.(None): of Ethics of Health Research and the Higher Council of Public Health.
p.(None): 4. LEGAL BASES
p.(None): - Constitution of the Republic Art. 68, 69.
p.(None): - Law on the Rights and Duties of Patients Art. 5 literal c), Art. 9 literal L), Art. 16, 17 and 18.
p.(None): - Medicines Law Art. 2, 29, 66, 68 74 b).
p.(None): - Health Code Art. 7 and 14
p.(None): - General Regulations of the Medicines Law Art. 34, 85
p.(None): - Technical Regulations of the American Center for Pharmaceutical Products. Medicines
p.(None): Page 4 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): of Human Use. Sanitary Registration Requirements. RTCA 11.03.59: 11.
p.(None): - American Central Technical Regulations. Pharmaceutical products. Drug Stability Studies for Use
p.(None): Human. RTCA 11.01.04: 10.
p.(None): - American Central Technical Regulations. Pharmaceutical products. Labeling of Pharmaceutical Products for Use
p.(None): Human. RTCA 11.01.02: 04.
p.(None): - American Central Technical Regulations. Pharmaceutical products. Medicines for Human Use. Good Practices of
p.(None): Manufacturing for the Pharmaceutical Industry. RTCA 11.03.42: 07.
p.(None): - Pharmaceutical products. Medicines for Human Use. Bioequivalence and Interchangeability. RTS
p.(None): 11.02.01: 16.
p.(None): - Salvadoran Technical Regulations RTS 11.02.02: 16. Pharmaceutical products. Medicines for Human Use.
p.(None): Pharmacovigilance
p.(None): - Guide to Good Clinical Practices (Document of the Americas).
p.(None): - Guide of Verification of Good Clinical Practices in Health Establishments.
p.(None): - Guidelines for Good Clinical Practices in Establishments in which Research or
p.(None): Clinical Trials (Adaptation of the Harmonized Tripartite Guide of the International Harmonization Conference
p.(None): ICHE 6R1).
p.(None): 5. RESPONSIBILITIES
p.(None): - CNEIS: Responsible for contributing to safeguard the dignity, rights, security and welfare of all
p.(None): and current and potential research participants. As well as in charge of receiving,
p.(None): evaluate, approve / not approve or observe a research protocol.
p.(None): - DNM: Responsible for evaluating approving / denying / observing clinical research protocols,
p.(None): approval of the importation of the medicinal product under investigation, monitoring and supervision of the trials
p.(None): clinical (EAS, SUSAR, Amendments to the protocol, Reports, support in PCB Audits, in others)
p.(None): - CSSP: Responsible for executing Good Clinical Practice Inspections.
...
p.(None): Applicability mechanism in El Salvador.
p.(None): - Curriculum vitae of the principal investigator and co-investigators.
p.(None): - Proof of payment of tariff.
p.(None): - Payment method of the researcher in El Salvador (attach a copy of the contract).
p.(None): - Letter of authorization from the center or centers where the study will be carried out.
p.(None): - Investigator's commitment to good clinical practices.
p.(None): - Certificate of Good Manufacturing Practices (BPM) of the manufacturer or Certificate of BPM
p.(None): issued by the Local Regulatory Authority. Applies if the product is not registered.
p.(None): - Primary and secondary packaging arts of the product or products to be used in the clinical study, which
p.(None): contain the lot numbers and the date of manufacture and expiration.
p.(None): - Other materials (Promotional, patient card, questionnaires, etc.).
p.(None): - Copy of the certificate of authorization of operation of the Health establishment where the
p.(None): Clinical Study, issued by the Higher Council of Public Health.
p.(None): - Copy of the updated payment of the operating annuity of the establishment of
p.(None): health where the clinical study will take place.
p.(None): Page 9 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Recognitions of documents related to Clinical Research
p.(None): The National Committee for Health Research Ethics, the National Directorate of Medicines and the Superior Council
p.(None): Public Health, may officially recognize relevant decisions, reports or information from trials
p.(None): Clinics of drug regulatory agencies that have been certified level IV by the Organization
p.(None): Pan American Health (PAHO), as well as by health authorities of the United States of America, Canada,
p.(None): Australia, Switzerland, Japan and by the European Medicines Agency (EMA) and other countries that have
p.(None): specific regulation for the regulation of Clinical Trials.
p.(None): In the case of drug research protocols that require evaluation in beings
p.(None): human, its review will be applicable regardless of the primary origin of the application, be it from the sector
p.(None): National, foreign, public or private.
p.(None): In compliance with the Constitution of the Republic of El Salvador, Article 68.- A Higher Council of Public Health
p.(None): will ensure the health of the people. It will consist of the same number of representatives of the Medical, Dental,
p.(None): Chemist - Pharmacist, Veterinarian, Clinical Laboratory, Psychology, Nursing and others at the level of
p.(None): Degree that the Higher Council of Public Health has qualified to have its respective board; will have a
p.(None): president and a secretary of appointment of the executive body. The law will determine your organization.
p.(None): The exercise of professions that are immediately related to the health of the people will be monitored
p.(None): by legal bodies formed by academics belonging to each profession. These organisms will have
p.(None): power to suspend the professional members of the guild under their control, when exercising their
p.(None): profession with manifest immorality or disability. The suspension of professionals may be resolved by the agencies
p.(None): competent in accordance with due process.
p.(None): Page 10 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): The Higher Council of Public Health will know and resolve the appeals that are brought against the
p.(None): resolutions pronounced by the organizations referred to in the previous paragraph.
p.(None): And in compliance with Art. 14. Literal d) Of the Health Code which details that:
p.(None): The powers of the Board are:
...
p.(None): http://cnfv.salud.sv/alertas-nacionales-de-seguridad/
p.(None): Types of adverse effects (AD):
p.(None): EA classification
p.(None): Adverse events can be classified into different categories:
p.(None): - Adverse Event (EA)
p.(None): - Adverse reaction (RA)
p.(None): - Unexpected adverse reaction (RAI)
p.(None): - Serious Adverse Event (EAS) or Serious Adverse Reaction (RAS)
p.(None): - Serious Adverse Reaction Suspected (RASS)
p.(None): - Adverse Reaction Serious Unexpected Suspected (RASIS / SUSAR)
p.(None): RESPONSIBILITIES
p.(None): There is a certain degree of responsibility when managing adverse events. When there is no sponsor
p.(None): externally, the research authority of the institution in charge of the project will fulfill the role of the sponsor. The
p.(None): Principal investigator (IP) or chief investigator (IJ) has full responsibility for conducting the study. In
p.(None): A Multicentre study, the IP has coordinated responsibilities to report adverse events to the CNEIS and the
p.(None): DNM In the case of studies of products already registered in the DNM that evaluate a new, new indication
p.(None): concentration if it is higher than the one already registered, new dosage or new dosage form for the purpose of
p.(None): registry; All studies of pharmacokinetics, bioavailability and bioequivalence will also be reported to
p.(None): CNFV Any IP / IJ that you have accepted to upload
p.(None): Page 32 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): with the areas of Pharmacovigilance, delegated by the sponsor, you must take both responsibilities, those of the IP and
p.(None): those of the sponsor.
p.(None): Serious Adverse Event (EAS) or Serious Drug Adverse Reaction (Serious RAM)
p.(None): Any unfavorable occurrence that at any dose:
p.(None): (a) results in death,
p.(None): (b) life threatening, requires patient hospitalization or prolongation of existing hospitalization,
p.(None): (c) results in persistent or significant disability / disability, or is a congenital anomaly / defect
p.(None): of birth
p.(None): Which EAS to report?
p.(None): - The management and reporting of arrangements for EAS must be implemented in all trials. In the agreements
p.(None): at the beginning of the trial, it should be established that EAS are defined as related to the disease and that, therefore,
p.(None): They are not subject to an expedited report. EAS management and reporting procedures must be clearly
p.(None): defined in the protocol.
p.(None): It is recommended that an Independent Data Monitoring Committee (CIMD) be installed so that on a regular basis
p.(None): data security reviews are made throughout the trial and when necessary, and recommend
p.(None): Sponsor continue, modify or end the trial. Again, this procedure must be defined in the
p.(None): protocol.
p.(None): The confidentiality and adherence of the data must be maintained both in your record and in your report.
p.(None): During rehearsal
p.(None): - For each EA an evaluation of the seriousness, the causality and the expectation must be made. The
p.(None): Responsibility for this evaluation is of the IP; and when there is
p.(None): Page 33 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): several, as in multicentric studies, the responsibility will fall on all IPs. It is appropriate that each IP
p.(None): in each site evaluate each event, before reporting it to the central IP. It must be specified in the protocol of
p.(None): clinical trial and use local POEs, and will take responsibility for determining and reporting each of the events at
p.(None): Sponsor and central IP, simultaneously. When you need to report expeditiously, this procedure assumes
p.(None): The responsibility for the initial determination and reporting to the central IP.
p.(None): Seriousness Assessment
p.(None): - The term seriousness is based on the evolution of the patient / event or action criterion. It is different from
p.(None): "Severity", which is used to refer to the intensity of a specific event.
p.(None): Causality Assessment
p.(None): - Most adverse events and adverse reactions to drugs that occur in a study, whether serious or not,
p.(None): they are expected to be toxicities due to the drug used in the study. The causation assignment must be made
p.(None): by the researcher responsible for the care of the participants, using the definitions shown in the
p.(None): following picture:
p.(None): Relationship Description
p.(None): Not related
p.(None): Unlikely
p.(None): Possible
p.(None): There is no evidence of any causal relationship.
p.(None): There is little evidence to suggest that there is a causal relationship (eg the event did not occur within a while
p.(None): reasonable after the medication was administered in the trial). There is no other reasonable explanation for the
p.(None): event (Ex. The clinical condition of the participant, other concomitant treatment, etc.).
p.(None): There is some evidence that suggests a causal relationship (eg because the event occurred within a while
p.(None): reasonable after administered on
p.(None): Page 34 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Relationship Description
p.(None): medication under study). However, the influence of other factors may have contributed to the event (eg.
p.(None): clinical condition of the patient, other concomitant treatments, etc.).
p.(None): There is evidence that suggests a causal relationship and there seems to be no influence
p.(None): Probable
p.(None): Definitive
p.(None): Cannot be evaluated
p.(None): of other factors.
p.(None): There is clear evidence of a causal relationship and any influence of other contributing factors may be
p.(None): discarded
p.(None): There is insufficient or incomplete evidence to make a clinical trial of causal relationship.
p.(None): All serious adverse events (EAS) should be reported immediately except those EAS that the
p.(None): protocol or other document (for example, Researcher's Brochure) identify that they do not need an immediate report.
p.(None): Immediate reports should be followed by detailed written reports.
p.(None): All local investigators must report any EAS or SUSAR, as required by the Committee on
p.(None): Local, National Research Ethics and the competent authority.
p.(None): It is necessary that all EAS and SUSAR be notified in physical and digital format (Email, CD or Memory
p.(None): USB)
p.(None): The CNEIS, must send all the information of EAS and / or SUSAR to the DNM, so that it carries out the evaluation and the
p.(None): corresponding tracking. If the EAS and / or SUSAR is related to the investigational drug, the DNM has the
p.(None): authority to suspend the prescription, dispensation and supply of investigational drugs, as
p.(None): established in article 74 of the Medicines Law, in order to control the sanitary surveillance of medicines.
p.(None): The CNEIS must send to the CNFV the results of the Clinical Trials of the medications that are
p.(None): they are registered with the DNM, regarding security and
p.(None): Page 35 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): effectiveness to compare them with the safety assessment contained in the Periodic Safety Reports
p.(None): (IPS) and Risk Management Plans (PGR).
p.(None): For all those Clinical Trials that have been carried out in El Salvador, the CNFV may request the data from the CNEIS
p.(None): obtained from the clinical study.
p.(None): DESCRIPTION OF THE PROCEDURE 8
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): When an EAS occurs, RAM would be, RAM would not be unexpected or SUSAR in El Salvador, the researcher
p.(None): shall
p.(None): inform the National Ethics Committee to the National Directorate
p.(None): one
p.(None): of Medicines and the National Pharmacovigilance Center
p.(None): (CNFV) within the first 24 hours from the knowledge by the principal investigator.
p.(None): For EAS and SUSAR:
p.(None): Prepare the report of serious adverse events (EAS) and SUSAR using the form; classified according to Dictionary
p.(None): doctor for systems regulatory activities (MedRA) and the form for reporting adverse events.
p.(None): For RAM Serious or Not Serious for Medications in
p.(None): 2 research that already have a Health Registry, the researcher must report the RAM
p.(None): Serious, through the following ways:
p.(None): - Through the filling of the RAM Suspicion Notification Sheet. (Annex 8)
p.(None): - Or, the online electronic format filling: E-REPORTING:
p.(None): http://cnfv.salud.sv/hoja-ram-esavi-electronica-en-linea/
p.(None): Sponsor /
p.(None): Principal investigator
p.(None): Sponsor / Principal Investigator
p.(None): Page 36 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): If there is any doubt about causation, the local investigator
p.(None): You must inform the study coordinating center, who
p.(None): 3 will notify the Principal Investigator. Pharmaceutical companies and / or other clinicians
p.(None): they must be interrogated to advise, in some cases.
p.(None): After receiving the EAS and SUSAR report, the CNEIS and DNM must be called for discussion and
p.(None): New case analysis of EAS and SUSAR, within the first 72 hours.
p.(None): The CNFV will be convened in cases where there are Serious or Non-Serious RAM for product studies already
p.(None): registered in the DNM as established in this manual.
p.(None): 5
p.(None): In the case of the Pre-Marketing studies, the CNFV
p.(None): technical support will only be provided to decide whether there is a causal relationship or not in a Serious Adverse Event or
p.(None): Serious Drug Adverse Reaction.
p.(None): The CNFV will issue a report to the CNEIS and the DNM of the process carried out on the RAM Serious or not It would be unexpected
p.(None): reported by the investigator within a period not exceeding 15 business days.
p.(None): They analyze the report and request audit programming from
p.(None): 6 BPC in follow-up of the EAS and SUSAR reported within the first 72 hours.
p.(None): Expose to the committee those persistent, fatal EAS and SUSAR
p.(None): 7
p.(None): or not expected.
p.(None): Perform BPC audit in a period of 10 days
p.(None): 8
p.(None): Skilful
p.(None): Sponsor / Local Researcher, Principal Investigator
p.(None): CNEIS administrative assistant
p.(None): Y
p.(None): Technician in charge of Clinical Trials Follow-up
p.(None): CNEIS and DNM
p.(None): Vocal
p.(None): CSSP CSSP Audit Team
p.(None): Page 37 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): Once the audit is completed, the Lead Auditor sends an audit report to the CNEIS in 10 business days.
p.(None): They receive a report from BPC in follow-up of the EAS and SUSAR, analyze and evaluate to define the relationship with
p.(None): the study and the
p.(None): 9 relevance of its continuity.
p.(None): CNEIS notifies the investigator about decisions made.
p.(None): Analyze and archive EAS and SUSAR tracking records and update Logbook.
p.(None): 10
p.(None): Notify the CNEIS Administrative Assistant about the update of the information.
p.(None): 11 Analyze and update information in Tracking Logs.
p.(None): Send a copy of all EAS and SUSAR reports to the Management
p.(None): 12
p.(None): National Medicines.
p.(None): CNEIS and DNM
p.(None): Technician in charge of Clinical Trials Follow-up
p.(None): Technician in charge of
...
p.(None): of the essay, as well as its profile of adverse events.
p.(None): Request information from the CNEIS about irregularities of data or special matters of interest that the
p.(None): DNM,
p.(None): 4
p.(None): during the internal examination of the marketing application
p.(None): (or presentation of the protocol).
p.(None): Inform the clinical investigator in advance, the date of the
p.(None): visit, to ensure that it is present and can access the study records in the
p.(None): moment of
p.(None): 5
p.(None): Audit. When an Audit is announced, the inspector
p.(None): inform the clinical investigator of the documents that must be at hand for the Audit and the
p.(None): installations
p.(None): CNEIS DNM
p.(None): CSSP Audit Team
p.(None): CSSP Audit Team
p.(None): CSSP Audit Team
p.(None): Page 48 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): that will be visited, if relevant.
p.(None): Hold a meeting with the principal investigator at the beginning of the Audit and present their official identification and
p.(None): Any official notice that may be requested. Explain the nature and scope of the Audit, and summarize
p.(None): briefly the methods and procedures that will be used to carry it out.
p.(None): Request information on:
p.(None): - Screening and income of patients to study
p.(None): - Obtaining informed consent
p.(None): 6 - Collection and analysis of study data
p.(None): - Registration, transcription and notification of data to the sponsor
p.(None): - The reception, return and administration of the test drug
p.(None): Other interviews can be conducted with the key study staff and, if relevant, with the subjects
p.(None): of the study, during the Audit and as situations arise that merit it.
p.(None): Determine if the test activities were carried out according to the protocol, to the requirements
p.(None): regulatory
p.(None): 7 applicable and to the BPC, and verify that the data was recorded and notified accurately,
p.(None): using the checklist
p.(None): Identify the study records through an inventory of
p.(None): 8
p.(None): the same. This will be done before the review begins.
p.(None): CSSP Audit Team
p.(None): CSSP Audit Team
p.(None): CSSP Audit Team
p.(None): Page 49 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): exhaustive records of specific subjects. You can facilitate this task by first having someone
p.(None): that you are familiar with the study documents and explain your organization and
p.(None): Location. The inspector will then check, at a minimum, that there is a case file for each subject
p.(None): registered in the center. Other essential documents will also be considered, for example, the approvals of the
p.(None): Ethics Committee, records of receipt of trial medications, others.
p.(None): Compare the copy of the protocol provided by the CNEIS and the clinical investigator's file protocol,
p.(None): to determine if there are differences in what refers to:
p.(None): - The selection of subjects (inclusion and exclusion criteria)
p.(None): - The number of subjects
p.(None): - The frequency and nature of the observations of the subjects
p.(None): 9
p.(None): - The dosage
p.(None): - The route of administration
p.(None): - The frequency of administration
p.(None): - Masking procedures
...
p.(None): Compare the original source data of the records of
p.(None): 10 the subjects with the data collection notebooks or the final report for the sponsor, in order
p.(None): to verify that
p.(None): CSSP Audit Team
p.(None): CSSP Audit Team
p.(None): Page 50 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): Source data has been fully and accurately notified. Select a representative sample of the
p.(None): subjects recruited at intervals, at the beginning, in the middle and at the end of the study. However, if a
p.(None): significant problem in a particular area (for example, not taking the test medication as required),
p.(None): audit this particular aspect of the study in all subjects. Identify source data that supports the following
p.(None): fundamental points:
p.(None): Were there subjects and went to the visits as notified? Subjects admitted to the study or those who
p.(None): completed,
p.(None): Did they meet the inclusion or exclusion criteria of the protocol?
p.(None): Regarding the dose and frequency of administration, did the subjects receive the
p.(None): trial medication according to the protocol?
p.(None): Were the significant assessment criteria data fully and correctly obtained and notified, with
p.(None): according to the protocol?
p.(None): Were adverse events reported to the sponsor and the regulatory authority?
p.(None): Review the study records of each subject to verify the correct administration of the dose in what is
p.(None): refers to the quantity, frequency, duration and route of administration.
p.(None): 11 In addition, examine the shipping and distribution records of the drug to reconstruct the route of
p.(None): distribution of the test drug and check the dates of receipt, the quantity and the
p.(None): medication identity of
p.(None): CSSP Audit Team
p.(None): Page 51 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): test, and to compare the use of the test drug with the amounts sent and returned to the promoter at the end of
p.(None): study. If unused supplies are not returned to the sponsor, the supervisor will verify that the
p.(None): Alternative provision was handled appropriately and documented. The supervisor will verify that the medication
p.(None): of the test was kept under appropriate conditions.
p.(None): Conclude the Audit by making its final comments to the clinical investigator. The supervisor will explain and comment
p.(None): The results of the visit. The results will be described in what
p.(None): 12 regarding its nature and scope (that is, how many records were reviewed and to what extent). The
p.(None): Results must be strictly objective, based on the records and information available
p.(None): during the audit.
p.(None): Thoroughly document the Audit, both during its completion and after its conclusion. The
p.(None): only tangible results of an audit are the written report and
p.(None): 13 supervisor notes. When serious breaches are observed, the
p.(None): legal or administrative sanctions against the clinical investigator will be based on the documented results of
p.(None): the auditory.
p.(None): Prepares the narrative report of the supervision in which the results of it are detailed, explaining the reason for
p.(None): the Audit, for example, if it was systematic or if it was performed with
p.(None): 14 a special purpose. It will also describe the scope of supervision, for example, if it was limited to one
p.(None): succinct review of the records to address a specific issue or if it was an exhaustive audit of the
p.(None): study completion To the
p.(None): CSSP Audit Team
p.(None): CSSP Audit Team
p.(None): CSSP Audit Team
p.(None): Page 52 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): Describe the scope of supervision, the report will indicate which records were considered and the number of
p.(None): documents or medical records that were considered in relation to the number of study subjects. The
p.(None): The report will also include the name of the trial drug, the study sponsor, the title and number of the
p.(None): protocol, the dates of the study and the number of subjects. Mention by name the individuals who performed
p.(None): important functions in the study, as well as to those who provided information during the supervision.
p.(None): The most important part of the report is the description of the results of the supervision. The inspector
p.(None): describe in detail each of the significant results. This description will be specific and quantify the
p.(None): which was observed based on the total number of records examined. The supervision observations will be
p.(None): objective and the report will include, as evidence, copies of the records obtained to document the results
p.(None): objectionable All tests must have all numbered pages and the report will refer specifically to
p.(None): they.
p.(None): The report will include a comment of the final interview with the clinical investigator, in which the
p.(None): Results of supervision. The response of the clinical investigator to the observations will be recorded.
p.(None): Finally, said report will be sent to the National Committee for Health Research Ethics.
p.(None): Page 53 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): Receive audit report from BPC for subsequent programming in the CNEIS agenda and notifies the
p.(None): Technical
p.(None): Responsible for the Follow-up of Clinical Trials.
p.(None): fifteen
p.(None): Evaluate audit results of Good Clinical Practices, and make a decision of the full prior notification to the
p.(None): investigator.
p.(None): Notify the Principal Investigator about the results and findings of the Good Practice Audit
...
p.(None): subject of a clinical trial, who has been given a medicinal product, and who does not necessarily
p.(None): I would have a causal relationship with this treatment. An EA can therefore be any sign
p.(None): unfavorable and unintended (including an abnormal finding on a laboratory test), symptom or disease
p.(None): time period associated with the use of a medicinal product under investigation (PMI), whether it is considered related or not
p.(None): to the PMI.
p.(None): 38. Adverse Reaction (RA): Any unfavorable and unintended response to a PMI, at a certain dose of
p.(None): administration. All EAs, judged as such by the reporting investigator or the sponsor,
p.(None): they qualify as an adverse reaction, as long as they have a reasonable causal relationship to a medicinal product. The
p.(None): Reasonable causal expression means that it converges in general with evidence or argument that suggests a
p.(None): causal relationship
p.(None): 39. Unexpected Adverse Reaction: It is an RA that, by its nature or severity, is not consistent with the information
p.(None): existing about the product, for example, in the researcher's manual for a product under investigation not
p.(None): marketed or in the summary of the product characteristics (CPR) of a product
p.(None): marketed It is also considered unexpected RA when the outcome of an adverse reaction is not consistent.
p.(None): with the existing information about the product. The side effects documented in the Report Form
p.(None): from
p.(None): Page 67 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Cases (FRC) that occur in a more severe form than anticipated, are also considered unexpected.
p.(None): 40. Serious Adverse Event (EAS) or Serious Drug Adverse Reaction (Serious RAM): any unfavorable occurrence
p.(None): the course and in the context of an investigation on a diagnostic product or procedure or
p.(None): Therapeutic resulting in death, life threatening, requires hospitalization or prolongation of
p.(None): Existing hospitalization, resulting in persistent or significant disability or disability, is an anomaly
p.(None): congenital or birth defect or is medically significant according to medical criteria. The above is
p.(None): applies without the presumed existence of a causal link between the application of the product or treatment
p.(None): and the adverse event.
p.(None): 41. Adverse Drug Reaction (ADR): harmful and unintentional response to a medicinal product related to
p.(None): any dose In clinical experience before the approval of a new medicinal product or its
p.(None): new uses, particularly when the therapeutic dose cannot be established, should be considered
p.(None): adverse drug reaction to any reaction that involves a causal relationship between a medicinal product and
p.(None): an adverse event as a reasonable possibility, that is, that the relationship cannot be ruled out.
p.(None): 42. Adverse Reaction Serious Unexpected Suspected (RASIS / SUSAR): Any suspected adverse reaction related to
p.(None): a PMI, which is unexpected and serious. The medical trial should be exercised to decide if an EA / RA is serious in
p.(None): other important situations other than those stated. EA / RA that are not immediately threatening to
p.(None): life or not result in death or hospitalization, but they need interventions to prevent one or more
p.(None): outcomes of the above, must also be considered as serious.
p.(None): 43. Investigator's Brochure [IB]: A compilation of clinical and non-clinical data on
p.(None): the research product (s) that is (are) relevant for the study of the product (s) in the
p.(None): research in humans.
p.(None): 44. Case Report Form (FRC) [“Case ReportForm” (CRF)]: A printed, optical or
p.(None): electronic, designed to record all the
p.(None): Page 68 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): information required in the protocol to be reported to the sponsor about each subject of the study.
p.(None): 45. Audit / supervision: The action of the regulatory authority (s) to carry out an official review of the
p.(None): documents, facilities, records and any other resource that the authority (ies) considers to be related
p.(None): with the study in health and that can be located in the place where the study is carried out, in the facilities of the
...
p.(None): subject. The term does not include any person other than an individual (that is, does not include a person
p.(None): corporation or agency). The obligations of a sponsor-researcher include both those of a sponsor
p.(None): like those of a researcher.
p.(None): 64. Standard Operating Procedures (POE) ["Standard OperatingProcedures
p.(None): (SOPs) ”]: Detailed and written instructions to achieve uniformity in the execution of a specific function.
p.(None): 65. Research medicinal product (PMI): Pharmaceutical form of an active ingredient or placebo
p.(None): that is being tested or used as a reference in a health study, including a product with an authorization of
p.(None): marketing when used or conditioned (formulated or packaged) in a different way than
p.(None): approved or when used to obtain more information about a previously approved use.
p.(None): 66. CPB (National) Compliance Monitoring Program: A particular program established by a country
p.(None): to monitor compliance with Good Clinical Practices within its territory, through inspections.
p.(None): 67. Research protocol: Document describing the object (s), design, methodology,
p.(None): statistical considerations and organization of a study. Generally, the protocol also provides
p.(None): background and rationale for the study, but these could be provided in other documents
p.(None): Page 71 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): referenced in the protocol. In the BPC guidelines, the term protocol refers to the protocol and the
p.(None): amendments to the protocol.
p.(None): 68. Adverse Drug Reaction (RAM): These are all harmful and unintentional responses to a product
p.(None): medicinal, related to any dose. The phrase ‘answers… to a medicinal product’ means that a
p.(None): causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, that is, that
p.(None): The relationship cannot be ruled out. With regard to medicinal products on the market: a response to
p.(None): a drug that is harmful and unintentional, and that occurs with doses normally used in humans to
p.(None): prophylaxis, diagnosis or treatment of diseases, or for modification of physiological function (see the Guide to
p.(None): the International Harmonization Conference for the Management of Clinical Safety Data: Definitions and Standards of
p.(None): an Immediate Report).
p.(None): 69. Unexpected Drug Adverse Reaction: Adverse reaction whose nature or severity is not
p.(None): consistent with the applicable product information (for example, that contained in the Researcher's Brochure
p.(None): for an unapproved research product, or packaging insert / summary of product characteristics
p.(None): approved) (see the Guide to the International Harmonization Conference for Data Management of
p.(None): Clinical Safety: Definitions and Standards of an Immediate Report).
p.(None): 70. Original Medical Record: See source documents. In this document, "subject", "individual" and "person" are
p.(None): They use with the same meaning.
p.(None): 71. Legally Accepted Representative: Individual, legal representative or other body authorized under the laws
p.(None): applicable to accept, on behalf of a probable candidate, his participation in the health study.
p.(None): 72. Applicable Regulatory Requirement (s): Any law (s) and regulation (s) that govern
p.(None): Conducting health studies of research products.
p.(None): 73. Site Where the Study is Performed: The place (s) where the related activities are carried out
p.(None): With the study.
p.(None): Page 72 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): 74. Sub-researcher: Any individual member of the health study group, appointed and supervised by the
p.(None): researcher to perform critical procedures related to the study and / or make important decisions
p.(None): related to it (for example, associates, residents, research fellow).
p.(None): 75. Subject of the Study: Individual who participates in a health study, either as a recipient of the
p.(None): product (s) under investigation or as a control. In this document, "subject", "individual" and "person" are used
p.(None): With the same meaning.
p.(None): 76. Vulnerable (or Vulnerated) Subjects: Individuals whose desire to participate in a health study may be
p.(None): influenced by the expectation, justified or not, of the benefits associated with your participation, or of a
p.(None): revenge on the part of the superior members of a hierarchy in case of refusing to participate. By
p.(None): For example, the members of a group with a hierarchical structure, such as that made up of medical students,
p.(None): dentistry, chemical-drug-biological and nursing, subordinate hospital and laboratory personnel,
p.(None): employees of the pharmaceutical industry, members of the armed forces and people who are
p.(None): detained / detained Other vulnerable (or violated) subjects include patients with diseases
p.(None): incurable, people in nursing homes, unemployed or homeless, patients in emergency situations,
p.(None): ethnic minority groups, homeless people, nomads, refugees, minors and those who cannot give their
p.(None): consent.
p.(None): 77. Impartial Witness: A person independent of the study, who cannot be influenced in bad faith
p.(None): by the personnel involved in the study, who is present in the process of obtaining the
p.(None): informed consent if the subject or the representative of the legally accepted subject does not know how to read, and who reads the
p.(None): "Informed Consent Form" and any other written information provided to the subject.
p.(None): to. Research Unit / Research Center: In-hospital entity responsible for: Promoting and
p.(None): develop research in the hospital Train hospital staff who request it in methodology
...
p.(None): Clinical cannot be considered as clinical practice.
p.(None): Page 81 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 4A. ASSESSMENT GUIDE FOR A HEALTH RESEARCH PROJECT
p.(None): INSTRUCTIVE:
p.(None): This instrument must be used by each of the members of the CNEIS, during the review of the
p.(None): documentation. It is a guide to review the formal, methodological and ethical aspects of the study. I know
p.(None): recommends that each evaluator mark with an “X” or write in the blank, as appropriate.
p.(None): Once the deliberation is finished, the secretary will complete the form that includes all the opinions
p.(None): and those that were filled individually will be removed.
p.(None): DATE APPLICATION DATE FIRST
p.(None): EVALUATION
p.(None): SECOND EVALUATION DATE
p.(None): DATE RESOLUTION (APPROVAL / REJECTION)
p.(None): LIST OF ELEMENTS TO EVALUATE IN A HEALTH RESEARCH PROTOCOL
p.(None): I.- IDENTIFICATION:
p.(None): Code
p.(None): Protocol Title
p.(None): Page 82 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): II.- EVALUATION OF THE SUMMARY OF THE PROJECT
p.(None): Little bit
p.(None): Information on Not recorded
p.(None): adequate
p.(None): Adequate
p.(None): Very suitable
p.(None): 1. Promoter
p.(None): 2. Research title
p.(None): 3. Type of investigation
p.(None): 4. Place of performance
p.(None): 5. Authority responsible for the institution of realization
p.(None): 6. Other study centers
p.(None): 7. Responsible researcher
p.(None): 8. Drug or Method to investigate. Information on manufacturing, expiration, registration
p.(None): 9. Stage or phase of the study
p.(None): 10. Objective of the study: efficacy, toxicity, dose, etc.
p.(None): 11. Design: random, double blind, etc.
p.(None): 12. Disease under study
p.(None): 13. Inclusion criteria
p.(None): 14. Exclusion criteria
p.(None): 15. Number of patients
p.(None): 16. Duration of the study
p.(None): 17. Schedule of realization
p.(None): 18. Financial responsible and damage insurance
p.(None): 19. Ethical considerations
p.(None): Page 83 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): III.- METHODOLOGICAL EVALUATION OF THE RESEARCH PROTOCOL
p.(None): Information about
p.(None): 1. Promoter information
p.(None): 2. Participating researchers
p.(None): 3. Realization centers
p.(None): 4. General Aspects
p.(None): 4.1. Preclinical and clinical history that supports the rational of the study
p.(None): 4.2. Justification
p.(None): 4.3. Main goal
p.(None): 4.4. Secondary objectives
p.(None): 4.5. Phase Study: I-II-III-IV
p.(None): 4.6. Kind of investigation
p.(None): 4.7. Design (parallel, crosslinking, etc.)
p.(None): 4.8. Sample's size calculation
p.(None): 5. Population to study
p.(None): 5.1. Type (patients, healthy volunteers or others)
p.(None): 5.2. Inclusion criteria
p.(None): 5.3. Exclusion criteria
p.(None): 5.4. Groups to compare
p.(None): 5.5. Demographic aspects
p.(None): 5.6. Prognostic Criteria
p.(None): 5.7. Stage of the disease
p.(None): 5.8. Treatment response measure
p.(None): 5.9. Associated disease
p.(None): 5.10. Similarity of patients with the general population
p.(None): 6. Compared treatments
p.(None): 6.1. Drug proposed as intervention
p.(None): 6.2. Dose selection
p.(None): 6.3. Dose (fixed, flexible, route of administration)
p.(None): 6.4. Treatments, (Treatments) attached (standardized, allowed, prohibited)
p.(None): 6.5. Treatment duration
p.(None): 6.6. Information of lot number, formulation, etc.
p.(None): Not included or provided
p.(None): Inappropriate
p.(None): Suitable
p.(None): Very suitable
p.(None): Page 84 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Information about
p.(None): 6.7. Drug recognized as Standard treatment
p.(None): 6.8. Justified placebo use
p.(None): 6.9. Masking
p.(None): 7. Details of the experimental design
p.(None): 7.1. Checked
p.(None): 7.2. Controls: active-inactive
p.(None): 7.3. Concurrent-historical
p.(None): 7.4. Assignment of Treatment with random distribution
p.(None): 7.5. Cleaning-stratification period
p.(None): 7.6. Periodicity of visits, laboratory exam, evaluations
p.(None): 7.7. Start and end of treatment
p.(None): 8. Data collection and analysis
p.(None): 8.1. Measures used to evaluate the objectives
p.(None): 8.2. Record of response variables
p.(None): 8.3. Observers (constants, variables)
p.(None): 8.4. Collection method (normalized)
p.(None): 8.5. Evaluation of incomplete or lost data
p.(None): 8.6. Evaluation of the degree of compliance Treatment
p.(None): 8.7. Statistical tests to apply
p.(None): 8.8. Intention to treat analysis
p.(None): 9. Adverse effects (EA)
p.(None): 9.1. Subjective (reported spontaneously or with directed questions)
p.(None): 9.2. Identification criteria
p.(None): 9.3. Classification and evaluation of the Same
p.(None): 10. Controls to minimize bias
p.(None): 10.1. Impartial (blind) observers
p.(None): 10.2. Patients are unaware of the treatment received (blind)
p.(None): Not included or provided
p.(None): Inappropriate
p.(None): Suitable
p.(None): Very suitable
p.(None): Page 85 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Information about
p.(None): 10.3 Impartial assessor (blind)
...
p.(None): Happening
p.(None): Causal Relationship of the event
p.(None): 1 = Definitive
p.(None): Action taken
p.(None): 0 = None 1 = Dose Reduction
p.(None): receiving the patient when the EAS started
p.(None): Total daily dose
p.(None): start of the most recent cycle
p.(None): (dd mmm yy)
p.(None): at present?
p.(None): 0 = No
p.(None): 1 = Yes
p.(None): End date (dd mmm yy)
p.(None): 2 = Probable
p.(None): 3 = Possible
p.(None): 4 =
p.(None): Unlikely 5 = No
p.(None): related 6 = No
p.(None): evaluable
p.(None): 2 = Delayed treatment 3 = Delayed and reduced treatment 4 = Permanently suspended treatment
p.(None): Page 111 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Patient number in the study
p.(None): Other treatments at the time of the event (Include concomitant medication, radiotherapy, surgery, palliative care).
p.(None): Continue on a separate sheet, if necessary. Exclude therapy administered for the management of EAS.
p.(None): Action taken
p.(None): Treatment
p.(None): Give the generic name of the drugs / treatment given in the last 30 days
p.(None): Total daily dose
p.(None): Route of Administration
p.(None): 1 = Oral 2 = Intravenous 3 = Subcutaneous 4 = Other (specify)
p.(None): Start Date (dd mmm yy)
p.(None): Currently happening?
p.(None): 0 = No
p.(None): 1 = Yes
p.(None): End date (dd mmm yy)
p.(None): 0 = None 1 = Dose reduction 2 = Delayed treatment 3 = Delayed and reduced treatment 4 = Treatment
p.(None): permanently suspended
p.(None): Page 112 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Other relevant information that facilitates the evaluation
p.(None): (Include medical history, drug or alcohol abuse, family history, special research findings, etc.)
p.(None): Was this event expected from the point of view of the patient's medical history?
p.(None): 0 = No
p.(None): 1 = Yes
p.(None): Additional Information:
p.(None): Authorized Health Professional Firm
p.(None): ………………………………………………………….
p.(None): .
p.(None): Contact phone number
p.(None): …………………………………………………………
p.(None): …… ..
p.(None): Name
p.(None): ……………………………………………………
p.(None): ...
p.(None): Report date
p.(None): d d m mm a a
p.(None): OFFICIAL USE ONLY
p.(None): Was the EAS drug related?
p.(None): Yes No Event No
p.(None): Was the event unexpected? Yes No Comments:
p.(None): Was the event a RASIS / SUSAR?
p.(None): Shipping Date Form
p.(None): Date of introduction in the
p.(None): If not
p.(None): d d m mm a a
p.(None): database d d m mm a a
p.(None): Code
p.(None): Page 113 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Form reviewed by
p.(None): (Firm) ……………………………………
p.(None): ………
p.(None): Review by a clinician (Signature) ……………………………………
p.(None): ...
p.(None): Date
p.(None): d d m mm a a
p.(None): Date
p.(None): d d m mm a a
p.(None): Page 114 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 9A SECURITY REPORT. CLINICAL TRIALS OF MEDICINAL RESEARCH PRODUCTS (PMI)
p.(None): Full name of the essay Short title
p.(None): Research product (s) under investigation (PMI) Sponsor
p.(None): CEIS that approved the study Principal investigator Trial start date
p.(None): Trial end date Target number of subjects for the entire trial
p.(None): Contact details for the person making the notification
p.(None): Name Address Telephone Fax
p.(None): E-mail
p.(None): Date of this notification
p.(None): Security information in the reported period
p.(None): Number of subjects included during the period under review
p.(None): How many patients have been included since the start of the trial
p.(None): Number of EAS observed
p.(None): Page 115 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): About the study
p.(None): Period covered by the report: a
p.(None): Insert the “gram flow” of the study
p.(None): RANDOM
...
p.(None): applicable regulatory requirements The researcher or a person designated by the researcher / institution must
p.(None): explain the correct use of the product under investigation to each subject and must verify at appropriate intervals
p.(None): for the study, that each subject is following the instructions appropriately.
p.(None): ASSIGNMENT PROCESSES
p.(None): RANDOM AND OPENING OF THE BLIND
p.(None): The researcher must follow the procedures
p.(None): YES NO Comments:
p.(None): Page 146 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): randomization of the study, if any, and you should ensure that the code only
p.(None): open in accordance with the protocol. If the study is blind, the researcher must document and
p.(None): Quickly explain to the sponsor any premature breaking of the code (for example,
p.(None): accidental breakage, breakdown by a serious adverse event) of the product under investigation.
p.(None): PROGRESS REPORTS YES NO Comments:
p.(None): The researcher must submit to the CNEIS / CEIS written summaries of the study status in
p.(None): annual or more frequently if requested
p.(None): The researcher must immediately submit written reports to the sponsor, the CNEIS / CEIS and,
p.(None): when applicable, to the institution about any significant change that affects the conduct of the study and / or
p.(None): increase the risks for the subjects
p.(None): SAFETY REPORTS YES NO Comments:
p.(None): The researcher must comply with the applicable regulatory requirements
p.(None): related to the report of
p.(None): unexpected serious adverse drug reactions
p.(None): For reported deaths, the investigator must provide the sponsor and the
p.(None): CNEIS / CEIS any additional information requested (for example, autopsy reports and medical reports
p.(None): from
p.(None): egress)
p.(None): TERMINATION OR SUSPENSION OF
p.(None): STUDY
p.(None): YES NO Comments:
p.(None): Page 147 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): If the study is terminated or suspended prematurely for any reason, the
p.(None): researcher / institution should inform quickly
p.(None): to the people in the study, you must ensure appropriate treatment and follow-up for the people and,
p.(None): when stipulated by regulatory requirements, you must inform the corresponding authorities by
p.(None): written a detailed explanation of this suspension or termination
p.(None): FINAL REPORT YES NO Comments:
p.(None): At the end of the study, the researcher, when applicable, must inform the institution, the
p.(None): Research / institution must provide the sponsor with all required reports, to the CNEIS / CEIS a
p.(None): summary of the result of the study and to the regulatory authorities any report requested.
p.(None): FINANCIAL ASPECTS YES NO Comments:
p.(None): The financial aspects of the study should be documented in an agreement between the
p.(None): Sponsor and researcher / institution. This document must be included in the presentation of the protocol. East
p.(None): agreement must include evidence of acceptance / commitment of the institution / administration
p.(None): hospital for the provision of facilities and services and the payments proposed by the sponsor
p.(None): Page 148 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
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p.(None): Sponsor and central IP, simultaneously. When you need to report expeditiously, this procedure assumes
p.(None): The responsibility for the initial determination and reporting to the central IP.
p.(None): Seriousness Assessment
p.(None): - The term seriousness is based on the evolution of the patient / event or action criterion. It is different from
p.(None): "Severity", which is used to refer to the intensity of a specific event.
p.(None): Causality Assessment
p.(None): - Most adverse events and adverse reactions to drugs that occur in a study, whether serious or not,
p.(None): they are expected to be toxicities due to the drug used in the study. The causation assignment must be made
p.(None): by the researcher responsible for the care of the participants, using the definitions shown in the
p.(None): following picture:
p.(None): Relationship Description
p.(None): Not related
p.(None): Unlikely
p.(None): Possible
p.(None): There is no evidence of any causal relationship.
p.(None): There is little evidence to suggest that there is a causal relationship (eg the event did not occur within a while
p.(None): reasonable after the medication was administered in the trial). There is no other reasonable explanation for the
p.(None): event (Ex. The clinical condition of the participant, other concomitant treatment, etc.).
p.(None): There is some evidence that suggests a causal relationship (eg because the event occurred within a while
p.(None): reasonable after administered on
p.(None): Page 34 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Relationship Description
p.(None): medication under study). However, the influence of other factors may have contributed to the event (eg.
p.(None): clinical condition of the patient, other concomitant treatments, etc.).
p.(None): There is evidence that suggests a causal relationship and there seems to be no influence
p.(None): Probable
p.(None): Definitive
p.(None): Cannot be evaluated
p.(None): of other factors.
p.(None): There is clear evidence of a causal relationship and any influence of other contributing factors may be
p.(None): discarded
p.(None): There is insufficient or incomplete evidence to make a clinical trial of causal relationship.
p.(None): All serious adverse events (EAS) should be reported immediately except those EAS that the
p.(None): protocol or other document (for example, Researcher's Brochure) identify that they do not need an immediate report.
p.(None): Immediate reports should be followed by detailed written reports.
p.(None): All local investigators must report any EAS or SUSAR, as required by the Committee on
p.(None): Local, National Research Ethics and the competent authority.
p.(None): It is necessary that all EAS and SUSAR be notified in physical and digital format (Email, CD or Memory
p.(None): USB)
p.(None): The CNEIS, must send all the information of EAS and / or SUSAR to the DNM, so that it carries out the evaluation and the
p.(None): corresponding tracking. If the EAS and / or SUSAR is related to the investigational drug, the DNM has the
p.(None): authority to suspend the prescription, dispensation and supply of investigational drugs, as
p.(None): established in article 74 of the Medicines Law, in order to control the sanitary surveillance of medicines.
p.(None): The CNEIS must send to the CNFV the results of the Clinical Trials of the medications that are
p.(None): they are registered with the DNM, regarding security and
p.(None): Page 35 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
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p.(None): Products to use in research.
p.(None): 8.1.7 MANUFACTURER'S NAME Establishment authorized to perform all
p.(None): operations that involve product manufacturing
p.(None): Pharmacists
p.(None): 8.1.8 COUNTRY OF ORIGIN Country where the
p.(None): medicine. In the event that more than one laboratory is involved in manufacturing, the country of origin is that in which
p.(None): performs the manufacture of at least the bulk medicine.
p.(None): 9. SIGNATURES AND SEAL S
p.(None): 9.1 RESEARCHER'S SIGNATURE: Signature of the principal investigator, responsible
p.(None): of clinical research.
p.(None): 9.2 SEAL OF THE MAIN RESEARCHER: Seal of the principal investigator, responsible for the
p.(None): clinical research.
p.(None): Name, signature and seal of the sponsor. When not applicable, the name, signature and seal of the representative must go
p.(None): 9.3 SIGNATURE OF THE SPONSOR OR ITS REPRESENTATIVE:
p.(None): from the sponsor, Contract Research Center or to whom the sponsor has delegated this function.
p.(None): Page 78 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 3 IDENTIFYING A CLINICAL TRIAL
p.(None): What is a clinical trial of a medicinal product?
p.(None): This algorithm and the footnotes to the table will help you answer this question. Please start in the column
p.(None): A and follow the instructions. There is additional information in the notes.
p.(None): A B C D
p.(None): AND
p.(None): Clinical trial of a medicinal product
p.(None): A non-interventional clinical trial?
p.(None): Is it a medicinal product (PM)? If you answer no to all the questions in column A, the activity is not
p.(None): a clinical trial of a PM. If you answer yes to any of the questions, go to column B.
p.(None): A.1 Is it a
p.(None): substance * or
p.(None): combination of substances presented as having
p.(None): properties of
p.(None): treatment or
p.(None): disease prevention in humans?
p.(None): A.2 Does the function of
p.(None): Is it not a medicinal product?
p.(None): If you answer yes to the questions in column B, the activity is not a clinical trial of a PM.
p.(None): If you answer no to this question, go to column C.
p.(None): B.1 Are you only administering any of the following substances?
p.(None): • Complete human blood **
p.(None): • Human blood cells
p.(None): • Human plasma
p.(None): • Fabrics, except one
p.(None): What effects of the medication are you looking for?
p.(None): If you answer not all the questions in column C, the activity is not a clinical trial. If yes
p.(None): to any of the questions, go to column D.
p.(None): C.1 To discover or verify / compare its clinical effects?
p.(None): C.2 To discover or verify / compare its pharmacological effects? (Ex. Pharmacodynamics)
p.(None): C.3 To identify or verify / compare your
p.(None): Why do you look for these effects?
p.(None): If you answer no to all
p.(None): questions in column D, the activity is not a clinical trial. If yes to
p.(None): Any of the questions below, go to column E.
p.(None): D.1 To determine or verify / compare the effectiveness of the medicine? vii
p.(None): Why do you look for these effects?
p.(None): If you answer yes to all questions, the activity is a non-interventionist essay.
p.(None): If the answers from columns A, B, C and D brought it to column E, and
p.(None): Answer no to any of these questions, the activity is a clinical trial.
p.(None): E.1 Is this a study of one or more medicinal products, which have market authorization in the
p.(None): region?
p.(None): E.2 Are the products prescribed in the usual way they are registered?
p.(None): E.3 Is the assignment of any patient involved in the
p.(None): Page 79 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): A B C D
p.(None): AND
p.(None): Is the substance like medicine?
p.(None): Ex. Can it be administered to human beings, either with a view to restoring, correcting or
p.(None): modify physiological functions, exerting a pharmacological, immunological or metabolic action;
p.(None): or to make a
p.(None): Medical diagnostic; or is it
p.(None): administered in another way, for a medical purpose?
p.(None): A.3 Is it an active substance in a form
p.(None): pharmaceutical?
p.(None): medicinal product with somatic cells ***
p.(None): • A food product (including dietary supplements) not presented as a medication
p.(None): • A cosmetic product
p.(None): +
p.(None): • A medical device
p.(None): adverse reactions?
p.(None): C.4 Study or verify / compare its absorption, distribution, metabolism or
p.(None): excretion?
p.(None): D.2 To determine, verify or
p.(None): compare the
p.(None): medication safety?
p.(None): study of a particular therapeutic strategy, falls within the current practice and does not
p.(None): decide in a protocol, in an advanced clinical trial? viii
p.(None): E.4 Is the decision to prescribe a particular medicinal product,
p.(None): clearly separated from the decision to include the patient in the study?
p.(None): E.5 Do not apply to patients included in the study other than
p.(None): those that apply in current practice?
p.(None): E.6 Will epidemiological methods be used to analyze data coming out of this study?
p.(None): * Substance is any material, regardless of its origin (human, animal, plant or chemical), which is administered to a
p.(None): human being.
p.(None): ** This does not include derivatives of human blood, human cells and human plasma that involves a process of
p.(None): manufacture.
p.(None): *** Somatic cell therapy medicinal products use live somatic cells of human (or animal) origin,
p.(None): whose biological characteristics have been manipulated to obtain a
p.(None): Page 80 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): therapeutic, diagnostic or preventive effect (in humans), through metabolic, pharmacological and
p.(None): immunological
p.(None): Any product ingested that is not a medicine is seen as food. A food cannot be classified as
p.(None): a medicine, unless it contains one or more ingredients generally seen as for a medical purpose or
p.(None): medicinal.
p.(None): + A "cosmetic product" means any substance or preparation with the intention of putting it in contact
p.(None): with various external parts of the human body (epidermis, hair system, nails, lips, and external genital organs),
p.(None): or in teeth and mucous membranes of the oral cavity, with exclusive or main views of cleaning, perfume
p.(None): or protect them in good condition, changes in appearance or correct body odors.
p.(None): Vii Efficacy is the concept of scientifically proving whether - and to what extent - a medicine is capable of
p.(None): diagnose, prevent or treat a disease.
p.(None): Viii The assignment of patients to a treatment group randomly and planned by a trial protocol
p.(None): Clinical cannot be considered as clinical practice.
p.(None): Page 81 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 4A. ASSESSMENT GUIDE FOR A HEALTH RESEARCH PROJECT
p.(None): INSTRUCTIVE:
p.(None): This instrument must be used by each of the members of the CNEIS, during the review of the
p.(None): documentation. It is a guide to review the formal, methodological and ethical aspects of the study. I know
p.(None): recommends that each evaluator mark with an “X” or write in the blank, as appropriate.
p.(None): Once the deliberation is finished, the secretary will complete the form that includes all the opinions
p.(None): and those that were filled individually will be removed.
p.(None): DATE APPLICATION DATE FIRST
p.(None): EVALUATION
p.(None): SECOND EVALUATION DATE
p.(None): DATE RESOLUTION (APPROVAL / REJECTION)
p.(None): LIST OF ELEMENTS TO EVALUATE IN A HEALTH RESEARCH PROTOCOL
p.(None): I.- IDENTIFICATION:
p.(None): Code
p.(None): Protocol Title
p.(None): Page 82 of 164
p.(None): Republic of El Salvador
...
Health / Healthy People
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p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): logistics, register, monitor and monitor the development of studies carried out in the institution.
p.(None): 78. Compliance Monitoring of the BPC: Periodic Audit of any of the parties involved in the
p.(None): conducting a health study (for example, the CNEIS of researchers, sponsors, etc.), for the purpose
p.(None): to verify compliance with the PCBs and the corresponding regulations.
p.(None): Page 74 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): 11. ANNEXES
p.(None): ANNEX 1. GUIDE TO DEVELOP THE LETTER OF INTENTIONS OF A RESEARCHER / RESEARCH TEAM
p.(None): ON THE LETTER OF INTENTION:
p.(None): You must enter:
p.(None): 1. APPLICANT RESEARCHER: Name, position, institution. The sponsoring company defines who the
p.(None): Principal investigator in the cases there are several research centers and researchers.
p.(None): 2. SPONSOR: Indicate the entity that finances and promotes the study.
p.(None): 3. TITLE OF THE PROTOCOL: If the title is very extensive, try to summarize it in a few words.
p.(None): 4. PURPOSE: Indicate the main objective of the study (only one).
p.(None): 5. MAIN EVALUATION PARAMETER (End Point): Indicate the chosen variable as the best expression
p.(None): of objective evaluation.
p.(None): 6. DESIGN: Indicate the methodology to be used: comparative study or not, randomized or not, blind
p.(None): or open, parallel / cross groups, case / control, cohorts, transversal, etc.
p.(None): 7. POPULATION AND NUMBER OF PARTICIPANTS: Indicate the origin of the sample (patients of an institution,
p.(None): healthy volunteers from a community, etc.) and the number of volunteers planned. In the case of animals
p.(None): laboratory, indicate species and number.
p.(None): 8. DURATION OF THE STUDY: Time during which the participant will remain in the study.
p.(None): 9. CENTERS, RESEARCHERS AND COLLABORATORS: Institutions where participants will be recruited, where
p.(None): Samples will be analyzed, when applicable. Name and affiliation of co-researchers and collaborators
p.(None): main.
p.(None): 10. Make clear the place, means and procedure to contact the responsible person (telephone numbers,
p.(None): email and postal address).
p.(None): Page 75 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 2 APPLICATION FOR EVALUATION OF CLINICAL RESEARCH PROTOCOLS IN HUMAN BEINGS
p.(None): NATIONAL COMMITTEE OF ETHICS OF HEALTH RESEARCH
p.(None): APPLICATION FOR EVALUATION OF CLINICAL RESEARCH PROTOCOLS IN HUMAN BEINGS
p.(None): FILL THE RMULAR PHONE TO MACHINE OR ELECTRONIC PHASE WITHOUT BUT NOR OR COOLING NES. DO NOT LEAVE SPACE IN
p.(None): WHITE
p.(None): 1. DATA OF THE PRO TO CO LO
p.(None): 1.1 PRO NO CO LO:
p.(None): 1.2 VERSION: 1.3 DATE:
p.(None): 1.4 TITLE OF THE PRO TO CO LO:
p.(None): 1.5 CENTER NUMBER S:
p.(None): 2.1 VERSION:
p.(None): 2. CO-INFENTIFIED INFORMATION
p.(None): 2.2 DATE (DAY / MONTH / YEAR):
p.(None): 3. O TRO S DO CUMENTO S
p.(None): 3.1 VERSION
p.(None): 3.2 DATE (DAY / MONTH / YEAR)
p.(None): 3.3 DO NOT MBRE:
p.(None): 4. INVESTIGATED MAIN R
p.(None): 4.1 NO MBRES AND LAST NAME:
p.(None): 4.4 NIT NUMBER:
p.(None): 4.2 EXACT ADDRESS OF THE RESEARCH SITE:
p.(None): 4.3 DUI NUMBER:
p.(None): 5. SUB-INVESTED RES
...
p.(None): adequate
p.(None): Adequate
p.(None): Very suitable
p.(None): 1. Promoter
p.(None): 2. Research title
p.(None): 3. Type of investigation
p.(None): 4. Place of performance
p.(None): 5. Authority responsible for the institution of realization
p.(None): 6. Other study centers
p.(None): 7. Responsible researcher
p.(None): 8. Drug or Method to investigate. Information on manufacturing, expiration, registration
p.(None): 9. Stage or phase of the study
p.(None): 10. Objective of the study: efficacy, toxicity, dose, etc.
p.(None): 11. Design: random, double blind, etc.
p.(None): 12. Disease under study
p.(None): 13. Inclusion criteria
p.(None): 14. Exclusion criteria
p.(None): 15. Number of patients
p.(None): 16. Duration of the study
p.(None): 17. Schedule of realization
p.(None): 18. Financial responsible and damage insurance
p.(None): 19. Ethical considerations
p.(None): Page 83 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): III.- METHODOLOGICAL EVALUATION OF THE RESEARCH PROTOCOL
p.(None): Information about
p.(None): 1. Promoter information
p.(None): 2. Participating researchers
p.(None): 3. Realization centers
p.(None): 4. General Aspects
p.(None): 4.1. Preclinical and clinical history that supports the rational of the study
p.(None): 4.2. Justification
p.(None): 4.3. Main goal
p.(None): 4.4. Secondary objectives
p.(None): 4.5. Phase Study: I-II-III-IV
p.(None): 4.6. Kind of investigation
p.(None): 4.7. Design (parallel, crosslinking, etc.)
p.(None): 4.8. Sample's size calculation
p.(None): 5. Population to study
p.(None): 5.1. Type (patients, healthy volunteers or others)
p.(None): 5.2. Inclusion criteria
p.(None): 5.3. Exclusion criteria
p.(None): 5.4. Groups to compare
p.(None): 5.5. Demographic aspects
p.(None): 5.6. Prognostic Criteria
p.(None): 5.7. Stage of the disease
p.(None): 5.8. Treatment response measure
p.(None): 5.9. Associated disease
p.(None): 5.10. Similarity of patients with the general population
p.(None): 6. Compared treatments
p.(None): 6.1. Drug proposed as intervention
p.(None): 6.2. Dose selection
p.(None): 6.3. Dose (fixed, flexible, route of administration)
p.(None): 6.4. Treatments, (Treatments) attached (standardized, allowed, prohibited)
p.(None): 6.5. Treatment duration
p.(None): 6.6. Information of lot number, formulation, etc.
p.(None): Not included or provided
p.(None): Inappropriate
p.(None): Suitable
p.(None): Very suitable
p.(None): Page 84 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Information about
p.(None): 6.7. Drug recognized as Standard treatment
p.(None): 6.8. Justified placebo use
p.(None): 6.9. Masking
p.(None): 7. Details of the experimental design
p.(None): 7.1. Checked
p.(None): 7.2. Controls: active-inactive
p.(None): 7.3. Concurrent-historical
p.(None): 7.4. Assignment of Treatment with random distribution
p.(None): 7.5. Cleaning-stratification period
p.(None): 7.6. Periodicity of visits, laboratory exam, evaluations
p.(None): 7.7. Start and end of treatment
p.(None): 8. Data collection and analysis
p.(None): 8.1. Measures used to evaluate the objectives
p.(None): 8.2. Record of response variables
p.(None): 8.3. Observers (constants, variables)
p.(None): 8.4. Collection method (normalized)
...
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p.(None): 78. Compliance Monitoring of the BPC: Periodic Audit of any of the parties involved in the
p.(None): conducting a health study (for example, the CNEIS of researchers, sponsors, etc.), for the purpose
p.(None): to verify compliance with the PCBs and the corresponding regulations.
p.(None): Page 74 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): 11. ANNEXES
p.(None): ANNEX 1. GUIDE TO DEVELOP THE LETTER OF INTENTIONS OF A RESEARCHER / RESEARCH TEAM
p.(None): ON THE LETTER OF INTENTION:
p.(None): You must enter:
p.(None): 1. APPLICANT RESEARCHER: Name, position, institution. The sponsoring company defines who the
p.(None): Principal investigator in the cases there are several research centers and researchers.
p.(None): 2. SPONSOR: Indicate the entity that finances and promotes the study.
p.(None): 3. TITLE OF THE PROTOCOL: If the title is very extensive, try to summarize it in a few words.
p.(None): 4. PURPOSE: Indicate the main objective of the study (only one).
p.(None): 5. MAIN EVALUATION PARAMETER (End Point): Indicate the chosen variable as the best expression
p.(None): of objective evaluation.
p.(None): 6. DESIGN: Indicate the methodology to be used: comparative study or not, randomized or not, blind
p.(None): or open, parallel / cross groups, case / control, cohorts, transversal, etc.
p.(None): 7. POPULATION AND NUMBER OF PARTICIPANTS: Indicate the origin of the sample (patients of an institution,
p.(None): healthy volunteers from a community, etc.) and the number of volunteers planned. In the case of animals
p.(None): laboratory, indicate species and number.
p.(None): 8. DURATION OF THE STUDY: Time during which the participant will remain in the study.
p.(None): 9. CENTERS, RESEARCHERS AND COLLABORATORS: Institutions where participants will be recruited, where
p.(None): Samples will be analyzed, when applicable. Name and affiliation of co-researchers and collaborators
p.(None): main.
p.(None): 10. Make clear the place, means and procedure to contact the responsible person (telephone numbers,
p.(None): email and postal address).
p.(None): Page 75 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 2 APPLICATION FOR EVALUATION OF CLINICAL RESEARCH PROTOCOLS IN HUMAN BEINGS
p.(None): NATIONAL COMMITTEE OF ETHICS OF HEALTH RESEARCH
p.(None): APPLICATION FOR EVALUATION OF CLINICAL RESEARCH PROTOCOLS IN HUMAN BEINGS
p.(None): FILL THE RMULAR PHONE TO MACHINE OR ELECTRONIC PHASE WITHOUT BUT NOR OR COOLING NES. DO NOT LEAVE SPACE IN
p.(None): WHITE
p.(None): 1. DATA OF THE PRO TO CO LO
p.(None): 1.1 PRO NO CO LO:
p.(None): 1.2 VERSION: 1.3 DATE:
p.(None): 1.4 TITLE OF THE PRO TO CO LO:
p.(None): 1.5 CENTER NUMBER S:
p.(None): 2.1 VERSION:
p.(None): 2. CO-INFENTIFIED INFORMATION
p.(None): 2.2 DATE (DAY / MONTH / YEAR):
p.(None): 3. O TRO S DO CUMENTO S
p.(None): 3.1 VERSION
p.(None): 3.2 DATE (DAY / MONTH / YEAR)
p.(None): 3.3 DO NOT MBRE:
p.(None): 4. INVESTIGATED MAIN R
p.(None): 4.1 NO MBRES AND LAST NAME:
p.(None): 4.4 NIT NUMBER:
p.(None): 4.2 EXACT ADDRESS OF THE RESEARCH SITE:
p.(None): 4.3 DUI NUMBER:
p.(None): 5. SUB-INVESTED RES
p.(None): 4.5 No. OF J.V.P.M .:
p.(None): 4.6 CO RREO:
p.(None): 4.7 NUMBER OF CO NTACT PHONE:
p.(None): 5.1 NO MBRES AND LAST NAME:
p.(None): 5.4 NIT NUMBER:
...
Health / Mentally Disabled
Searching for indicator disability:
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p.(None): Public Health, may officially recognize relevant decisions, reports or information from trials
p.(None): Clinics of drug regulatory agencies that have been certified level IV by the Organization
p.(None): Pan American Health (PAHO), as well as by health authorities of the United States of America, Canada,
p.(None): Australia, Switzerland, Japan and by the European Medicines Agency (EMA) and other countries that have
p.(None): specific regulation for the regulation of Clinical Trials.
p.(None): In the case of drug research protocols that require evaluation in beings
p.(None): human, its review will be applicable regardless of the primary origin of the application, be it from the sector
p.(None): National, foreign, public or private.
p.(None): In compliance with the Constitution of the Republic of El Salvador, Article 68.- A Higher Council of Public Health
p.(None): will ensure the health of the people. It will consist of the same number of representatives of the Medical, Dental,
p.(None): Chemist - Pharmacist, Veterinarian, Clinical Laboratory, Psychology, Nursing and others at the level of
p.(None): Degree that the Higher Council of Public Health has qualified to have its respective board; will have a
p.(None): president and a secretary of appointment of the executive body. The law will determine your organization.
p.(None): The exercise of professions that are immediately related to the health of the people will be monitored
p.(None): by legal bodies formed by academics belonging to each profession. These organisms will have
p.(None): power to suspend the professional members of the guild under their control, when exercising their
p.(None): profession with manifest immorality or disability. The suspension of professionals may be resolved by the agencies
p.(None): competent in accordance with due process.
p.(None): Page 10 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): The Higher Council of Public Health will know and resolve the appeals that are brought against the
p.(None): resolutions pronounced by the organizations referred to in the previous paragraph.
p.(None): And in compliance with Art. 14. Literal d) Of the Health Code which details that:
p.(None): The powers of the Board are:
p.(None): d) Authorize prior favorable report of the respective Supervisory Board, the opening and
p.(None): operation of clinical biological laboratories, radiological cabinets, hospitals, clinics
p.(None): social assistance, optical cabinets, denture laboratories.
p.(None): In reference to the above it is necessary that:
p.(None): << The Health establishment where the Clinical Study will be carried out, is authorized by the Council
p.(None): Senior Public Health >>
p.(None): PAYMENT OF TARIFFS (requirement N ° 6, Annex 3):
p.(None): It represents the right that every research project receives the evaluation of ethical considerations according to
p.(None): international and harmonized guidelines for the country, Audit of Good Clinical Practices, review of
p.(None): Addenda, adverse effects, modifications and other processes related to the execution of the investigation.
p.(None): Payment of fees for the ethical evaluation of first-time investigations with molecules, procedures
p.(None): invasive clinics, blood sample management or biological tissue collection for genetic analysis, is the
p.(None): next:
p.(None): TYPE OF ORGANIZATION TARIFFS
p.(None): International pharmaceutical companies. $ 2,400.00
p.(None): National pharmaceutical companies US $ 1,600.00 Non-organizations
...
p.(None): - Serious Adverse Reaction Suspected (RASS)
p.(None): - Adverse Reaction Serious Unexpected Suspected (RASIS / SUSAR)
p.(None): RESPONSIBILITIES
p.(None): There is a certain degree of responsibility when managing adverse events. When there is no sponsor
p.(None): externally, the research authority of the institution in charge of the project will fulfill the role of the sponsor. The
p.(None): Principal investigator (IP) or chief investigator (IJ) has full responsibility for conducting the study. In
p.(None): A Multicentre study, the IP has coordinated responsibilities to report adverse events to the CNEIS and the
p.(None): DNM In the case of studies of products already registered in the DNM that evaluate a new, new indication
p.(None): concentration if it is higher than the one already registered, new dosage or new dosage form for the purpose of
p.(None): registry; All studies of pharmacokinetics, bioavailability and bioequivalence will also be reported to
p.(None): CNFV Any IP / IJ that you have accepted to upload
p.(None): Page 32 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): with the areas of Pharmacovigilance, delegated by the sponsor, you must take both responsibilities, those of the IP and
p.(None): those of the sponsor.
p.(None): Serious Adverse Event (EAS) or Serious Drug Adverse Reaction (Serious RAM)
p.(None): Any unfavorable occurrence that at any dose:
p.(None): (a) results in death,
p.(None): (b) life threatening, requires patient hospitalization or prolongation of existing hospitalization,
p.(None): (c) results in persistent or significant disability / disability, or is a congenital anomaly / defect
p.(None): of birth
p.(None): Which EAS to report?
p.(None): - The management and reporting of arrangements for EAS must be implemented in all trials. In the agreements
p.(None): at the beginning of the trial, it should be established that EAS are defined as related to the disease and that, therefore,
p.(None): They are not subject to an expedited report. EAS management and reporting procedures must be clearly
p.(None): defined in the protocol.
p.(None): It is recommended that an Independent Data Monitoring Committee (CIMD) be installed so that on a regular basis
p.(None): data security reviews are made throughout the trial and when necessary, and recommend
p.(None): Sponsor continue, modify or end the trial. Again, this procedure must be defined in the
p.(None): protocol.
p.(None): The confidentiality and adherence of the data must be maintained both in your record and in your report.
p.(None): During rehearsal
p.(None): - For each EA an evaluation of the seriousness, the causality and the expectation must be made. The
p.(None): Responsibility for this evaluation is of the IP; and when there is
p.(None): Page 33 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): several, as in multicentric studies, the responsibility will fall on all IPs. It is appropriate that each IP
p.(None): in each site evaluate each event, before reporting it to the central IP. It must be specified in the protocol of
p.(None): clinical trial and use local POEs, and will take responsibility for determining and reporting each of the events at
p.(None): Sponsor and central IP, simultaneously. When you need to report expeditiously, this procedure assumes
p.(None): The responsibility for the initial determination and reporting to the central IP.
p.(None): Seriousness Assessment
...
p.(None): to the PMI.
p.(None): 38. Adverse Reaction (RA): Any unfavorable and unintended response to a PMI, at a certain dose of
p.(None): administration. All EAs, judged as such by the reporting investigator or the sponsor,
p.(None): they qualify as an adverse reaction, as long as they have a reasonable causal relationship to a medicinal product. The
p.(None): Reasonable causal expression means that it converges in general with evidence or argument that suggests a
p.(None): causal relationship
p.(None): 39. Unexpected Adverse Reaction: It is an RA that, by its nature or severity, is not consistent with the information
p.(None): existing about the product, for example, in the researcher's manual for a product under investigation not
p.(None): marketed or in the summary of the product characteristics (CPR) of a product
p.(None): marketed It is also considered unexpected RA when the outcome of an adverse reaction is not consistent.
p.(None): with the existing information about the product. The side effects documented in the Report Form
p.(None): from
p.(None): Page 67 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Cases (FRC) that occur in a more severe form than anticipated, are also considered unexpected.
p.(None): 40. Serious Adverse Event (EAS) or Serious Drug Adverse Reaction (Serious RAM): any unfavorable occurrence
p.(None): the course and in the context of an investigation on a diagnostic product or procedure or
p.(None): Therapeutic resulting in death, life threatening, requires hospitalization or prolongation of
p.(None): Existing hospitalization, resulting in persistent or significant disability or disability, is an anomaly
p.(None): congenital or birth defect or is medically significant according to medical criteria. The above is
p.(None): applies without the presumed existence of a causal link between the application of the product or treatment
p.(None): and the adverse event.
p.(None): 41. Adverse Drug Reaction (ADR): harmful and unintentional response to a medicinal product related to
p.(None): any dose In clinical experience before the approval of a new medicinal product or its
p.(None): new uses, particularly when the therapeutic dose cannot be established, should be considered
p.(None): adverse drug reaction to any reaction that involves a causal relationship between a medicinal product and
p.(None): an adverse event as a reasonable possibility, that is, that the relationship cannot be ruled out.
p.(None): 42. Adverse Reaction Serious Unexpected Suspected (RASIS / SUSAR): Any suspected adverse reaction related to
p.(None): a PMI, which is unexpected and serious. The medical trial should be exercised to decide if an EA / RA is serious in
p.(None): other important situations other than those stated. EA / RA that are not immediately threatening to
p.(None): life or not result in death or hospitalization, but they need interventions to prevent one or more
p.(None): outcomes of the above, must also be considered as serious.
p.(None): 43. Investigator's Brochure [IB]: A compilation of clinical and non-clinical data on
p.(None): the research product (s) that is (are) relevant for the study of the product (s) in the
p.(None): research in humans.
p.(None): 44. Case Report Form (FRC) [“Case ReportForm” (CRF)]: A printed, optical or
p.(None): electronic, designed to record all the
p.(None): Page 68 of 164
p.(None): Republic of El Salvador
...
p.(None): DC
p.(None): • Mr., Dr. ………… .............., Principal Investigator.
p.(None): • C.E.I.S. Secretariat
p.(None): Page 108 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 8 SERIOUS ADVERSE EVENTS REPORT FORM
p.(None): Please send via FAX, within the first 24 hours after the event notification.
p.(None): Patient Initials …………………………………………
p.(None): ... ... ................
p.(None): Hospital Registry of
p.(None): patient .............. ……………… ..… ...............
p.(None): Treating doctor. …………………………………………
p.(None): …………….… .........
p.(None): Patient ID:
p.(None): Date of birth:
p.(None): d d m mm aaa Hospital …………………………………………………
p.(None): ………… ..… .............
p.(None): Report Type Test Arm Sex Height
p.(None): Weight
p.(None): 1 = Initial 2 = Interim 3 = Final
p.(None): 1 = 1 =
p.(None): 2 = Male
p.(None): .
p.(None): 2 =
p.(None): Female cm kg
p.(None): Date of last treatment administered prior to EAS
p.(None): d d m mm a a
p.(None): Was the treatment under study at the full dose, according to the protocol, before the event?
p.(None): 0 = No, specify …………………………………… ...
p.(None): 1 = Yes
p.(None): Why is the event considered serious? (Choose the most serious)
p.(None): Where did the EAS occur?
p.(None): Page 109 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Why is the event considered serious? (Choose the most serious)
p.(None): Where did the EAS occur?
p.(None): 1 = It resulted in death 2 = Threatened life
p.(None): 3 = Required hospitalization or prolongation of existing hospitalization
p.(None): 4 = It resulted in permanent disability / significant disability 5 = It resulted in congenital anomaly / birth defect
p.(None): 6 = Another important medical event
p.(None): 1 = Hospital
p.(None): 2 = Outpatient clinic
p.(None): 3 = House
p.(None): 4 = Hospice
p.(None): 5 = Other,
p.(None): specify …………………………………………… ..
p.(None): Briefly, describe the EAS (Include relevant symptoms, body part, relevant laboratory tests and
p.(None): treatment received). Continue on a separate sheet, if necessary.
p.(None): Page 110 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): EAS Details
p.(None): EAS Status
p.(None): Serious Adverse Event Name:
p.(None): Name
p.(None): EAS duration (dd mmm yy)
p.(None): Date of appearance
p.(None): 1 = Solved
p.(None): 2 = Solved with sequels
p.(None): 3 = Persists
p.(None): 4 = It got worse
p.(None): 5 = Fatal
p.(None): 6 = Not evaluable
p.(None): Expected
p.(None): 1 = Expected *
p.(None): 2 = Not expected
p.(None): Date of resolution
p.(None): Grade
p.(None): Or check here if it persists
p.(None): * Was the event one of those listed in the protocol, as an undesirable effect recognized for medication in the
p.(None): test? See protocol page.
p.(None): Trial treatment
p.(None): Trial drugs
p.(None): which was
p.(None): Date
p.(None): Happening
p.(None): Causal Relationship of the event
p.(None): 1 = Definitive
p.(None): Action taken
p.(None): 0 = None 1 = Dose Reduction
p.(None): receiving the patient when the EAS started
p.(None): Total daily dose
p.(None): start of the most recent cycle
p.(None): (dd mmm yy)
p.(None): at present?
p.(None): 0 = No
p.(None): 1 = Yes
p.(None): End date (dd mmm yy)
p.(None): 2 = Probable
p.(None): 3 = Possible
p.(None): 4 =
p.(None): Unlikely 5 = No
p.(None): related 6 = No
p.(None): evaluable
...
Health / Motherhood/Family
Searching for indicator family:
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p.(None): CNEIS will indicate audit of studies already initiated. The payment of tariffs for the execution of Good Audits
p.(None): Clinical Practices according to the previous condition is as follows:
p.(None): CPB compliance review in studies already initiated
p.(None): Duty
p.(None): International pharmaceutical companies US $ 900.00
p.(None): National pharmaceutical companies US $ 600.00 Non-organizations
p.(None): non-governmental
p.(None): profit and foreign companies or universities
p.(None): $ 600.00
p.(None): Page 13 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): DESCRIPTION OF THE PROCEDURE 1
p.(None): Every person / institution / body that will submit a research project must submit it to
p.(None): ethical evaluation considering next steps:
p.(None): No. ACTIVITIES
p.(None): Download the documents for the identification of the fulfillment of prerequisites to the submission of projects of
p.(None): research at the following address: http://www.cneis.org.sv/ section Download documents:
p.(None): http://www.cneis.org.sv/descarga-de-documentos/
p.(None): in which you will find the following information:
p.(None): 1 1. Guide to Good Clinical Practices.
p.(None): 2. Good Clinical Practices Verification Guide.
p.(None): 3. User Guide for the Presentation of Clinical Research Protocols of the Directorate
p.(None): National Medicines.
p.(None): 4. Application Form for evaluation of clinical research protocols in humans.
p.(None): Request Authorization Letter from the authority of the center or centers
p.(None): health (includes hospitals, Minister of Health, Regional Directors of Health in the case of Units
p.(None): Community Family Health
p.(None): two
p.(None): located, private clinics) for conducting the study within
p.(None): the installations. It includes knowledge of the head of the hospital service, if applicable.
p.(None): PERSON IN CHARGE
p.(None): Sponsor / Researchers
p.(None): Principal investigator / team of researchers
p.(None): 3 Prepare Letter of intent of the researcher on the study. Investigator
p.(None): principal
p.(None): Page 14 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): No. ACTIVITIES
p.(None): Print protocol in its original version, with an edition date when the original is written in another language;
p.(None): Protocol translated into Spanish,
p.(None): with edition date and 4 printed copies and an electronic copy.
p.(None): 4
p.(None): Any protocol, independent of its type, must include the section “Ethical considerations”.
p.(None): Consult by telephone or in person with the Assistant of the National Ethics Committee of the
p.(None): Health Research, telephone 2561-2520, CSSP Facilities, building N ° 2, second level, on
p.(None): 5 the fulfillment of requirements for filling out the request for evaluation of medicines to be used
p.(None): in research protocols,
p.(None): as well as the requirements and identification of the payment of tariff or exemption thereof.
p.(None): PERSON IN CHARGE
p.(None): Principal investigator
p.(None): Principal investigator
p.(None): Page 15 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): PROCESS DIAGRAM - PROCEDURE 1
p.(None): PROCEDURE 1
p.(None): REVIEW OF REQUIREMENTS FOR SUBMISSION OF RESEARCH PROJECTS OR PROTOCOLS
...
p.(None): - “Evaluation guide for a health research project” (ANNEX 4A, 4B and 4C)
p.(None): - Requirements for elaboration of an informed consent, model of the basic structure of the IC and list
p.(None): of verification of requirements of the information document (ANNEX 5A, 5B and 5C)
p.(None): DESCRIPTION OF THE PROCEDURE 4
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): Members of the
p.(None): 1 Read the protocol and its annexes
p.(None): CNEIS
p.(None): Record the observations in writing on the form
p.(None): two
p.(None): corresponding evaluation.
p.(None): CNEIS members
p.(None): Page 22 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): Send the completed evaluation form to the secretary of the committee in the stipulated time.
p.(None): In the case of full evaluations, in the span of
p.(None): four to ten weeks, each member of the committee and the
p.(None): 3 DNM must send the relevant results and comments electronically to the committee secretary.
p.(None): In the case of expedited evaluations, within seven days, send the committee secretary the
p.(None): relevant results and comments electronically.
p.(None): Define the session in which each protocol will be discussed,
p.(None): 4 according to the reception of comments and the evaluation period.
p.(None): In the case of clinical trials that, due to their complexity or specialty, are required to consult a
p.(None): Advisory Committee of Independent Experts, the President of the CNEIS in agreement with the other members thereof,
p.(None): will invite members of groups directly involved in the type of project through official mechanisms
p.(None): proposed (group of patients, family support,
p.(None): 5
p.(None): representatives of community organizations,
p.(None): specialists, statistician, specialist in research methodology, others according to their expertise).
p.(None): This consultation will be an input for the final resolution. This procedure must be performed within the
p.(None): defined period for evaluation.
p.(None): CNEIS members
p.(None): President of CNEIS
p.(None): CNEIS
p.(None): Expert Advisory Committee
p.(None): Page 23 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): Develop the session for the protocol discussion of
p.(None): 5 according to the final resolution guide and establish the corresponding final opinion.
p.(None): The plenary by consensus decides the resolution as follows:
p.(None): Approved without restrictions (ASR)
p.(None): 6
p.(None): Evaluated with observations and request for amendments (FI =
p.(None): Information is missing)
p.(None): Not approved (PRT = Protocol rejected for technical and ethical reasons)
p.(None): CNEIS Reviewers
p.(None): CNEIS Secretary
p.(None): NOTE:
p.(None): The Researcher must inform the National Committee of Health Research Ethics when the Study will begin
p.(None): Clinician authorized by the CNEIS, also must inform when the Clinical Study has finished as
p.(None): established in procedure 14 of this manual.
p.(None): Page 24 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): PROCEDURE 5. ELABORATION OF THE RESOLUTION ACT OF A RESEARCH PROJECT
...
p.(None): 2. Name and surname of the participant, legal representative or witness
p.(None): 3. Research title
p.(None): 4. Statement of reading the information sheet and understanding of it
p.(None): 5. Statement of having been able to ask any question freely
p.(None): 6. Statement of having received sufficient information
p.(None): 7. Statement of having been informed by an investigator whose first and last name is recorded
p.(None): 8. Statement that your participation is voluntary and competent
p.(None): 9. Statement of understanding that you can withdraw without prejudice
p.(None): 10. Expression of free conformity
p.(None): 11. In the case of people over 12 years of age and under 18, there is an Informed Assent Form (AI).
p.(None): 12. Date of edition of the Informed Consent (CI) version
p.(None): Not included or provided
p.(None): Poorly suited
p.(None): Adequate
p.(None): Very suitable
p.(None): Page 88 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): INVESTIGATIONS WITH PEOPLE WHO SUFFER MENTAL AFFECTIONS OR BEHAVIOR DISORDERS
p.(None): Observations:
p.(None): Criteria YES NO
p.(None): The objective of the research seeks to obtain knowledge applicable to the health of this type of people
p.(None): Informed Consent is adapted to your ability to nod
p.(None): There is no risk of mandatory participation
p.(None): The risk-benefit ratio is acceptable.
p.(None): The benefits are superior to the treatments currently available
p.(None): The support of a family member, director or legal guardian is considered in the decision
p.(None): INVESTIGATIONS WITH PARTICIPATION OF PRISONERS
p.(None): Criteria YES NO Comments:
p.(None): The study does not deprive of medications with therapeutic or prophylactic effects, if you have a
p.(None): disease or risk of contracting it
p.(None): The principle of voluntariness is fulfilled
p.(None): Page 89 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): RESEARCH WITH PARTICIPATION OF PERSONS OF ETHNIC COMMUNITIES, MINORITY GROUPS OR VULNERED COMMUNITIES
p.(None): IN HUMAN RIGHTS
p.(None): Criteria YES NO Comments
p.(None): The study does not discriminate against any other community
p.(None): The objective seeks to obtain knowledge applicable to that community
p.(None): Enough information from that community is reported
p.(None): The community is informed of the conduct of the study
p.(None): Informed Consent is adapted to the culture of that community
p.(None): Questions to the researcher, by the members of the National Research Ethics Committee in
p.(None): Health (CNEIS), and complementary information:
p.(None): SAW. GENERAL CONCLUSIONS OF THE ETHICAL ASSESSMENT
p.(None): Information about 0 1 2
p.(None): 3
p.(None): 1. Relevance and extension of the information provided
p.(None): 2. Form of data collection in relation to objectives, statistical analysis and scientific efficiency
p.(None): 3. Potential to extract information with the least exposure of the subjects
...
p.(None): receiving the patient when the EAS started
p.(None): Total daily dose
p.(None): start of the most recent cycle
p.(None): (dd mmm yy)
p.(None): at present?
p.(None): 0 = No
p.(None): 1 = Yes
p.(None): End date (dd mmm yy)
p.(None): 2 = Probable
p.(None): 3 = Possible
p.(None): 4 =
p.(None): Unlikely 5 = No
p.(None): related 6 = No
p.(None): evaluable
p.(None): 2 = Delayed treatment 3 = Delayed and reduced treatment 4 = Permanently suspended treatment
p.(None): Page 111 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Patient number in the study
p.(None): Other treatments at the time of the event (Include concomitant medication, radiotherapy, surgery, palliative care).
p.(None): Continue on a separate sheet, if necessary. Exclude therapy administered for the management of EAS.
p.(None): Action taken
p.(None): Treatment
p.(None): Give the generic name of the drugs / treatment given in the last 30 days
p.(None): Total daily dose
p.(None): Route of Administration
p.(None): 1 = Oral 2 = Intravenous 3 = Subcutaneous 4 = Other (specify)
p.(None): Start Date (dd mmm yy)
p.(None): Currently happening?
p.(None): 0 = No
p.(None): 1 = Yes
p.(None): End date (dd mmm yy)
p.(None): 0 = None 1 = Dose reduction 2 = Delayed treatment 3 = Delayed and reduced treatment 4 = Treatment
p.(None): permanently suspended
p.(None): Page 112 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Other relevant information that facilitates the evaluation
p.(None): (Include medical history, drug or alcohol abuse, family history, special research findings, etc.)
p.(None): Was this event expected from the point of view of the patient's medical history?
p.(None): 0 = No
p.(None): 1 = Yes
p.(None): Additional Information:
p.(None): Authorized Health Professional Firm
p.(None): ………………………………………………………….
p.(None): .
p.(None): Contact phone number
p.(None): …………………………………………………………
p.(None): …… ..
p.(None): Name
p.(None): ……………………………………………………
p.(None): ...
p.(None): Report date
p.(None): d d m mm a a
p.(None): OFFICIAL USE ONLY
p.(None): Was the EAS drug related?
p.(None): Yes No Event No
p.(None): Was the event unexpected? Yes No Comments:
p.(None): Was the event a RASIS / SUSAR?
p.(None): Shipping Date Form
p.(None): Date of introduction in the
p.(None): If not
p.(None): d d m mm a a
p.(None): database d d m mm a a
p.(None): Code
p.(None): Page 113 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Form reviewed by
p.(None): (Firm) ……………………………………
p.(None): ………
p.(None): Review by a clinician (Signature) ……………………………………
p.(None): ...
p.(None): Date
p.(None): d d m mm a a
p.(None): Date
p.(None): d d m mm a a
p.(None): Page 114 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 9A SECURITY REPORT. CLINICAL TRIALS OF MEDICINAL RESEARCH PRODUCTS (PMI)
p.(None): Full name of the essay Short title
p.(None): Research product (s) under investigation (PMI) Sponsor
p.(None): CEIS that approved the study Principal investigator Trial start date
p.(None): Trial end date Target number of subjects for the entire trial
p.(None): Contact details for the person making the notification
p.(None): Name Address Telephone Fax
...
p.(None): RESEARCH COMPETENCES
p.(None): Academic training in research, good clinical practices. You must provide evidence of those requirements to
p.(None): through your updated Curriculum Vitae and / or any other relevant related documentation
p.(None): The researcher is completely familiar with the proper use of the product in
p.(None): investigation, as described in the protocol, current copy of the Investigator Brochure,
p.(None): in product information and other relevant sources of information.
p.(None): There is a dated and signed list of suitable persons to whom it has delegated tasks
p.(None): significant related to the study, containing their names and functions that have been delegated to them
p.(None): YES NO Comments:
p.(None): ADEQUATE RESOURCES YES NO Comments:
p.(None): The researcher must have sufficient time to conduct and properly complete the study within the
p.(None): agreed period.
p.(None): The researcher must have a sufficient number of qualified personnel and adequate facilities for the
p.(None): expected duration of the study in order to conduct it appropriately and safely
p.(None): Training of the research team should be documented including: name of each person trained,
p.(None): training program and dates. Source: Curriculum Vitae
p.(None): Page 144 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): MEDICAL CARE FOR PARTICIPATING STUDENTS
p.(None): Appropriate medical care is provided to the person in case of an adverse event, including values
p.(None): of clinically significant laboratory, related to the study. Source: Protocol
p.(None): There is an authorization letter from the authority of the health center (it includes
p.(None): hospitals, Community Family Health Units, clinics) to carry out the study within
p.(None): the installations. It includes knowledge of the head of the hospital service, if applicable.
p.(None): The researcher must seek through prior agreements with the sponsor the
p.(None): continuity of treatment to research subjects once their
p.(None): Participation in the study if your interruption jeopardizes your safety within the frameworks
p.(None): applicable regulators. Source: procedures described in the research protocol.
p.(None): AUTHORIZATION OF THE ETHICAL CONSIDERATIONS OF THE RESEARCH
p.(None): Before starting a study, the researcher / institution must have the
p.(None): favorable approval / opinion, written and dated, of the CNEIS / CEIS study protocol, the
p.(None): Informed consent form, updates, recruitment procedures
p.(None): of subjects (for example, announcements) and any other written information that will be provided to
p.(None): YES NO Comments:
p.(None): YES NO Comments:
p.(None): Page 145 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): persons
p.(None): COMPLIANCE WITH THE PROTOCOL YES NO Comments:
p.(None): The researcher / institution must conduct the study in accordance with the protocol agreed with the
p.(None): sponsor and favorable approval / opinion of the CNEIS / CEIS and, if necessary, by the authorities
p.(None): Regulatory
p.(None): The investigator or the person designated by the investigator must document and explain any
p.(None): deviation from the approved protocol, except for changes involving only logistic or administrative aspects
p.(None): of the study (for example, change of monitors, change of telephone number).
...
Health / ill
Searching for indicator ill:
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p.(None): Legally acceptable is authorizing such access.
p.(None): n) That the documents that identify the Subject will be confidential and, as allowed by law and
p.(None): Relevant regulations will not be publicly available. If the results of the study are published, the identity of the
p.(None): Subject will be confidential.
p.(None): o) That the Subject or his legal representative will be informed at all times if new information is available that
p.(None): may be relevant to the subject's decision to continue participating in the study.
p.(None): p) The people to contact for additional information about the study and the
p.(None): Rights of the Subjects of the study, and / or in case of damages related to the study [Researcher
p.(None): principal, co-investigator, data from
p.(None): Page 99 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Health Research Ethics Committee (CEIS) with stamp, date of evaluation and signature of the President].
p.(None): q) The foreseeable circumstances and / or the reasons under which the participation of the
p.(None): Subject in the study.
p.(None): r) The expected duration of the Subject's participation in the study.
p.(None): s) The approximate number of subjects involved in the study.
p.(None): t) In the case of minors, the assent of the minor (s) and the identity of the legal guardian that
p.(None): Sign the Consent.
p.(None): The instrument or form must meet the following requirements:
p.(None): - Must be prepared thinking of a Research Subject, healthy or ill, and not the editor of a magazine
p.(None): scientific The translation from English or another language into Spanish must be adapted to the subject's language and not
p.(None): literal translation.
p.(None): - The contents must be organized in headings.
p.(None): - It must be written with short sentences, using a separate point to separate the sentences.
p.(None): - It must be written in simple words, avoiding the use of technicalities and numerical probabilistic expressions.
p.(None): - If possible, drawings must be included.
p.(None): - The design must be attractive.
p.(None): - Its extension should not be more than 2 pages.
p.(None): - We must evaluate or validate the readability and ease of understanding of the text (with people outside the field of
p.(None): healthcare professionals).
p.(None): Informed Consent Form
p.(None): The Informed Consent Form is the document that the person or their legal representative and the
p.(None): witness (if applicable) will sign and date, to leave with it documented evidence or proof that the Subject
p.(None): has received sufficient information about the study, the research product and its rights as
p.(None): Subject of Research and who wishes to participate freely and voluntarily in the study.
p.(None): If the Subject is illiterate, the signature can be replaced by the fingerprint, but in these
p.(None): Page 100 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Cases must include 2 witnesses.
...
Health / of childbearing age/fertile
Searching for indicator fertile:
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p.(None): Page 100 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Cases must include 2 witnesses.
p.(None): In cases where the Research Subjects are between 12 and 18 years old, in addition to the consent of the parents or
p.(None): Legal representatives, a Assent Form must be included, which must also be signed by the minor.
p.(None): Page 101 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 5B BASIC STRUCTURE MODEL OF THE INFORMATION DOCUMENT FOR THE RESEARCH SUBJECT AND FORM
p.(None): OF INFORMED CONSENT
p.(None): I-General Information
p.(None): 1- [Study Title]
p.(None): 2- [Protocol Number] 3- [Sponsor / Address]
p.(None): 4- [Principal Investigator]
p.(None): 5- [Telephone]
p.(None): 6- [Participating Centers / Address] 7-. [Introduction]
p.(None): II-Specific information (from the study)
p.(None): 8- [Purpose of the Study] 9- [Background]
p.(None): 10- [Study Duration]
p.(None): 11- [Expected Number of Participating Subjects] 12- [Exclusions]
p.(None): 13- [Study Design]
p.(None): 14- [Study Treatment]
p.(None): 15- [Study Procedures]
p.(None): 16- [Additional / optional studies (Sub-studies)] 17- [Possible Risks and Discomforts]
p.(None): 18- [Precautions]
p.(None): 19- [Women of Fertile Age] 20- [Possible Benefits]
p.(None): III Rights of the person
p.(None): 21- [Notification of New Findings] 22- [Treatment Alternatives]
p.(None): Page 102 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): 23- [Options at the end of the Study] 24- [Confidentiality]
p.(None): 25- [Payment per Participation] 26- [Costs]
p.(None): 27- [Compensation for Damages or Injuries Related to the Study] 28- [Voluntary Participation and Retirement]
p.(None): 29- [Questions / Contacts]
p.(None): IV-Consent to participate
p.(None): 30- [General Information]
p.(None): 31- [Subject Consent Statement] 32- [Additional Declarations]
p.(None): 33- [Signature Requirements]
p.(None): Page 103 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 5C CHECKLIST OF INFORMATION DOCUMENT REQUIREMENTS FOR THE SUBJECT OF
p.(None): RESEARCH AND INFORMED CONSENT FORM
p.(None): Protocol No .:
p.(None): Is required:
p.(None): Statement that the study involves research
p.(None): Explanation of the purpose of the investigation
p.(None): Study treatment (s) and probability of randomization for each treatment
p.(None): Expected duration of the person's participation
p.(None): Description of the procedures to follow, including all invasive procedures
p.(None): Responsibilities of the person
p.(None): Identification of any procedures that are experimental
p.(None): Details of any aspect of the study that is experimental
...
Health / patients in emergency situations
Searching for indicator emergencies:
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p.(None): 6 of the study phase described in the protocol, during the three business days of receiving the protocol; with the
p.(None): purpose of verifying the aspects related to the Regulations of the National Directorate of Medicines, in
p.(None): in terms of production, marketing, subtraction, waste, expiration and all those
p.(None): related procedures
p.(None): CNEIS administrative assistant
p.(None): Page 18 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): PROCEDURE 3: DETERMINATION OF THE TYPE OF RESEARCH PROJECT
p.(None): OBJECTIVE: To determine the type of evaluation that the research protocols will receive according to their
p.(None): features.
p.(None): RESPONSIBLE:
p.(None): - Administrative Assistant of the CNEIS.
p.(None): - Technician in charge of Monitoring Clinical Trials
p.(None): - National Committee for Health Research Ethics.
p.(None): - National Directorate of Medicines
p.(None): MATERIALS:
p.(None): - Research protocols.
p.(None): - Guide for identification of a clinical trial (ANNEX 4).
p.(None): EVALUATION MECHANISMS:
p.(None): - Evaluation that requires full: corresponds to projects that involve risks beyond the minimum for
p.(None): research subjects and, therefore, should be evaluated by the majority of the members and be discussed in
p.(None): full. The necessary quorum is half plus one, respecting multidisciplinarity.
p.(None): - Expedited evaluation: corresponds to projects that carry minimal ethical risks for the subjects of
p.(None): investigation and therefore, can be evaluated by two or three members of the Committee without discussion
p.(None): of the full. As well as studies of importance to Public Health, during national emergencies.
p.(None): The two main criteria that an expedited review must meet are:
p.(None): - The study does not involve more than what is considered minimum irrigation
p.(None): Page 19 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): - The study must fit into one or more of the following categories defined by CNEIS itself:
p.(None): ➢ Data collection through non-invasive procedures commonly used in clinical practice.
p.(None): ➢ Studies involving materials already collected, which may be data or samples
p.(None): ➢ Review of the periodic report of a study previously approved by the CIS and that is no longer enrolling new
p.(None): subjects, either that there are no additional risks identified or that it is limited only to data analysis.
p.(None): ➢ Review of minor amendments.
p.(None): Projects that do not require evaluation: corresponds to projects whose purpose is the evaluation of a
p.(None): program, in which its purpose is not to produce new, generalizable knowledge, but its
p.(None): knowledge is relevant only to a specific person or program.
p.(None): DESCRIPTION OF THE PROCEDURE 3
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): Assistant
p.(None): Present to the plenary the investigation protocols and their
p.(None): one
p.(None): full documentation.
p.(None): CNEIS administrative
p.(None): Read the list of summaries of the projects of which
p.(None): two
p.(None): Review requested.
p.(None): CNEIS Secretary
p.(None): Decide the type of evaluation, according to the evaluation mechanisms and the President assigns the persons
p.(None): Who
p.(None): 3
p.(None): will carry out the expedited evaluations and those that require
p.(None): full.
p.(None): CNEIS,
p.(None): Chairman of the Committee
...
Health / visual impairment
Searching for indicator blind:
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p.(None): in the health study).
p.(None): 29. Amendment to the Protocol: Amendments are changes made to a research study, after having
p.(None): obtained a favorable opinion from the ethical point of view of the corresponding CNEIS and the authorization of
p.(None): a regulatory body (unit or research center or others that apply). They can be made to the protocol, to
p.(None): other essential documents and other aspects of the study development. All protocols of
p.(None): study must have clearly written the version number and date, in order to maintain an adequate record and
p.(None): audit; and any amendment must match the date and version number.
p.(None): 30. Clinical Study / Trial (RCT): Any research conducted in humans with the intention of discovering or
p.(None): verify the clinical, pharmacological and / or any other pharmaco-dynamic effects of the product (s) in
p.(None): investigation; and / or identify any adverse reaction to research product (s); and / or to study
p.(None): the absorption, distribution, metabolism and excretion of product (s) under investigation, in order to verify
p.(None): its safety and / or effectiveness.
p.(None): 31. Report of a Clinical Study: A written description of a study of any therapeutic agent,
p.(None): prophylactic or diagnostic performed in humans, in which the clinical and statistical description,
p.(None): Presentations and analyzes are fully integrated into a single report (see International Conference Guide
p.(None): of Harmonization for the Structure and Content of the Clinical Study Reports).
p.(None): 32. Clinical Study, Intermediate Report (“InterimAnalysis”): A report of intermediate results and its
p.(None): evaluation based on analyzes performed during the course of a study.
p.(None): 33. Blind / Masking Study: Procedure in which one or more parts of the study are unaware
p.(None): the assignment (s) to the treatment. Simple blind study generally refers to the fact that the
p.(None): subject (s) do not know the assignment and double blind study refers to the subject (s),
p.(None): Page 66 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Researcher (s), monitor and in some cases the analyst, do not know the allocation to treatment.
p.(None): 34. Multicenter Study: A health study conducted according to a single protocol but in more than
p.(None): a place and, therefore, made by more than one researcher.
p.(None): 35. Non-clinical study: Biomedical studies not performed in humans.
p.(None): 36. Adverse Event (EA): Any adverse medical occurrence in a patient or subject of an investigation
p.(None): in health to whom a pharmaceutical product was administered and which does not necessarily have a
p.(None): causal relationship with this treatment.
p.(None): 37. Adverse Event (EA): It is any unfavorable medical outcome that occurs in a patient or a
p.(None): subject of a clinical trial, who has been given a medicinal product, and who does not necessarily
p.(None): I would have a causal relationship with this treatment. An EA can therefore be any sign
p.(None): unfavorable and unintended (including an abnormal finding on a laboratory test), symptom or disease
p.(None): time period associated with the use of a medicinal product under investigation (PMI), whether it is considered related or not
p.(None): to the PMI.
p.(None): 38. Adverse Reaction (RA): Any unfavorable and unintended response to a PMI, at a certain dose of
p.(None): administration. All EAs, judged as such by the reporting investigator or the sponsor,
p.(None): they qualify as an adverse reaction, as long as they have a reasonable causal relationship to a medicinal product. The
p.(None): Reasonable causal expression means that it converges in general with evidence or argument that suggests a
p.(None): causal relationship
...
p.(None): develop research in the hospital Train hospital staff who request it in methodology
p.(None): of research, to develop research with internal validity, technically evaluate, support the
p.(None): Page 73 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): logistics, register, monitor and monitor the development of studies carried out in the institution.
p.(None): 78. Compliance Monitoring of the BPC: Periodic Audit of any of the parties involved in the
p.(None): conducting a health study (for example, the CNEIS of researchers, sponsors, etc.), for the purpose
p.(None): to verify compliance with the PCBs and the corresponding regulations.
p.(None): Page 74 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): 11. ANNEXES
p.(None): ANNEX 1. GUIDE TO DEVELOP THE LETTER OF INTENTIONS OF A RESEARCHER / RESEARCH TEAM
p.(None): ON THE LETTER OF INTENTION:
p.(None): You must enter:
p.(None): 1. APPLICANT RESEARCHER: Name, position, institution. The sponsoring company defines who the
p.(None): Principal investigator in the cases there are several research centers and researchers.
p.(None): 2. SPONSOR: Indicate the entity that finances and promotes the study.
p.(None): 3. TITLE OF THE PROTOCOL: If the title is very extensive, try to summarize it in a few words.
p.(None): 4. PURPOSE: Indicate the main objective of the study (only one).
p.(None): 5. MAIN EVALUATION PARAMETER (End Point): Indicate the chosen variable as the best expression
p.(None): of objective evaluation.
p.(None): 6. DESIGN: Indicate the methodology to be used: comparative study or not, randomized or not, blind
p.(None): or open, parallel / cross groups, case / control, cohorts, transversal, etc.
p.(None): 7. POPULATION AND NUMBER OF PARTICIPANTS: Indicate the origin of the sample (patients of an institution,
p.(None): healthy volunteers from a community, etc.) and the number of volunteers planned. In the case of animals
p.(None): laboratory, indicate species and number.
p.(None): 8. DURATION OF THE STUDY: Time during which the participant will remain in the study.
p.(None): 9. CENTERS, RESEARCHERS AND COLLABORATORS: Institutions where participants will be recruited, where
p.(None): Samples will be analyzed, when applicable. Name and affiliation of co-researchers and collaborators
p.(None): main.
p.(None): 10. Make clear the place, means and procedure to contact the responsible person (telephone numbers,
p.(None): email and postal address).
p.(None): Page 75 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 2 APPLICATION FOR EVALUATION OF CLINICAL RESEARCH PROTOCOLS IN HUMAN BEINGS
p.(None): NATIONAL COMMITTEE OF ETHICS OF HEALTH RESEARCH
p.(None): APPLICATION FOR EVALUATION OF CLINICAL RESEARCH PROTOCOLS IN HUMAN BEINGS
p.(None): FILL THE RMULAR PHONE TO MACHINE OR ELECTRONIC PHASE WITHOUT BUT NOR OR COOLING NES. DO NOT LEAVE SPACE IN
p.(None): WHITE
p.(None): 1. DATA OF THE PRO TO CO LO
p.(None): 1.1 PRO NO CO LO:
p.(None): 1.2 VERSION: 1.3 DATE:
p.(None): 1.4 TITLE OF THE PRO TO CO LO:
p.(None): 1.5 CENTER NUMBER S:
p.(None): 2.1 VERSION:
p.(None): 2. CO-INFENTIFIED INFORMATION
p.(None): 2.2 DATE (DAY / MONTH / YEAR):
p.(None): 3. O TRO S DO CUMENTO S
p.(None): 3.1 VERSION
p.(None): 3.2 DATE (DAY / MONTH / YEAR)
...
p.(None): ANNEX 4A. ASSESSMENT GUIDE FOR A HEALTH RESEARCH PROJECT
p.(None): INSTRUCTIVE:
p.(None): This instrument must be used by each of the members of the CNEIS, during the review of the
p.(None): documentation. It is a guide to review the formal, methodological and ethical aspects of the study. I know
p.(None): recommends that each evaluator mark with an “X” or write in the blank, as appropriate.
p.(None): Once the deliberation is finished, the secretary will complete the form that includes all the opinions
p.(None): and those that were filled individually will be removed.
p.(None): DATE APPLICATION DATE FIRST
p.(None): EVALUATION
p.(None): SECOND EVALUATION DATE
p.(None): DATE RESOLUTION (APPROVAL / REJECTION)
p.(None): LIST OF ELEMENTS TO EVALUATE IN A HEALTH RESEARCH PROTOCOL
p.(None): I.- IDENTIFICATION:
p.(None): Code
p.(None): Protocol Title
p.(None): Page 82 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): II.- EVALUATION OF THE SUMMARY OF THE PROJECT
p.(None): Little bit
p.(None): Information on Not recorded
p.(None): adequate
p.(None): Adequate
p.(None): Very suitable
p.(None): 1. Promoter
p.(None): 2. Research title
p.(None): 3. Type of investigation
p.(None): 4. Place of performance
p.(None): 5. Authority responsible for the institution of realization
p.(None): 6. Other study centers
p.(None): 7. Responsible researcher
p.(None): 8. Drug or Method to investigate. Information on manufacturing, expiration, registration
p.(None): 9. Stage or phase of the study
p.(None): 10. Objective of the study: efficacy, toxicity, dose, etc.
p.(None): 11. Design: random, double blind, etc.
p.(None): 12. Disease under study
p.(None): 13. Inclusion criteria
p.(None): 14. Exclusion criteria
p.(None): 15. Number of patients
p.(None): 16. Duration of the study
p.(None): 17. Schedule of realization
p.(None): 18. Financial responsible and damage insurance
p.(None): 19. Ethical considerations
p.(None): Page 83 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): III.- METHODOLOGICAL EVALUATION OF THE RESEARCH PROTOCOL
p.(None): Information about
p.(None): 1. Promoter information
p.(None): 2. Participating researchers
p.(None): 3. Realization centers
p.(None): 4. General Aspects
p.(None): 4.1. Preclinical and clinical history that supports the rational of the study
p.(None): 4.2. Justification
p.(None): 4.3. Main goal
p.(None): 4.4. Secondary objectives
p.(None): 4.5. Phase Study: I-II-III-IV
p.(None): 4.6. Kind of investigation
p.(None): 4.7. Design (parallel, crosslinking, etc.)
p.(None): 4.8. Sample's size calculation
p.(None): 5. Population to study
p.(None): 5.1. Type (patients, healthy volunteers or others)
p.(None): 5.2. Inclusion criteria
p.(None): 5.3. Exclusion criteria
p.(None): 5.4. Groups to compare
p.(None): 5.5. Demographic aspects
p.(None): 5.6. Prognostic Criteria
p.(None): 5.7. Stage of the disease
p.(None): 5.8. Treatment response measure
p.(None): 5.9. Associated disease
p.(None): 5.10. Similarity of patients with the general population
p.(None): 6. Compared treatments
p.(None): 6.1. Drug proposed as intervention
p.(None): 6.2. Dose selection
p.(None): 6.3. Dose (fixed, flexible, route of administration)
p.(None): 6.4. Treatments, (Treatments) attached (standardized, allowed, prohibited)
p.(None): 6.5. Treatment duration
p.(None): 6.6. Information of lot number, formulation, etc.
p.(None): Not included or provided
p.(None): Inappropriate
p.(None): Suitable
p.(None): Very suitable
p.(None): Page 84 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Information about
p.(None): 6.7. Drug recognized as Standard treatment
p.(None): 6.8. Justified placebo use
p.(None): 6.9. Masking
p.(None): 7. Details of the experimental design
p.(None): 7.1. Checked
p.(None): 7.2. Controls: active-inactive
p.(None): 7.3. Concurrent-historical
p.(None): 7.4. Assignment of Treatment with random distribution
p.(None): 7.5. Cleaning-stratification period
p.(None): 7.6. Periodicity of visits, laboratory exam, evaluations
p.(None): 7.7. Start and end of treatment
p.(None): 8. Data collection and analysis
p.(None): 8.1. Measures used to evaluate the objectives
p.(None): 8.2. Record of response variables
p.(None): 8.3. Observers (constants, variables)
p.(None): 8.4. Collection method (normalized)
p.(None): 8.5. Evaluation of incomplete or lost data
p.(None): 8.6. Evaluation of the degree of compliance Treatment
p.(None): 8.7. Statistical tests to apply
p.(None): 8.8. Intention to treat analysis
p.(None): 9. Adverse effects (EA)
p.(None): 9.1. Subjective (reported spontaneously or with directed questions)
p.(None): 9.2. Identification criteria
p.(None): 9.3. Classification and evaluation of the Same
p.(None): 10. Controls to minimize bias
p.(None): 10.1. Impartial (blind) observers
p.(None): 10.2. Patients are unaware of the treatment received (blind)
p.(None): Not included or provided
p.(None): Inappropriate
p.(None): Suitable
p.(None): Very suitable
p.(None): Page 85 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Information about
p.(None): 10.3 Impartial assessor (blind)
p.(None): 10.4 Blind statistical analysis (does not identify groups)
p.(None): Not included or provided
p.(None): Inappropriate
p.(None): Suitable
p.(None): Very suitable
p.(None): 11. Individual Registration Sheet
p.(None): IV.- EVALUATION OF THE PATIENT INFORMATION SHEET
p.(None): Information about
p.(None): 1. Copy of the investigation protocol summary
p.(None): 2. Objective to be achieved with the study and treatment
p.(None): 3. Methodology to follow
p.(None): 4. Proposed treatment and placebo if any
p.(None): 5. Expected benefits of the proposed method for the participant
p.(None): 6. Expected benefits of the proposed method for society
p.(None): 7. Risks and inconveniences arising from the investigation
p.(None): 8. Possible adverse events
p.(None): 9. Risks and benefits of alternative methods to that proposed
p.(None): 10. Risks and benefits of non-participation in the study
p.(None): 11. Voluntary nature of participation
p.(None): 12. Right not to participate and to withdraw freely from the study without prejudice of any kind
p.(None): 13. Right to expand information as per participant's need
p.(None): 14. Confidentiality of the data obtained and its scope
p.(None): 15. Damage insurance and compensation guarantee for
p.(None): Not included or provided
p.(None): Poorly suited
p.(None): Adequate
p.(None): Very suitable
p.(None): Page 86 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Information about
p.(None): injury or death of the participant
p.(None): 16. Researcher responsible for informing the subject at any time during the study
p.(None): 17. Reference place for health care
p.(None): 18. The degree to which your medical care will be covered during the study, in case of any inconvenience
...
p.(None): 2. Hearing / Ear
p.(None): 3. Blood / Bone Marrow
p.(None): 4. Cardiac Arrhythmia
p.(None): 5. Cardiac in General
p.(None): 6. Coagulation
p.(None): 7. Constitutional Symptoms
p.(None): 8. Death
p.(None): 9. Dermatology / Skin
p.(None): 10. Endocrine
p.(None): 11. Gastrointestinal
p.(None): 12. Growth and Development
p.(None): Body system
p.(None): 13. Hemorrhage / Bleeding
p.(None): 14. Hepatobiliary / Pancreas
p.(None): 15. Infection
p.(None): 16. Lymphatic
p.(None): 17. Metabolic / Laboratory
p.(None): 18. Skeletal muscle / soft tissues
p.(None): 19. Neurology
p.(None): 20. Eyepiece / Visual
p.(None): 21. Pain
p.(None): 22. Pulmonary / Upper respiratory tract
p.(None): 23. Renal / Genitourinary
p.(None): 24. Secondary Malignancy
p.(None): 25. Sexual / Reproductive Function
p.(None): 26. Intra-operative Surgery / Injuria 27. Syndromes
p.(None): Page 118 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Comment field
p.(None): 28. Vascular
p.(None): 29. Other
p.(None): Case reference number
p.(None): country
p.(None): This is a number that uniquely identifies the AES event This refers to the country where the case occurred
p.(None): Date of birth Date of birth (day-month-year) Sex F = female M = male
p.(None): PMI dose in mg
p.(None): Date the patient started the event-related cycle (day-month-year)
p.(None): Date of treatment
p.(None): EA Appearance Date
p.(None): Adverse reaction
p.(None): Evolution
p.(None): Date symptoms started (day-month-year)
p.(None): Describe the symptoms that the patient experienced during the event manifestation, event progression, exams,
p.(None): etc.
p.(None): It refers to the given treatment (trial or other)
p.(None): Other comments
p.(None): Results of the Blind survey (when applicable)
p.(None): This section is optional, it is only filled if it is relevant (eg due to disagreement on causation, concomitant medication
p.(None): also suspicious, etc.).
p.(None): Provide details, if the Blind survey was performed
p.(None): Page 119 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 9B SECURITY REPORTS COVER
p.(None): CLINICAL TRIAL OF MEDICINAL RESEARCH PRODUCT (PMI) SECURITY REPORT TO THE ETHICS COMMITTEE
p.(None): CORRESPONDING RESEARCH
p.(None): Please indicate what type (s) of Security Report (s) you wish to notify with this COVER (check all that
p.(None): correspond). Use a different sheet for each clinical trial.
p.(None): Expedited report of a serious adverse local reaction (RASIS)
p.(None): Notify only the RASIS occurred in the sites within El Salvador
p.(None): 6 month security report
p.(None): Include a global list of all RASIS related to the medicinal product under investigation and that have
p.(None): occurred in the reported period
p.(None): Annual Security Report
p.(None): Include a global list of all suspected or expected serious local adverse reactions (RASS)
p.(None): related to the PMI and that have occurred in the reported period
p.(None): Other
p.(None): For example, reports from the Data Monitoring Committee or other security review Full title of the study:
p.(None): Research sponsor: Name of principal / chief investigator:
p.(None): Name of the corresponding CEIS:
p.(None): CEIS evaluation report number:
p.(None): Page 120 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Contact details of the person making the notification
p.(None): Name:
p.(None): Address:
p.(None): Phone:
p.(None): Fax:
p.(None): E-mail:
p.(None): Date of notification: Signature:
p.(None): List of attached documents
p.(None): Please list each report submitted with this notification (insert rows, as required).
...
p.(None): Informed consent form, updates, recruitment procedures
p.(None): of subjects (for example, announcements) and any other written information that will be provided to
p.(None): YES NO Comments:
p.(None): YES NO Comments:
p.(None): Page 145 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): persons
p.(None): COMPLIANCE WITH THE PROTOCOL YES NO Comments:
p.(None): The researcher / institution must conduct the study in accordance with the protocol agreed with the
p.(None): sponsor and favorable approval / opinion of the CNEIS / CEIS and, if necessary, by the authorities
p.(None): Regulatory
p.(None): The investigator or the person designated by the investigator must document and explain any
p.(None): deviation from the approved protocol, except for changes involving only logistic or administrative aspects
p.(None): of the study (for example, change of monitors, change of telephone number).
p.(None): RESEARCH PRODUCTS YES NO Comments:
p.(None): The product delivery records are available to the study site, the inventory on the site, the use
p.(None): in each subject and the return to the sponsor or alternate disposition of the unused medicine
p.(None): The product (s) are stored as specified by the sponsor and in accordance with the
p.(None): applicable regulatory requirements The researcher or a person designated by the researcher / institution must
p.(None): explain the correct use of the product under investigation to each subject and must verify at appropriate intervals
p.(None): for the study, that each subject is following the instructions appropriately.
p.(None): ASSIGNMENT PROCESSES
p.(None): RANDOM AND OPENING OF THE BLIND
p.(None): The researcher must follow the procedures
p.(None): YES NO Comments:
p.(None): Page 146 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): randomization of the study, if any, and you should ensure that the code only
p.(None): open in accordance with the protocol. If the study is blind, the researcher must document and
p.(None): Quickly explain to the sponsor any premature breaking of the code (for example,
p.(None): accidental breakage, breakdown by a serious adverse event) of the product under investigation.
p.(None): PROGRESS REPORTS YES NO Comments:
p.(None): The researcher must submit to the CNEIS / CEIS written summaries of the study status in
p.(None): annual or more frequently if requested
p.(None): The researcher must immediately submit written reports to the sponsor, the CNEIS / CEIS and,
p.(None): when applicable, to the institution about any significant change that affects the conduct of the study and / or
p.(None): increase the risks for the subjects
p.(None): SAFETY REPORTS YES NO Comments:
p.(None): The researcher must comply with the applicable regulatory requirements
p.(None): related to the report of
p.(None): unexpected serious adverse drug reactions
p.(None): For reported deaths, the investigator must provide the sponsor and the
p.(None): CNEIS / CEIS any additional information requested (for example, autopsy reports and medical reports
p.(None): from
p.(None): egress)
p.(None): TERMINATION OR SUSPENSION OF
p.(None): STUDY
p.(None): YES NO Comments:
p.(None): Page 147 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): If the study is terminated or suspended prematurely for any reason, the
p.(None): researcher / institution should inform quickly
p.(None): to the people in the study, you must ensure appropriate treatment and follow-up for the people and,
p.(None): when stipulated by regulatory requirements, you must inform the corresponding authorities by
p.(None): written a detailed explanation of this suspension or termination
p.(None): FINAL REPORT YES NO Comments:
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.(None): - The irregularities of the data
p.(None): - The complaints
p.(None): National Committee for Health Research Ethics and National Directorate of Medicines
p.(None): Page 47 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): Request in writing to the CSSP the Audit of one or more research centers, attaching information
p.(None): about him
p.(None): protocol, the modifications, the form of the
p.(None): two
p.(None): authorization with knowledge of the cause, samples of
p.(None): data collection notebooks (FRC), study reports, reports of serious adverse events, etc.
p.(None): Prepare the audit plan for the center and the study to be audited, in agreement with the CNEIS,
p.(None): specifying specific source documents and centers to visit.
p.(None): Note: When planning the Audit, the supervisor must understand the scientific objectives, the
p.(None): criteria of
p.(None): 3
p.(None): inclusion and exclusion, concomitant medications
p.(None): allowed and not allowed, visits and analytical procedures required, any special requirements
p.(None): for handling or storage of the test article, and known information about the medication
p.(None): of the essay, as well as its profile of adverse events.
p.(None): Request information from the CNEIS about irregularities of data or special matters of interest that the
p.(None): DNM,
p.(None): 4
p.(None): during the internal examination of the marketing application
p.(None): (or presentation of the protocol).
p.(None): Inform the clinical investigator in advance, the date of the
p.(None): visit, to ensure that it is present and can access the study records in the
p.(None): moment of
p.(None): 5
p.(None): Audit. When an Audit is announced, the inspector
p.(None): inform the clinical investigator of the documents that must be at hand for the Audit and the
p.(None): installations
p.(None): CNEIS DNM
p.(None): CSSP Audit Team
p.(None): CSSP Audit Team
p.(None): CSSP Audit Team
p.(None): Page 48 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): that will be visited, if relevant.
p.(None): Hold a meeting with the principal investigator at the beginning of the Audit and present their official identification and
p.(None): Any official notice that may be requested. Explain the nature and scope of the Audit, and summarize
p.(None): briefly the methods and procedures that will be used to carry it out.
p.(None): Request information on:
p.(None): - Screening and income of patients to study
p.(None): - Obtaining informed consent
p.(None): 6 - Collection and analysis of study data
p.(None): - Registration, transcription and notification of data to the sponsor
p.(None): - The reception, return and administration of the test drug
p.(None): Other interviews can be conducted with the key study staff and, if relevant, with the subjects
p.(None): of the study, during the Audit and as situations arise that merit it.
p.(None): Determine if the test activities were carried out according to the protocol, to the requirements
p.(None): regulatory
p.(None): 7 applicable and to the BPC, and verify that the data was recorded and notified accurately,
p.(None): using the checklist
p.(None): Identify the study records through an inventory of
p.(None): 8
...
p.(None): Good Clinical Practice (BPC) requirements and applicable regulatory requirements.
p.(None): 22. Source Data: All information in original records and certified copies of the original records of
p.(None): clinical findings, observations or other activities in
p.(None): Page 64 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): a health study necessary for the reconstruction and evaluation of the study. The source data is contained in
p.(None): source documents (original records or certified copies).
p.(None): 23. Hospital departments and services: Direct patient care units in hospitals
p.(None): o Health units, where the subjects to be included in the studies will be identified and recruited.
p.(None): 24. Serious deviation: It is defined as any violation of the correct conditions and principles of the BPC, in
p.(None): relationship with the essay, or the disrespect for the protocol of that essay or its amendments. It is considered "serious" that
p.(None): deviation that can significantly affect the safety or physical (or mental) integrity of the subjects in the
p.(None): study, or its scientific value.
p.(None): It is the responsibility of the sponsor to determine the impact of the deviation on the scientific value of the trial. Yes
p.(None): someone is not sure how to do it, you should ask for advice from the competent authority, the sponsor or the
p.(None): CEIS.
p.(None): 25. Hospital Management: Instance that, in his position as legal representative of the Hospital, will consider whether
p.(None): the institution and / or the person proposing the study will respect hospital regulations, as well as
p.(None): the confidentiality of the data, and if they may have the right to access the data and the hospital patients.
p.(None): 26. Documentation: All records, in any form (including, but not limited to records
p.(None): written, electronic, magnetic, optical and scanner, X-rays and electrocardiograms, etc.) that describe or record
p.(None): the methods, conduction and / or results of a study, the factors that affect a study and the actions taken.
p.(None): 27. Essential Documents: Documents that individually and collectively allow an evaluation of the conduct of
p.(None): a study, and the quality of general data.
p.(None): 28. Source Documents: Original documents, data and records (eg hospital records, sheets
p.(None): clinics, lab notes, memoranda, subjects diaries or evaluation checklists,
p.(None): pharmacy delivery records, recorded data of automated instruments, copies or
p.(None): certified transcripts after verifying that they are exact copies,
p.(None): Page 65 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): microfiche, photographic negatives, magnetic media or microfilm, X-rays, subjects' files and
p.(None): records kept in pharmacies, in laboratories and in the medical-technical departments involved
p.(None): in the health study).
p.(None): 29. Amendment to the Protocol: Amendments are changes made to a research study, after having
p.(None): obtained a favorable opinion from the ethical point of view of the corresponding CNEIS and the authorization of
p.(None): a regulatory body (unit or research center or others that apply). They can be made to the protocol, to
p.(None): other essential documents and other aspects of the study development. All protocols of
p.(None): study must have clearly written the version number and date, in order to maintain an adequate record and
...
p.(None): Regulatory (s) considered appropriate.
p.(None): 46. Inspector / supervisor: A person conducting inspections of the study on behalf of the Authority of
p.(None): (National) Surveillance of Compliance with the BPC.
p.(None): 47. Institution (medical): Any public or private entity, agency or dental medical facility where they are conducted
p.(None): Health studies
p.(None): 48. Basic, pre-clinical or fundamental research: It is the experimental or technical work that is carried out
p.(None): primarily to acquire new knowledge of the underlying phenomenon and observable facts, without an application
p.(None): particular or use established. It can be divided into pure basic research and oriented basic research. In
p.(None): This type of research study subjects are cells, tissues, molecules and / or experimental animals. East
p.(None): type of research is carried out mainly within a specialized laboratory
p.(None): 49. Clinical Research: Patient oriented research. Research conducted with subjects
p.(None): humans (or with material of human origin, such as tissues, specimens, and cognitive phenomena) to
p.(None): which the researcher interacts directly with human subjects. It also includes studies
p.(None): epidemiological and behavioral studies and results research and research in services of
p.(None): Health.
p.(None): 50. Process research or evaluation of health systems (or research in health services or
p.(None): operational research): Field of research that examines the impact of the organization, financing and
p.(None): administration of health care services in the delivery, quality, costs, access and results of these
p.(None): services. In this type of research the subject of study are the processes or relationships within the
p.(None): health institutions.
p.(None): Page 69 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): 51. Public health research: Whose subject of research are the communities.
p.(None): 52. Health research: “Process of obtaining systematic knowledge and technologies that can be
p.(None): used to improve the health of individuals and groups. Provides basic information about health status
p.(None): and population disease; seeks to develop instruments for the prevention, cure and relief of the effects of
p.(None): diseases; and strives to plan better approaches for individual and community health services. ”
p.(None): 53. Researcher: Person responsible for conducting a health study at the site where the
p.(None): study. If a study is conducted by a group of individuals, the researcher is the responsible leader.
p.(None): of the group and will be called principal investigator.
p.(None): 54. Coordinating Investigator: A researcher, in a Multicenter study, who is assigned the responsibility of
p.(None): coordinate the researchers in the different participating centers.
p.(None): 55. Researcher / Institution: Expression that means “The researcher and / or the Institution, when
p.(None): stipulate the applicable regulatory requirements ”.
p.(None): 56. Head of the Unit / Research Center: Personnel responsible and designated in their hospital function as the
p.(None): Manager of the Research Units / Centers and responsible for compliance with the development standards of
p.(None): health research with human subjects, as well as standard operating procedures.
p.(None): 57. Monitoring: The act of monitoring the process of a health study and ensuring that it is conducted,
...
p.(None): 2. Objective to be achieved with the study and treatment
p.(None): 3. Methodology to follow
p.(None): 4. Proposed treatment and placebo if any
p.(None): 5. Expected benefits of the proposed method for the participant
p.(None): 6. Expected benefits of the proposed method for society
p.(None): 7. Risks and inconveniences arising from the investigation
p.(None): 8. Possible adverse events
p.(None): 9. Risks and benefits of alternative methods to that proposed
p.(None): 10. Risks and benefits of non-participation in the study
p.(None): 11. Voluntary nature of participation
p.(None): 12. Right not to participate and to withdraw freely from the study without prejudice of any kind
p.(None): 13. Right to expand information as per participant's need
p.(None): 14. Confidentiality of the data obtained and its scope
p.(None): 15. Damage insurance and compensation guarantee for
p.(None): Not included or provided
p.(None): Poorly suited
p.(None): Adequate
p.(None): Very suitable
p.(None): Page 86 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Information about
p.(None): injury or death of the participant
p.(None): 16. Researcher responsible for informing the subject at any time during the study
p.(None): 17. Reference place for health care
p.(None): 18. The degree to which your medical care will be covered during the study, in case of any inconvenience
p.(None): 19. Ethics committee that evaluated the research
p.(None): 20. If you will receive any compensation or gift for your participation
p.(None): 21. Understanding the information
p.(None): 22. Information on the subject's access to the product under test, if it is effective from the
p.(None): completion of the investigation and until its commercialization, and if it will be delivered free of charge or
p.(None): I would have to pay
p.(None): for him
p.(None): 23. Information on the subject's access to the product being tested, if it is effective and after its
p.(None): marketing, and if it will be delivered to you for free or you would have to pay for it
p.(None): 24. In the case of people over 12 and under 18, there is an Informed Assent Form
p.(None): 25. Dissemination and right to know the results (mechanism or form as you will know them)
p.(None): 26. There is a safeguard of the data, limitations and consequences of its breach
p.(None): Not included or provided
p.(None): Poorly suited
p.(None): Adequate
p.(None): Very suitable
p.(None): Page 87 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): V.- EVALUATION OF INFORMED CONSENT
p.(None): Information about
p.(None): 1. Identification: date and place for signatures
p.(None): 2. Name and surname of the participant, legal representative or witness
p.(None): 3. Research title
p.(None): 4. Statement of reading the information sheet and understanding of it
p.(None): 5. Statement of having been able to ask any question freely
p.(None): 6. Statement of having received sufficient information
p.(None): 7. Statement of having been informed by an investigator whose first and last name is recorded
p.(None): 8. Statement that your participation is voluntary and competent
p.(None): 9. Statement of understanding that you can withdraw without prejudice
p.(None): 10. Expression of free conformity
p.(None): 11. In the case of people over 12 years of age and under 18, there is an Informed Assent Form (AI).
p.(None): 12. Date of edition of the Informed Consent (CI) version
p.(None): Not included or provided
p.(None): Poorly suited
p.(None): Adequate
p.(None): Very suitable
...
p.(None): 14. Health care forecast in case of adverse effect and the degree to which it will be provided
p.(None): 15. Plan to provide the best treatment tested to the subjects, at the end of the investigation
p.(None): 16. Plan to provide the best proven treatment to the community, at the end of the investigation
p.(None): 17. Compensation and compensation provisions for damages
p.(None): 18. Investigator's liability insurance
p.(None): 19. Confidentiality requirements
p.(None): Maximum score 57 points.
p.(None): Page 91 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 4B ETHICAL EVALUATION GUIDE FOR RESEARCH PROTOCOLS DIFFERENT FROM CLINICAL TRIALS
p.(None): Principle analysis Adequate Not applicable
p.(None): Inadequate AUTONOMY
p.(None): Protection of confidentiality Obtaining
p.(None): consent / assent, voluntariness, information, understanding
p.(None): Substitution decisions (legal representative) BENEFIT
p.(None): Risk / benefit ratio Risk not exceeding the minimum NO MALEFICENCE
p.(None): Correct methodology: plausible hypothesis, justification and objectives, sample size
p.(None): Clinical equiponderance: interventions are considered equal in efficacy and safety Suitability
p.(None): of the researcher (training experience, sufficient time for the study) Safety clauses
p.(None): Suitability of research site / facilities JUSTIFICIA
p.(None): Equitable selection of subjects Compensation for damages
p.(None): Social utility
p.(None): Access to interventions
p.(None): VULNERABILITY
p.(None): Vulnerable, discriminated populations have been identified,
p.(None): Page 92 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Principle analysis Adequate Not applicable
p.(None): Inadequate
p.(None): which?
p.(None): Individual guarantees of vulnerability protection are completed
p.(None): The expected results suppose a direct benefit for the participants
p.(None): CONSEQUENCES ANALYSIS
p.(None): For the study subjects
p.(None): For society (responds to the health needs and problems of the country)
p.(None): Page 93 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 4C GUIDE FOR FINAL RESOLUTION
p.(None): At this stage, the important thing is that there is sufficient deliberation for each of the criteria. It's not about
p.(None): Mark the number of people who agree or disagree with the criteria. Only in particular cases, should
p.(None): record if one of the members did not agree with the opinion of the rest and the discussion was exhausted. In case of no
p.(None): If there is agreement, it will be convenient to suspend the discussion and resume it in an upcoming session.
p.(None): Definitions of the numbers in this guide:
p.(None): 1. Evaluate a treatment, intervention or theory that will improve health and well-being, or knowledge.
p.(None): The justification is the scarcity of resources and avoid exploitation. Scientific knowledge is evaluated, the
...
p.(None): + Bravo M, Zunino M.E., Document on “Informed Consent”, CEC SSMS, 2002 and Fernández M., L., Consent
p.(None): informed in clinical practice, 2002.
p.(None): Page 98 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): e) The responsibilities of the Subject.
p.(None): f) Those aspects of the study that are experimental.
p.(None): g) The reasonably foreseeable risks and inconveniences for the Subject and, where relevant, for the embryo,
p.(None): Fetus or nursing child.
p.(None): h) Reasonably expected benefits. When no clinical benefit is intended for the Subject, it should be
p.(None): informed of it.
p.(None): i) Alternative procedures or treatments that may exist for the Subject, and its risks and benefits
p.(None): potentials of importance
p.(None): j) The compensation and / or treatment available to the Subject, in the case of damages related to the study.
p.(None): k) Advance payment arrangement, if any, to the Subject participating in the study (for phase I and II studies).
p.(None): l) That the participation of the Subject in the study is voluntary and that the Subject may refuse their participation or
p.(None): abandon a study without penalty or loss of benefits to which you would otherwise have been entitled.
p.(None): m) That the monitor (s), auditor (s), the Ethics Committee and the regulatory authorities will have free
p.(None): access to the original clinical history of the Subject, for the verification of the procedures and / or data of the
p.(None): study, without violating the right to confidentiality of the Subject, as allowed by law and
p.(None): relevant regulations; and that, by signing the Informed Consent form, the Subject or his representative
p.(None): Legally acceptable is authorizing such access.
p.(None): n) That the documents that identify the Subject will be confidential and, as allowed by law and
p.(None): Relevant regulations will not be publicly available. If the results of the study are published, the identity of the
p.(None): Subject will be confidential.
p.(None): o) That the Subject or his legal representative will be informed at all times if new information is available that
p.(None): may be relevant to the subject's decision to continue participating in the study.
p.(None): p) The people to contact for additional information about the study and the
p.(None): Rights of the Subjects of the study, and / or in case of damages related to the study [Researcher
p.(None): principal, co-investigator, data from
p.(None): Page 99 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Health Research Ethics Committee (CEIS) with stamp, date of evaluation and signature of the President].
p.(None): q) The foreseeable circumstances and / or the reasons under which the participation of the
p.(None): Subject in the study.
p.(None): r) The expected duration of the Subject's participation in the study.
p.(None): s) The approximate number of subjects involved in the study.
p.(None): t) In the case of minors, the assent of the minor (s) and the identity of the legal guardian that
p.(None): Sign the Consent.
p.(None): The instrument or form must meet the following requirements:
p.(None): - Must be prepared thinking of a Research Subject, healthy or ill, and not the editor of a magazine
...
p.(None): ANNEX 5C CHECKLIST OF INFORMATION DOCUMENT REQUIREMENTS FOR THE SUBJECT OF
p.(None): RESEARCH AND INFORMED CONSENT FORM
p.(None): Protocol No .:
p.(None): Is required:
p.(None): Statement that the study involves research
p.(None): Explanation of the purpose of the investigation
p.(None): Study treatment (s) and probability of randomization for each treatment
p.(None): Expected duration of the person's participation
p.(None): Description of the procedures to follow, including all invasive procedures
p.(None): Responsibilities of the person
p.(None): Identification of any procedures that are experimental
p.(None): Details of any aspect of the study that is experimental
p.(None): Description of any reasonably unforeseen risks or discomforts for the person and, when
p.(None): applicable, an embryo, fetus or nursing child
p.(None): When there is no intended clinical benefit for the subject, the person should be aware of it.
p.(None): Description of any benefits reasonably expected for the person or for others
p.(None): Disclosure of specific alternate procedures or treatment appropriate to the person, and their benefits and
p.(None): potential potential risks
p.(None): Any anticipated expenses for the person while participating in the study
p.(None): Proportional advance payment, if any, for the person to participate in the study
p.(None): Explain the conditions under which the researcher can exclude people from the study without their
p.(None): consent
p.(None): Inform the person about who will have access to their medical records (monitor, auditor, JRI,
p.(None): regulatory authorities) to verify the procedures and data of the study, and that the
p.(None): confidentiality to the extent permitted by applicable laws and regulations. If the study results
p.(None): are published, the identity of the person will remain confidential information
p.(None): By signing the Informed Consent Form, the person provides access to their records
p.(None): doctors
p.(None): That the subject's medical records will be kept under strict confidentiality, and will be
p.(None): Page 104 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): protected by applicable local and federal regulations, and will not be made public knowledge
p.(None): Compensation and / or treatment (s) available to the person in the case of a study related injury
p.(None): People to communicate with:
p.(None): For questions about the study
p.(None): For questions about the rights of the person under investigation
p.(None): In the case of a research related injury
p.(None): Statement that participation is voluntary and that the person may withdraw from the study at
p.(None): any time without being punished or losing the benefits to which the person has anyway
p.(None): right
p.(None): Statement of the anticipated circumstances under which the investigator may suspend the
p.(None): participation of the person without the consent of the person
p.(None): Additional costs for the person that may arise from participation in the study
p.(None): The person - or the person's representative - will be notified in a timely manner if new ones develop
p.(None): significant findings during the course of the investigation, which may affect the disposition of
p.(None): the person to continue participating
p.(None): Approximate number of people
p.(None): Consequences of the withdrawal of the person and the procedures at the time of termination
p.(None): Statement that the treatment or procedures may involve risks to the person (or to the person
...
p.(None): Health Research, or:
p.(None): b) It was public domain at the time of discovery by the National Committee for Health Research Ethics,
p.(None): or:
p.(None): c) It has become part of the public domain, or:
p.(None): d) It has been available to you by a third party without abuse of trust or of the obligations of
p.(None): Confidentiality to the National Committee for Health Research Ethics.
p.(None): I promise not to communicate the deliberations and results of the team of
p.(None): Page 152 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): in which it participates, as well as the resulting recommendations
p.(None): and / or the decisions of the National Committee for Health Research Ethics to third parties, except as
p.(None): explicitly agreed the National Committee for Health Research Ethics.
p.(None): You will perform your responsibilities exclusively in your capacity as a
p.(None): of the National Committee of Ethics of Health Research. Signing this
p.(None): agreement, you confirm that you have no financial interest and / or other relationship with the parties, which:
p.(None): a) They could have a commercial interest created by obtaining access to any part of the referred information
p.(None): previously and / or:
p.(None): b) You may have an interest created in the result of the appreciation of the products, in which you will participate
p.(None): but it will not limit parties such as the producer that has been evaluated or from competent producers.
p.(None): I accept the provisions and conditions contained in this document and for the record, I sign this document:
p.(None): Name:
p.(None): Entity:
p.(None): Date:
p.(None): Firm:
p.(None): Page 153 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 18 EXTERNAL EXPERTS
p.(None): 1. OBJECTIVES
p.(None): Establish the criteria for the integration and operation of the Committees of External Experts to guarantee the
p.(None): quality in the documentary and administrative functioning, and comply with international guidelines for the process of
p.(None): decision making of the National Committee for Health Research Ethics.
p.(None): 2. REACH
p.(None): Understand the performance guidelines of professionals hired as External Experts of the National Committee of
p.(None): Health Research Ethics, from your contract for evaluation to the delivery of reports and opinions by
p.(None): part of the Committee of External Experts, in addition to providing guidance to the ethics committees of the
p.(None): research (CNEIS / CEIS) on which organizations depend to examine and monitor the ethics of the
p.(None): research, as well as researchers who design and carry out health research studies.
p.(None): 3. PRIOR REQUIREMENTS
...
Searching for indicator access to information:
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p.(None): Receive and review action plan in conjunction with CSSP and DNM
p.(None): Request follow-up audit of Good Clinical Practices
p.(None): Prepare and execute BPC tracking audit
p.(None): Submit BPC follow-up audit report
p.(None): C
p.(None): Page 150 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 16. CONFIDENTIALITY AGREEMENT
p.(None): CONFIDENTIALITY ACT
p.(None): With the objective of guaranteeing the highest reliability in the labor relations between the parties and contributing to the
p.(None): development and improvement of the missions that the National Committee for Health Research Ethics fulfills
p.(None): Adopt this agreement.
p.(None): On the one hand, in his capacity as Chairman of the National Ethics Committee of the
p.(None): Health Research, Start Paseo General Escalón # 3551, San Salvador, El Salvador, Central America. For other
p.(None): part: as
p.(None): has accepted and has been authorized by his institution to collaborate as of the Committee
p.(None): National Health Research Ethics.
p.(None): Both parties reciprocally recognize their capacity and state that they have agreed to sign the precepts
p.(None): established in this Confidentiality Agreement.
p.(None): First: The National Committee for Health Research Ethics makes available to the Expert the information
p.(None): required for the performance of its work.
p.(None): Second: During his work he will have access to information with character
p.(None): confidential that should not be used for outside purposes.
p.(None): The parties that sign this agreement must comply with it in full and comply with the provisions of this
p.(None): Confidentiality Agreement sign two copies of it with the same tenor and equal validity in legal force.
p.(None): Given in San Salvador on the 20th day of the month of XXX of the XXXX year.
p.(None): PRESIDENT NAME
p.(None): Page 151 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 17. DECLARATION OF ABSENCE OF CONFLICTS OF INTEREST
p.(None): Declaration of Absence of Conflicts of Interest
p.(None): In the course of performing your duties as under this agreement, you will have
p.(None): access to information owned by the National Committee for Health Research Ethics. You agree to try
p.(None): this information as confidential (hereinafter as "information")
p.(None): I,
p.(None): I compromise to:
p.(None): a) Not to use the information for any other purpose than to fulfill my obligations under this agreement; Y
p.(None): b) Not disclose or provide the information to any third party who does not have a working relationship and
p.(None): Confidentiality in it and to use the information properly.
p.(None): It will not relate to any obligation of confidentiality and will not use it until you are clearly not
p.(None): able to demonstrate that any part of the information:
p.(None): a) It was known by you before any disclosure or discovery by the National Ethics Committee of
p.(None): Health Research, or:
p.(None): b) It was public domain at the time of discovery by the National Committee for Health Research Ethics,
p.(None): or:
p.(None): c) It has become part of the public domain, or:
p.(None): d) It has been available to you by a third party without abuse of trust or of the obligations of
p.(None): Confidentiality to the National Committee for Health Research Ethics.
p.(None): I promise not to communicate the deliberations and results of the team of
p.(None): Page 152 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): in which it participates, as well as the resulting recommendations
...
Social / Age
Searching for indicator age:
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p.(None): the development of the same, sent to the CNEIS
p.(None): or to the CEIS.
p.(None): RESPONSIBLE:
p.(None): - Sponsor
p.(None): - Principal investigator
p.(None): - CNEIS / CEIS
p.(None): - National Directorate of Medicines
p.(None): MATERIALS:
p.(None): - Description of the amendment and amendment report. (ANNEX 10A and 10B).
p.(None): - Reasons for the proposed amendment.
p.(None): - Copy of the proposed changes to the protocol or any other document, demonstrating what was written before and
p.(None): after.
p.(None): - Data supporting the amendment, including any changes to the risk-benefit analysis.
p.(None): TYPES OF AMENDMENT:
p.(None): An amendment to the research project may be substantial or minor (not substantial).
p.(None): Substantial amendment: A substantial amendment may be defined as an amendment to the protocol or to any
p.(None): Another substantial document, which can affect to a significant degree:
p.(None): - The safety or physical or mental integrity of the subjects in the study
p.(None): - The scientific value of the study
p.(None): - Conducting or administering the study
p.(None): Page 37 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): - The quality or safety of any medicinal product under investigation used in the trial.
p.(None): Substantial amendments may be:
p.(None): Amendments related to the protocol
p.(None): - Purpose of the essay
p.(None): - Trial design
p.(None): - Recruitment procedure
p.(None): - Measures of effectiveness
p.(None): - Sample calendar
p.(None): - Added or subtracted from exams or measures
p.(None): - Number of participants
p.(None): - Age range of participants
p.(None): - Inclusion criteria
p.(None): - Exclusion criteria
p.(None): - Security monitoring
p.(None): - Duration of exposure to the medicinal product under investigation
p.(None): - Change of dose of the medicinal product under investigation
p.(None): - Comparator change
p.(None): - Amendments to other study documentation
p.(None): - Participant information sheet
p.(None): - Informed consent
p.(None): - Questionnaires
p.(None): - Invitation card
p.(None): - Letters to the Chief or Principal Investigator, and other clinicians
p.(None): - Information sheets for relatives or caregivers
p.(None): - The file of the Medicinal Product in Research (PMI)
p.(None): - Amendments related to trial arrangements
p.(None): - Change the Principal Investigator or add new ones (this means: researchers who
p.(None): direct the research in each center)
p.(None): Page 38 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): - Change in the coordinating researcher
p.(None): - Change in the study site or add new sites
p.(None): - Change of sponsor or legal representative
p.(None): - Change of the definition of completion of the study
p.(None): - Change in PMI provider
p.(None): Minor (non-substantial) amendment: A minor amendment can be defined as a change in the details of the study that does not
p.(None): it will have significant implications for the participants in it, or for its management, administration or value
p.(None): scientific.
p.(None): Minor amendments can be:
p.(None): - Corrections of typographical errors in the study documents
...
p.(None): completion of the investigation and until its commercialization, and if it will be delivered free of charge or
p.(None): I would have to pay
p.(None): for him
p.(None): 23. Information on the subject's access to the product being tested, if it is effective and after its
p.(None): marketing, and if it will be delivered to you for free or you would have to pay for it
p.(None): 24. In the case of people over 12 and under 18, there is an Informed Assent Form
p.(None): 25. Dissemination and right to know the results (mechanism or form as you will know them)
p.(None): 26. There is a safeguard of the data, limitations and consequences of its breach
p.(None): Not included or provided
p.(None): Poorly suited
p.(None): Adequate
p.(None): Very suitable
p.(None): Page 87 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): V.- EVALUATION OF INFORMED CONSENT
p.(None): Information about
p.(None): 1. Identification: date and place for signatures
p.(None): 2. Name and surname of the participant, legal representative or witness
p.(None): 3. Research title
p.(None): 4. Statement of reading the information sheet and understanding of it
p.(None): 5. Statement of having been able to ask any question freely
p.(None): 6. Statement of having received sufficient information
p.(None): 7. Statement of having been informed by an investigator whose first and last name is recorded
p.(None): 8. Statement that your participation is voluntary and competent
p.(None): 9. Statement of understanding that you can withdraw without prejudice
p.(None): 10. Expression of free conformity
p.(None): 11. In the case of people over 12 years of age and under 18, there is an Informed Assent Form (AI).
p.(None): 12. Date of edition of the Informed Consent (CI) version
p.(None): Not included or provided
p.(None): Poorly suited
p.(None): Adequate
p.(None): Very suitable
p.(None): Page 88 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): INVESTIGATIONS WITH PEOPLE WHO SUFFER MENTAL AFFECTIONS OR BEHAVIOR DISORDERS
p.(None): Observations:
p.(None): Criteria YES NO
p.(None): The objective of the research seeks to obtain knowledge applicable to the health of this type of people
p.(None): Informed Consent is adapted to your ability to nod
p.(None): There is no risk of mandatory participation
p.(None): The risk-benefit ratio is acceptable.
p.(None): The benefits are superior to the treatments currently available
p.(None): The support of a family member, director or legal guardian is considered in the decision
p.(None): INVESTIGATIONS WITH PARTICIPATION OF PRISONERS
p.(None): Criteria YES NO Comments:
p.(None): The study does not deprive of medications with therapeutic or prophylactic effects, if you have a
p.(None): disease or risk of contracting it
p.(None): The principle of voluntariness is fulfilled
p.(None): Page 89 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
...
p.(None): Page 100 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Cases must include 2 witnesses.
p.(None): In cases where the Research Subjects are between 12 and 18 years old, in addition to the consent of the parents or
p.(None): Legal representatives, a Assent Form must be included, which must also be signed by the minor.
p.(None): Page 101 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 5B BASIC STRUCTURE MODEL OF THE INFORMATION DOCUMENT FOR THE RESEARCH SUBJECT AND FORM
p.(None): OF INFORMED CONSENT
p.(None): I-General Information
p.(None): 1- [Study Title]
p.(None): 2- [Protocol Number] 3- [Sponsor / Address]
p.(None): 4- [Principal Investigator]
p.(None): 5- [Telephone]
p.(None): 6- [Participating Centers / Address] 7-. [Introduction]
p.(None): II-Specific information (from the study)
p.(None): 8- [Purpose of the Study] 9- [Background]
p.(None): 10- [Study Duration]
p.(None): 11- [Expected Number of Participating Subjects] 12- [Exclusions]
p.(None): 13- [Study Design]
p.(None): 14- [Study Treatment]
p.(None): 15- [Study Procedures]
p.(None): 16- [Additional / optional studies (Sub-studies)] 17- [Possible Risks and Discomforts]
p.(None): 18- [Precautions]
p.(None): 19- [Women of Fertile Age] 20- [Possible Benefits]
p.(None): III Rights of the person
p.(None): 21- [Notification of New Findings] 22- [Treatment Alternatives]
p.(None): Page 102 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): 23- [Options at the end of the Study] 24- [Confidentiality]
p.(None): 25- [Payment per Participation] 26- [Costs]
p.(None): 27- [Compensation for Damages or Injuries Related to the Study] 28- [Voluntary Participation and Retirement]
p.(None): 29- [Questions / Contacts]
p.(None): IV-Consent to participate
p.(None): 30- [General Information]
p.(None): 31- [Subject Consent Statement] 32- [Additional Declarations]
p.(None): 33- [Signature Requirements]
p.(None): Page 103 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 5C CHECKLIST OF INFORMATION DOCUMENT REQUIREMENTS FOR THE SUBJECT OF
p.(None): RESEARCH AND INFORMED CONSENT FORM
p.(None): Protocol No .:
p.(None): Is required:
p.(None): Statement that the study involves research
p.(None): Explanation of the purpose of the investigation
p.(None): Study treatment (s) and probability of randomization for each treatment
p.(None): Expected duration of the person's participation
p.(None): Description of the procedures to follow, including all invasive procedures
p.(None): Responsibilities of the person
p.(None): Identification of any procedures that are experimental
p.(None): Details of any aspect of the study that is experimental
p.(None): Description of any reasonably unforeseen risks or discomforts for the person and, when
...
Social / Child
Searching for indicator child:
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p.(None): - Information for the Research Subject
p.(None): The written information document is a written summary of the minimum information that must be communicated to
p.(None): the person to comply with the substantive ethical principle of Informed Consent. This information document
p.(None): It will be the basis or guide for verbal explanation and discussion of the study with the Subject or his legal representative. I know
p.(None): recognizes that this document will not be the only source of information that the Subject will receive in the process of
p.(None): Informed consent.
p.(None): Information content:
p.(None): a) That the study involves an investigation (study title).
p.(None): b) The purpose of the study.
p.(None): c) The treatment (or intervention) under study and the probability of randomization to treatment or
p.(None): procedure, where applicable.
p.(None): d) The procedures to follow in the study, including all invasive procedures.
p.(None): + Bravo M, Zunino M.E., Document on “Informed Consent”, CEC SSMS, 2002 and Fernández M., L., Consent
p.(None): informed in clinical practice, 2002.
p.(None): Page 98 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): e) The responsibilities of the Subject.
p.(None): f) Those aspects of the study that are experimental.
p.(None): g) The reasonably foreseeable risks and inconveniences for the Subject and, where relevant, for the embryo,
p.(None): Fetus or nursing child.
p.(None): h) Reasonably expected benefits. When no clinical benefit is intended for the Subject, it should be
p.(None): informed of it.
p.(None): i) Alternative procedures or treatments that may exist for the Subject, and its risks and benefits
p.(None): potentials of importance
p.(None): j) The compensation and / or treatment available to the Subject, in the case of damages related to the study.
p.(None): k) Advance payment arrangement, if any, to the Subject participating in the study (for phase I and II studies).
p.(None): l) That the participation of the Subject in the study is voluntary and that the Subject may refuse their participation or
p.(None): abandon a study without penalty or loss of benefits to which you would otherwise have been entitled.
p.(None): m) That the monitor (s), auditor (s), the Ethics Committee and the regulatory authorities will have free
p.(None): access to the original clinical history of the Subject, for the verification of the procedures and / or data of the
p.(None): study, without violating the right to confidentiality of the Subject, as allowed by law and
p.(None): relevant regulations; and that, by signing the Informed Consent form, the Subject or his representative
p.(None): Legally acceptable is authorizing such access.
p.(None): n) That the documents that identify the Subject will be confidential and, as allowed by law and
p.(None): Relevant regulations will not be publicly available. If the results of the study are published, the identity of the
p.(None): Subject will be confidential.
p.(None): o) That the Subject or his legal representative will be informed at all times if new information is available that
...
p.(None): National Committee for Health Research Ethics
p.(None): 23- [Options at the end of the Study] 24- [Confidentiality]
p.(None): 25- [Payment per Participation] 26- [Costs]
p.(None): 27- [Compensation for Damages or Injuries Related to the Study] 28- [Voluntary Participation and Retirement]
p.(None): 29- [Questions / Contacts]
p.(None): IV-Consent to participate
p.(None): 30- [General Information]
p.(None): 31- [Subject Consent Statement] 32- [Additional Declarations]
p.(None): 33- [Signature Requirements]
p.(None): Page 103 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 5C CHECKLIST OF INFORMATION DOCUMENT REQUIREMENTS FOR THE SUBJECT OF
p.(None): RESEARCH AND INFORMED CONSENT FORM
p.(None): Protocol No .:
p.(None): Is required:
p.(None): Statement that the study involves research
p.(None): Explanation of the purpose of the investigation
p.(None): Study treatment (s) and probability of randomization for each treatment
p.(None): Expected duration of the person's participation
p.(None): Description of the procedures to follow, including all invasive procedures
p.(None): Responsibilities of the person
p.(None): Identification of any procedures that are experimental
p.(None): Details of any aspect of the study that is experimental
p.(None): Description of any reasonably unforeseen risks or discomforts for the person and, when
p.(None): applicable, an embryo, fetus or nursing child
p.(None): When there is no intended clinical benefit for the subject, the person should be aware of it.
p.(None): Description of any benefits reasonably expected for the person or for others
p.(None): Disclosure of specific alternate procedures or treatment appropriate to the person, and their benefits and
p.(None): potential potential risks
p.(None): Any anticipated expenses for the person while participating in the study
p.(None): Proportional advance payment, if any, for the person to participate in the study
p.(None): Explain the conditions under which the researcher can exclude people from the study without their
p.(None): consent
p.(None): Inform the person about who will have access to their medical records (monitor, auditor, JRI,
p.(None): regulatory authorities) to verify the procedures and data of the study, and that the
p.(None): confidentiality to the extent permitted by applicable laws and regulations. If the study results
p.(None): are published, the identity of the person will remain confidential information
p.(None): By signing the Informed Consent Form, the person provides access to their records
p.(None): doctors
p.(None): That the subject's medical records will be kept under strict confidentiality, and will be
p.(None): Page 104 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): protected by applicable local and federal regulations, and will not be made public knowledge
p.(None): Compensation and / or treatment (s) available to the person in the case of a study related injury
p.(None): People to communicate with:
p.(None): For questions about the study
p.(None): For questions about the rights of the person under investigation
p.(None): In the case of a research related injury
p.(None): Statement that participation is voluntary and that the person may withdraw from the study at
p.(None): any time without being punished or losing the benefits to which the person has anyway
p.(None): right
p.(None): Statement of the anticipated circumstances under which the investigator may suspend the
p.(None): participation of the person without the consent of the person
p.(None): Additional costs for the person that may arise from participation in the study
p.(None): The person - or the person's representative - will be notified in a timely manner if new ones develop
p.(None): significant findings during the course of the investigation, which may affect the disposition of
p.(None): the person to continue participating
p.(None): Approximate number of people
p.(None): Consequences of the withdrawal of the person and the procedures at the time of termination
p.(None): Statement that the treatment or procedures may involve risks to the person (or to the person
p.(None): embryo, fetus or nursing child) that are currently unforeseen
p.(None): Page 105 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 6 MINUTES FOR RESOLUTION OF A RESEARCH PROJECT
p.(None): Institution:
p.(None): ACT N °: / EVALUATION ACT
p.(None): HEALTH STUDY PROTOCOL Nº ..........
p.(None): On ……………, on ……. Days of the month of …… del. , H. Committee Committee
p.(None): of Health Research Ethics ………………………………… .., with the assistance of its permanent members:
p.(None): [full name, position on the Committee (chairman, secretary, permanent member, alternate member and the
p.(None): profession of each)] ………………………………………………………………, have reviewed the documents submitted by
p.(None): ..........................., Principal Investigator, namely:
p.(None): 1. Protocol ".................", version ...................
p.(None): 2. Protocol ".................", Spanish version of ....................
p.(None): 3. Investigator Brochure ......
p.(None): 4. Informed Consent Form of the Protocol "...........", Spanish version, ...................
p.(None): 5. The curriculum vitae of ........................................ In addition, to know Background
p.(None): exposed by .................. in the session of the day .............., has considered that the sponsored clinical study
p.(None): by ................, (does not present ethical objections) (presents the following observations):
p.(None): 1) The members of the Committee declared (Having or not having a conflict of interest).
p.(None): 2) The design conforms to the standards of Research in Human Beings.
p.(None): 3) The benefit ratio was considered acceptable.
...
Social / Ethnicity
Searching for indicator ethnic:
(return to top)
p.(None): 12. Date of edition of the Informed Consent (CI) version
p.(None): Not included or provided
p.(None): Poorly suited
p.(None): Adequate
p.(None): Very suitable
p.(None): Page 88 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): INVESTIGATIONS WITH PEOPLE WHO SUFFER MENTAL AFFECTIONS OR BEHAVIOR DISORDERS
p.(None): Observations:
p.(None): Criteria YES NO
p.(None): The objective of the research seeks to obtain knowledge applicable to the health of this type of people
p.(None): Informed Consent is adapted to your ability to nod
p.(None): There is no risk of mandatory participation
p.(None): The risk-benefit ratio is acceptable.
p.(None): The benefits are superior to the treatments currently available
p.(None): The support of a family member, director or legal guardian is considered in the decision
p.(None): INVESTIGATIONS WITH PARTICIPATION OF PRISONERS
p.(None): Criteria YES NO Comments:
p.(None): The study does not deprive of medications with therapeutic or prophylactic effects, if you have a
p.(None): disease or risk of contracting it
p.(None): The principle of voluntariness is fulfilled
p.(None): Page 89 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): RESEARCH WITH PARTICIPATION OF PERSONS OF ETHNIC COMMUNITIES, MINORITY GROUPS OR VULNERED COMMUNITIES
p.(None): IN HUMAN RIGHTS
p.(None): Criteria YES NO Comments
p.(None): The study does not discriminate against any other community
p.(None): The objective seeks to obtain knowledge applicable to that community
p.(None): Enough information from that community is reported
p.(None): The community is informed of the conduct of the study
p.(None): Informed Consent is adapted to the culture of that community
p.(None): Questions to the researcher, by the members of the National Research Ethics Committee in
p.(None): Health (CNEIS), and complementary information:
p.(None): SAW. GENERAL CONCLUSIONS OF THE ETHICAL ASSESSMENT
p.(None): Information about 0 1 2
p.(None): 3
p.(None): 1. Relevance and extension of the information provided
p.(None): 2. Form of data collection in relation to objectives, statistical analysis and scientific efficiency
p.(None): 3. Potential to extract information with the least exposure of the subjects
p.(None): 4. Justification of the predictable risks and inconveniences with the benefits for the subject
p.(None): 5. Justification of the predictable risks and inconveniences with the benefits for society
p.(None): 6. Adaptation of the researcher to the proposed project according to experience in the subject
p.(None): 7. Adequacy of the place of performance, considering the resources available
p.(None): Page 90 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Information about 0 1 2
p.(None): 3
p.(None): 8. Adequacy of medical supervision and follow-up of subjects
p.(None): 9. Adequacy of forecasts to monitor the course of the investigation
...
Social / Fetus/Neonate
Searching for indicator fetus:
(return to top)
p.(None): - Information for the Research Subject
p.(None): The written information document is a written summary of the minimum information that must be communicated to
p.(None): the person to comply with the substantive ethical principle of Informed Consent. This information document
p.(None): It will be the basis or guide for verbal explanation and discussion of the study with the Subject or his legal representative. I know
p.(None): recognizes that this document will not be the only source of information that the Subject will receive in the process of
p.(None): Informed consent.
p.(None): Information content:
p.(None): a) That the study involves an investigation (study title).
p.(None): b) The purpose of the study.
p.(None): c) The treatment (or intervention) under study and the probability of randomization to treatment or
p.(None): procedure, where applicable.
p.(None): d) The procedures to follow in the study, including all invasive procedures.
p.(None): + Bravo M, Zunino M.E., Document on “Informed Consent”, CEC SSMS, 2002 and Fernández M., L., Consent
p.(None): informed in clinical practice, 2002.
p.(None): Page 98 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): e) The responsibilities of the Subject.
p.(None): f) Those aspects of the study that are experimental.
p.(None): g) The reasonably foreseeable risks and inconveniences for the Subject and, where relevant, for the embryo,
p.(None): Fetus or nursing child.
p.(None): h) Reasonably expected benefits. When no clinical benefit is intended for the Subject, it should be
p.(None): informed of it.
p.(None): i) Alternative procedures or treatments that may exist for the Subject, and its risks and benefits
p.(None): potentials of importance
p.(None): j) The compensation and / or treatment available to the Subject, in the case of damages related to the study.
p.(None): k) Advance payment arrangement, if any, to the Subject participating in the study (for phase I and II studies).
p.(None): l) That the participation of the Subject in the study is voluntary and that the Subject may refuse their participation or
p.(None): abandon a study without penalty or loss of benefits to which you would otherwise have been entitled.
p.(None): m) That the monitor (s), auditor (s), the Ethics Committee and the regulatory authorities will have free
p.(None): access to the original clinical history of the Subject, for the verification of the procedures and / or data of the
p.(None): study, without violating the right to confidentiality of the Subject, as allowed by law and
p.(None): relevant regulations; and that, by signing the Informed Consent form, the Subject or his representative
p.(None): Legally acceptable is authorizing such access.
p.(None): n) That the documents that identify the Subject will be confidential and, as allowed by law and
p.(None): Relevant regulations will not be publicly available. If the results of the study are published, the identity of the
p.(None): Subject will be confidential.
...
p.(None): Page 102 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): 23- [Options at the end of the Study] 24- [Confidentiality]
p.(None): 25- [Payment per Participation] 26- [Costs]
p.(None): 27- [Compensation for Damages or Injuries Related to the Study] 28- [Voluntary Participation and Retirement]
p.(None): 29- [Questions / Contacts]
p.(None): IV-Consent to participate
p.(None): 30- [General Information]
p.(None): 31- [Subject Consent Statement] 32- [Additional Declarations]
p.(None): 33- [Signature Requirements]
p.(None): Page 103 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 5C CHECKLIST OF INFORMATION DOCUMENT REQUIREMENTS FOR THE SUBJECT OF
p.(None): RESEARCH AND INFORMED CONSENT FORM
p.(None): Protocol No .:
p.(None): Is required:
p.(None): Statement that the study involves research
p.(None): Explanation of the purpose of the investigation
p.(None): Study treatment (s) and probability of randomization for each treatment
p.(None): Expected duration of the person's participation
p.(None): Description of the procedures to follow, including all invasive procedures
p.(None): Responsibilities of the person
p.(None): Identification of any procedures that are experimental
p.(None): Details of any aspect of the study that is experimental
p.(None): Description of any reasonably unforeseen risks or discomforts for the person and, when
p.(None): applicable, an embryo, fetus or nursing child
p.(None): When there is no intended clinical benefit for the subject, the person should be aware of it.
p.(None): Description of any benefits reasonably expected for the person or for others
p.(None): Disclosure of specific alternate procedures or treatment appropriate to the person, and their benefits and
p.(None): potential potential risks
p.(None): Any anticipated expenses for the person while participating in the study
p.(None): Proportional advance payment, if any, for the person to participate in the study
p.(None): Explain the conditions under which the researcher can exclude people from the study without their
p.(None): consent
p.(None): Inform the person about who will have access to their medical records (monitor, auditor, JRI,
p.(None): regulatory authorities) to verify the procedures and data of the study, and that the
p.(None): confidentiality to the extent permitted by applicable laws and regulations. If the study results
p.(None): are published, the identity of the person will remain confidential information
p.(None): By signing the Informed Consent Form, the person provides access to their records
p.(None): doctors
p.(None): That the subject's medical records will be kept under strict confidentiality, and will be
p.(None): Page 104 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): protected by applicable local and federal regulations, and will not be made public knowledge
p.(None): Compensation and / or treatment (s) available to the person in the case of a study related injury
p.(None): People to communicate with:
p.(None): For questions about the study
p.(None): For questions about the rights of the person under investigation
p.(None): In the case of a research related injury
p.(None): Statement that participation is voluntary and that the person may withdraw from the study at
p.(None): any time without being punished or losing the benefits to which the person has anyway
p.(None): right
p.(None): Statement of the anticipated circumstances under which the investigator may suspend the
p.(None): participation of the person without the consent of the person
p.(None): Additional costs for the person that may arise from participation in the study
p.(None): The person - or the person's representative - will be notified in a timely manner if new ones develop
p.(None): significant findings during the course of the investigation, which may affect the disposition of
p.(None): the person to continue participating
p.(None): Approximate number of people
p.(None): Consequences of the withdrawal of the person and the procedures at the time of termination
p.(None): Statement that the treatment or procedures may involve risks to the person (or to the person
p.(None): embryo, fetus or nursing child) that are currently unforeseen
p.(None): Page 105 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 6 MINUTES FOR RESOLUTION OF A RESEARCH PROJECT
p.(None): Institution:
p.(None): ACT N °: / EVALUATION ACT
p.(None): HEALTH STUDY PROTOCOL Nº ..........
p.(None): On ……………, on ……. Days of the month of …… del. , H. Committee Committee
p.(None): of Health Research Ethics ………………………………… .., with the assistance of its permanent members:
p.(None): [full name, position on the Committee (chairman, secretary, permanent member, alternate member and the
p.(None): profession of each)] ………………………………………………………………, have reviewed the documents submitted by
p.(None): ..........................., Principal Investigator, namely:
p.(None): 1. Protocol ".................", version ...................
p.(None): 2. Protocol ".................", Spanish version of ....................
p.(None): 3. Investigator Brochure ......
p.(None): 4. Informed Consent Form of the Protocol "...........", Spanish version, ...................
p.(None): 5. The curriculum vitae of ........................................ In addition, to know Background
p.(None): exposed by .................. in the session of the day .............., has considered that the sponsored clinical study
p.(None): by ................, (does not present ethical objections) (presents the following observations):
p.(None): 1) The members of the Committee declared (Having or not having a conflict of interest).
p.(None): 2) The design conforms to the standards of Research in Human Beings.
p.(None): 3) The benefit ratio was considered acceptable.
...
Social / Homeless Persons
Searching for indicator homeless:
(return to top)
p.(None): 74. Sub-researcher: Any individual member of the health study group, appointed and supervised by the
p.(None): researcher to perform critical procedures related to the study and / or make important decisions
p.(None): related to it (for example, associates, residents, research fellow).
p.(None): 75. Subject of the Study: Individual who participates in a health study, either as a recipient of the
p.(None): product (s) under investigation or as a control. In this document, "subject", "individual" and "person" are used
p.(None): With the same meaning.
p.(None): 76. Vulnerable (or Vulnerated) Subjects: Individuals whose desire to participate in a health study may be
p.(None): influenced by the expectation, justified or not, of the benefits associated with your participation, or of a
p.(None): revenge on the part of the superior members of a hierarchy in case of refusing to participate. By
p.(None): For example, the members of a group with a hierarchical structure, such as that made up of medical students,
p.(None): dentistry, chemical-drug-biological and nursing, subordinate hospital and laboratory personnel,
p.(None): employees of the pharmaceutical industry, members of the armed forces and people who are
p.(None): detained / detained Other vulnerable (or violated) subjects include patients with diseases
p.(None): incurable, people in nursing homes, unemployed or homeless, patients in emergency situations,
p.(None): ethnic minority groups, homeless people, nomads, refugees, minors and those who cannot give their
p.(None): consent.
p.(None): 77. Impartial Witness: A person independent of the study, who cannot be influenced in bad faith
p.(None): by the personnel involved in the study, who is present in the process of obtaining the
p.(None): informed consent if the subject or the representative of the legally accepted subject does not know how to read, and who reads the
p.(None): "Informed Consent Form" and any other written information provided to the subject.
p.(None): to. Research Unit / Research Center: In-hospital entity responsible for: Promoting and
p.(None): develop research in the hospital Train hospital staff who request it in methodology
p.(None): of research, to develop research with internal validity, technically evaluate, support the
p.(None): Page 73 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): logistics, register, monitor and monitor the development of studies carried out in the institution.
p.(None): 78. Compliance Monitoring of the BPC: Periodic Audit of any of the parties involved in the
p.(None): conducting a health study (for example, the CNEIS of researchers, sponsors, etc.), for the purpose
p.(None): to verify compliance with the PCBs and the corresponding regulations.
p.(None): Page 74 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): 11. ANNEXES
p.(None): ANNEX 1. GUIDE TO DEVELOP THE LETTER OF INTENTIONS OF A RESEARCHER / RESEARCH TEAM
p.(None): ON THE LETTER OF INTENTION:
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.(None): Every person / institution / body that will submit a research project must submit it to
p.(None): ethical evaluation considering next steps:
p.(None): No. ACTIVITIES
p.(None): Download the documents for the identification of the fulfillment of prerequisites to the submission of projects of
p.(None): research at the following address: http://www.cneis.org.sv/ section Download documents:
p.(None): http://www.cneis.org.sv/descarga-de-documentos/
p.(None): in which you will find the following information:
p.(None): 1 1. Guide to Good Clinical Practices.
p.(None): 2. Good Clinical Practices Verification Guide.
p.(None): 3. User Guide for the Presentation of Clinical Research Protocols of the Directorate
p.(None): National Medicines.
p.(None): 4. Application Form for evaluation of clinical research protocols in humans.
p.(None): Request Authorization Letter from the authority of the center or centers
p.(None): health (includes hospitals, Minister of Health, Regional Directors of Health in the case of Units
p.(None): Community Family Health
p.(None): two
p.(None): located, private clinics) for conducting the study within
p.(None): the installations. It includes knowledge of the head of the hospital service, if applicable.
p.(None): PERSON IN CHARGE
p.(None): Sponsor / Researchers
p.(None): Principal investigator / team of researchers
p.(None): 3 Prepare Letter of intent of the researcher on the study. Investigator
p.(None): principal
p.(None): Page 14 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): No. ACTIVITIES
p.(None): Print protocol in its original version, with an edition date when the original is written in another language;
p.(None): Protocol translated into Spanish,
p.(None): with edition date and 4 printed copies and an electronic copy.
p.(None): 4
p.(None): Any protocol, independent of its type, must include the section “Ethical considerations”.
p.(None): Consult by telephone or in person with the Assistant of the National Ethics Committee of the
p.(None): Health Research, telephone 2561-2520, CSSP Facilities, building N ° 2, second level, on
p.(None): 5 the fulfillment of requirements for filling out the request for evaluation of medicines to be used
p.(None): in research protocols,
p.(None): as well as the requirements and identification of the payment of tariff or exemption thereof.
p.(None): PERSON IN CHARGE
p.(None): Principal investigator
p.(None): Principal investigator
p.(None): Page 15 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): PROCESS DIAGRAM - PROCEDURE 1
p.(None): PROCEDURE 1
p.(None): REVIEW OF REQUIREMENTS FOR SUBMISSION OF RESEARCH PROJECTS OR PROTOCOLS
p.(None): Sponsor/
p.(None): Researchers
p.(None): Principal investigator/
p.(None): team of researchers
p.(None): Start
p.(None): Download documents to identify compliance with prerequisites
p.(None): http://www.cneis.org.sv/
p.(None): Request authorization letter from the authority of the
p.(None): or health centers
p.(None): Prepare Investigator Letter of Intent
p.(None): about the study
p.(None): Print protocol in its original version, with an edition date when the original is written in another language;
p.(None): Protocol translated into Spanish, with edition date and 3 hard copies and one electronic copy.
p.(None): Consult by telephone or in person with the Assistant of the Committee, on compliance with requirements for
p.(None): the filling of the medication evaluation request to be used in research protocols
p.(None): The end
p.(None): Page 16 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): PROCEDURE 2: RECEPTION OF A HEALTH RESEARCH PROJECT OR PROTOCOL
p.(None): OBJECTIVE: To facilitate the reception of the research protocols submitted to the National Ethics Committee of
p.(None): Health Research (CNEIS) and the National Directorate of Medicines (DNM) for the latter to carry out the
p.(None): respective evaluation.
p.(None): RESPONSIBLE:
p.(None): - Administrative Assistant of the CNEIS.
p.(None): MATERIALS:
p.(None): - Application for Evaluation of Clinical Research Protocols in Human Beings (ANNEX 2)
p.(None): - Document reception form (ANNEX 3).
p.(None): - Electronic file for registration and storage of research projects.
p.(None): DESCRIPTION OF PROCEDURE 2
p.(None): No. ACTIVITIES
p.(None): Receipt of letter of intent and documents according to request guide for evaluation of protocols for
p.(None): investigation.
p.(None): one
p.(None): Tool to use:
p.(None): Application for Protocol Evaluation.
p.(None): PERSON IN CHARGE
p.(None): CNEIS administrative assistant
p.(None): Review Request for Evaluation of Research Protocols
p.(None): Clinic in Human Beings, previous verification of the voucher
p.(None): two
p.(None): of payment of tariffs according to type of investigation and according to source
p.(None): financing, if at least one of the requirements is not met
p.(None): CNEIS administrative assistant
...
p.(None): Compensation for damages
p.(None): Members present
p.(None): one
p.(None): scientific
p.(None): 1 2
p.(None): of the subjects
p.(None): 3
p.(None): favorable profit
p.(None): 4
p.(None): (Declaration of conflict of interest)
p.(None): 5
p.(None): meets requirements
p.(None): 6
p.(None): the subjects
p.(None): 7 8
p.(None): two
p.(None): 3
p.(None): 4
p.(None): 5
p.(None): 6
p.(None): 7
p.(None): 8
p.(None): Total
p.(None): Page 96 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Resolution:
p.(None): Evaluation No. Date I II
p.(None): III
p.(None): Observation
p.(None): Approved without restrictions (ASR)
p.(None): Evaluated with observations and request for amendments (FI)
p.(None): Not approved (RCT)
p.(None): Page 97 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 5A REQUIREMENTS FOR THE DEVELOPMENT OF AN INFORMED CONSENT (CI)
p.(None): Informed Consent is a communicative and deliberative process within the relationship between the researcher and the
p.(None): Subject or potential research participant, where joint decisions and agreements are made +. The
p.(None): form is a documentary support that guarantees that the most relevant information has been offered by the
p.(None): researcher, and received and understood by the Research participant Subject, and allows to verify if there is
p.(None): acceptance or rejection of the proposal.
p.(None): Any informed consent form must include - expressed in understandable language - two parts:
p.(None): Information for the Research Subject and Informed Consent Form.
p.(None): - Information for the Research Subject
p.(None): The written information document is a written summary of the minimum information that must be communicated to
p.(None): the person to comply with the substantive ethical principle of Informed Consent. This information document
p.(None): It will be the basis or guide for verbal explanation and discussion of the study with the Subject or his legal representative. I know
p.(None): recognizes that this document will not be the only source of information that the Subject will receive in the process of
p.(None): Informed consent.
p.(None): Information content:
p.(None): a) That the study involves an investigation (study title).
p.(None): b) The purpose of the study.
p.(None): c) The treatment (or intervention) under study and the probability of randomization to treatment or
p.(None): procedure, where applicable.
p.(None): d) The procedures to follow in the study, including all invasive procedures.
p.(None): + Bravo M, Zunino M.E., Document on “Informed Consent”, CEC SSMS, 2002 and Fernández M., L., Consent
p.(None): informed in clinical practice, 2002.
p.(None): Page 98 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): e) The responsibilities of the Subject.
p.(None): f) Those aspects of the study that are experimental.
...
p.(None): Relevant regulations will not be publicly available. If the results of the study are published, the identity of the
p.(None): Subject will be confidential.
p.(None): o) That the Subject or his legal representative will be informed at all times if new information is available that
p.(None): may be relevant to the subject's decision to continue participating in the study.
p.(None): p) The people to contact for additional information about the study and the
p.(None): Rights of the Subjects of the study, and / or in case of damages related to the study [Researcher
p.(None): principal, co-investigator, data from
p.(None): Page 99 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Health Research Ethics Committee (CEIS) with stamp, date of evaluation and signature of the President].
p.(None): q) The foreseeable circumstances and / or the reasons under which the participation of the
p.(None): Subject in the study.
p.(None): r) The expected duration of the Subject's participation in the study.
p.(None): s) The approximate number of subjects involved in the study.
p.(None): t) In the case of minors, the assent of the minor (s) and the identity of the legal guardian that
p.(None): Sign the Consent.
p.(None): The instrument or form must meet the following requirements:
p.(None): - Must be prepared thinking of a Research Subject, healthy or ill, and not the editor of a magazine
p.(None): scientific The translation from English or another language into Spanish must be adapted to the subject's language and not
p.(None): literal translation.
p.(None): - The contents must be organized in headings.
p.(None): - It must be written with short sentences, using a separate point to separate the sentences.
p.(None): - It must be written in simple words, avoiding the use of technicalities and numerical probabilistic expressions.
p.(None): - If possible, drawings must be included.
p.(None): - The design must be attractive.
p.(None): - Its extension should not be more than 2 pages.
p.(None): - We must evaluate or validate the readability and ease of understanding of the text (with people outside the field of
p.(None): healthcare professionals).
p.(None): Informed Consent Form
p.(None): The Informed Consent Form is the document that the person or their legal representative and the
p.(None): witness (if applicable) will sign and date, to leave with it documented evidence or proof that the Subject
p.(None): has received sufficient information about the study, the research product and its rights as
p.(None): Subject of Research and who wishes to participate freely and voluntarily in the study.
p.(None): If the Subject is illiterate, the signature can be replaced by the fingerprint, but in these
p.(None): Page 100 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Cases must include 2 witnesses.
p.(None): In cases where the Research Subjects are between 12 and 18 years old, in addition to the consent of the parents or
...
p.(None): doctors and / or specialized. It must be submitted for authorization to the corresponding CEIS and notify the Center or
p.(None): Research unit.
p.(None): Details of the Principal Investigator:
p.(None): Name Address:
p.(None): Telephone: E-mail: Fax:
p.(None): Full title of the study:
p.(None): Name of the corresponding CEIS: Reference number of the CEIS: Start date of the study: Protocol reference
p.(None): (if applicable), current version and date:
p.(None): Amendment number and date:
p.(None): Page 123 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Type of amendment (indicate all that apply in bold)
p.(None): (a) Amendment to the information previously given to the CNEIS in the Application Form Yes No
p.(None): If yes, refer to the application section to the CNEIS ("Summary of Changes")
p.(None): (b) Amendment to the protocol
p.(None): If not
p.(None): If yes, submit the revised protocol with a new version number and date, noting the changes clearly,
p.(None): or document a list of changes and the two texts (the previous one and the revised one).
p.(None): (c) Amendment to the information sheet and informed consent (s) for the participants, or any other
p.(None): study support document
p.(None): If not
p.(None): If yes, submit all revised documents with new version numbers and dates, noting changes in form
p.(None): evident.
p.(None): Is this a modified version of an amendment previously notified to the CNEIS and gives an unfavorable opinion?
p.(None): If not
p.(None): Summary of Changes
p.(None): Briefly summarize the main changes proposed in this amendment, with a language
p.(None): Understandable for a layman. Explain the purpose of the changes and their meaning for the study. In
p.(None): Page 124 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): In the case of a modified amendment, indicate the modifications that have been made.
p.(None): If the amendment significantly alters the study design or methodology, or may otherwise affect
p.(None): The scientific value of the study must include supporting scientific information (or attach it separately).
p.(None): Indicate whether additional scientific criticism has been obtained or not.
p.(None): Any other relevant information
p.(None): Those who apply can indicate any specific ethical problem related to the amendment, which is desired
p.(None): the opinion of the CEIS.
p.(None): List of attached documents
p.(None): Document Version Date
p.(None): Statement
p.(None): I confirm that the information in this format is accurate and I assume full responsibility for it.
p.(None): I consider it reasonable that the proposed amendment should be implemented. Signature of the Chief Investigator
p.(None): ……. ………………………………
p.(None): Name …….………………………………
p.(None): Date of submission …………………………………….
p.(None): Page 125 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 10B SUBSTANTIAL AMENDMENT FORMAT FOR CLINICAL PRODUCT TESTS
p.(None): RESEARCH MEDICINALS (PMI)
p.(None): NOTIFICATION OF A SUBSTANCIAL AMENDMENT TO A CLINICAL TRIAL OF A MEDICINAL PRODUCT FOR HUMAN USE, DIRECTED
...
Social / Literacy
Searching for indicator illiterate:
(return to top)
p.(None): Sign the Consent.
p.(None): The instrument or form must meet the following requirements:
p.(None): - Must be prepared thinking of a Research Subject, healthy or ill, and not the editor of a magazine
p.(None): scientific The translation from English or another language into Spanish must be adapted to the subject's language and not
p.(None): literal translation.
p.(None): - The contents must be organized in headings.
p.(None): - It must be written with short sentences, using a separate point to separate the sentences.
p.(None): - It must be written in simple words, avoiding the use of technicalities and numerical probabilistic expressions.
p.(None): - If possible, drawings must be included.
p.(None): - The design must be attractive.
p.(None): - Its extension should not be more than 2 pages.
p.(None): - We must evaluate or validate the readability and ease of understanding of the text (with people outside the field of
p.(None): healthcare professionals).
p.(None): Informed Consent Form
p.(None): The Informed Consent Form is the document that the person or their legal representative and the
p.(None): witness (if applicable) will sign and date, to leave with it documented evidence or proof that the Subject
p.(None): has received sufficient information about the study, the research product and its rights as
p.(None): Subject of Research and who wishes to participate freely and voluntarily in the study.
p.(None): If the Subject is illiterate, the signature can be replaced by the fingerprint, but in these
p.(None): Page 100 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Cases must include 2 witnesses.
p.(None): In cases where the Research Subjects are between 12 and 18 years old, in addition to the consent of the parents or
p.(None): Legal representatives, a Assent Form must be included, which must also be signed by the minor.
p.(None): Page 101 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 5B BASIC STRUCTURE MODEL OF THE INFORMATION DOCUMENT FOR THE RESEARCH SUBJECT AND FORM
p.(None): OF INFORMED CONSENT
p.(None): I-General Information
p.(None): 1- [Study Title]
p.(None): 2- [Protocol Number] 3- [Sponsor / Address]
p.(None): 4- [Principal Investigator]
p.(None): 5- [Telephone]
p.(None): 6- [Participating Centers / Address] 7-. [Introduction]
p.(None): II-Specific information (from the study)
p.(None): 8- [Purpose of the Study] 9- [Background]
p.(None): 10- [Study Duration]
p.(None): 11- [Expected Number of Participating Subjects] 12- [Exclusions]
p.(None): 13- [Study Design]
p.(None): 14- [Study Treatment]
p.(None): 15- [Study Procedures]
p.(None): 16- [Additional / optional studies (Sub-studies)] 17- [Possible Risks and Discomforts]
p.(None): 18- [Precautions]
p.(None): 19- [Women of Fertile Age] 20- [Possible Benefits]
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.(None): Page 65 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): microfiche, photographic negatives, magnetic media or microfilm, X-rays, subjects' files and
p.(None): records kept in pharmacies, in laboratories and in the medical-technical departments involved
p.(None): in the health study).
p.(None): 29. Amendment to the Protocol: Amendments are changes made to a research study, after having
p.(None): obtained a favorable opinion from the ethical point of view of the corresponding CNEIS and the authorization of
p.(None): a regulatory body (unit or research center or others that apply). They can be made to the protocol, to
p.(None): other essential documents and other aspects of the study development. All protocols of
p.(None): study must have clearly written the version number and date, in order to maintain an adequate record and
p.(None): audit; and any amendment must match the date and version number.
p.(None): 30. Clinical Study / Trial (RCT): Any research conducted in humans with the intention of discovering or
p.(None): verify the clinical, pharmacological and / or any other pharmaco-dynamic effects of the product (s) in
p.(None): investigation; and / or identify any adverse reaction to research product (s); and / or to study
p.(None): the absorption, distribution, metabolism and excretion of product (s) under investigation, in order to verify
p.(None): its safety and / or effectiveness.
p.(None): 31. Report of a Clinical Study: A written description of a study of any therapeutic agent,
p.(None): prophylactic or diagnostic performed in humans, in which the clinical and statistical description,
p.(None): Presentations and analyzes are fully integrated into a single report (see International Conference Guide
p.(None): of Harmonization for the Structure and Content of the Clinical Study Reports).
p.(None): 32. Clinical Study, Intermediate Report (“InterimAnalysis”): A report of intermediate results and its
p.(None): evaluation based on analyzes performed during the course of a study.
p.(None): 33. Blind / Masking Study: Procedure in which one or more parts of the study are unaware
p.(None): the assignment (s) to the treatment. Simple blind study generally refers to the fact that the
p.(None): subject (s) do not know the assignment and double blind study refers to the subject (s),
p.(None): Page 66 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Researcher (s), monitor and in some cases the analyst, do not know the allocation to treatment.
p.(None): 34. Multicenter Study: A health study conducted according to a single protocol but in more than
p.(None): a place and, therefore, made by more than one researcher.
p.(None): 35. Non-clinical study: Biomedical studies not performed in humans.
p.(None): 36. Adverse Event (EA): Any adverse medical occurrence in a patient or subject of an investigation
p.(None): in health to whom a pharmaceutical product was administered and which does not necessarily have a
p.(None): causal relationship with this treatment.
p.(None): 37. Adverse Event (EA): It is any unfavorable medical outcome that occurs in a patient or a
p.(None): subject of a clinical trial, who has been given a medicinal product, and who does not necessarily
p.(None): I would have a causal relationship with this treatment. An EA can therefore be any sign
p.(None): unfavorable and unintended (including an abnormal finding on a laboratory test), symptom or disease
p.(None): time period associated with the use of a medicinal product under investigation (PMI), whether it is considered related or not
p.(None): to the PMI.
p.(None): 38. Adverse Reaction (RA): Any unfavorable and unintended response to a PMI, at a certain dose of
p.(None): administration. All EAs, judged as such by the reporting investigator or the sponsor,
p.(None): they qualify as an adverse reaction, as long as they have a reasonable causal relationship to a medicinal product. The
p.(None): Reasonable causal expression means that it converges in general with evidence or argument that suggests a
p.(None): causal relationship
p.(None): 39. Unexpected Adverse Reaction: It is an RA that, by its nature or severity, is not consistent with the information
p.(None): existing about the product, for example, in the researcher's manual for a product under investigation not
p.(None): marketed or in the summary of the product characteristics (CPR) of a product
p.(None): marketed It is also considered unexpected RA when the outcome of an adverse reaction is not consistent.
...
p.(None): B.2 Full title of the essay:
p.(None): B.3 Sponsor's code number for the protocol, version and date:
p.(None): C. IDENTIFICATION OF THE SPONSOR RESPONSIBLE FOR THE APPLICATION
p.(None): C.1 Sponsor
p.(None): C.1.1 Organization:
p.(None): C.1.2 Name of the contact person:
p.(None): C.1.3 Address:
p.(None): C.1.4 Telephone number:
p.(None): C.1.5 Fax number:
p.(None): C.1.6 E-mail:
p.(None): C.2 Legal Representative of the sponsor in the country, for the purpose of the trial (if different from the sponsor)
p.(None): * For substantial amendments, only notify when the competent authority (CA) has determined
p.(None): previously (eg quality data). The sponsor must not only submit the amendment to the CA, but also inform the
p.(None): CEIS that has notified, marking "for information only". Similarly, the sponsor must inform the CA of
p.(None): any notification of a substantial amendment that was previously determined by the CEIS (eg Sites for
p.(None): study completion).
p.(None): Page 127 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): C.2.1 Organization:
p.(None): C.2.2 Name of the contact person:
p.(None): C.2.3 Address:
p.(None): C.2.4 Telephone number:
p.(None): C.2.5 Fax number:
p.(None): C.2.6 E-mail:
p.(None): D. IDENTIFICATION OF THE APPLICANT (Check the appropriate box)
p.(None): D.1 Request to the CEIS
p.(None): D.1.1 Sponsor
p.(None): D.1.2 Legal Representative of the sponsor
p.(None): D.1.3 Person or organization authorized to make the application
p.(None): D.1.4 Researcher in charge of the application, when applicable:
p.(None): D.1.4.1. Study coordinator (for multicentric studies):
p.(None): D.1.4.2. Principal investigator (for single-center trials):
p.(None): D.1.5 Complete
p.(None): D.1.5.1 Organization:
p.(None): D.1.5.2 Name:
p.(None): D.1.5.3 Address:
p.(None): D.1.5.4 Telephone number:
p.(None): D.1.5.5 Fax number:
p.(None): D.1.5.6 E-mail:
p.(None): D.2 Request to the competent authority
p.(None): D.2.1 Sponsor
p.(None): D.2.2 Legal Representative of the sponsor
p.(None): D.2.3 Person or organization authorized by the sponsor to make the application
p.(None): D.2.4 Complete
p.(None): D.2.4.1 Organization:
p.(None): D.2.4.2 Name:
p.(None): Page 128 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): D.2.4.3 Address:
p.(None): D.2.4.4 Telephone number:
p.(None): D.2.4.5 Fax number:
p.(None): D.2.4.6. E-mail:
p.(None): E. IDENTIFICATION OF THE SUBSTANTIAL AMENDMENT
p.(None): E.1 Sponsor's code number for the substantial amendment, version and date for the clinical trial
p.(None): concerning:
p.(None): E.2 Substantial amendment type
p.(None): E.2.1 Amendment to the informed consent information Yes
p.(None): Do not
p.(None): E.2.2 Amendment to the protocol
p.(None): If not
p.(None): E.2.3 Amendment to other attached documents, in the initial application form
p.(None): If not
p.(None): E.2.3.1 If yes, specify:
p.(None): E.2.4 Amendment to other documents or information Yes No
p.(None): E.2.4.1 If yes, specify:
p.(None): E.2.5 This amendment concerns urgent security measures, which have already been implemented
p.(None): If not
p.(None): E.2.6 This amendment is to notify a temporary suspension to the test Yes
p.(None): Do not
p.(None): E.2.7 This amendment is to request to restart the test Yes No
p.(None): E.3 Reason for the substantial amendment:
...
Social / Occupation
Searching for indicator occupation:
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p.(None): MATERIALS:
p.(None): - Final investigation report
p.(None): DESCRIPTION OF THE PROCEDURE 15
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): Prepare summary of the final investigation report
p.(None): within the first 3 months after the end of
p.(None): one
p.(None): process of analysis and interpretation of information
p.(None): Collected in the project.
p.(None): Incorporate the following information in the report:
p.(None): • If the objectives were achieved
p.(None): • Main findings
p.(None): two
p.(None): • Arrangements for publication or dissemination of the
p.(None): research, including any feedback to participants.
p.(None): Review in full final report verifying that the
p.(None): 3
p.(None): information about the motives is complete and give
p.(None): Sponsor / Principal Investigator
p.(None): Sponsor / Principal Investigator
p.(None): CNEIS DNM
p.(None): Page 58 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): income to be placed next to the complete project file.
p.(None): Prepare notification of report review and delivery to
p.(None): 4 principal investigator, sponsor and National Directorate of Medicines
p.(None): CNEIS administrative assistant
p.(None): Page 59 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): PROCEDURE 16. RESEARCH OF THE ARCHIVES OF THE CNEIS
p.(None): OBJECTIVE: To comply with the requirement of Good Clinical Practices for CEIS (in section 3.5.1), which
p.(None): requires keeping all relevant records (written procedures, member lists, lists of
p.(None): membership of members and their occupation, documents submitted, minutes of meetings and correspondence) by a
p.(None): three-year period after completing the study and making them available at the time the
p.(None): regulatory authority (s) request them.
p.(None): RESPONSIBLE:
p.(None): - Members of the Health Research Ethics Committee (CNEIS)
p.(None): FILE CONTENT:
p.(None): The files (sources of printed, magnetic or electronic data) must include, at least:
p.(None): - Procedures manual: regulations, operational guides, manuals, national and / or international standards,
p.(None): technical documents, the procedures manual with their respective annexes, the applicable regulatory texts.
p.(None): - List of identification and curriculum vitae of each member of the CNEIS, updated.
p.(None): - Financial records (fee income, operating expenses), summary of expenses, and forms of
p.(None): consumption and order, or monthly expense.
p.(None): - Minutes of meetings of the Committee, listed consecutively by year.
p.(None): - Reports of CNEIS decisions. Approval Minutes and reports of rejection and suspension ordered
p.(None): correlatively, foliated per year.
p.(None): - Reports of serious adverse events and reports of the Independent Data Monitoring Committees (CSSP),
p.(None): backed by CNEIS analysis reports.
p.(None): - Correspondence received (documentation sent by investigators, correspondence exchanged
p.(None): with them and other actors).
p.(None): - Correspondence dispatched by the CNEIS.
p.(None): Page 60 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): - Protocols evaluated, with all the documentation analyzed, Minutes of Approval, copy of follow-up reports,
p.(None): reports and amendments.
...
Social / Property Ownership
Searching for indicator property:
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p.(None): of a Hospital, University or institution dedicated to research, whose objective is to ensure the protection of the
p.(None): dignity and rights of the people who participate as research subjects *.
p.(None): 14. Independent Data Monitoring Committee (CIMD) (Data Monitoring and Security Council, Monitoring Committee,
p.(None): Data Monitoring Committee): An independent data monitoring committee that the sponsor can
p.(None): establish to evaluate the progress of a health study in intervals, the data
p.(None): Page 63 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): safety and critical points for the evaluation of effectiveness, and recommend to the sponsor if it should
p.(None): continue, modify or stop a study.
p.(None): 15. National Committee for Health Research Ethics (CNEIS): Governing body of the ethical framework for research in
p.(None): health in El Salvador, whose main objective is to protect the rights of the human beings who participate as
p.(None): research subjects and among whose functions is the accreditation of local committees, to develop their
p.(None): functions framed within current regulations.
p.(None): 16. Comparator (Product): A research or commercialized product (for example, active control) or placebo
p.(None): used as a reference in a clinical study.
p.(None): 17. Confidentiality: Failure to disclose to others - unless they are authorized personnel - information that
p.(None): is the property of the sponsor or the identity of a subject.
p.(None): 18. Informed Consent: The process by which a subject voluntarily confirms their desire to
p.(None): participate in a particular study, after being informed about all the relevant aspects so that your
p.(None): Decision regarding your participation be free and responsible. Informed consent is
p.(None): document through a written, signed and dated “Informed Consent Form”.
p.(None): 19. Contract: Written, dated and signed agreement between two persons or more parties involved, which establishes any
p.(None): arrangement on the delegation and distribution of work and obligations for the development of an investigation and, if
p.(None): If necessary, on financial matters. The protocol can serve as the basis for a contract.
p.(None): 20. Quality Control (CC): The techniques and operational activities carried out within the system of
p.(None): quality assurance to verify that the quality requirements of the
p.(None): activities related to the study.
p.(None): 21. Compliance (in relation to studies): Attachment to all requirements related to the study,
p.(None): Good Clinical Practice (BPC) requirements and applicable regulatory requirements.
p.(None): 22. Source Data: All information in original records and certified copies of the original records of
p.(None): clinical findings, observations or other activities in
p.(None): Page 64 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): a health study necessary for the reconstruction and evaluation of the study. The source data is contained in
p.(None): source documents (original records or certified copies).
...
Social / Racial Minority
Searching for indicator minority:
(return to top)
p.(None): 12. Date of edition of the Informed Consent (CI) version
p.(None): Not included or provided
p.(None): Poorly suited
p.(None): Adequate
p.(None): Very suitable
p.(None): Page 88 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): INVESTIGATIONS WITH PEOPLE WHO SUFFER MENTAL AFFECTIONS OR BEHAVIOR DISORDERS
p.(None): Observations:
p.(None): Criteria YES NO
p.(None): The objective of the research seeks to obtain knowledge applicable to the health of this type of people
p.(None): Informed Consent is adapted to your ability to nod
p.(None): There is no risk of mandatory participation
p.(None): The risk-benefit ratio is acceptable.
p.(None): The benefits are superior to the treatments currently available
p.(None): The support of a family member, director or legal guardian is considered in the decision
p.(None): INVESTIGATIONS WITH PARTICIPATION OF PRISONERS
p.(None): Criteria YES NO Comments:
p.(None): The study does not deprive of medications with therapeutic or prophylactic effects, if you have a
p.(None): disease or risk of contracting it
p.(None): The principle of voluntariness is fulfilled
p.(None): Page 89 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): RESEARCH WITH PARTICIPATION OF PERSONS OF ETHNIC COMMUNITIES, MINORITY GROUPS OR VULNERED COMMUNITIES
p.(None): IN HUMAN RIGHTS
p.(None): Criteria YES NO Comments
p.(None): The study does not discriminate against any other community
p.(None): The objective seeks to obtain knowledge applicable to that community
p.(None): Enough information from that community is reported
p.(None): The community is informed of the conduct of the study
p.(None): Informed Consent is adapted to the culture of that community
p.(None): Questions to the researcher, by the members of the National Research Ethics Committee in
p.(None): Health (CNEIS), and complementary information:
p.(None): SAW. GENERAL CONCLUSIONS OF THE ETHICAL ASSESSMENT
p.(None): Information about 0 1 2
p.(None): 3
p.(None): 1. Relevance and extension of the information provided
p.(None): 2. Form of data collection in relation to objectives, statistical analysis and scientific efficiency
p.(None): 3. Potential to extract information with the least exposure of the subjects
p.(None): 4. Justification of the predictable risks and inconveniences with the benefits for the subject
p.(None): 5. Justification of the predictable risks and inconveniences with the benefits for society
p.(None): 6. Adaptation of the researcher to the proposed project according to experience in the subject
p.(None): 7. Adequacy of the place of performance, considering the resources available
p.(None): Page 90 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Information about 0 1 2
p.(None): 3
p.(None): 8. Adequacy of medical supervision and follow-up of subjects
p.(None): 9. Adequacy of forecasts to monitor the course of the investigation
p.(None): 10. Adequacy of the information to be
...
Social / Soldier
Searching for indicator armed forces:
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p.(None): 72. Applicable Regulatory Requirement (s): Any law (s) and regulation (s) that govern
p.(None): Conducting health studies of research products.
p.(None): 73. Site Where the Study is Performed: The place (s) where the related activities are carried out
p.(None): With the study.
p.(None): Page 72 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): 74. Sub-researcher: Any individual member of the health study group, appointed and supervised by the
p.(None): researcher to perform critical procedures related to the study and / or make important decisions
p.(None): related to it (for example, associates, residents, research fellow).
p.(None): 75. Subject of the Study: Individual who participates in a health study, either as a recipient of the
p.(None): product (s) under investigation or as a control. In this document, "subject", "individual" and "person" are used
p.(None): With the same meaning.
p.(None): 76. Vulnerable (or Vulnerated) Subjects: Individuals whose desire to participate in a health study may be
p.(None): influenced by the expectation, justified or not, of the benefits associated with your participation, or of a
p.(None): revenge on the part of the superior members of a hierarchy in case of refusing to participate. By
p.(None): For example, the members of a group with a hierarchical structure, such as that made up of medical students,
p.(None): dentistry, chemical-drug-biological and nursing, subordinate hospital and laboratory personnel,
p.(None): employees of the pharmaceutical industry, members of the armed forces and people who are
p.(None): detained / detained Other vulnerable (or violated) subjects include patients with diseases
p.(None): incurable, people in nursing homes, unemployed or homeless, patients in emergency situations,
p.(None): ethnic minority groups, homeless people, nomads, refugees, minors and those who cannot give their
p.(None): consent.
p.(None): 77. Impartial Witness: A person independent of the study, who cannot be influenced in bad faith
p.(None): by the personnel involved in the study, who is present in the process of obtaining the
p.(None): informed consent if the subject or the representative of the legally accepted subject does not know how to read, and who reads the
p.(None): "Informed Consent Form" and any other written information provided to the subject.
p.(None): to. Research Unit / Research Center: In-hospital entity responsible for: Promoting and
p.(None): develop research in the hospital Train hospital staff who request it in methodology
p.(None): of research, to develop research with internal validity, technically evaluate, support the
p.(None): Page 73 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
...
Social / Unemployment
Searching for indicator unemployed:
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p.(None): National Committee for Health Research Ethics
p.(None): 74. Sub-researcher: Any individual member of the health study group, appointed and supervised by the
p.(None): researcher to perform critical procedures related to the study and / or make important decisions
p.(None): related to it (for example, associates, residents, research fellow).
p.(None): 75. Subject of the Study: Individual who participates in a health study, either as a recipient of the
p.(None): product (s) under investigation or as a control. In this document, "subject", "individual" and "person" are used
p.(None): With the same meaning.
p.(None): 76. Vulnerable (or Vulnerated) Subjects: Individuals whose desire to participate in a health study may be
p.(None): influenced by the expectation, justified or not, of the benefits associated with your participation, or of a
p.(None): revenge on the part of the superior members of a hierarchy in case of refusing to participate. By
p.(None): For example, the members of a group with a hierarchical structure, such as that made up of medical students,
p.(None): dentistry, chemical-drug-biological and nursing, subordinate hospital and laboratory personnel,
p.(None): employees of the pharmaceutical industry, members of the armed forces and people who are
p.(None): detained / detained Other vulnerable (or violated) subjects include patients with diseases
p.(None): incurable, people in nursing homes, unemployed or homeless, patients in emergency situations,
p.(None): ethnic minority groups, homeless people, nomads, refugees, minors and those who cannot give their
p.(None): consent.
p.(None): 77. Impartial Witness: A person independent of the study, who cannot be influenced in bad faith
p.(None): by the personnel involved in the study, who is present in the process of obtaining the
p.(None): informed consent if the subject or the representative of the legally accepted subject does not know how to read, and who reads the
p.(None): "Informed Consent Form" and any other written information provided to the subject.
p.(None): to. Research Unit / Research Center: In-hospital entity responsible for: Promoting and
p.(None): develop research in the hospital Train hospital staff who request it in methodology
p.(None): of research, to develop research with internal validity, technically evaluate, support the
p.(None): Page 73 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): logistics, register, monitor and monitor the development of studies carried out in the institution.
p.(None): 78. Compliance Monitoring of the BPC: Periodic Audit of any of the parties involved in the
p.(None): conducting a health study (for example, the CNEIS of researchers, sponsors, etc.), for the purpose
p.(None): to verify compliance with the PCBs and the corresponding regulations.
...
Social / Victim of Abuse
Searching for indicator abuse:
(return to top)
p.(None): Action taken
p.(None): 0 = None 1 = Dose Reduction
p.(None): receiving the patient when the EAS started
p.(None): Total daily dose
p.(None): start of the most recent cycle
p.(None): (dd mmm yy)
p.(None): at present?
p.(None): 0 = No
p.(None): 1 = Yes
p.(None): End date (dd mmm yy)
p.(None): 2 = Probable
p.(None): 3 = Possible
p.(None): 4 =
p.(None): Unlikely 5 = No
p.(None): related 6 = No
p.(None): evaluable
p.(None): 2 = Delayed treatment 3 = Delayed and reduced treatment 4 = Permanently suspended treatment
p.(None): Page 111 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Patient number in the study
p.(None): Other treatments at the time of the event (Include concomitant medication, radiotherapy, surgery, palliative care).
p.(None): Continue on a separate sheet, if necessary. Exclude therapy administered for the management of EAS.
p.(None): Action taken
p.(None): Treatment
p.(None): Give the generic name of the drugs / treatment given in the last 30 days
p.(None): Total daily dose
p.(None): Route of Administration
p.(None): 1 = Oral 2 = Intravenous 3 = Subcutaneous 4 = Other (specify)
p.(None): Start Date (dd mmm yy)
p.(None): Currently happening?
p.(None): 0 = No
p.(None): 1 = Yes
p.(None): End date (dd mmm yy)
p.(None): 0 = None 1 = Dose reduction 2 = Delayed treatment 3 = Delayed and reduced treatment 4 = Treatment
p.(None): permanently suspended
p.(None): Page 112 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Other relevant information that facilitates the evaluation
p.(None): (Include medical history, drug or alcohol abuse, family history, special research findings, etc.)
p.(None): Was this event expected from the point of view of the patient's medical history?
p.(None): 0 = No
p.(None): 1 = Yes
p.(None): Additional Information:
p.(None): Authorized Health Professional Firm
p.(None): ………………………………………………………….
p.(None): .
p.(None): Contact phone number
p.(None): …………………………………………………………
p.(None): …… ..
p.(None): Name
p.(None): ……………………………………………………
p.(None): ...
p.(None): Report date
p.(None): d d m mm a a
p.(None): OFFICIAL USE ONLY
p.(None): Was the EAS drug related?
p.(None): Yes No Event No
p.(None): Was the event unexpected? Yes No Comments:
p.(None): Was the event a RASIS / SUSAR?
p.(None): Shipping Date Form
p.(None): Date of introduction in the
p.(None): If not
p.(None): d d m mm a a
p.(None): database d d m mm a a
p.(None): Code
p.(None): Page 113 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Form reviewed by
p.(None): (Firm) ……………………………………
p.(None): ………
p.(None): Review by a clinician (Signature) ……………………………………
p.(None): ...
p.(None): Date
p.(None): d d m mm a a
p.(None): Date
p.(None): d d m mm a a
p.(None): Page 114 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 9A SECURITY REPORT. CLINICAL TRIALS OF MEDICINAL RESEARCH PRODUCTS (PMI)
p.(None): Full name of the essay Short title
p.(None): Research product (s) under investigation (PMI) Sponsor
p.(None): CEIS that approved the study Principal investigator Trial start date
p.(None): Trial end date Target number of subjects for the entire trial
...
p.(None): PRESIDENT NAME
p.(None): Page 151 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 17. DECLARATION OF ABSENCE OF CONFLICTS OF INTEREST
p.(None): Declaration of Absence of Conflicts of Interest
p.(None): In the course of performing your duties as under this agreement, you will have
p.(None): access to information owned by the National Committee for Health Research Ethics. You agree to try
p.(None): this information as confidential (hereinafter as "information")
p.(None): I,
p.(None): I compromise to:
p.(None): a) Not to use the information for any other purpose than to fulfill my obligations under this agreement; Y
p.(None): b) Not disclose or provide the information to any third party who does not have a working relationship and
p.(None): Confidentiality in it and to use the information properly.
p.(None): It will not relate to any obligation of confidentiality and will not use it until you are clearly not
p.(None): able to demonstrate that any part of the information:
p.(None): a) It was known by you before any disclosure or discovery by the National Ethics Committee of
p.(None): Health Research, or:
p.(None): b) It was public domain at the time of discovery by the National Committee for Health Research Ethics,
p.(None): or:
p.(None): c) It has become part of the public domain, or:
p.(None): d) It has been available to you by a third party without abuse of trust or of the obligations of
p.(None): Confidentiality to the National Committee for Health Research Ethics.
p.(None): I promise not to communicate the deliberations and results of the team of
p.(None): Page 152 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): in which it participates, as well as the resulting recommendations
p.(None): and / or the decisions of the National Committee for Health Research Ethics to third parties, except as
p.(None): explicitly agreed the National Committee for Health Research Ethics.
p.(None): You will perform your responsibilities exclusively in your capacity as a
p.(None): of the National Committee of Ethics of Health Research. Signing this
p.(None): agreement, you confirm that you have no financial interest and / or other relationship with the parties, which:
p.(None): a) They could have a commercial interest created by obtaining access to any part of the referred information
p.(None): previously and / or:
p.(None): b) You may have an interest created in the result of the appreciation of the products, in which you will participate
p.(None): but it will not limit parties such as the producer that has been evaluated or from competent producers.
p.(None): I accept the provisions and conditions contained in this document and for the record, I sign this document:
p.(None): Name:
p.(None): Entity:
p.(None): Date:
p.(None): Firm:
p.(None): Page 153 of 164
p.(None): Republic of El Salvador
...
Social / Women
Searching for indicator women:
(return to top)
p.(None): If the Subject is illiterate, the signature can be replaced by the fingerprint, but in these
p.(None): Page 100 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Cases must include 2 witnesses.
p.(None): In cases where the Research Subjects are between 12 and 18 years old, in addition to the consent of the parents or
p.(None): Legal representatives, a Assent Form must be included, which must also be signed by the minor.
p.(None): Page 101 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 5B BASIC STRUCTURE MODEL OF THE INFORMATION DOCUMENT FOR THE RESEARCH SUBJECT AND FORM
p.(None): OF INFORMED CONSENT
p.(None): I-General Information
p.(None): 1- [Study Title]
p.(None): 2- [Protocol Number] 3- [Sponsor / Address]
p.(None): 4- [Principal Investigator]
p.(None): 5- [Telephone]
p.(None): 6- [Participating Centers / Address] 7-. [Introduction]
p.(None): II-Specific information (from the study)
p.(None): 8- [Purpose of the Study] 9- [Background]
p.(None): 10- [Study Duration]
p.(None): 11- [Expected Number of Participating Subjects] 12- [Exclusions]
p.(None): 13- [Study Design]
p.(None): 14- [Study Treatment]
p.(None): 15- [Study Procedures]
p.(None): 16- [Additional / optional studies (Sub-studies)] 17- [Possible Risks and Discomforts]
p.(None): 18- [Precautions]
p.(None): 19- [Women of Fertile Age] 20- [Possible Benefits]
p.(None): III Rights of the person
p.(None): 21- [Notification of New Findings] 22- [Treatment Alternatives]
p.(None): Page 102 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): 23- [Options at the end of the Study] 24- [Confidentiality]
p.(None): 25- [Payment per Participation] 26- [Costs]
p.(None): 27- [Compensation for Damages or Injuries Related to the Study] 28- [Voluntary Participation and Retirement]
p.(None): 29- [Questions / Contacts]
p.(None): IV-Consent to participate
p.(None): 30- [General Information]
p.(None): 31- [Subject Consent Statement] 32- [Additional Declarations]
p.(None): 33- [Signature Requirements]
p.(None): Page 103 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 5C CHECKLIST OF INFORMATION DOCUMENT REQUIREMENTS FOR THE SUBJECT OF
p.(None): RESEARCH AND INFORMED CONSENT FORM
p.(None): Protocol No .:
p.(None): Is required:
p.(None): Statement that the study involves research
p.(None): Explanation of the purpose of the investigation
p.(None): Study treatment (s) and probability of randomization for each treatment
p.(None): Expected duration of the person's participation
p.(None): Description of the procedures to follow, including all invasive procedures
p.(None): Responsibilities of the person
p.(None): Identification of any procedures that are experimental
p.(None): Details of any aspect of the study that is experimental
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.(None): - National Committee for Health Research Ethics.
p.(None): - National Directorate of Medicines
p.(None): MATERIALS:
p.(None): - Research protocols.
p.(None): - Guide for identification of a clinical trial (ANNEX 4).
p.(None): EVALUATION MECHANISMS:
p.(None): - Evaluation that requires full: corresponds to projects that involve risks beyond the minimum for
p.(None): research subjects and, therefore, should be evaluated by the majority of the members and be discussed in
p.(None): full. The necessary quorum is half plus one, respecting multidisciplinarity.
p.(None): - Expedited evaluation: corresponds to projects that carry minimal ethical risks for the subjects of
p.(None): investigation and therefore, can be evaluated by two or three members of the Committee without discussion
p.(None): of the full. As well as studies of importance to Public Health, during national emergencies.
p.(None): The two main criteria that an expedited review must meet are:
p.(None): - The study does not involve more than what is considered minimum irrigation
p.(None): Page 19 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): - The study must fit into one or more of the following categories defined by CNEIS itself:
p.(None): ➢ Data collection through non-invasive procedures commonly used in clinical practice.
p.(None): ➢ Studies involving materials already collected, which may be data or samples
p.(None): ➢ Review of the periodic report of a study previously approved by the CIS and that is no longer enrolling new
p.(None): subjects, either that there are no additional risks identified or that it is limited only to data analysis.
p.(None): ➢ Review of minor amendments.
p.(None): Projects that do not require evaluation: corresponds to projects whose purpose is the evaluation of a
p.(None): program, in which its purpose is not to produce new, generalizable knowledge, but its
p.(None): knowledge is relevant only to a specific person or program.
p.(None): DESCRIPTION OF THE PROCEDURE 3
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): Assistant
p.(None): Present to the plenary the investigation protocols and their
p.(None): one
p.(None): full documentation.
p.(None): CNEIS administrative
p.(None): Read the list of summaries of the projects of which
p.(None): two
p.(None): Review requested.
p.(None): CNEIS Secretary
p.(None): Decide the type of evaluation, according to the evaluation mechanisms and the President assigns the persons
p.(None): Who
p.(None): 3
p.(None): will carry out the expedited evaluations and those that require
p.(None): full.
p.(None): CNEIS,
p.(None): Chairman of the Committee
p.(None): Deliver electronic or printed versions of the protocols to
p.(None): 4
p.(None): the members of the committee for evaluation of the protocols,
p.(None): CNEIS Technical Assistant
p.(None): Page 20 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): reporting in the minutes the name of the people to whom the protocols have been delivered.
p.(None): Notifies the Technician in charge of the follow-up of Clinical Trials, for updating databases of
p.(None): assignments of investigation protocols of Committee staff.
p.(None): Page 21 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): PROCEDURE 4: EVALUATION OF PROTOCOLS
...
p.(None): It is necessary that all Security Reports be notified in physical and digital format (Email, CD or
p.(None): Pen drive).
p.(None): DESCRIPTION OF THE PROCEDURE 9
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): Determine if the Clinical Trial corresponds to a Product
p.(None): Medicinal in Research (PMI-ECA) —including the
p.(None): one
p.(None): gene therapy—, or other care research of the
p.(None): Health.
p.(None): Include information about the protocol, contact information, all information about the effects that are not
p.(None): classified
p.(None): two
p.(None): as serious, related to the period (every 6 months and
p.(None): annual report), according to the safety report.
p.(None): Deliver a copy, using the cover and the guide for
p.(None): 3
p.(None): Preparation of the safety report.
p.(None): Sponsor / Principal Investigator
p.(None): Sponsor / Principal Investigator
p.(None): Sponsor / Researcher
p.(None): Page 35 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): principal
p.(None): Receive the documents according to the formats and file with all the documents related to the study.
p.(None): 4
p.(None): Notifies the Technician in charge of the Clinical Trials Follow-up of the DNM.
p.(None): Analyze and update information in Logs of
p.(None): 5
p.(None): tracing.
p.(None): CNEIS administrative assistant
p.(None): Technician in charge of Monitoring Clinical Trials.
p.(None): Page 36 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): PROCEDURE 10. REPORT OF AMENDMENTS
p.(None): OBJECTIVE: To homogenize the procedure for receiving substantial or minor amendments, to studies authorized during
p.(None): the development of the same, sent to the CNEIS
p.(None): or to the CEIS.
p.(None): RESPONSIBLE:
p.(None): - Sponsor
p.(None): - Principal investigator
p.(None): - CNEIS / CEIS
p.(None): - National Directorate of Medicines
p.(None): MATERIALS:
p.(None): - Description of the amendment and amendment report. (ANNEX 10A and 10B).
p.(None): - Reasons for the proposed amendment.
p.(None): - Copy of the proposed changes to the protocol or any other document, demonstrating what was written before and
p.(None): after.
p.(None): - Data supporting the amendment, including any changes to the risk-benefit analysis.
p.(None): TYPES OF AMENDMENT:
p.(None): An amendment to the research project may be substantial or minor (not substantial).
p.(None): Substantial amendment: A substantial amendment may be defined as an amendment to the protocol or to any
p.(None): Another substantial document, which can affect to a significant degree:
p.(None): - The safety or physical or mental integrity of the subjects in the study
p.(None): - The scientific value of the study
p.(None): - Conducting or administering the study
p.(None): Page 37 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): - The quality or safety of any medicinal product under investigation used in the trial.
p.(None): Substantial amendments may be:
p.(None): Amendments related to the protocol
p.(None): - Purpose of the essay
p.(None): - Trial design
p.(None): - Recruitment procedure
p.(None): - Measures of effectiveness
p.(None): - Sample calendar
p.(None): - Added or subtracted from exams or measures
p.(None): - Number of participants
p.(None): - Age range of participants
p.(None): - Inclusion criteria
p.(None): - Exclusion criteria
p.(None): - Security monitoring
p.(None): - Duration of exposure to the medicinal product under investigation
p.(None): - Change of dose of the medicinal product under investigation
p.(None): - Comparator change
p.(None): - Amendments to other study documentation
p.(None): - Participant information sheet
p.(None): - Informed consent
p.(None): - Questionnaires
p.(None): - Invitation card
p.(None): - Letters to the Chief or Principal Investigator, and other clinicians
p.(None): - Information sheets for relatives or caregivers
p.(None): - The file of the Medicinal Product in Research (PMI)
p.(None): - Amendments related to trial arrangements
p.(None): - Change the Principal Investigator or add new ones (this means: researchers who
p.(None): direct the research in each center)
p.(None): Page 38 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): - Change in the coordinating researcher
p.(None): - Change in the study site or add new sites
p.(None): - Change of sponsor or legal representative
p.(None): - Change of the definition of completion of the study
p.(None): - Change in PMI provider
p.(None): Minor (non-substantial) amendment: A minor amendment can be defined as a change in the details of the study that does not
p.(None): it will have significant implications for the participants in it, or for its management, administration or value
p.(None): scientific.
p.(None): Minor amendments can be:
p.(None): - Corrections of typographical errors in the study documents
p.(None): - Minor clarifications to the protocol
p.(None): - Changes in the research team (apart from changes to the Chief or Principal Investigator)
p.(None): - Extension of the study beyond the period specified in the application form
p.(None): - Changes in financing arrangements
p.(None): - Changes in the documentation used by the research team to record the study data (Ex.
p.(None): Case Report Forms)
p.(None): - Changes in logistics arrangements for storage or transport of samples
p.(None): - Inclusion of new sites in studies exempt from “site specific determination” (SSA).
p.(None): It is necessary that all Amendment Reports be notified in physical and digital format (Email, CD or
p.(None): Pen drive).
p.(None): Page 39 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): DESCRIPTION OF THE PROCEDURE 10
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): Determine if the amendment is substantial or not. Taking into account the format information of
p.(None): amendments
p.(None): Substantial for clinical trials of medicinal products
p.(None): 1 under investigation (PMI) and deliver notification format and description of the amendment, together
p.(None): with all updated documentation, such as consent forms or protocols.
p.(None): Send amendment to both the CNEIS and the Center or Unit
p.(None): 2 of Research that authorized the study, before the amendment takes action.
p.(None): Reception and notification of amendment.
p.(None): Deliver to CNEIS and DNM in next session for
p.(None): 3
p.(None): respective review and authorization in next session, prior
p.(None): to the implementation of the amendment.
p.(None): Analyze the amendments, classify the type of amendment as substantial or less.
p.(None): In cases of substantial amendments, it must be ruled whether it is approved or rejected by the National Directorate of
p.(None): Medications and the National Ethics Committee of the
p.(None): 6
p.(None): Health Research, preparing approval certificate
p.(None): before being implemented.
p.(None): In the case of minor amendments, it will be read and sent to file with all the information
p.(None): of the protocol, providing a copy to the DNM.
p.(None): Sponsor / Principal Investigator
p.(None): Sponsor / Principal Investigator
p.(None): CNEIS administrative assistant
p.(None): CNEIS DNM
p.(None): Page 40 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): Assistant
p.(None): Notify the investigator of the authorization, observation or
p.(None): 7
p.(None): Denial of the reported amendment.
p.(None): CNEIS administrative
p.(None): TIMES FOR REVISION OF AMENDMENTS:
p.(None): - In the case of substantial amendments, they must be reviewed within a period of 15 business days, from
p.(None): of the notification by the Administrative Assistant of the CNEIS.
p.(None): - In the case of non-substantial amendments, they must be reviewed within a period of 7 business days, starting from
p.(None): the notification by the Administrative Assistant of the CNEIS.
p.(None): Page 41 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): PROCEDURE 11. REPORT OF SERIOUS DEVIATIONS OF THE STUDY
p.(None): OBJECTIVE: Standardize the procedure for notification of serious deviations from Good Clinical Practices (PCB) or
p.(None): of the approved study protocol.
p.(None): RESPONSIBLE:
p.(None): - Sponsor
p.(None): - Principal investigator
p.(None): - CSSP Audit Team
p.(None): - CNEIS
p.(None): MATERIALS:
p.(None): - Summary of deviations, including justification, according to notification format. (ANNEX 11)
p.(None): It is necessary that all Reports of Serious Deviations in the Study be notified in physical and digital format
p.(None): (Email, CD or USB Memory).
...
p.(None): study, without violating the right to confidentiality of the Subject, as allowed by law and
p.(None): relevant regulations; and that, by signing the Informed Consent form, the Subject or his representative
p.(None): Legally acceptable is authorizing such access.
p.(None): n) That the documents that identify the Subject will be confidential and, as allowed by law and
p.(None): Relevant regulations will not be publicly available. If the results of the study are published, the identity of the
p.(None): Subject will be confidential.
p.(None): o) That the Subject or his legal representative will be informed at all times if new information is available that
p.(None): may be relevant to the subject's decision to continue participating in the study.
p.(None): p) The people to contact for additional information about the study and the
p.(None): Rights of the Subjects of the study, and / or in case of damages related to the study [Researcher
p.(None): principal, co-investigator, data from
p.(None): Page 99 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Health Research Ethics Committee (CEIS) with stamp, date of evaluation and signature of the President].
p.(None): q) The foreseeable circumstances and / or the reasons under which the participation of the
p.(None): Subject in the study.
p.(None): r) The expected duration of the Subject's participation in the study.
p.(None): s) The approximate number of subjects involved in the study.
p.(None): t) In the case of minors, the assent of the minor (s) and the identity of the legal guardian that
p.(None): Sign the Consent.
p.(None): The instrument or form must meet the following requirements:
p.(None): - Must be prepared thinking of a Research Subject, healthy or ill, and not the editor of a magazine
p.(None): scientific The translation from English or another language into Spanish must be adapted to the subject's language and not
p.(None): literal translation.
p.(None): - The contents must be organized in headings.
p.(None): - It must be written with short sentences, using a separate point to separate the sentences.
p.(None): - It must be written in simple words, avoiding the use of technicalities and numerical probabilistic expressions.
p.(None): - If possible, drawings must be included.
p.(None): - The design must be attractive.
p.(None): - Its extension should not be more than 2 pages.
p.(None): - We must evaluate or validate the readability and ease of understanding of the text (with people outside the field of
p.(None): healthcare professionals).
p.(None): Informed Consent Form
p.(None): The Informed Consent Form is the document that the person or their legal representative and the
p.(None): witness (if applicable) will sign and date, to leave with it documented evidence or proof that the Subject
p.(None): has received sufficient information about the study, the research product and its rights as
p.(None): Subject of Research and who wishes to participate freely and voluntarily in the study.
p.(None): If the Subject is illiterate, the signature can be replaced by the fingerprint, but in these
p.(None): Page 100 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Cases must include 2 witnesses.
p.(None): In cases where the Research Subjects are between 12 and 18 years old, in addition to the consent of the parents or
p.(None): Legal representatives, a Assent Form must be included, which must also be signed by the minor.
p.(None): Page 101 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 5B BASIC STRUCTURE MODEL OF THE INFORMATION DOCUMENT FOR THE RESEARCH SUBJECT AND FORM
p.(None): OF INFORMED CONSENT
p.(None): I-General Information
p.(None): 1- [Study Title]
p.(None): 2- [Protocol Number] 3- [Sponsor / Address]
p.(None): 4- [Principal Investigator]
p.(None): 5- [Telephone]
p.(None): 6- [Participating Centers / Address] 7-. [Introduction]
p.(None): II-Specific information (from the study)
p.(None): 8- [Purpose of the Study] 9- [Background]
p.(None): 10- [Study Duration]
p.(None): 11- [Expected Number of Participating Subjects] 12- [Exclusions]
p.(None): 13- [Study Design]
p.(None): 14- [Study Treatment]
p.(None): 15- [Study Procedures]
p.(None): 16- [Additional / optional studies (Sub-studies)] 17- [Possible Risks and Discomforts]
p.(None): 18- [Precautions]
p.(None): 19- [Women of Fertile Age] 20- [Possible Benefits]
p.(None): III Rights of the person
p.(None): 21- [Notification of New Findings] 22- [Treatment Alternatives]
p.(None): Page 102 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): 23- [Options at the end of the Study] 24- [Confidentiality]
p.(None): 25- [Payment per Participation] 26- [Costs]
p.(None): 27- [Compensation for Damages or Injuries Related to the Study] 28- [Voluntary Participation and Retirement]
p.(None): 29- [Questions / Contacts]
p.(None): IV-Consent to participate
...
Social / embryo
Searching for indicator embryo:
(return to top)
p.(None): Information for the Research Subject and Informed Consent Form.
p.(None): - Information for the Research Subject
p.(None): The written information document is a written summary of the minimum information that must be communicated to
p.(None): the person to comply with the substantive ethical principle of Informed Consent. This information document
p.(None): It will be the basis or guide for verbal explanation and discussion of the study with the Subject or his legal representative. I know
p.(None): recognizes that this document will not be the only source of information that the Subject will receive in the process of
p.(None): Informed consent.
p.(None): Information content:
p.(None): a) That the study involves an investigation (study title).
p.(None): b) The purpose of the study.
p.(None): c) The treatment (or intervention) under study and the probability of randomization to treatment or
p.(None): procedure, where applicable.
p.(None): d) The procedures to follow in the study, including all invasive procedures.
p.(None): + Bravo M, Zunino M.E., Document on “Informed Consent”, CEC SSMS, 2002 and Fernández M., L., Consent
p.(None): informed in clinical practice, 2002.
p.(None): Page 98 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): e) The responsibilities of the Subject.
p.(None): f) Those aspects of the study that are experimental.
p.(None): g) The reasonably foreseeable risks and inconveniences for the Subject and, where relevant, for the embryo,
p.(None): Fetus or nursing child.
p.(None): h) Reasonably expected benefits. When no clinical benefit is intended for the Subject, it should be
p.(None): informed of it.
p.(None): i) Alternative procedures or treatments that may exist for the Subject, and its risks and benefits
p.(None): potentials of importance
p.(None): j) The compensation and / or treatment available to the Subject, in the case of damages related to the study.
p.(None): k) Advance payment arrangement, if any, to the Subject participating in the study (for phase I and II studies).
p.(None): l) That the participation of the Subject in the study is voluntary and that the Subject may refuse their participation or
p.(None): abandon a study without penalty or loss of benefits to which you would otherwise have been entitled.
p.(None): m) That the monitor (s), auditor (s), the Ethics Committee and the regulatory authorities will have free
p.(None): access to the original clinical history of the Subject, for the verification of the procedures and / or data of the
p.(None): study, without violating the right to confidentiality of the Subject, as allowed by law and
p.(None): relevant regulations; and that, by signing the Informed Consent form, the Subject or his representative
p.(None): Legally acceptable is authorizing such access.
p.(None): n) That the documents that identify the Subject will be confidential and, as allowed by law and
p.(None): Relevant regulations will not be publicly available. If the results of the study are published, the identity of the
p.(None): Subject will be confidential.
...
p.(None): 21- [Notification of New Findings] 22- [Treatment Alternatives]
p.(None): Page 102 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): 23- [Options at the end of the Study] 24- [Confidentiality]
p.(None): 25- [Payment per Participation] 26- [Costs]
p.(None): 27- [Compensation for Damages or Injuries Related to the Study] 28- [Voluntary Participation and Retirement]
p.(None): 29- [Questions / Contacts]
p.(None): IV-Consent to participate
p.(None): 30- [General Information]
p.(None): 31- [Subject Consent Statement] 32- [Additional Declarations]
p.(None): 33- [Signature Requirements]
p.(None): Page 103 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 5C CHECKLIST OF INFORMATION DOCUMENT REQUIREMENTS FOR THE SUBJECT OF
p.(None): RESEARCH AND INFORMED CONSENT FORM
p.(None): Protocol No .:
p.(None): Is required:
p.(None): Statement that the study involves research
p.(None): Explanation of the purpose of the investigation
p.(None): Study treatment (s) and probability of randomization for each treatment
p.(None): Expected duration of the person's participation
p.(None): Description of the procedures to follow, including all invasive procedures
p.(None): Responsibilities of the person
p.(None): Identification of any procedures that are experimental
p.(None): Details of any aspect of the study that is experimental
p.(None): Description of any reasonably unforeseen risks or discomforts for the person and, when
p.(None): applicable, an embryo, fetus or nursing child
p.(None): When there is no intended clinical benefit for the subject, the person should be aware of it.
p.(None): Description of any benefits reasonably expected for the person or for others
p.(None): Disclosure of specific alternate procedures or treatment appropriate to the person, and their benefits and
p.(None): potential potential risks
p.(None): Any anticipated expenses for the person while participating in the study
p.(None): Proportional advance payment, if any, for the person to participate in the study
p.(None): Explain the conditions under which the researcher can exclude people from the study without their
p.(None): consent
p.(None): Inform the person about who will have access to their medical records (monitor, auditor, JRI,
p.(None): regulatory authorities) to verify the procedures and data of the study, and that the
p.(None): confidentiality to the extent permitted by applicable laws and regulations. If the study results
p.(None): are published, the identity of the person will remain confidential information
p.(None): By signing the Informed Consent Form, the person provides access to their records
p.(None): doctors
p.(None): That the subject's medical records will be kept under strict confidentiality, and will be
p.(None): Page 104 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): protected by applicable local and federal regulations, and will not be made public knowledge
p.(None): Compensation and / or treatment (s) available to the person in the case of a study related injury
p.(None): People to communicate with:
p.(None): For questions about the study
p.(None): For questions about the rights of the person under investigation
p.(None): In the case of a research related injury
p.(None): Statement that participation is voluntary and that the person may withdraw from the study at
p.(None): any time without being punished or losing the benefits to which the person has anyway
p.(None): right
p.(None): Statement of the anticipated circumstances under which the investigator may suspend the
p.(None): participation of the person without the consent of the person
p.(None): Additional costs for the person that may arise from participation in the study
p.(None): The person - or the person's representative - will be notified in a timely manner if new ones develop
p.(None): significant findings during the course of the investigation, which may affect the disposition of
p.(None): the person to continue participating
p.(None): Approximate number of people
p.(None): Consequences of the withdrawal of the person and the procedures at the time of termination
p.(None): Statement that the treatment or procedures may involve risks to the person (or to the person
p.(None): embryo, fetus or nursing child) that are currently unforeseen
p.(None): Page 105 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 6 MINUTES FOR RESOLUTION OF A RESEARCH PROJECT
p.(None): Institution:
p.(None): ACT N °: / EVALUATION ACT
p.(None): HEALTH STUDY PROTOCOL Nº ..........
p.(None): On ……………, on ……. Days of the month of …… del. , H. Committee Committee
p.(None): of Health Research Ethics ………………………………… .., with the assistance of its permanent members:
p.(None): [full name, position on the Committee (chairman, secretary, permanent member, alternate member and the
p.(None): profession of each)] ………………………………………………………………, have reviewed the documents submitted by
p.(None): ..........................., Principal Investigator, namely:
p.(None): 1. Protocol ".................", version ...................
p.(None): 2. Protocol ".................", Spanish version of ....................
p.(None): 3. Investigator Brochure ......
p.(None): 4. Informed Consent Form of the Protocol "...........", Spanish version, ...................
p.(None): 5. The curriculum vitae of ........................................ In addition, to know Background
p.(None): exposed by .................. in the session of the day .............., has considered that the sponsored clinical study
p.(None): by ................, (does not present ethical objections) (presents the following observations):
p.(None): 1) The members of the Committee declared (Having or not having a conflict of interest).
p.(None): 2) The design conforms to the standards of Research in Human Beings.
...
Social / employees
Searching for indicator employees:
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p.(None): applicable to accept, on behalf of a probable candidate, his participation in the health study.
p.(None): 72. Applicable Regulatory Requirement (s): Any law (s) and regulation (s) that govern
p.(None): Conducting health studies of research products.
p.(None): 73. Site Where the Study is Performed: The place (s) where the related activities are carried out
p.(None): With the study.
p.(None): Page 72 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): 74. Sub-researcher: Any individual member of the health study group, appointed and supervised by the
p.(None): researcher to perform critical procedures related to the study and / or make important decisions
p.(None): related to it (for example, associates, residents, research fellow).
p.(None): 75. Subject of the Study: Individual who participates in a health study, either as a recipient of the
p.(None): product (s) under investigation or as a control. In this document, "subject", "individual" and "person" are used
p.(None): With the same meaning.
p.(None): 76. Vulnerable (or Vulnerated) Subjects: Individuals whose desire to participate in a health study may be
p.(None): influenced by the expectation, justified or not, of the benefits associated with your participation, or of a
p.(None): revenge on the part of the superior members of a hierarchy in case of refusing to participate. By
p.(None): For example, the members of a group with a hierarchical structure, such as that made up of medical students,
p.(None): dentistry, chemical-drug-biological and nursing, subordinate hospital and laboratory personnel,
p.(None): employees of the pharmaceutical industry, members of the armed forces and people who are
p.(None): detained / detained Other vulnerable (or violated) subjects include patients with diseases
p.(None): incurable, people in nursing homes, unemployed or homeless, patients in emergency situations,
p.(None): ethnic minority groups, homeless people, nomads, refugees, minors and those who cannot give their
p.(None): consent.
p.(None): 77. Impartial Witness: A person independent of the study, who cannot be influenced in bad faith
p.(None): by the personnel involved in the study, who is present in the process of obtaining the
p.(None): informed consent if the subject or the representative of the legally accepted subject does not know how to read, and who reads the
p.(None): "Informed Consent Form" and any other written information provided to the subject.
p.(None): to. Research Unit / Research Center: In-hospital entity responsible for: Promoting and
p.(None): develop research in the hospital Train hospital staff who request it in methodology
p.(None): of research, to develop research with internal validity, technically evaluate, support the
p.(None): Page 73 of 164
p.(None): Republic of El Salvador
...
Social / ethnic minority
Searching for indicator ethnic minority:
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p.(None): related to it (for example, associates, residents, research fellow).
p.(None): 75. Subject of the Study: Individual who participates in a health study, either as a recipient of the
p.(None): product (s) under investigation or as a control. In this document, "subject", "individual" and "person" are used
p.(None): With the same meaning.
p.(None): 76. Vulnerable (or Vulnerated) Subjects: Individuals whose desire to participate in a health study may be
p.(None): influenced by the expectation, justified or not, of the benefits associated with your participation, or of a
p.(None): revenge on the part of the superior members of a hierarchy in case of refusing to participate. By
p.(None): For example, the members of a group with a hierarchical structure, such as that made up of medical students,
p.(None): dentistry, chemical-drug-biological and nursing, subordinate hospital and laboratory personnel,
p.(None): employees of the pharmaceutical industry, members of the armed forces and people who are
p.(None): detained / detained Other vulnerable (or violated) subjects include patients with diseases
p.(None): incurable, people in nursing homes, unemployed or homeless, patients in emergency situations,
p.(None): ethnic minority groups, homeless people, nomads, refugees, minors and those who cannot give their
p.(None): consent.
p.(None): 77. Impartial Witness: A person independent of the study, who cannot be influenced in bad faith
p.(None): by the personnel involved in the study, who is present in the process of obtaining the
p.(None): informed consent if the subject or the representative of the legally accepted subject does not know how to read, and who reads the
p.(None): "Informed Consent Form" and any other written information provided to the subject.
p.(None): to. Research Unit / Research Center: In-hospital entity responsible for: Promoting and
p.(None): develop research in the hospital Train hospital staff who request it in methodology
p.(None): of research, to develop research with internal validity, technically evaluate, support the
p.(None): Page 73 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): logistics, register, monitor and monitor the development of studies carried out in the institution.
p.(None): 78. Compliance Monitoring of the BPC: Periodic Audit of any of the parties involved in the
p.(None): conducting a health study (for example, the CNEIS of researchers, sponsors, etc.), for the purpose
p.(None): to verify compliance with the PCBs and the corresponding regulations.
p.(None): Page 74 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): 11. ANNEXES
...
Social / parents
Searching for indicator parents:
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p.(None): literal translation.
p.(None): - The contents must be organized in headings.
p.(None): - It must be written with short sentences, using a separate point to separate the sentences.
p.(None): - It must be written in simple words, avoiding the use of technicalities and numerical probabilistic expressions.
p.(None): - If possible, drawings must be included.
p.(None): - The design must be attractive.
p.(None): - Its extension should not be more than 2 pages.
p.(None): - We must evaluate or validate the readability and ease of understanding of the text (with people outside the field of
p.(None): healthcare professionals).
p.(None): Informed Consent Form
p.(None): The Informed Consent Form is the document that the person or their legal representative and the
p.(None): witness (if applicable) will sign and date, to leave with it documented evidence or proof that the Subject
p.(None): has received sufficient information about the study, the research product and its rights as
p.(None): Subject of Research and who wishes to participate freely and voluntarily in the study.
p.(None): If the Subject is illiterate, the signature can be replaced by the fingerprint, but in these
p.(None): Page 100 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Cases must include 2 witnesses.
p.(None): In cases where the Research Subjects are between 12 and 18 years old, in addition to the consent of the parents or
p.(None): Legal representatives, a Assent Form must be included, which must also be signed by the minor.
p.(None): Page 101 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 5B BASIC STRUCTURE MODEL OF THE INFORMATION DOCUMENT FOR THE RESEARCH SUBJECT AND FORM
p.(None): OF INFORMED CONSENT
p.(None): I-General Information
p.(None): 1- [Study Title]
p.(None): 2- [Protocol Number] 3- [Sponsor / Address]
p.(None): 4- [Principal Investigator]
p.(None): 5- [Telephone]
p.(None): 6- [Participating Centers / Address] 7-. [Introduction]
p.(None): II-Specific information (from the study)
p.(None): 8- [Purpose of the Study] 9- [Background]
p.(None): 10- [Study Duration]
p.(None): 11- [Expected Number of Participating Subjects] 12- [Exclusions]
p.(None): 13- [Study Design]
p.(None): 14- [Study Treatment]
p.(None): 15- [Study Procedures]
p.(None): 16- [Additional / optional studies (Sub-studies)] 17- [Possible Risks and Discomforts]
p.(None): 18- [Precautions]
p.(None): 19- [Women of Fertile Age] 20- [Possible Benefits]
p.(None): III Rights of the person
p.(None): 21- [Notification of New Findings] 22- [Treatment Alternatives]
p.(None): Page 102 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): 23- [Options at the end of the Study] 24- [Confidentiality]
p.(None): 25- [Payment per Participation] 26- [Costs]
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
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p.(None): the terms and conditions of appointments, offices, secretariat structure, procedures
p.(None): internal, and quorum requirements. Ethics Committees must act in accordance with their procedures
p.(None): written operations ”5. Glossaries of research ethics define Procedures
p.(None): Standardized operations such as written procedures, detailed for the uniform development of
p.(None): a function6.
p.(None): The procedures differ from the policies in that they are practical, detailed, specific and specific tactics.
p.(None): detailed directives that allow implementing a policy. Written operating procedures are needed because they are
p.(None): requirement to evaluate the proper functioning of a committee, and are the reference used to instruct and remember. Yes
p.(None): well on many occasions institutions can work without written procedures, that is not so effective
p.(None): not desirable. The procedures are not only necessary to meet requirements and be decorative, but must arrive
p.(None): to be a comprehensive and practical description of the different functions of the research ethics committee. The
p.(None): Results of having them would be:
p.(None): - Establish consistency in how situations are handled
p.(None): - Promote a reduction of errors
p.(None): - Provide clarity about responsibility in the distribution of tasks
p.(None): 3 BOE 33, Saturday, February 7, 2004. MINISTRY OF HEALTH AND CONSUMPTION, 2316 ROYAL DECREE 223/2004, of February 6,
p.(None): with which clinical trials with medications are regulated.
p.(None): 4. Opinion of the commissions, bill of clinical investigations with medicines, products
p.(None): doctors, dental products, biological products, gene therapy and cell therapy. The commissions of
p.(None): Social Action and Public Health and General Legislation of the Argentine Republic.
p.(None): 5 Operational guides for ethics committees that evaluate biomedical research, World Health Organization,
p.(None): 2000
p.(None): 6 Definition of terms. General Glossary Course of Introduction to Research Ethics, Bioethics Network
p.(None): Latin American
p.(None): Page 2 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): - Help faster and better training of new committee members
p.(None): - Provide a partial defense against complaints arising from an alleged unequal treatment in determinations
p.(None): of the committees.
p.(None): Within this framework, it is necessary to establish harmonized procedures for Good Clinical Practices defined for
p.(None): our country, which can serve as a basis for both regulatory agencies and researchers, Committees of
p.(None): Ethics, Universities and Companies.
p.(None): Page 3 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): 2. OBJECTIVES
p.(None): 2.1 GENERAL
p.(None): - Standardize the operational procedures of the National Committee for Health Research Ethics (CNEIS) and
p.(None): Local Committee for Health Research (CLEIS) of El Salvador, to guarantee quality in the
...
p.(None): In the case of full evaluations, in the span of
p.(None): four to ten weeks, each member of the committee and the
p.(None): 3 DNM must send the relevant results and comments electronically to the committee secretary.
p.(None): In the case of expedited evaluations, within seven days, send the committee secretary the
p.(None): relevant results and comments electronically.
p.(None): Define the session in which each protocol will be discussed,
p.(None): 4 according to the reception of comments and the evaluation period.
p.(None): In the case of clinical trials that, due to their complexity or specialty, are required to consult a
p.(None): Advisory Committee of Independent Experts, the President of the CNEIS in agreement with the other members thereof,
p.(None): will invite members of groups directly involved in the type of project through official mechanisms
p.(None): proposed (group of patients, family support,
p.(None): 5
p.(None): representatives of community organizations,
p.(None): specialists, statistician, specialist in research methodology, others according to their expertise).
p.(None): This consultation will be an input for the final resolution. This procedure must be performed within the
p.(None): defined period for evaluation.
p.(None): CNEIS members
p.(None): President of CNEIS
p.(None): CNEIS
p.(None): Expert Advisory Committee
p.(None): Page 23 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): Develop the session for the protocol discussion of
p.(None): 5 according to the final resolution guide and establish the corresponding final opinion.
p.(None): The plenary by consensus decides the resolution as follows:
p.(None): Approved without restrictions (ASR)
p.(None): 6
p.(None): Evaluated with observations and request for amendments (FI =
p.(None): Information is missing)
p.(None): Not approved (PRT = Protocol rejected for technical and ethical reasons)
p.(None): CNEIS Reviewers
p.(None): CNEIS Secretary
p.(None): NOTE:
p.(None): The Researcher must inform the National Committee of Health Research Ethics when the Study will begin
p.(None): Clinician authorized by the CNEIS, also must inform when the Clinical Study has finished as
p.(None): established in procedure 14 of this manual.
p.(None): Page 24 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): PROCEDURE 5. ELABORATION OF THE RESOLUTION ACT OF A RESEARCH PROJECT
p.(None): OBJECTIVE: Standardize the preparation of the minutes and the memorandums of notification, evaluation
p.(None): of the research projects that have been submitted to the Committee and the National Directorate of Medicines (in case
p.(None): of a clinical study).
p.(None): RESPONSIBLE:
p.(None): - Secretary of the CNEIS
p.(None): - Administrative assistant
p.(None): MATERIALS:
p.(None): - Guide for the preparation of the resolution document (ANNEX 7)
p.(None): - Notification format for researchers. (ANNEX 8)
p.(None): DESCRIPTION OF THE PROCEDURE 5
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): Prepare the resolution document containing the opinion, which
p.(None): will be signed by the President and the Secretary, placing the
p.(None): one
p.(None): correlative number established by the Committee, using the
p.(None): guide to the minutes of resolution.
p.(None): It clearly identifies the Evaluation Committee, as well as the evaluated research project, the
p.(None): investigator
p.(None): responsible, the place where the recruitment of
p.(None): two
p.(None): patients, the final opinion of the evaluation and the declaration
p.(None): of conflict of interest of the members of the Committee in case it occurs.
p.(None): CNEIS Secretary
p.(None): CNEIS Secretary
p.(None): Page 25 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): Keep the minutes in the Committee file, together with the
p.(None): 3
p.(None): Related documentation.
p.(None): Prepare the memorandum following the notification format for researchers, specifying the respective
p.(None): number the
p.(None): 4
p.(None): Informed consent document approved, sealed and
p.(None): signed on each of its pages.
p.(None): Communicate to the investigator, clearly the times of delivery of information or notification to the CNEIS, which must meet
p.(None): in the cases of (delivery of continuity reports, security reports or adverse events, and all
p.(None): the tracking documents; as well as the validity period of the approval of the research protocol.
p.(None): 5 Information delivery times:
p.(None): ✓ Serious Adverse Events, EAS: first 24 hours.
p.(None): ✓ Serious unrelated adverse events: one week.
p.(None): ✓ Non-serious internal adverse events associated and not associated with the study: three weeks.
p.(None): ✓ Safety and continuity reports: quarterly, semi-annually and annually.
p.(None): Validity of approval of the research protocol: one year.
p.(None): CNEIS administrative assistant
p.(None): CNEIS administrative assistant
p.(None): CNEIS Reviewers
p.(None): Page 26 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): PROCEDURE 6. EVALUATION MEETING WITH THE INVESTIGATOR
...
p.(None): File the corrective action plan with all the
p.(None): 7 information on the research project and notify the Technician in charge of the Monitoring of Tests
p.(None): Clinics
p.(None): Analyze and update information in Logs of
p.(None): 8
p.(None): tracing.
p.(None): CNEIS administrative assistant
p.(None): Technician in charge of Monitoring Clinical Trials.
p.(None): Page 44 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): PROCEDURE 12. PERIODIC REPORT OF PROGRESS IN RESEARCH OR CONTINUITY
p.(None): OBJECTIVES: Homogenize the procedure for receiving the periodic progress report on the investigation, or request
p.(None): of renewal of the ethical evaluation.
p.(None): RESPONSIBLE:
p.(None): - Sponsor
p.(None): - Principal investigator
p.(None): - National Committee for Health Research Ethics
p.(None): MATERIALS:
p.(None): - Continuity Report (ANNEX 12)
p.(None): DESCRIPTION OF THE PROCEDURE 12
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): Prepare continuity report with the information
p.(None): related to:
p.(None): one
p.(None): - Start of inclusion of study subjects
p.(None): - Completion of data collection
p.(None): Request renewal of ethical authorization when the period
p.(None): 2 of validity of the project has ended and it has not ended for different reasons.
p.(None): Receive the continuity report and notify the Technician in charge of Clinical Trials Follow-up.
p.(None): 3
p.(None): Include in the agenda of the next CNEIS meeting, to
p.(None): Review and analysis.
p.(None): Sponsor / Principal Investigator
p.(None): Sponsor / Principal Investigator
p.(None): Administrative assistant
p.(None): Fully evaluate the continuity report and deliver an opinion
p.(None): 4
p.(None): according to exposed information, and prepare notification
p.(None): Administrative Assistant and
p.(None): Page 45 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): of results.
p.(None): Send to the DNM all periodic reports of research progress or continuity.
p.(None): Analyze and update information in Logs of
p.(None): 5
p.(None): tracing.
p.(None): Send notification to principal investigator and CSSP supervisory team. A copy of the notification must be
p.(None): 6
p.(None): filed next to the project information of
p.(None): investigation
p.(None): Technician in charge of Monitoring Clinical Trials.
p.(None): Administrative and Technical Assistant in charge of Monitoring Clinical Trials
p.(None): Administrative assistant
p.(None): Page 46 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): PROCEDURE 13: AUDIT OF GOOD CLINICAL PRACTICES TO RESEARCH CENTERS
p.(None): OBJECTIVES: Define the mechanism and criteria for carrying out the audits of PCBs to all parties
p.(None): involved in clinical research with the purpose of monitoring compliance with them.
p.(None): RESPONSIBLE:
p.(None): - Sponsor
p.(None): - Principal investigator
p.(None): - National Committee for Health Research Ethics
p.(None): - CSSP CSSP Audit Team
p.(None): MATERIALS:
p.(None): - Checklist of requirements for compliance with good clinical practices. (annex 14).
p.(None): DESCRIPTION OF THE PROCEDURE 13
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): Identify the studies that will be inspected according to the following criteria:
p.(None): The importance of proof for decision making
...
p.(None): CEIS.
p.(None): 25. Hospital Management: Instance that, in his position as legal representative of the Hospital, will consider whether
p.(None): the institution and / or the person proposing the study will respect hospital regulations, as well as
p.(None): the confidentiality of the data, and if they may have the right to access the data and the hospital patients.
p.(None): 26. Documentation: All records, in any form (including, but not limited to records
p.(None): written, electronic, magnetic, optical and scanner, X-rays and electrocardiograms, etc.) that describe or record
p.(None): the methods, conduction and / or results of a study, the factors that affect a study and the actions taken.
p.(None): 27. Essential Documents: Documents that individually and collectively allow an evaluation of the conduct of
p.(None): a study, and the quality of general data.
p.(None): 28. Source Documents: Original documents, data and records (eg hospital records, sheets
p.(None): clinics, lab notes, memoranda, subjects diaries or evaluation checklists,
p.(None): pharmacy delivery records, recorded data of automated instruments, copies or
p.(None): certified transcripts after verifying that they are exact copies,
p.(None): Page 65 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): microfiche, photographic negatives, magnetic media or microfilm, X-rays, subjects' files and
p.(None): records kept in pharmacies, in laboratories and in the medical-technical departments involved
p.(None): in the health study).
p.(None): 29. Amendment to the Protocol: Amendments are changes made to a research study, after having
p.(None): obtained a favorable opinion from the ethical point of view of the corresponding CNEIS and the authorization of
p.(None): a regulatory body (unit or research center or others that apply). They can be made to the protocol, to
p.(None): other essential documents and other aspects of the study development. All protocols of
p.(None): study must have clearly written the version number and date, in order to maintain an adequate record and
p.(None): audit; and any amendment must match the date and version number.
p.(None): 30. Clinical Study / Trial (RCT): Any research conducted in humans with the intention of discovering or
p.(None): verify the clinical, pharmacological and / or any other pharmaco-dynamic effects of the product (s) in
p.(None): investigation; and / or identify any adverse reaction to research product (s); and / or to study
p.(None): the absorption, distribution, metabolism and excretion of product (s) under investigation, in order to verify
p.(None): its safety and / or effectiveness.
p.(None): 31. Report of a Clinical Study: A written description of a study of any therapeutic agent,
p.(None): prophylactic or diagnostic performed in humans, in which the clinical and statistical description,
p.(None): Presentations and analyzes are fully integrated into a single report (see International Conference Guide
p.(None): of Harmonization for the Structure and Content of the Clinical Study Reports).
p.(None): 32. Clinical Study, Intermediate Report (“InterimAnalysis”): A report of intermediate results and its
p.(None): evaluation based on analyzes performed during the course of a study.
p.(None): 33. Blind / Masking Study: Procedure in which one or more parts of the study are unaware
...
p.(None): study. If a study is conducted by a group of individuals, the researcher is the responsible leader.
p.(None): of the group and will be called principal investigator.
p.(None): 54. Coordinating Investigator: A researcher, in a Multicenter study, who is assigned the responsibility of
p.(None): coordinate the researchers in the different participating centers.
p.(None): 55. Researcher / Institution: Expression that means “The researcher and / or the Institution, when
p.(None): stipulate the applicable regulatory requirements ”.
p.(None): 56. Head of the Unit / Research Center: Personnel responsible and designated in their hospital function as the
p.(None): Manager of the Research Units / Centers and responsible for compliance with the development standards of
p.(None): health research with human subjects, as well as standard operating procedures.
p.(None): 57. Monitoring: The act of monitoring the process of a health study and ensuring that it is conducted,
p.(None): Registered and reported in accordance with the protocol, Standard Operating Procedures (SOP), Good Practice
p.(None): Clinic (BPC) and the applicable regulatory requirements.
p.(None): 58. Monitoring, Report of: A written report from the monitor to the sponsor, according to the SOPs of the
p.(None): sponsor, after each visit to the study site and / or any other communication related to the study.
p.(None): 59. Level of compliance with the BPC: The level of compliance of the center with the Principles of the BPC, as
p.(None): Evaluate the (National) Surveillance Authority of compliance with the PCBs.
p.(None): Page 70 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): 60. Opinion (in relation to CEIS): The trial and / or advice provided by a CEIS.
p.(None): 61. Contract Research Organization (ICO)
p.(None): ["ContractResearchOrganization" (CRO)]: Person or organization (commercial, academic or otherwise) hired by the
p.(None): Sponsor to perform one or more of the sponsor's duties and functions related to the study.
p.(None): 62. Sponsor: Individual, company, institution or organization responsible for initiating, administering / controlling
p.(None): and / or fund a clinical study.
p.(None): 63. Sponsor-Researcher: Individual who initiates and conducts, alone or with others, a health study
p.(None): and under whose immediate direction the product under investigation is administered (or delivered to, or used) by the
p.(None): subject. The term does not include any person other than an individual (that is, does not include a person
p.(None): corporation or agency). The obligations of a sponsor-researcher include both those of a sponsor
p.(None): like those of a researcher.
p.(None): 64. Standard Operating Procedures (POE) ["Standard OperatingProcedures
p.(None): (SOPs) ”]: Detailed and written instructions to achieve uniformity in the execution of a specific function.
p.(None): 65. Research medicinal product (PMI): Pharmaceutical form of an active ingredient or placebo
p.(None): that is being tested or used as a reference in a health study, including a product with an authorization of
p.(None): marketing when used or conditioned (formulated or packaged) in a different way than
p.(None): approved or when used to obtain more information about a previously approved use.
p.(None): 66. CPB (National) Compliance Monitoring Program: A particular program established by a country
p.(None): to monitor compliance with Good Clinical Practices within its territory, through inspections.
...
p.(None): Pharmacists
p.(None): 12 Stability Studies of Medicines for Human Use
p.(None): 13 Other materials (Promotional, patient card, questionnaires, etc.)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS) (ES P ACIO
p.(None): EXCLUS IVO CNEIS) (ES P ACIO
p.(None): EXCLUS IVO CNEIS) (ES P ACIO
p.(None): EXCLUS IVO CNEIS) (ES P ACIO
p.(None): EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): THE FOLLOWING BOXES ARE NOT FOR USE OR FICIAL. (EXCLUSIVE CNEIS SPACE)
p.(None): 11. FINAL OPINION
p.(None): 11.1 RECEIVED DATE:
p.(None): 11.3 PROCESS RESULT:
p.(None): 11.5 SIGNATURE AND SEAL:
p.(None): Approved Denied
p.(None): 11.2 No. ASSIGNED CNEIS: 11.4 No. APPROVAL DATE:
p.(None): Page 77 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): NATIONAL COMMITTEE OF ETHICS OF HEALTH RESEARCH
p.(None): APPLICATION FOR EVALUATION OF CLINICAL RESEARCH PROTOCOLS IN HUMAN BEINGS
p.(None): 1. DATA OF THE PRO TO CO LO
p.(None): APPLICATION FILLING INSTRUCTION
p.(None): 1.1 PROTOCOL No: Protocol number, as
p.(None): appears in the protocol
p.(None): 1.2 VERSION: Version of
p.(None): protocol that is subject to authorization
p.(None): 1.3 DATE: Date of
p.(None): version of the protocol to authorize
p.(None): 1.4 TITLE OF THE PROTOCOL: Full title, as it appears in the
p.(None): protocol
p.(None): 1.5 NUMBER OF CENTERS: Full name of the centers
p.(None): research where the study will take place
p.(None): 2. CO-INFENTIFIED INFORMATION
p.(None): 2.1 VERSION: Version of
p.(None): informed consent submitted to authorization
p.(None): 2.2 DATE: Date of
p.(None): informed consent submitted to authorization
p.(None): 3. O TRO S DO CUMENTO S (Promotional, patient cards, questionnaires, etc.)
p.(None): 3.1 VERSION: Version number
p.(None): of the document to be authorized
p.(None): 3.2 DATE (DAY / MONTH / YEAR): Date of the document to be authorized
p.(None): 3.3 NAME: Name of the document
p.(None): to be authorized
p.(None): 4. INVESTIGATED MAIN R
p.(None): 4.1 NAMES AND SURNAMES: Full name of the
p.(None): principal investigator.
p.(None): 4.2 EXACT ADDRESS OF THE SITE
p.(None): INVESTIGATION
...
p.(None): Clinical equiponderance: interventions are considered equal in efficacy and safety Suitability
p.(None): of the researcher (training experience, sufficient time for the study) Safety clauses
p.(None): Suitability of research site / facilities JUSTIFICIA
p.(None): Equitable selection of subjects Compensation for damages
p.(None): Social utility
p.(None): Access to interventions
p.(None): VULNERABILITY
p.(None): Vulnerable, discriminated populations have been identified,
p.(None): Page 92 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Principle analysis Adequate Not applicable
p.(None): Inadequate
p.(None): which?
p.(None): Individual guarantees of vulnerability protection are completed
p.(None): The expected results suppose a direct benefit for the participants
p.(None): CONSEQUENCES ANALYSIS
p.(None): For the study subjects
p.(None): For society (responds to the health needs and problems of the country)
p.(None): Page 93 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 4C GUIDE FOR FINAL RESOLUTION
p.(None): At this stage, the important thing is that there is sufficient deliberation for each of the criteria. It's not about
p.(None): Mark the number of people who agree or disagree with the criteria. Only in particular cases, should
p.(None): record if one of the members did not agree with the opinion of the rest and the discussion was exhausted. In case of no
p.(None): If there is agreement, it will be convenient to suspend the discussion and resume it in an upcoming session.
p.(None): Definitions of the numbers in this guide:
p.(None): 1. Evaluate a treatment, intervention or theory that will improve health and well-being, or knowledge.
p.(None): The justification is the scarcity of resources and avoid exploitation. Scientific knowledge is evaluated, the
p.(None): citizen level understanding of social values.
p.(None): 2. The study has a clear hypothesis, uses accepted scientific principles and methods - which
p.(None): they include statistical techniques— to produce reliable and valid data.
p.(None): 3. In the selection of subjects or participants, people or populations are not selected
p.(None): stigmatized, or violated for risky investigations, while the most favored are offered
p.(None): participate in investigations of more beneficial potential (The principle of Distributive Justice is fulfilled).
p.(None): 4. Potential risks and damages are minimized, maximizing potential benefits so that
p.(None): the risks to the subjects are proportional to the benefits and to the society (Respect
p.(None): by the principle of No Maleficence / Charity).
p.(None): 5. The evaluation was carried out with the participation of members outside the investigation, stating whether or not they exist
p.(None): existence of conflict of interest. It fulfills the commitment to render public account. There is independence
p.(None): Intellectual, economic and all kinds of researchers.
p.(None): 6. Informed Consent is clear and understandable. Describe the purpose, its risks and benefits
p.(None): potential, the existing alternatives. Secure the
p.(None): Page 94 of 164
p.(None): Republic of El Salvador
...
p.(None): For use in all cases of research other than clinical trials with PMI.
p.(None): It must be completed legibly and so that people who lack knowledge can understand it
p.(None): doctors and / or specialized. It must be submitted for authorization to the corresponding CEIS and notify the Center or
p.(None): Research unit.
p.(None): Details of the Principal Investigator:
p.(None): Name Address:
p.(None): Telephone: E-mail: Fax:
p.(None): Full title of the study:
p.(None): Name of the corresponding CEIS: Reference number of the CEIS: Start date of the study: Protocol reference
p.(None): (if applicable), current version and date:
p.(None): Amendment number and date:
p.(None): Page 123 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Type of amendment (indicate all that apply in bold)
p.(None): (a) Amendment to the information previously given to the CNEIS in the Application Form Yes No
p.(None): If yes, refer to the application section to the CNEIS ("Summary of Changes")
p.(None): (b) Amendment to the protocol
p.(None): If not
p.(None): If yes, submit the revised protocol with a new version number and date, noting the changes clearly,
p.(None): or document a list of changes and the two texts (the previous one and the revised one).
p.(None): (c) Amendment to the information sheet and informed consent (s) for the participants, or any other
p.(None): study support document
p.(None): If not
p.(None): If yes, submit all revised documents with new version numbers and dates, noting changes in form
p.(None): evident.
p.(None): Is this a modified version of an amendment previously notified to the CNEIS and gives an unfavorable opinion?
p.(None): If not
p.(None): Summary of Changes
p.(None): Briefly summarize the main changes proposed in this amendment, with a language
p.(None): Understandable for a layman. Explain the purpose of the changes and their meaning for the study. In
p.(None): Page 124 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): In the case of a modified amendment, indicate the modifications that have been made.
p.(None): If the amendment significantly alters the study design or methodology, or may otherwise affect
p.(None): The scientific value of the study must include supporting scientific information (or attach it separately).
p.(None): Indicate whether additional scientific criticism has been obtained or not.
p.(None): Any other relevant information
p.(None): Those who apply can indicate any specific ethical problem related to the amendment, which is desired
p.(None): the opinion of the CEIS.
p.(None): List of attached documents
p.(None): Document Version Date
p.(None): Statement
p.(None): I confirm that the information in this format is accurate and I assume full responsibility for it.
p.(None): I consider it reasonable that the proposed amendment should be implemented. Signature of the Chief Investigator
p.(None): ……. ………………………………
p.(None): Name …….………………………………
p.(None): Date of submission …………………………………….
p.(None): Page 125 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 10B SUBSTANTIAL AMENDMENT FORMAT FOR CLINICAL PRODUCT TESTS
p.(None): RESEARCH MEDICINALS (PMI)
p.(None): NOTIFICATION OF A SUBSTANCIAL AMENDMENT TO A CLINICAL TRIAL OF A MEDICINAL PRODUCT FOR HUMAN USE, DIRECTED
p.(None): TO THE HEALTH RESEARCH ETHICS COMMITTEE AND THE COMPETENT AUTHORITY.
p.(None): For official use:
p.(None): Date of receipt of the request: Date:
p.(None): Basis for non-acceptance / negative opinion:
p.(None): Start date of the procedure: Authorization / positive opinion:
p.(None): Registration number of the corresponding CEIS: Withdrawal of the application of the amendment
p.(None): Competent authority for the study: Date:
p.(None): To be filled out by the applicant:
p.(None): This form must be submitted to the corresponding CNEIS, for the opinion on a substantial amendment, and then must
p.(None): present to the competent authority, when applicable.
p.(None): Page 126 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): A. TYPE OF NOTIFICATION
p.(None): A.1 Notification for an opinion of the CNEIS:
p.(None): A.2 Notification to the competent authority:
p.(None): A.3 Information notification only *:
p.(None): A.3.1 To the CNEIS:
p.(None): A.3.2 To the competent authority:
p.(None): B. TEST IDENTIFICATION:
p.(None): B.1 Does the substantial amendment concern several trials involving PMI? If not
p.(None): B.1.1 If the answer is yes, repeat this section as many times as necessary
p.(None): B.2 Full title of the essay:
p.(None): B.3 Sponsor's code number for the protocol, version and date:
p.(None): C. IDENTIFICATION OF THE SPONSOR RESPONSIBLE FOR THE APPLICATION
p.(None): C.1 Sponsor
p.(None): C.1.1 Organization:
p.(None): C.1.2 Name of the contact person:
p.(None): C.1.3 Address:
p.(None): C.1.4 Telephone number:
p.(None): C.1.5 Fax number:
p.(None): C.1.6 E-mail:
p.(None): C.2 Legal Representative of the sponsor in the country, for the purpose of the trial (if different from the sponsor)
p.(None): * For substantial amendments, only notify when the competent authority (CA) has determined
p.(None): previously (eg quality data). The sponsor must not only submit the amendment to the CA, but also inform the
p.(None): CEIS that has notified, marking "for information only". Similarly, the sponsor must inform the CA of
p.(None): any notification of a substantial amendment that was previously determined by the CEIS (eg Sites for
p.(None): study completion).
p.(None): Page 127 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): C.2.1 Organization:
p.(None): C.2.2 Name of the contact person:
p.(None): C.2.3 Address:
p.(None): C.2.4 Telephone number:
p.(None): C.2.5 Fax number:
p.(None): C.2.6 E-mail:
...
p.(None): ADEQUATE RESOURCES YES NO Comments:
p.(None): The researcher must have sufficient time to conduct and properly complete the study within the
p.(None): agreed period.
p.(None): The researcher must have a sufficient number of qualified personnel and adequate facilities for the
p.(None): expected duration of the study in order to conduct it appropriately and safely
p.(None): Training of the research team should be documented including: name of each person trained,
p.(None): training program and dates. Source: Curriculum Vitae
p.(None): Page 144 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): MEDICAL CARE FOR PARTICIPATING STUDENTS
p.(None): Appropriate medical care is provided to the person in case of an adverse event, including values
p.(None): of clinically significant laboratory, related to the study. Source: Protocol
p.(None): There is an authorization letter from the authority of the health center (it includes
p.(None): hospitals, Community Family Health Units, clinics) to carry out the study within
p.(None): the installations. It includes knowledge of the head of the hospital service, if applicable.
p.(None): The researcher must seek through prior agreements with the sponsor the
p.(None): continuity of treatment to research subjects once their
p.(None): Participation in the study if your interruption jeopardizes your safety within the frameworks
p.(None): applicable regulators. Source: procedures described in the research protocol.
p.(None): AUTHORIZATION OF THE ETHICAL CONSIDERATIONS OF THE RESEARCH
p.(None): Before starting a study, the researcher / institution must have the
p.(None): favorable approval / opinion, written and dated, of the CNEIS / CEIS study protocol, the
p.(None): Informed consent form, updates, recruitment procedures
p.(None): of subjects (for example, announcements) and any other written information that will be provided to
p.(None): YES NO Comments:
p.(None): YES NO Comments:
p.(None): Page 145 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): persons
p.(None): COMPLIANCE WITH THE PROTOCOL YES NO Comments:
p.(None): The researcher / institution must conduct the study in accordance with the protocol agreed with the
p.(None): sponsor and favorable approval / opinion of the CNEIS / CEIS and, if necessary, by the authorities
p.(None): Regulatory
p.(None): The investigator or the person designated by the investigator must document and explain any
p.(None): deviation from the approved protocol, except for changes involving only logistic or administrative aspects
p.(None): of the study (for example, change of monitors, change of telephone number).
p.(None): RESEARCH PRODUCTS YES NO Comments:
p.(None): The product delivery records are available to the study site, the inventory on the site, the use
p.(None): in each subject and the return to the sponsor or alternate disposition of the unused medicine
p.(None): The product (s) are stored as specified by the sponsor and in accordance with the
p.(None): applicable regulatory requirements The researcher or a person designated by the researcher / institution must
p.(None): explain the correct use of the product under investigation to each subject and must verify at appropriate intervals
p.(None): for the study, that each subject is following the instructions appropriately.
p.(None): ASSIGNMENT PROCESSES
p.(None): RANDOM AND OPENING OF THE BLIND
p.(None): The researcher must follow the procedures
p.(None): YES NO Comments:
p.(None): Page 146 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): randomization of the study, if any, and you should ensure that the code only
p.(None): open in accordance with the protocol. If the study is blind, the researcher must document and
p.(None): Quickly explain to the sponsor any premature breaking of the code (for example,
p.(None): accidental breakage, breakdown by a serious adverse event) of the product under investigation.
p.(None): PROGRESS REPORTS YES NO Comments:
...
p.(None): I accept the provisions and conditions contained in this document and for the record, I sign this document:
p.(None): Name:
p.(None): Entity:
p.(None): Date:
p.(None): Firm:
p.(None): Page 153 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 18 EXTERNAL EXPERTS
p.(None): 1. OBJECTIVES
p.(None): Establish the criteria for the integration and operation of the Committees of External Experts to guarantee the
p.(None): quality in the documentary and administrative functioning, and comply with international guidelines for the process of
p.(None): decision making of the National Committee for Health Research Ethics.
p.(None): 2. REACH
p.(None): Understand the performance guidelines of professionals hired as External Experts of the National Committee of
p.(None): Health Research Ethics, from your contract for evaluation to the delivery of reports and opinions by
p.(None): part of the Committee of External Experts, in addition to providing guidance to the ethics committees of the
p.(None): research (CNEIS / CEIS) on which organizations depend to examine and monitor the ethics of the
p.(None): research, as well as researchers who design and carry out health research studies.
p.(None): 3. PRIOR REQUIREMENTS
p.(None): Application filed by the National Committee for Health Research Ethics in which it applies
p.(None): conformation of the Committee of External Experts as technical-scientific evaluators that issue an opinion
p.(None): based on your judgment and experience, on certain topics.
p.(None): 4. DESCRIPTION
p.(None): RESPONSIBLE DESCRIPTION
p.(None): The CNEIS may establish and approve by resolution the Committees of External Experts it deems necessary. The
p.(None): Committees will be composed of External Experts and CNEIS officials, with adequate training and experience,
p.(None): which may be permanent or temporary.
p.(None): The CNEIS will establish the organizational structure of the Committees of External Experts in the resolutions of
p.(None): appointment.
p.(None): CREATION OF EXTERNAL EXPERTS COMMITTEES
p.(None): Page 154 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): RESPONSIBLE DESCRIPTION
p.(None): The Committees of External Experts will have a document that will define at least the following elements: objective
p.(None): and scope, composition, designation of the leader, secretariat, declaration of absence of conflict of interest,
p.(None): functions of the members, agenda, minutes and operating procedure including the quorum to meet, members with
p.(None): right to vote and decision making.
p.(None): The Committees of External Experts may be convened according to their schedule of meetings or under
p.(None): justified circumstances, if extraordinary sessions are required to solve problems
p.(None): specific.
p.(None): The members of the Committees of External Experts cannot participate in work sessions if previously
p.(None): have not deposited a declaration of absence of conflict of interest or if the last declaration of absence of
p.(None): Conflict of interest dates back more than a year.
p.(None): In case of absence of deposit of declaration of absence of conflict of interest, it is suspended
...
p.(None): (Call, conformity of the expert's labor entity, Curriculum Vitae, labor profile of the
p.(None): External Expert, declaration of conflicts of interest and copy of the resolution of appointment), and will record the
p.(None): External Experts appointed, with their qualification and professional experience, in the Registers of External Experts of the
p.(None): CNEIS
p.(None): The CNEIS establishes as a prerequisite to the use of the External Expert the signing of its commitment to
p.(None): confidentiality, in relation to all the information that is given to you or that is generated in your work as an Expert
p.(None): External.
p.(None): The External Expert must sign a confidentiality agreement as a sign of their commitment in this regard.
p.(None): The hiring and remuneration of the External Expert will be governed by the applicable regulations of the Procurement Law
p.(None): and Public Administration Contracts (LACAP) and their contract time. The type of contract will be
p.(None): liquidated as professional services, based on the payroll based on specialty, approved.
p.(None): CONFIDENTIALITY D
p.(None): HIRING
p.(None): The period, number of meetings and duration of the Committees of External Experts MEETINGS
p.(None): Page 157 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): RESPONSIBLE DESCRIPTION
p.(None): they may differ due to the type or complexity of the investigation to be carried out and must be justified and defined by
p.(None): the one who chairs it to be included in the minutes of installation of Committees of External Experts with a duration limit
p.(None): 3 months containing in them 6 meetings maximum to make an opinion and respond to the case for which
p.(None): It was shaped.
p.(None): Each Committee of External Experts held at the institution must have established the following:
p.(None): - Name of the leader External Expert
p.(None): - Name of the secretary of the Committee of External Experts
p.(None): - Name of External Experts
p.(None): - Sessions to celebrate
p.(None): - Calls
p.(None): - Quorums
p.(None): - Minutes
p.(None): - Validity
p.(None): To hold the meetings in order to solve a problem in the Committees of External Experts, you must:
p.(None): - Define the Agenda to be developed or the objective of the Committee meeting.
p.(None): - Convene the participants and the guests attaching the agenda to be developed, the objective of the
p.(None): Committee and the purpose of the meeting.
p.(None): - Indicate in the call the information or reports necessary to present during the activity.
p.(None): - Develop the scheduled meeting or activity at the appointed time.
p.(None): - Verify the approval of the previous minutes and the follow-up to commitments of the previous minutes when applicable.
p.(None): - Prepare the attendance record.
p.(None): - Raise Minutes of the results of the development of the agenda highlighting as a priority:
p.(None): - The topics discussed
p.(None): Page 158 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): RESPONSIBLE DESCRIPTION
p.(None): - The decisions made
p.(None): - Assigned tasks or commitments
p.(None): - Record disagreements in decision making.
p.(None): The draft of the minutes is sent by email to the members of the Committee that formed the meeting, with the
p.(None): in order to make the observations or adjustments deemed pertinent.
p.(None): Email comments, corrections and observations regarding the draft of the minutes submitted
...
General/Other / Dependent
Searching for indicator dependent:
(return to top)
p.(None): 7) The curriculum background of the Principal Investigator guarantees the execution of the study within
p.(None): ethically acceptable frameworks.
p.(None): 8) Observations and recommendations
p.(None): Consequently, the Health Research Ethics Committee of ……………………………… .. approves (rejects)
p.(None): unanimity (most of its members)
p.(None): Name and signatures of the president and secretary
p.(None): DC.
p.(None): • Principal investigator.
p.(None): • Institution.
p.(None): • C.E.I.S. Secretariat
p.(None): Page 106 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 7 NOTIFICATION FOR THE MAIN RESEARCHER
p.(None): Institution………………..
p.(None): Health Research Ethics Committee MEMORAND Nº: /
p.(None): ANT .: Minutes of the Council of the Health Research Ethics Committee of ..................
p.(None): MAT .: Submit Evaluation Report .............
p.(None): Date,
p.(None): SR., Dr ................... (Name, position, institution) MAIN RESEARCHER
p.(None): PRESENT.
p.(None): Of our consideration:
p.(None): Attachment I send to you, Informed Consent, final version of. (Date)
p.(None): signed and stamped, and Evaluation Act No. ...... of (date) .........., which certifies that the Board of Ethics Committee
p.(None): of Research in Health of (institution), DICTAMEN the research protocol called “...................”,
p.(None): sponsored by ..................., to perform in ..................., dependent on ... ...
p.(None): We ask you to inform this Committee about the start of the study and inform, within the deadlines
p.(None): established [within the first 24 hours the related serious adverse events, one week the
p.(None): serious unrelated adverse events, three weeks for internal non-serious adverse events], events
p.(None): associated and not associated with the study, quarterly reports and annual safety and continuity reports, the
p.(None): evidence of benefit, rejection of the participation of subjects, the number of subjects enrolled and / or
p.(None): any important antecedents observed during the execution of the investigation, as well as the amendments and
p.(None): deviations, in a timely manner.
p.(None): Page 107 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): In addition, it is reported that the duration of the project approval is one year, extendable according to
p.(None): communication and official request.
p.(None): Say hello,
p.(None): …………………………………………. ..........................................
p.(None): Secretary- President
p.(None): Health Research Ethics Committee
p.(None): DC
p.(None): • Mr., Dr. ………… .............., Principal Investigator.
p.(None): • C.E.I.S. Secretariat
p.(None): Page 108 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 8 SERIOUS ADVERSE EVENTS REPORT FORM
p.(None): Please send via FAX, within the first 24 hours after the event notification.
p.(None): Patient Initials …………………………………………
p.(None): ... ... ................
p.(None): Hospital Registry of
p.(None): patient .............. ……………… ..… ...............
p.(None): Treating doctor. …………………………………………
...
General/Other / Impaired Autonomy
Searching for indicator autonomy:
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p.(None): 6. Adaptation of the researcher to the proposed project according to experience in the subject
p.(None): 7. Adequacy of the place of performance, considering the resources available
p.(None): Page 90 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Information about 0 1 2
p.(None): 3
p.(None): 8. Adequacy of medical supervision and follow-up of subjects
p.(None): 9. Adequacy of forecasts to monitor the course of the investigation
p.(None): 10. Adequacy of the information to be
p.(None): provided to the patient, representatives, witnesses, etc.
p.(None): 11. Means to give information and obtain consent
p.(None): 12. Assurance that participants will have all the information during the investigation
p.(None): relevant available
p.(None): 13. Forecasts to answer the questions and requirements of the participants during the study
p.(None): 14. Health care forecast in case of adverse effect and the degree to which it will be provided
p.(None): 15. Plan to provide the best treatment tested to the subjects, at the end of the investigation
p.(None): 16. Plan to provide the best proven treatment to the community, at the end of the investigation
p.(None): 17. Compensation and compensation provisions for damages
p.(None): 18. Investigator's liability insurance
p.(None): 19. Confidentiality requirements
p.(None): Maximum score 57 points.
p.(None): Page 91 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 4B ETHICAL EVALUATION GUIDE FOR RESEARCH PROTOCOLS DIFFERENT FROM CLINICAL TRIALS
p.(None): Principle analysis Adequate Not applicable
p.(None): Inadequate AUTONOMY
p.(None): Protection of confidentiality Obtaining
p.(None): consent / assent, voluntariness, information, understanding
p.(None): Substitution decisions (legal representative) BENEFIT
p.(None): Risk / benefit ratio Risk not exceeding the minimum NO MALEFICENCE
p.(None): Correct methodology: plausible hypothesis, justification and objectives, sample size
p.(None): Clinical equiponderance: interventions are considered equal in efficacy and safety Suitability
p.(None): of the researcher (training experience, sufficient time for the study) Safety clauses
p.(None): Suitability of research site / facilities JUSTIFICIA
p.(None): Equitable selection of subjects Compensation for damages
p.(None): Social utility
p.(None): Access to interventions
p.(None): VULNERABILITY
p.(None): Vulnerable, discriminated populations have been identified,
p.(None): Page 92 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Principle analysis Adequate Not applicable
p.(None): Inadequate
p.(None): which?
p.(None): Individual guarantees of vulnerability protection are completed
p.(None): The expected results suppose a direct benefit for the participants
p.(None): CONSEQUENCES ANALYSIS
p.(None): For the study subjects
p.(None): For society (responds to the health needs and problems of the country)
p.(None): Page 93 of 164
...
p.(None): The justification is the scarcity of resources and avoid exploitation. Scientific knowledge is evaluated, the
p.(None): citizen level understanding of social values.
p.(None): 2. The study has a clear hypothesis, uses accepted scientific principles and methods - which
p.(None): they include statistical techniques— to produce reliable and valid data.
p.(None): 3. In the selection of subjects or participants, people or populations are not selected
p.(None): stigmatized, or violated for risky investigations, while the most favored are offered
p.(None): participate in investigations of more beneficial potential (The principle of Distributive Justice is fulfilled).
p.(None): 4. Potential risks and damages are minimized, maximizing potential benefits so that
p.(None): the risks to the subjects are proportional to the benefits and to the society (Respect
p.(None): by the principle of No Maleficence / Charity).
p.(None): 5. The evaluation was carried out with the participation of members outside the investigation, stating whether or not they exist
p.(None): existence of conflict of interest. It fulfills the commitment to render public account. There is independence
p.(None): Intellectual, economic and all kinds of researchers.
p.(None): 6. Informed Consent is clear and understandable. Describe the purpose, its risks and benefits
p.(None): potential, the existing alternatives. Secure the
p.(None): Page 94 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): understanding and willingness to make decisions about participation in research (Principle of
p.(None): Autonomy).
p.(None): 7. Respect for people is guaranteed in the sense of: the possibility of allowing them to leave
p.(None): of the investigation, the protection of your privacy through confidentiality, the provision of information about
p.(None): of risks or benefits discovered in the course of the investigation, the provision of information about
p.(None): results of clinical research, continuous monitoring of well-being (Respect for Autonomy and Charity).
p.(None): 8. It is stated in the Informed Consent that the Sponsoring Institution, backed by the policy
p.(None): insurance, covers 100% of expenses for medical treatment for health recovery, due to damage
p.(None): directly related to the study, freeing the subject and his legal representatives from expenses, and the
p.(None): institution where research is carried out.
p.(None): Page 95 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Social value or
p.(None): Scientific validity
p.(None): Equitable selection
p.(None): Risk Reason
p.(None): Decision Criteria
p.(None): Independent evaluation
p.(None): Informed consent
p.(None): Respect for
p.(None): Compensation for damages
p.(None): Members present
p.(None): one
p.(None): scientific
p.(None): 1 2
p.(None): of the subjects
p.(None): 3
p.(None): favorable profit
p.(None): 4
p.(None): (Declaration of conflict of interest)
p.(None): 5
p.(None): meets requirements
p.(None): 6
p.(None): the subjects
p.(None): 7 8
p.(None): two
p.(None): 3
p.(None): 4
p.(None): 5
p.(None): 6
p.(None): 7
p.(None): 8
p.(None): Total
p.(None): Page 96 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Resolution:
p.(None): Evaluation No. Date I II
p.(None): III
p.(None): Observation
p.(None): Approved without restrictions (ASR)
p.(None): Evaluated with observations and request for amendments (FI)
p.(None): Not approved (RCT)
p.(None): Page 97 of 164
p.(None): Republic of El Salvador
...
General/Other / Manipulable
Searching for indicator manipulated:
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p.(None): modify physiological functions, exerting a pharmacological, immunological or metabolic action;
p.(None): or to make a
p.(None): Medical diagnostic; or is it
p.(None): administered in another way, for a medical purpose?
p.(None): A.3 Is it an active substance in a form
p.(None): pharmaceutical?
p.(None): medicinal product with somatic cells ***
p.(None): • A food product (including dietary supplements) not presented as a medication
p.(None): • A cosmetic product
p.(None): +
p.(None): • A medical device
p.(None): adverse reactions?
p.(None): C.4 Study or verify / compare its absorption, distribution, metabolism or
p.(None): excretion?
p.(None): D.2 To determine, verify or
p.(None): compare the
p.(None): medication safety?
p.(None): study of a particular therapeutic strategy, falls within the current practice and does not
p.(None): decide in a protocol, in an advanced clinical trial? viii
p.(None): E.4 Is the decision to prescribe a particular medicinal product,
p.(None): clearly separated from the decision to include the patient in the study?
p.(None): E.5 Do not apply to patients included in the study other than
p.(None): those that apply in current practice?
p.(None): E.6 Will epidemiological methods be used to analyze data coming out of this study?
p.(None): * Substance is any material, regardless of its origin (human, animal, plant or chemical), which is administered to a
p.(None): human being.
p.(None): ** This does not include derivatives of human blood, human cells and human plasma that involves a process of
p.(None): manufacture.
p.(None): *** Somatic cell therapy medicinal products use live somatic cells of human (or animal) origin,
p.(None): whose biological characteristics have been manipulated to obtain a
p.(None): Page 80 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): therapeutic, diagnostic or preventive effect (in humans), through metabolic, pharmacological and
p.(None): immunological
p.(None): Any product ingested that is not a medicine is seen as food. A food cannot be classified as
p.(None): a medicine, unless it contains one or more ingredients generally seen as for a medical purpose or
p.(None): medicinal.
p.(None): + A "cosmetic product" means any substance or preparation with the intention of putting it in contact
p.(None): with various external parts of the human body (epidermis, hair system, nails, lips, and external genital organs),
p.(None): or in teeth and mucous membranes of the oral cavity, with exclusive or main views of cleaning, perfume
p.(None): or protect them in good condition, changes in appearance or correct body odors.
p.(None): Vii Efficacy is the concept of scientifically proving whether - and to what extent - a medicine is capable of
p.(None): diagnose, prevent or treat a disease.
p.(None): Viii The assignment of patients to a treatment group randomly and planned by a trial protocol
p.(None): Clinical cannot be considered as clinical practice.
p.(None): Page 81 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 4A. ASSESSMENT GUIDE FOR A HEALTH RESEARCH PROJECT
p.(None): INSTRUCTIVE:
p.(None): This instrument must be used by each of the members of the CNEIS, during the review of the
p.(None): documentation. It is a guide to review the formal, methodological and ethical aspects of the study. I know
...
General/Other / Public Emergency
Searching for indicator emergency:
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p.(None): researcher to perform critical procedures related to the study and / or make important decisions
p.(None): related to it (for example, associates, residents, research fellow).
p.(None): 75. Subject of the Study: Individual who participates in a health study, either as a recipient of the
p.(None): product (s) under investigation or as a control. In this document, "subject", "individual" and "person" are used
p.(None): With the same meaning.
p.(None): 76. Vulnerable (or Vulnerated) Subjects: Individuals whose desire to participate in a health study may be
p.(None): influenced by the expectation, justified or not, of the benefits associated with your participation, or of a
p.(None): revenge on the part of the superior members of a hierarchy in case of refusing to participate. By
p.(None): For example, the members of a group with a hierarchical structure, such as that made up of medical students,
p.(None): dentistry, chemical-drug-biological and nursing, subordinate hospital and laboratory personnel,
p.(None): employees of the pharmaceutical industry, members of the armed forces and people who are
p.(None): detained / detained Other vulnerable (or violated) subjects include patients with diseases
p.(None): incurable, people in nursing homes, unemployed or homeless, patients in emergency situations,
p.(None): ethnic minority groups, homeless people, nomads, refugees, minors and those who cannot give their
p.(None): consent.
p.(None): 77. Impartial Witness: A person independent of the study, who cannot be influenced in bad faith
p.(None): by the personnel involved in the study, who is present in the process of obtaining the
p.(None): informed consent if the subject or the representative of the legally accepted subject does not know how to read, and who reads the
p.(None): "Informed Consent Form" and any other written information provided to the subject.
p.(None): to. Research Unit / Research Center: In-hospital entity responsible for: Promoting and
p.(None): develop research in the hospital Train hospital staff who request it in methodology
p.(None): of research, to develop research with internal validity, technically evaluate, support the
p.(None): Page 73 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): logistics, register, monitor and monitor the development of studies carried out in the institution.
p.(None): 78. Compliance Monitoring of the BPC: Periodic Audit of any of the parties involved in the
p.(None): conducting a health study (for example, the CNEIS of researchers, sponsors, etc.), for the purpose
p.(None): to verify compliance with the PCBs and the corresponding regulations.
p.(None): Page 74 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
...
p.(None): Title of the section or subsection is on the next page along with their respective content.
p.(None): - Whenever appropriate and to limit the size of the documentation, reference is made to the standards
p.(None): applicable national or international technical and management.
p.(None): - Likewise, you can use colors or other convenient formats, as long as they are
p.(None): formal.
p.(None): DOCUMENTS SUBMISSION
p.(None): - It is requested to present all the documentation ordered according to the correlative index, ringed or
p.(None): pasted, it will depend on the criteria of each researcher.
p.(None): Page 163 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): 12. BIBLIOGRAPHY
p.(None): 1. https://www.ich.org/products/guidelines.html
p.(None): 2. http://unesdoc.unesco.org/images/0013/001393/139309e.pdf Guide No 1: Creation of Bioethics Committees. UNESCO
p.(None): 3. http://www.nlm.nih.gov/nichsr/hta101/ta101014.html
p.(None): 4. http://www.suht.nhs.uk/index.cfm?articleid=2814
p.(None): 5. http://www3.imperial.ac.uk/clinicalresearchgovernanceoffice/standardoperating procedures
p.(None): 6. Council for International Organizations of Medical Sciences. International ethical guidelines for biomedical
p.(None): research involving human subjects (CIOMS). Geneva, Switzerland: World Health Organization 2002 (consulted
p.(None): 2012 Dec 13). Available at http: // www. recerca.uab.es/ceeah/docs/CIOMS.pdf
p.(None): 7. Emanuel EJ, Wendler D, Grady C. What Makes Clinical Research Ethical? JAMA 2000; 283: 2701-2711.
p.(None): 8. An Instructional Guide for Peer Reviewers of Biomedical Manuscripts. Annals of Emergency Medicine
p.(None): (accessed 2012 Dec 5). Available in
p.(None): http://www3.us.elsevierhealth.com/extractor/graphics/em-acep/index.html. 13.
p.(None): 9. Practical guide to health research. Scientific and Technical Publication No. 620. Drafting of the protocol of
p.(None): Research: Presentation of a research proposal. Washington, D.C: Pan American Organization of the
p.(None): Health (PAHO) 2008 (accessed 2012 Dec 2). Available in
p.(None): http://www.sld.cu/galerias/pdf/sitios/ rehabilitacion-bal / ops_protocolo.pdf. 14. Haynes RB, Mulrow CD, Huth EJ,
p.(None): Altman DG, Gardner MJ. More Informative Abstracts Revisited. Ann Intern Med 1990; 113: 69-76. fifteen.
p.(None): 10. How to review the evidence: Systematic Identification and Review of the Scientific Literature. Canberra:
p.(None): National Health and Medical Research Council (NHRMC) 2000 (accessed 2012 Dec 12).
p.(None): Available at http://www.nhmrc.gov.au/_files_nhmrc/publications/ attachments / cp65.pdf.
...
General/Other / Relationship to Authority
Searching for indicator authority:
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p.(None): of Health and Consumption, in its article 14, literal 2, it is mentioned that “the Clinical Research Ethics Committees
p.(None): they must elaborate and follow for their
p.(None): 1 * In general, we will talk about “Health Research Ethics Committee”, instead of “Ethics Committee of
p.(None): Clinical Research ”, which has dominated until recently. This is due to the trend that seeks to modify
p.(None): the very nature of these committees, so that they are increasingly broad and inclusive. However,
p.(None): because it is something that is in process and in many official documents it follows
p.(None): Speaking of "clinical research", both expressions can be found in this document.
p.(None): 1 Mile L., Operational guides for the operation of a CEC. University of Chile, Bioethics Unit, PAHO / WHO.
p.(None): 2 Good Clinical Practices-Document of the Americas, Pan American Health Organization, 2005.
p.(None): Page 1 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): operation of standard work procedures ”3, and also mentioned in the guidelines
p.(None): contained in B.O. 09/21/11 - Resolution 1480/11-MS - Approving the Guide for Research with Human Beings, in
p.(None): Argentina4.
p.(None): Operational guidelines for the operation of a research ethics committee dictated by WHO
p.(None): They refer: “The Ethics Committees must publicly indicate the operational procedures that determine the authority
p.(None): under which the committee is established, the functions and tasks of the Ethics Committees, the requirements of its members,
p.(None): the terms and conditions of appointments, offices, secretariat structure, procedures
p.(None): internal, and quorum requirements. Ethics Committees must act in accordance with their procedures
p.(None): written operations ”5. Glossaries of research ethics define Procedures
p.(None): Standardized operations such as written procedures, detailed for the uniform development of
p.(None): a function6.
p.(None): The procedures differ from the policies in that they are practical, detailed, specific and specific tactics.
p.(None): detailed directives that allow implementing a policy. Written operating procedures are needed because they are
p.(None): requirement to evaluate the proper functioning of a committee, and are the reference used to instruct and remember. Yes
p.(None): well on many occasions institutions can work without written procedures, that is not so effective
p.(None): not desirable. The procedures are not only necessary to meet requirements and be decorative, but must arrive
p.(None): to be a comprehensive and practical description of the different functions of the research ethics committee. The
p.(None): Results of having them would be:
p.(None): - Establish consistency in how situations are handled
p.(None): - Promote a reduction of errors
p.(None): - Provide clarity about responsibility in the distribution of tasks
p.(None): 3 BOE 33, Saturday, February 7, 2004. MINISTRY OF HEALTH AND CONSUMPTION, 2316 ROYAL DECREE 223/2004, of February 6,
p.(None): with which clinical trials with medications are regulated.
...
p.(None): duly completed in printed format:
p.(None): - Application Form for evaluation of clinical research protocols in humans (Annex 2)
p.(None): Page 8 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): - Letter requesting evaluation of the protocol addressed to the ethics committee (original or copy).
p.(None): - Complete original protocol of the study in Spanish, containing original informed consent,
p.(None): Informed assent (if applicable) and investigator's brochure (Legal documents must be submitted in
p.(None): Spanish or with their respective translation, in accordance with Salvadoran notarial legislation; in the case of
p.(None): documents from abroad, must be presented apostilled or consularized, in original and copy
p.(None): for confrontation.)
p.(None): - Four copies of the full protocol of the study in Spanish and one copy in electronic.
p.(None): - Report (summary) of pre-clinical phase I and Phase II studies when applicable.
p.(None): - Information on the insurance policy for the research subject granted by the sponsor, specifying the
p.(None): Applicability mechanism in El Salvador.
p.(None): - Curriculum vitae of the principal investigator and co-investigators.
p.(None): - Proof of payment of tariff.
p.(None): - Payment method of the researcher in El Salvador (attach a copy of the contract).
p.(None): - Letter of authorization from the center or centers where the study will be carried out.
p.(None): - Investigator's commitment to good clinical practices.
p.(None): - Certificate of Good Manufacturing Practices (BPM) of the manufacturer or Certificate of BPM
p.(None): issued by the Local Regulatory Authority. Applies if the product is not registered.
p.(None): - Primary and secondary packaging arts of the product or products to be used in the clinical study, which
p.(None): contain the lot numbers and the date of manufacture and expiration.
p.(None): - Other materials (Promotional, patient card, questionnaires, etc.).
p.(None): - Copy of the certificate of authorization of operation of the Health establishment where the
p.(None): Clinical Study, issued by the Higher Council of Public Health.
p.(None): - Copy of the updated payment of the operating annuity of the establishment of
p.(None): health where the clinical study will take place.
p.(None): Page 9 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Recognitions of documents related to Clinical Research
p.(None): The National Committee for Health Research Ethics, the National Directorate of Medicines and the Superior Council
p.(None): Public Health, may officially recognize relevant decisions, reports or information from trials
p.(None): Clinics of drug regulatory agencies that have been certified level IV by the Organization
p.(None): Pan American Health (PAHO), as well as by health authorities of the United States of America, Canada,
p.(None): Australia, Switzerland, Japan and by the European Medicines Agency (EMA) and other countries that have
p.(None): specific regulation for the regulation of Clinical Trials.
p.(None): In the case of drug research protocols that require evaluation in beings
p.(None): human, its review will be applicable regardless of the primary origin of the application, be it from the sector
p.(None): National, foreign, public or private.
...
p.(None): In the case of investigations already initiated with molecules, invasive clinical procedures, sample handling
p.(None): blood or biological tissue collection for genetic analysis, which have not received an initial audit,
p.(None): CNEIS will indicate audit of studies already initiated. The payment of tariffs for the execution of Good Audits
p.(None): Clinical Practices according to the previous condition is as follows:
p.(None): CPB compliance review in studies already initiated
p.(None): Duty
p.(None): International pharmaceutical companies US $ 900.00
p.(None): National pharmaceutical companies US $ 600.00 Non-organizations
p.(None): non-governmental
p.(None): profit and foreign companies or universities
p.(None): $ 600.00
p.(None): Page 13 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): DESCRIPTION OF THE PROCEDURE 1
p.(None): Every person / institution / body that will submit a research project must submit it to
p.(None): ethical evaluation considering next steps:
p.(None): No. ACTIVITIES
p.(None): Download the documents for the identification of the fulfillment of prerequisites to the submission of projects of
p.(None): research at the following address: http://www.cneis.org.sv/ section Download documents:
p.(None): http://www.cneis.org.sv/descarga-de-documentos/
p.(None): in which you will find the following information:
p.(None): 1 1. Guide to Good Clinical Practices.
p.(None): 2. Good Clinical Practices Verification Guide.
p.(None): 3. User Guide for the Presentation of Clinical Research Protocols of the Directorate
p.(None): National Medicines.
p.(None): 4. Application Form for evaluation of clinical research protocols in humans.
p.(None): Request Authorization Letter from the authority of the center or centers
p.(None): health (includes hospitals, Minister of Health, Regional Directors of Health in the case of Units
p.(None): Community Family Health
p.(None): two
p.(None): located, private clinics) for conducting the study within
p.(None): the installations. It includes knowledge of the head of the hospital service, if applicable.
p.(None): PERSON IN CHARGE
p.(None): Sponsor / Researchers
p.(None): Principal investigator / team of researchers
p.(None): 3 Prepare Letter of intent of the researcher on the study. Investigator
p.(None): principal
p.(None): Page 14 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): No. ACTIVITIES
p.(None): Print protocol in its original version, with an edition date when the original is written in another language;
p.(None): Protocol translated into Spanish,
p.(None): with edition date and 4 printed copies and an electronic copy.
p.(None): 4
p.(None): Any protocol, independent of its type, must include the section “Ethical considerations”.
p.(None): Consult by telephone or in person with the Assistant of the National Ethics Committee of the
p.(None): Health Research, telephone 2561-2520, CSSP Facilities, building N ° 2, second level, on
p.(None): 5 the fulfillment of requirements for filling out the request for evaluation of medicines to be used
p.(None): in research protocols,
p.(None): as well as the requirements and identification of the payment of tariff or exemption thereof.
p.(None): PERSON IN CHARGE
p.(None): Principal investigator
p.(None): Principal investigator
p.(None): Page 15 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): PROCESS DIAGRAM - PROCEDURE 1
p.(None): PROCEDURE 1
p.(None): REVIEW OF REQUIREMENTS FOR SUBMISSION OF RESEARCH PROJECTS OR PROTOCOLS
p.(None): Sponsor/
p.(None): Researchers
p.(None): Principal investigator/
p.(None): team of researchers
p.(None): Start
p.(None): Download documents to identify compliance with prerequisites
p.(None): http://www.cneis.org.sv/
p.(None): Request authorization letter from the authority of the
p.(None): or health centers
p.(None): Prepare Investigator Letter of Intent
p.(None): about the study
p.(None): Print protocol in its original version, with an edition date when the original is written in another language;
p.(None): Protocol translated into Spanish, with edition date and 3 hard copies and one electronic copy.
p.(None): Consult by telephone or in person with the Assistant of the Committee, on compliance with requirements for
p.(None): the filling of the medication evaluation request to be used in research protocols
p.(None): The end
p.(None): Page 16 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): PROCEDURE 2: RECEPTION OF A HEALTH RESEARCH PROJECT OR PROTOCOL
p.(None): OBJECTIVE: To facilitate the reception of the research protocols submitted to the National Ethics Committee of
p.(None): Health Research (CNEIS) and the National Directorate of Medicines (DNM) for the latter to carry out the
p.(None): respective evaluation.
p.(None): RESPONSIBLE:
p.(None): - Administrative Assistant of the CNEIS.
p.(None): MATERIALS:
p.(None): - Application for Evaluation of Clinical Research Protocols in Human Beings (ANNEX 2)
p.(None): - Document reception form (ANNEX 3).
p.(None): - Electronic file for registration and storage of research projects.
p.(None): DESCRIPTION OF PROCEDURE 2
p.(None): No. ACTIVITIES
p.(None): Receipt of letter of intent and documents according to request guide for evaluation of protocols for
p.(None): investigation.
p.(None): one
p.(None): Tool to use:
p.(None): Application for Protocol Evaluation.
p.(None): PERSON IN CHARGE
p.(None): CNEIS administrative assistant
p.(None): Review Request for Evaluation of Research Protocols
...
p.(None): RESPONSIBLE:
p.(None): - Sponsor
p.(None): - Principal investigator
p.(None): - Administrative assistant
p.(None): - Chairman of the committee
p.(None): - Member of the CNEIS
p.(None): - National Pharmacovigilance Center
p.(None): - Specialist Physician of the National Directorate of Medicines
p.(None): - Lead Inspector of the Higher Council of Public Health
p.(None): - Technician in charge of Monitoring Clinical Trials
p.(None): MATERIALS:
p.(None): - Report of serious adverse events (EAS) and SUSAR using the form (ANNEX 8).
p.(None): REQUIREMENT:
p.(None): - All EAS and SUSAR must be presented in Spanish.
p.(None): CONTACTS FOR NOTIFICATION OF ADVERSE EVENTS CNEIS
p.(None): Email: cneiselsalvador@cssp.gob.sv
p.(None): Phone: 25612520
p.(None): Page 31 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): DNM
p.(None): Mail: assay.clinicos@medicamentos.gob.sv
p.(None): Telephone: 2522-5000
p.(None): CNFV
p.(None): Email: cnfv.elsalvador@gmail.com
p.(None): Telephone: 2522-5056
p.(None): Download site to RAM report form:
p.(None): http://cnfv.salud.sv/alertas-nacionales-de-seguridad/
p.(None): Types of adverse effects (AD):
p.(None): EA classification
p.(None): Adverse events can be classified into different categories:
p.(None): - Adverse Event (EA)
p.(None): - Adverse reaction (RA)
p.(None): - Unexpected adverse reaction (RAI)
p.(None): - Serious Adverse Event (EAS) or Serious Adverse Reaction (RAS)
p.(None): - Serious Adverse Reaction Suspected (RASS)
p.(None): - Adverse Reaction Serious Unexpected Suspected (RASIS / SUSAR)
p.(None): RESPONSIBILITIES
p.(None): There is a certain degree of responsibility when managing adverse events. When there is no sponsor
p.(None): externally, the research authority of the institution in charge of the project will fulfill the role of the sponsor. The
p.(None): Principal investigator (IP) or chief investigator (IJ) has full responsibility for conducting the study. In
p.(None): A Multicentre study, the IP has coordinated responsibilities to report adverse events to the CNEIS and the
p.(None): DNM In the case of studies of products already registered in the DNM that evaluate a new, new indication
p.(None): concentration if it is higher than the one already registered, new dosage or new dosage form for the purpose of
p.(None): registry; All studies of pharmacokinetics, bioavailability and bioequivalence will also be reported to
p.(None): CNFV Any IP / IJ that you have accepted to upload
p.(None): Page 32 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): with the areas of Pharmacovigilance, delegated by the sponsor, you must take both responsibilities, those of the IP and
p.(None): those of the sponsor.
p.(None): Serious Adverse Event (EAS) or Serious Drug Adverse Reaction (Serious RAM)
p.(None): Any unfavorable occurrence that at any dose:
p.(None): (a) results in death,
p.(None): (b) life threatening, requires patient hospitalization or prolongation of existing hospitalization,
p.(None): (c) results in persistent or significant disability / disability, or is a congenital anomaly / defect
p.(None): of birth
p.(None): Which EAS to report?
p.(None): - The management and reporting of arrangements for EAS must be implemented in all trials. In the agreements
p.(None): at the beginning of the trial, it should be established that EAS are defined as related to the disease and that, therefore,
...
p.(None): event (Ex. The clinical condition of the participant, other concomitant treatment, etc.).
p.(None): There is some evidence that suggests a causal relationship (eg because the event occurred within a while
p.(None): reasonable after administered on
p.(None): Page 34 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Relationship Description
p.(None): medication under study). However, the influence of other factors may have contributed to the event (eg.
p.(None): clinical condition of the patient, other concomitant treatments, etc.).
p.(None): There is evidence that suggests a causal relationship and there seems to be no influence
p.(None): Probable
p.(None): Definitive
p.(None): Cannot be evaluated
p.(None): of other factors.
p.(None): There is clear evidence of a causal relationship and any influence of other contributing factors may be
p.(None): discarded
p.(None): There is insufficient or incomplete evidence to make a clinical trial of causal relationship.
p.(None): All serious adverse events (EAS) should be reported immediately except those EAS that the
p.(None): protocol or other document (for example, Researcher's Brochure) identify that they do not need an immediate report.
p.(None): Immediate reports should be followed by detailed written reports.
p.(None): All local investigators must report any EAS or SUSAR, as required by the Committee on
p.(None): Local, National Research Ethics and the competent authority.
p.(None): It is necessary that all EAS and SUSAR be notified in physical and digital format (Email, CD or Memory
p.(None): USB)
p.(None): The CNEIS, must send all the information of EAS and / or SUSAR to the DNM, so that it carries out the evaluation and the
p.(None): corresponding tracking. If the EAS and / or SUSAR is related to the investigational drug, the DNM has the
p.(None): authority to suspend the prescription, dispensation and supply of investigational drugs, as
p.(None): established in article 74 of the Medicines Law, in order to control the sanitary surveillance of medicines.
p.(None): The CNEIS must send to the CNFV the results of the Clinical Trials of the medications that are
p.(None): they are registered with the DNM, regarding security and
p.(None): Page 35 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): effectiveness to compare them with the safety assessment contained in the Periodic Safety Reports
p.(None): (IPS) and Risk Management Plans (PGR).
p.(None): For all those Clinical Trials that have been carried out in El Salvador, the CNFV may request the data from the CNEIS
p.(None): obtained from the clinical study.
p.(None): DESCRIPTION OF THE PROCEDURE 8
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): When an EAS occurs, RAM would be, RAM would not be unexpected or SUSAR in El Salvador, the researcher
p.(None): shall
p.(None): inform the National Ethics Committee to the National Directorate
p.(None): one
p.(None): of Medicines and the National Pharmacovigilance Center
p.(None): (CNFV) within the first 24 hours from the knowledge by the principal investigator.
p.(None): For EAS and SUSAR:
p.(None): Prepare the report of serious adverse events (EAS) and SUSAR using the form; classified according to Dictionary
p.(None): doctor for systems regulatory activities (MedRA) and the form for reporting adverse events.
p.(None): For RAM Serious or Not Serious for Medications in
p.(None): 2 research that already have a Health Registry, the researcher must report the RAM
p.(None): Serious, through the following ways:
...
p.(None): 9
p.(None): - The dosage
p.(None): - The route of administration
p.(None): - The frequency of administration
p.(None): - Masking procedures
p.(None): - If there are differences, determine if they were documented by protocol modifications and if they are
p.(None): approved in accordance with the applicable regulatory requirements.
p.(None): Compare the original source data of the records of
p.(None): 10 the subjects with the data collection notebooks or the final report for the sponsor, in order
p.(None): to verify that
p.(None): CSSP Audit Team
p.(None): CSSP Audit Team
p.(None): Page 50 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): Source data has been fully and accurately notified. Select a representative sample of the
p.(None): subjects recruited at intervals, at the beginning, in the middle and at the end of the study. However, if a
p.(None): significant problem in a particular area (for example, not taking the test medication as required),
p.(None): audit this particular aspect of the study in all subjects. Identify source data that supports the following
p.(None): fundamental points:
p.(None): Were there subjects and went to the visits as notified? Subjects admitted to the study or those who
p.(None): completed,
p.(None): Did they meet the inclusion or exclusion criteria of the protocol?
p.(None): Regarding the dose and frequency of administration, did the subjects receive the
p.(None): trial medication according to the protocol?
p.(None): Were the significant assessment criteria data fully and correctly obtained and notified, with
p.(None): according to the protocol?
p.(None): Were adverse events reported to the sponsor and the regulatory authority?
p.(None): Review the study records of each subject to verify the correct administration of the dose in what is
p.(None): refers to the quantity, frequency, duration and route of administration.
p.(None): 11 In addition, examine the shipping and distribution records of the drug to reconstruct the route of
p.(None): distribution of the test drug and check the dates of receipt, the quantity and the
p.(None): medication identity of
p.(None): CSSP Audit Team
p.(None): Page 51 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): test, and to compare the use of the test drug with the amounts sent and returned to the promoter at the end of
p.(None): study. If unused supplies are not returned to the sponsor, the supervisor will verify that the
p.(None): Alternative provision was handled appropriately and documented. The supervisor will verify that the medication
p.(None): of the test was kept under appropriate conditions.
p.(None): Conclude the Audit by making its final comments to the clinical investigator. The supervisor will explain and comment
p.(None): The results of the visit. The results will be described in what
p.(None): 12 regarding its nature and scope (that is, how many records were reviewed and to what extent). The
p.(None): Results must be strictly objective, based on the records and information available
p.(None): during the audit.
p.(None): Thoroughly document the Audit, both during its completion and after its conclusion. The
p.(None): only tangible results of an audit are the written report and
p.(None): 13 supervisor notes. When serious breaches are observed, the
...
p.(None): within the first 3 months after the end of
p.(None): one
p.(None): process of analysis and interpretation of information
p.(None): Collected in the project.
p.(None): Incorporate the following information in the report:
p.(None): • If the objectives were achieved
p.(None): • Main findings
p.(None): two
p.(None): • Arrangements for publication or dissemination of the
p.(None): research, including any feedback to participants.
p.(None): Review in full final report verifying that the
p.(None): 3
p.(None): information about the motives is complete and give
p.(None): Sponsor / Principal Investigator
p.(None): Sponsor / Principal Investigator
p.(None): CNEIS DNM
p.(None): Page 58 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): income to be placed next to the complete project file.
p.(None): Prepare notification of report review and delivery to
p.(None): 4 principal investigator, sponsor and National Directorate of Medicines
p.(None): CNEIS administrative assistant
p.(None): Page 59 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): PROCEDURE 16. RESEARCH OF THE ARCHIVES OF THE CNEIS
p.(None): OBJECTIVE: To comply with the requirement of Good Clinical Practices for CEIS (in section 3.5.1), which
p.(None): requires keeping all relevant records (written procedures, member lists, lists of
p.(None): membership of members and their occupation, documents submitted, minutes of meetings and correspondence) by a
p.(None): three-year period after completing the study and making them available at the time the
p.(None): regulatory authority (s) request them.
p.(None): RESPONSIBLE:
p.(None): - Members of the Health Research Ethics Committee (CNEIS)
p.(None): FILE CONTENT:
p.(None): The files (sources of printed, magnetic or electronic data) must include, at least:
p.(None): - Procedures manual: regulations, operational guides, manuals, national and / or international standards,
p.(None): technical documents, the procedures manual with their respective annexes, the applicable regulatory texts.
p.(None): - List of identification and curriculum vitae of each member of the CNEIS, updated.
p.(None): - Financial records (fee income, operating expenses), summary of expenses, and forms of
p.(None): consumption and order, or monthly expense.
p.(None): - Minutes of meetings of the Committee, listed consecutively by year.
p.(None): - Reports of CNEIS decisions. Approval Minutes and reports of rejection and suspension ordered
p.(None): correlatively, foliated per year.
p.(None): - Reports of serious adverse events and reports of the Independent Data Monitoring Committees (CSSP),
p.(None): backed by CNEIS analysis reports.
p.(None): - Correspondence received (documentation sent by investigators, correspondence exchanged
p.(None): with them and other actors).
p.(None): - Correspondence dispatched by the CNEIS.
p.(None): Page 60 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): - Protocols evaluated, with all the documentation analyzed, Minutes of Approval, copy of follow-up reports,
p.(None): reports and amendments.
p.(None): - Documents submitted by the project sponsor.
p.(None): - Periodic reports on the study and the final report. Protocol in its different versions, manual of the
...
p.(None): 10. GLOSSARY
p.(None): 1. Approval (in relation to the CNEIS): The affirmative decision of the Health Research Ethics Committee that
p.(None): The clinical study was reviewed and can be conducted in the institution within the guidelines established by the
p.(None): CEIS, the institution, Good Clinical Practice (BPC) and the applicable regulatory requirements.
p.(None): 2. Quality Assurance (CA): All planned and systematic actions that are established to
p.(None): ensure that the study is being carried out and that the data is generated, documented (recorded) and
p.(None): reported in compliance with Good Clinical Practice (BPC) and regulatory requirements
p.(None): applicable.
p.(None): 3. Randomization: The process of assigning the subjects of a study to the treatment groups
p.(None): or control using chance to determine subjects, in order to reduce bias.
p.(None): 4. Audit: A systematic and independent review of related activities and documents
p.(None): with the study to determine if the activities evaluated were performed and the data were recorded,
p.(None): analyzed and reported accurately according to the protocol, Standard Operating Procedures of the
p.(None): Sponsor (POE), Good Clinical Practice (BPC) and applicable regulatory requirements.
p.(None): 5. Study Data Audit: A comparison of the source data and records associated with the
p.(None): intermediate or final report to determine if the source data were accurately reported, establish
p.(None): if the studies were carried out according to the protocol and the applicable PCBs, obtain information
p.(None): additional not provided in the report, and establish whether procedures were used to obtain the data
p.(None): They could invalidate them.
p.(None): 6. Authority of Surveillance (National) of the Compliance of the BPC: A body of norms, established within a
p.(None): country, which has the responsibility of monitoring the compliance of the PCBs within its territory and of carrying out
p.(None): other functions related to the PCBs, as determined nationally, in the case of El Salvador this
p.(None): entity is the Higher Council of Public Health.
p.(None): Page 62 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): 7. Regulatory Authorities: Refers to the authority responsible for the regulation of investigations and
p.(None): medicines. They can be agencies that have the power to regulate. In the guidelines of Good Practice
p.(None): Clinic of the International Harmonization Conference, the term Regulatory Authorities includes the
p.(None): authorities that review the submitted clinical data and those that carry out inspections. Sometimes it
p.(None): refers to these organizations as competent authorities.
p.(None): 8. Well-being (of the study subjects): The physical and mental integrity of the subjects participating in a study
p.(None): in health.
p.(None): 9. Good Clinical Practices (PCB): A standard for design, conduction, realization, monitoring,
p.(None): audit, registration, analysis and report of clinical studies that provides a guarantee that the data and
p.(None): the reported results are credible and accurate and that rights are protected,
p.(None): integrity and confidentiality of the subjects of the study.
p.(None): 10. Center where the study is carried out: Place (s) where the activities related to the
p.(None): study.
p.(None): 11. Subject Identification Code: A unique identifier that the investigator assigns to each subject of the study
p.(None): to protect its identity, and that is used instead of the name of the subject when the investigator reports events
p.(None): Adverse and / or some other data related to the study.
p.(None): 12. Coordinating Committee: A committee that can be organized by the sponsor to coordinate the conduct of a
p.(None): Multicentre study.
p.(None): 13. Ethics Committee of Clinical / Health Research (CEIC / CEIS) of an institution: Autonomous entity within
...
p.(None): 20. Quality Control (CC): The techniques and operational activities carried out within the system of
p.(None): quality assurance to verify that the quality requirements of the
p.(None): activities related to the study.
p.(None): 21. Compliance (in relation to studies): Attachment to all requirements related to the study,
p.(None): Good Clinical Practice (BPC) requirements and applicable regulatory requirements.
p.(None): 22. Source Data: All information in original records and certified copies of the original records of
p.(None): clinical findings, observations or other activities in
p.(None): Page 64 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): a health study necessary for the reconstruction and evaluation of the study. The source data is contained in
p.(None): source documents (original records or certified copies).
p.(None): 23. Hospital departments and services: Direct patient care units in hospitals
p.(None): o Health units, where the subjects to be included in the studies will be identified and recruited.
p.(None): 24. Serious deviation: It is defined as any violation of the correct conditions and principles of the BPC, in
p.(None): relationship with the essay, or the disrespect for the protocol of that essay or its amendments. It is considered "serious" that
p.(None): deviation that can significantly affect the safety or physical (or mental) integrity of the subjects in the
p.(None): study, or its scientific value.
p.(None): It is the responsibility of the sponsor to determine the impact of the deviation on the scientific value of the trial. Yes
p.(None): someone is not sure how to do it, you should ask for advice from the competent authority, the sponsor or the
p.(None): CEIS.
p.(None): 25. Hospital Management: Instance that, in his position as legal representative of the Hospital, will consider whether
p.(None): the institution and / or the person proposing the study will respect hospital regulations, as well as
p.(None): the confidentiality of the data, and if they may have the right to access the data and the hospital patients.
p.(None): 26. Documentation: All records, in any form (including, but not limited to records
p.(None): written, electronic, magnetic, optical and scanner, X-rays and electrocardiograms, etc.) that describe or record
p.(None): the methods, conduction and / or results of a study, the factors that affect a study and the actions taken.
p.(None): 27. Essential Documents: Documents that individually and collectively allow an evaluation of the conduct of
p.(None): a study, and the quality of general data.
p.(None): 28. Source Documents: Original documents, data and records (eg hospital records, sheets
p.(None): clinics, lab notes, memoranda, subjects diaries or evaluation checklists,
p.(None): pharmacy delivery records, recorded data of automated instruments, copies or
p.(None): certified transcripts after verifying that they are exact copies,
p.(None): Page 65 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): microfiche, photographic negatives, magnetic media or microfilm, X-rays, subjects' files and
p.(None): records kept in pharmacies, in laboratories and in the medical-technical departments involved
p.(None): in the health study).
p.(None): 29. Amendment to the Protocol: Amendments are changes made to a research study, after having
...
p.(None): 41. Adverse Drug Reaction (ADR): harmful and unintentional response to a medicinal product related to
p.(None): any dose In clinical experience before the approval of a new medicinal product or its
p.(None): new uses, particularly when the therapeutic dose cannot be established, should be considered
p.(None): adverse drug reaction to any reaction that involves a causal relationship between a medicinal product and
p.(None): an adverse event as a reasonable possibility, that is, that the relationship cannot be ruled out.
p.(None): 42. Adverse Reaction Serious Unexpected Suspected (RASIS / SUSAR): Any suspected adverse reaction related to
p.(None): a PMI, which is unexpected and serious. The medical trial should be exercised to decide if an EA / RA is serious in
p.(None): other important situations other than those stated. EA / RA that are not immediately threatening to
p.(None): life or not result in death or hospitalization, but they need interventions to prevent one or more
p.(None): outcomes of the above, must also be considered as serious.
p.(None): 43. Investigator's Brochure [IB]: A compilation of clinical and non-clinical data on
p.(None): the research product (s) that is (are) relevant for the study of the product (s) in the
p.(None): research in humans.
p.(None): 44. Case Report Form (FRC) [“Case ReportForm” (CRF)]: A printed, optical or
p.(None): electronic, designed to record all the
p.(None): Page 68 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): information required in the protocol to be reported to the sponsor about each subject of the study.
p.(None): 45. Audit / supervision: The action of the regulatory authority (s) to carry out an official review of the
p.(None): documents, facilities, records and any other resource that the authority (ies) considers to be related
p.(None): with the study in health and that can be located in the place where the study is carried out, in the facilities of the
p.(None): sponsor and / or contract research organization (ICO) or other sites than the authority (s)
p.(None): Regulatory (s) considered appropriate.
p.(None): 46. Inspector / supervisor: A person conducting inspections of the study on behalf of the Authority of
p.(None): (National) Surveillance of Compliance with the BPC.
p.(None): 47. Institution (medical): Any public or private entity, agency or dental medical facility where they are conducted
p.(None): Health studies
p.(None): 48. Basic, pre-clinical or fundamental research: It is the experimental or technical work that is carried out
p.(None): primarily to acquire new knowledge of the underlying phenomenon and observable facts, without an application
p.(None): particular or use established. It can be divided into pure basic research and oriented basic research. In
p.(None): This type of research study subjects are cells, tissues, molecules and / or experimental animals. East
p.(None): type of research is carried out mainly within a specialized laboratory
p.(None): 49. Clinical Research: Patient oriented research. Research conducted with subjects
p.(None): humans (or with material of human origin, such as tissues, specimens, and cognitive phenomena) to
p.(None): which the researcher interacts directly with human subjects. It also includes studies
p.(None): epidemiological and behavioral studies and results research and research in services of
p.(None): Health.
p.(None): 50. Process research or evaluation of health systems (or research in health services or
p.(None): operational research): Field of research that examines the impact of the organization, financing and
p.(None): administration of health care services in the delivery, quality, costs, access and results of these
p.(None): services. In this type of research the subject of study are the processes or relationships within the
p.(None): health institutions.
p.(None): Page 69 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
...
p.(None): and population disease; seeks to develop instruments for the prevention, cure and relief of the effects of
p.(None): diseases; and strives to plan better approaches for individual and community health services. ”
p.(None): 53. Researcher: Person responsible for conducting a health study at the site where the
p.(None): study. If a study is conducted by a group of individuals, the researcher is the responsible leader.
p.(None): of the group and will be called principal investigator.
p.(None): 54. Coordinating Investigator: A researcher, in a Multicenter study, who is assigned the responsibility of
p.(None): coordinate the researchers in the different participating centers.
p.(None): 55. Researcher / Institution: Expression that means “The researcher and / or the Institution, when
p.(None): stipulate the applicable regulatory requirements ”.
p.(None): 56. Head of the Unit / Research Center: Personnel responsible and designated in their hospital function as the
p.(None): Manager of the Research Units / Centers and responsible for compliance with the development standards of
p.(None): health research with human subjects, as well as standard operating procedures.
p.(None): 57. Monitoring: The act of monitoring the process of a health study and ensuring that it is conducted,
p.(None): Registered and reported in accordance with the protocol, Standard Operating Procedures (SOP), Good Practice
p.(None): Clinic (BPC) and the applicable regulatory requirements.
p.(None): 58. Monitoring, Report of: A written report from the monitor to the sponsor, according to the SOPs of the
p.(None): sponsor, after each visit to the study site and / or any other communication related to the study.
p.(None): 59. Level of compliance with the BPC: The level of compliance of the center with the Principles of the BPC, as
p.(None): Evaluate the (National) Surveillance Authority of compliance with the PCBs.
p.(None): Page 70 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): 60. Opinion (in relation to CEIS): The trial and / or advice provided by a CEIS.
p.(None): 61. Contract Research Organization (ICO)
p.(None): ["ContractResearchOrganization" (CRO)]: Person or organization (commercial, academic or otherwise) hired by the
p.(None): Sponsor to perform one or more of the sponsor's duties and functions related to the study.
p.(None): 62. Sponsor: Individual, company, institution or organization responsible for initiating, administering / controlling
p.(None): and / or fund a clinical study.
p.(None): 63. Sponsor-Researcher: Individual who initiates and conducts, alone or with others, a health study
p.(None): and under whose immediate direction the product under investigation is administered (or delivered to, or used) by the
p.(None): subject. The term does not include any person other than an individual (that is, does not include a person
p.(None): corporation or agency). The obligations of a sponsor-researcher include both those of a sponsor
p.(None): like those of a researcher.
p.(None): 64. Standard Operating Procedures (POE) ["Standard OperatingProcedures
p.(None): (SOPs) ”]: Detailed and written instructions to achieve uniformity in the execution of a specific function.
p.(None): 65. Research medicinal product (PMI): Pharmaceutical form of an active ingredient or placebo
p.(None): that is being tested or used as a reference in a health study, including a product with an authorization of
p.(None): marketing when used or conditioned (formulated or packaged) in a different way than
...
p.(None): INVESTIGATION.
p.(None): 9.1 SIGNATURE OF THE INVESTIGATOR: 9.2 SEAL OF THE MAIN RESEARCHER:
p.(None): 9.3 SIGNATURE OF THE SPONSOR OR ITS
p.(None): REPRESENTATIVE
p.(None): 10. OJ CUMENTO S Q UE MUST ACO MPAÑAR SO LICITUD
p.(None): NO DO CUMENTATION
p.(None): PRESENTS THE REQUIREMENT (EXCLUSIVE SPACE CNEIS)
p.(None): YES NO DOES NOT APPLY
p.(None): 1 Request for evaluation of the protocol addressed to the ethics committee (original or copy).
p.(None): Full original protocol of the study in Spanish, containing original informed consent and
p.(None): Researcher's brochure (Legal documents must be submitted in Spanish or with your
p.(None): respective
p.(None): 2 translation, in accordance with Salvadoran notarial legislation; in the case of documents
p.(None): coming from
p.(None): abroad, must be presented apostilled or consularized, in original and copy for confrontation.)
p.(None): 3 Four copies of the full study protocol in Spanish and one electronic copy
p.(None): Information on the insurance policy for the research subject granted by the sponsor, specifying
p.(None): 4 the applicability mechanism in El Salvador
p.(None): 5 Curriculum of the principal investigator and co-investigators.
p.(None): 6 Proof of payment of tariff
p.(None): 7 Payment method of the researcher in El Salvador (attach a copy of the contract)
p.(None): 8 Letter of authorization from the center or centers where the study will be carried out
p.(None): 9 Investigator's commitment to good clinical practices
p.(None): Certificate of Good Manufacturing Practices (BPM) of the manufacturer or Certificate of BPM issued by the
p.(None): 10 Local Regulatory Authority. Applies if the product is not registered.
p.(None): Primary and secondary packaging of the product or products to be used in the clinical study with its
p.(None): label of
p.(None): 11 identification, containing storage conditions and lot numbers and expiration date.
p.(None): Stability studies in accordance with the provisions of RTCA 11.01.04.10 Products
p.(None): Pharmacists
p.(None): 12 Stability Studies of Medicines for Human Use
p.(None): 13 Other materials (Promotional, patient card, questionnaires, etc.)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS) (ES P ACIO
p.(None): EXCLUS IVO CNEIS) (ES P ACIO
p.(None): EXCLUS IVO CNEIS) (ES P ACIO
p.(None): EXCLUS IVO CNEIS) (ES P ACIO
p.(None): EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
...
p.(None): Vii Efficacy is the concept of scientifically proving whether - and to what extent - a medicine is capable of
p.(None): diagnose, prevent or treat a disease.
p.(None): Viii The assignment of patients to a treatment group randomly and planned by a trial protocol
p.(None): Clinical cannot be considered as clinical practice.
p.(None): Page 81 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 4A. ASSESSMENT GUIDE FOR A HEALTH RESEARCH PROJECT
p.(None): INSTRUCTIVE:
p.(None): This instrument must be used by each of the members of the CNEIS, during the review of the
p.(None): documentation. It is a guide to review the formal, methodological and ethical aspects of the study. I know
p.(None): recommends that each evaluator mark with an “X” or write in the blank, as appropriate.
p.(None): Once the deliberation is finished, the secretary will complete the form that includes all the opinions
p.(None): and those that were filled individually will be removed.
p.(None): DATE APPLICATION DATE FIRST
p.(None): EVALUATION
p.(None): SECOND EVALUATION DATE
p.(None): DATE RESOLUTION (APPROVAL / REJECTION)
p.(None): LIST OF ELEMENTS TO EVALUATE IN A HEALTH RESEARCH PROTOCOL
p.(None): I.- IDENTIFICATION:
p.(None): Code
p.(None): Protocol Title
p.(None): Page 82 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): II.- EVALUATION OF THE SUMMARY OF THE PROJECT
p.(None): Little bit
p.(None): Information on Not recorded
p.(None): adequate
p.(None): Adequate
p.(None): Very suitable
p.(None): 1. Promoter
p.(None): 2. Research title
p.(None): 3. Type of investigation
p.(None): 4. Place of performance
p.(None): 5. Authority responsible for the institution of realization
p.(None): 6. Other study centers
p.(None): 7. Responsible researcher
p.(None): 8. Drug or Method to investigate. Information on manufacturing, expiration, registration
p.(None): 9. Stage or phase of the study
p.(None): 10. Objective of the study: efficacy, toxicity, dose, etc.
p.(None): 11. Design: random, double blind, etc.
p.(None): 12. Disease under study
p.(None): 13. Inclusion criteria
p.(None): 14. Exclusion criteria
p.(None): 15. Number of patients
p.(None): 16. Duration of the study
p.(None): 17. Schedule of realization
p.(None): 18. Financial responsible and damage insurance
p.(None): 19. Ethical considerations
p.(None): Page 83 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): III.- METHODOLOGICAL EVALUATION OF THE RESEARCH PROTOCOL
p.(None): Information about
p.(None): 1. Promoter information
p.(None): 2. Participating researchers
p.(None): 3. Realization centers
p.(None): 4. General Aspects
p.(None): 4.1. Preclinical and clinical history that supports the rational of the study
p.(None): 4.2. Justification
p.(None): 4.3. Main goal
p.(None): 4.4. Secondary objectives
p.(None): 4.5. Phase Study: I-II-III-IV
p.(None): 4.6. Kind of investigation
p.(None): 4.7. Design (parallel, crosslinking, etc.)
p.(None): 4.8. Sample's size calculation
p.(None): 5. Population to study
p.(None): 5.1. Type (patients, healthy volunteers or others)
p.(None): 5.2. Inclusion criteria
p.(None): 5.3. Exclusion criteria
p.(None): 5.4. Groups to compare
p.(None): 5.5. Demographic aspects
p.(None): 5.6. Prognostic Criteria
p.(None): 5.7. Stage of the disease
...
p.(None): Understandable for a layman. Explain the purpose of the changes and their meaning for the study. In
p.(None): Page 124 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): In the case of a modified amendment, indicate the modifications that have been made.
p.(None): If the amendment significantly alters the study design or methodology, or may otherwise affect
p.(None): The scientific value of the study must include supporting scientific information (or attach it separately).
p.(None): Indicate whether additional scientific criticism has been obtained or not.
p.(None): Any other relevant information
p.(None): Those who apply can indicate any specific ethical problem related to the amendment, which is desired
p.(None): the opinion of the CEIS.
p.(None): List of attached documents
p.(None): Document Version Date
p.(None): Statement
p.(None): I confirm that the information in this format is accurate and I assume full responsibility for it.
p.(None): I consider it reasonable that the proposed amendment should be implemented. Signature of the Chief Investigator
p.(None): ……. ………………………………
p.(None): Name …….………………………………
p.(None): Date of submission …………………………………….
p.(None): Page 125 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 10B SUBSTANTIAL AMENDMENT FORMAT FOR CLINICAL PRODUCT TESTS
p.(None): RESEARCH MEDICINALS (PMI)
p.(None): NOTIFICATION OF A SUBSTANCIAL AMENDMENT TO A CLINICAL TRIAL OF A MEDICINAL PRODUCT FOR HUMAN USE, DIRECTED
p.(None): TO THE HEALTH RESEARCH ETHICS COMMITTEE AND THE COMPETENT AUTHORITY.
p.(None): For official use:
p.(None): Date of receipt of the request: Date:
p.(None): Basis for non-acceptance / negative opinion:
p.(None): Start date of the procedure: Authorization / positive opinion:
p.(None): Registration number of the corresponding CEIS: Withdrawal of the application of the amendment
p.(None): Competent authority for the study: Date:
p.(None): To be filled out by the applicant:
p.(None): This form must be submitted to the corresponding CNEIS, for the opinion on a substantial amendment, and then must
p.(None): present to the competent authority, when applicable.
p.(None): Page 126 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): A. TYPE OF NOTIFICATION
p.(None): A.1 Notification for an opinion of the CNEIS:
p.(None): A.2 Notification to the competent authority:
p.(None): A.3 Information notification only *:
p.(None): A.3.1 To the CNEIS:
p.(None): A.3.2 To the competent authority:
p.(None): B. TEST IDENTIFICATION:
p.(None): B.1 Does the substantial amendment concern several trials involving PMI? If not
p.(None): B.1.1 If the answer is yes, repeat this section as many times as necessary
p.(None): B.2 Full title of the essay:
p.(None): B.3 Sponsor's code number for the protocol, version and date:
p.(None): C. IDENTIFICATION OF THE SPONSOR RESPONSIBLE FOR THE APPLICATION
p.(None): C.1 Sponsor
p.(None): C.1.1 Organization:
p.(None): C.1.2 Name of the contact person:
p.(None): C.1.3 Address:
p.(None): C.1.4 Telephone number:
p.(None): C.1.5 Fax number:
p.(None): C.1.6 E-mail:
p.(None): C.2 Legal Representative of the sponsor in the country, for the purpose of the trial (if different from the sponsor)
p.(None): * For substantial amendments, only notify when the competent authority (CA) has determined
p.(None): previously (eg quality data). The sponsor must not only submit the amendment to the CA, but also inform the
p.(None): CEIS that has notified, marking "for information only". Similarly, the sponsor must inform the CA of
p.(None): any notification of a substantial amendment that was previously determined by the CEIS (eg Sites for
p.(None): study completion).
p.(None): Page 127 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): C.2.1 Organization:
p.(None): C.2.2 Name of the contact person:
p.(None): C.2.3 Address:
p.(None): C.2.4 Telephone number:
p.(None): C.2.5 Fax number:
p.(None): C.2.6 E-mail:
p.(None): D. IDENTIFICATION OF THE APPLICANT (Check the appropriate box)
p.(None): D.1 Request to the CEIS
p.(None): D.1.1 Sponsor
p.(None): D.1.2 Legal Representative of the sponsor
p.(None): D.1.3 Person or organization authorized to make the application
p.(None): D.1.4 Researcher in charge of the application, when applicable:
p.(None): D.1.4.1. Study coordinator (for multicentric studies):
p.(None): D.1.4.2. Principal investigator (for single-center trials):
p.(None): D.1.5 Complete
p.(None): D.1.5.1 Organization:
p.(None): D.1.5.2 Name:
p.(None): D.1.5.3 Address:
p.(None): D.1.5.4 Telephone number:
p.(None): D.1.5.5 Fax number:
p.(None): D.1.5.6 E-mail:
p.(None): D.2 Request to the competent authority
p.(None): D.2.1 Sponsor
p.(None): D.2.2 Legal Representative of the sponsor
p.(None): D.2.3 Person or organization authorized by the sponsor to make the application
p.(None): D.2.4 Complete
p.(None): D.2.4.1 Organization:
p.(None): D.2.4.2 Name:
p.(None): Page 128 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): D.2.4.3 Address:
p.(None): D.2.4.4 Telephone number:
p.(None): D.2.4.5 Fax number:
p.(None): D.2.4.6. E-mail:
p.(None): E. IDENTIFICATION OF THE SUBSTANTIAL AMENDMENT
p.(None): E.1 Sponsor's code number for the substantial amendment, version and date for the clinical trial
p.(None): concerning:
p.(None): E.2 Substantial amendment type
p.(None): E.2.1 Amendment to the informed consent information Yes
p.(None): Do not
p.(None): E.2.2 Amendment to the protocol
p.(None): If not
p.(None): E.2.3 Amendment to other attached documents, in the initial application form
p.(None): If not
p.(None): E.2.3.1 If yes, specify:
p.(None): E.2.4 Amendment to other documents or information Yes No
p.(None): E.2.4.1 If yes, specify:
p.(None): E.2.5 This amendment concerns urgent security measures, which have already been implemented
p.(None): If not
p.(None): E.2.6 This amendment is to notify a temporary suspension to the test Yes
p.(None): Do not
p.(None): E.2.7 This amendment is to request to restart the test Yes No
p.(None): E.3 Reason for the substantial amendment:
p.(None): E.3.1 Changes in the safety or integrity of the subjects, in the test Yes
p.(None): Do not
p.(None): Page 129 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): E.3.2 Changes in the interpretation of the relationship “scientific documents / test value”
...
p.(None): overall risk / benefit for the medicinal product for research (free text):
p.(None): F. REASONS FOR THE SUBSTANTIAL AMENDMENT (one or two sentences):
p.(None): G. BRIEF DESCRIPTION OF THE CHANGES (free text):
p.(None): H. CHANGE OF CLINICAL TRIAL RESEARCH SITES
p.(None): H.1 Exchange rate
p.(None): H.1.1 New site added
p.(None): H.1.1.1 Principal Investigator (provide details)
p.(None): H.1.1.1.1 First Name:
p.(None): H.1.1.1.2 Middle Name (if applicable)
p.(None): H.1.1.1.3 Surname
p.(None): H.1.1.1.4 Qualifications (Dr. ...)
p.(None): H.1.1.1.5 Professional Management
p.(None): H.2 Removal of a research site
p.(None): Page 131 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): H.2.1 Principal Investigator (provide details)
p.(None): H.2.1.1 First Name
p.(None): H.2.1.2 Middle name (if applicable)
p.(None): H.2.1.3 Surname
p.(None): H.2.1.4 Qualifications (Dr. ...)
p.(None): H.2.1.5 Professional Management
p.(None): H.3 Change of coordinating researcher (provide details of coordinating researcher)
p.(None): H.3.1 First Name
p.(None): H.3.2 Middle name (if applicable)
p.(None): H.3.3 Surname
p.(None): H.3.4 Qualification (Dr. ...)
p.(None): H.3.5 Professional Management:
p.(None): H.3.6 State the name of the previous coordinating researcher:
p.(None): H.4 Change of the principal investigator at an existing site (provide details about the new principal investigator)
p.(None): H.4.1 First name
p.(None): H.4.2 Middle name (if applicable)
p.(None): H.4.3 Surname
p.(None): H.4.4 Qualification (Dr. ...)
p.(None): H.4.5 Professional Management:
p.(None): H.4.6 State the name of the previous principal investigator:
p.(None): I. CHANGE OF INSTRUCTIONS TO THE COMPETENT AUTHORITY, FOR FEEDBACK TO THE SPONSOR
p.(None): I.1 Change of electronic contact for application feedback Yes
p.(None): Do not
p.(None): If yes, provide the new email in which you wish to receive feedback:
p.(None): Page 132 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): J. LIST OF DOCUMENTS ADDED TO THE NOTIFICATION FORM
p.(None): Please submit only relevant documents and / or explanatory references to those already submitted (when applicable). Make
p.(None): Clear references to any change of the separate pages, and submit old and new texts. Check the box
p.(None): appropriate
p.(None): J.1 Declaration letter of the type of amendment and the reason (s)
p.(None): J.2 Summary of proposed amendments
p.(None): J.3 List of modified documents (identity, version, date)
p.(None): J.4 Pages with the previous and new words (if applicable)
p.(None): J.5 Supporting information
p.(None): J.6 Copy of initial application form, with amendment data highlighted
p.(None): J.7 Comments on any new aspect of the amendment
p.(None): K. APPLICANT'S SIGNATURE
p.(None): K.1 I confirm that [I confirm in the name of the sponsor that]:
p.(None): The information given in this document is correct, that the test will be conducted according to the protocol, the
p.(None): national regulation and the principles of Good Clinical Practices; and it is reasonable that the
p.(None): proposed amendment.
p.(None): K.2 Application for the Clinical Research Ethics Committee:
p.(None): K.2.1 Signature:
p.(None): K.2.2 Name:
p.(None): K.2.3 Date:
p.(None): Page 133 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): K.3. Application for the competent authority:
p.(None): K.3.1 Signature:
p.(None): K.3.2 Name:
p.(None): K.3.3 Date:
p.(None): Page 134 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 11 NOTIFICATION OF SERIOUS DEVIATIONS
p.(None): Sponsor:
p.(None): Date on which the deviation was identified:
p.(None): Individual or organization that committed the deviation:
p.(None): Details of the study:
p.(None): Title:
p.(None): Principal Investigator / Chief:
p.(None): Registration number (if applicable):
p.(None): Number of CEIS Evaluation Minutes:
p.(None): Date of ethical approval:
p.(None): Details of the deviation, including the cause:
p.(None): Details of the action taken:
p.(None): Signature of the one who prepared the report: Date:
p.(None): Page 135 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 12 CONTINUITY REPORT
p.(None): CONTINUITY REPORT
p.(None): Date of this report (day / month / year): Study number evaluated: Principal Investigator:
p.(None): Protocol Title:
p.(None): FEATURES
p.(None): Sponsor: Financing: Yes No
p.(None): Estimated project duration (months or years):
p.(None): IMPORTANT DATES
p.(None): Initial approval by the CEIS (day / month / year):
p.(None): Last revision (day / month / year):
p.(None): Inclusion of the first patient (day / month / year):
p.(None): Closing date (day / month / year, when applicable):
p.(None): Revisions of amendments and CEIS approval dates:
p.(None): No. Date (day / month / year): No. Date (day / month / year): No. Date (day / month / year): No.
p.(None): Date (day / month / year): No. Date (day / month / year): No. Date (day / month / year): No.
p.(None): Date (day / month / year): No. Date (day / month / year):
p.(None): CURRENT STATUS OF THE PROTOCOL
...
p.(None): That the study be closed to the inclusion of participants, but that it remains open to follow-up.
p.(None): On what date do you want this study closure to be effective (day / month / year):
p.(None): Study completed (only one of the following two criteria is met):
p.(None): Page 138 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): CONTINUITY REPORT
p.(None): All data entries are completed, as is the analysis.
p.(None): All subjects and future data collection and analysis have been transferred to a protocol of
p.(None): long term follow up. Take note that it is the responsibility of the researcher to certify / document the transfer
p.(None): of participants to a long-term follow-up study, and that the Informed Consent to
p.(None): The long-term study must be obtained.
p.(None): FOR STUDIES THAT WILL CONTINUE INCLUDING PARTICIPANTS, ATTACH A COPY OF THE LAST INFORMED CONSENT APPROVED
p.(None): CERTIFICATIONS
p.(None): Signature of the Principal Investigator
p.(None): Date
p.(None): Sponsor Signature (if applicable)
p.(None): Date
p.(None): Signature of the monitor (if applicable)
p.(None): Date
p.(None): Page 139 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 13A NOTIFICATION OF FINALIZATION OF A CLINICAL TRIAL OF A RESEARCH MEDICINAL PRODUCT
p.(None): (ECA-PMI)
p.(None): This notification must be delivered within the first 90 days after the end of a trial.
p.(None): clinical, or within the first 15 days, if the completion was premature.
p.(None): Date received by the authority:
p.(None): To be filled by the applicant:
p.(None): Protocol identification
p.(None): Title:
p.(None): Approval date:
p.(None): Sponsor Protocol Number:
p.(None): Applicant Identification
p.(None): B.1. Sponsor ID
p.(None): 1. Name of the sponsor:
p.(None): 2. Name of the legal representative of the sponsor in the country:
p.(None): 3. Address:
p.(None): 4. Telephone / Fax:
p.(None): 5. E-mail:
p.(None): B.2. Investigators Identification
p.(None): 1. Name of the principal investigator:
p.(None): 2. If there are several sites, cite the names of the responsible researchers per site:
p.(None): Study Completion
p.(None): The study ends on the country site: Completion date:
p.(None): Page 140 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): The study ends at all sites in other countries:
p.(None): Finish date:
p.(None): This completion is premature:
p.(None): If yes, write the date:
p.(None): What causes premature completion of the study? Security
p.(None): Lack of effectiveness
p.(None): The study did not start Other
p.(None): If you answered yes to any of the above, please add a brief summary freely.
p.(None): Justification for premature completion of the study Number of patients included before completion Effects
p.(None): in patients due to premature termination
p.(None): Through my signature I state that the above is reliable.
p.(None): F.
p.(None): Name Date:
p.(None): Page 141 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 13B NOTIFICATION OF FINALIZATION OF A STUDY THAT DOES NOT INVOLVE MEDICINAL PRODUCTS IN RESEARCH
p.(None): This notification must be delivered within the first 90 days after the end of a clinical trial, or within
...
p.(None): ANNEX 14. CHECKLIST OF REQUIREMENTS FOR FULFILLMENT OF GOOD CLINICAL PRACTICES.
p.(None): Criterion
p.(None): RESEARCH COMPETENCES
p.(None): Academic training in research, good clinical practices. You must provide evidence of those requirements to
p.(None): through your updated Curriculum Vitae and / or any other relevant related documentation
p.(None): The researcher is completely familiar with the proper use of the product in
p.(None): investigation, as described in the protocol, current copy of the Investigator Brochure,
p.(None): in product information and other relevant sources of information.
p.(None): There is a dated and signed list of suitable persons to whom it has delegated tasks
p.(None): significant related to the study, containing their names and functions that have been delegated to them
p.(None): YES NO Comments:
p.(None): ADEQUATE RESOURCES YES NO Comments:
p.(None): The researcher must have sufficient time to conduct and properly complete the study within the
p.(None): agreed period.
p.(None): The researcher must have a sufficient number of qualified personnel and adequate facilities for the
p.(None): expected duration of the study in order to conduct it appropriately and safely
p.(None): Training of the research team should be documented including: name of each person trained,
p.(None): training program and dates. Source: Curriculum Vitae
p.(None): Page 144 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): MEDICAL CARE FOR PARTICIPATING STUDENTS
p.(None): Appropriate medical care is provided to the person in case of an adverse event, including values
p.(None): of clinically significant laboratory, related to the study. Source: Protocol
p.(None): There is an authorization letter from the authority of the health center (it includes
p.(None): hospitals, Community Family Health Units, clinics) to carry out the study within
p.(None): the installations. It includes knowledge of the head of the hospital service, if applicable.
p.(None): The researcher must seek through prior agreements with the sponsor the
p.(None): continuity of treatment to research subjects once their
p.(None): Participation in the study if your interruption jeopardizes your safety within the frameworks
p.(None): applicable regulators. Source: procedures described in the research protocol.
p.(None): AUTHORIZATION OF THE ETHICAL CONSIDERATIONS OF THE RESEARCH
p.(None): Before starting a study, the researcher / institution must have the
p.(None): favorable approval / opinion, written and dated, of the CNEIS / CEIS study protocol, the
p.(None): Informed consent form, updates, recruitment procedures
p.(None): of subjects (for example, announcements) and any other written information that will be provided to
p.(None): YES NO Comments:
p.(None): YES NO Comments:
p.(None): Page 145 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): persons
p.(None): COMPLIANCE WITH THE PROTOCOL YES NO Comments:
p.(None): The researcher / institution must conduct the study in accordance with the protocol agreed with the
p.(None): sponsor and favorable approval / opinion of the CNEIS / CEIS and, if necessary, by the authorities
p.(None): Regulatory
p.(None): The investigator or the person designated by the investigator must document and explain any
...
General/Other / cioms guidelines
Searching for indicator cioms:
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p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): - If you need to add extra spaces between paragraphs it can be done freely to improve the visualization of
p.(None): sections of the document It is recommended that sections or subsections titles not be at the bottom of a page and the
p.(None): rest of the content of these in the following; for that matter, add the necessary spaces so that the
p.(None): Title of the section or subsection is on the next page along with their respective content.
p.(None): - Whenever appropriate and to limit the size of the documentation, reference is made to the standards
p.(None): applicable national or international technical and management.
p.(None): - Likewise, you can use colors or other convenient formats, as long as they are
p.(None): formal.
p.(None): DOCUMENTS SUBMISSION
p.(None): - It is requested to present all the documentation ordered according to the correlative index, ringed or
p.(None): pasted, it will depend on the criteria of each researcher.
p.(None): Page 163 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): 12. BIBLIOGRAPHY
p.(None): 1. https://www.ich.org/products/guidelines.html
p.(None): 2. http://unesdoc.unesco.org/images/0013/001393/139309e.pdf Guide No 1: Creation of Bioethics Committees. UNESCO
p.(None): 3. http://www.nlm.nih.gov/nichsr/hta101/ta101014.html
p.(None): 4. http://www.suht.nhs.uk/index.cfm?articleid=2814
p.(None): 5. http://www3.imperial.ac.uk/clinicalresearchgovernanceoffice/standardoperating procedures
p.(None): 6. Council for International Organizations of Medical Sciences. International ethical guidelines for biomedical
p.(None): research involving human subjects (CIOMS). Geneva, Switzerland: World Health Organization 2002 (consulted
p.(None): 2012 Dec 13). Available at http: // www. recerca.uab.es/ceeah/docs/CIOMS.pdf
p.(None): 7. Emanuel EJ, Wendler D, Grady C. What Makes Clinical Research Ethical? JAMA 2000; 283: 2701-2711.
p.(None): 8. An Instructional Guide for Peer Reviewers of Biomedical Manuscripts. Annals of Emergency Medicine
p.(None): (accessed 2012 Dec 5). Available in
p.(None): http://www3.us.elsevierhealth.com/extractor/graphics/em-acep/index.html. 13.
p.(None): 9. Practical guide to health research. Scientific and Technical Publication No. 620. Drafting of the protocol of
p.(None): Research: Presentation of a research proposal. Washington, D.C: Pan American Organization of the
p.(None): Health (PAHO) 2008 (accessed 2012 Dec 2). Available in
p.(None): http://www.sld.cu/galerias/pdf/sitios/ rehabilitacion-bal / ops_protocolo.pdf. 14. Haynes RB, Mulrow CD, Huth EJ,
p.(None): Altman DG, Gardner MJ. More Informative Abstracts Revisited. Ann Intern Med 1990; 113: 69-76. fifteen.
p.(None): 10. How to review the evidence: Systematic Identification and Review of the Scientific Literature. Canberra:
p.(None): National Health and Medical Research Council (NHRMC) 2000 (accessed 2012 Dec 12).
p.(None): Available at http://www.nhmrc.gov.au/_files_nhmrc/publications/ attachments / cp65.pdf.
...
General/Other / participants in a control group
Searching for indicator placebo:
(return to top)
p.(None): 12. Coordinating Committee: A committee that can be organized by the sponsor to coordinate the conduct of a
p.(None): Multicentre study.
p.(None): 13. Ethics Committee of Clinical / Health Research (CEIC / CEIS) of an institution: Autonomous entity within
p.(None): of a Hospital, University or institution dedicated to research, whose objective is to ensure the protection of the
p.(None): dignity and rights of the people who participate as research subjects *.
p.(None): 14. Independent Data Monitoring Committee (CIMD) (Data Monitoring and Security Council, Monitoring Committee,
p.(None): Data Monitoring Committee): An independent data monitoring committee that the sponsor can
p.(None): establish to evaluate the progress of a health study in intervals, the data
p.(None): Page 63 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): safety and critical points for the evaluation of effectiveness, and recommend to the sponsor if it should
p.(None): continue, modify or stop a study.
p.(None): 15. National Committee for Health Research Ethics (CNEIS): Governing body of the ethical framework for research in
p.(None): health in El Salvador, whose main objective is to protect the rights of the human beings who participate as
p.(None): research subjects and among whose functions is the accreditation of local committees, to develop their
p.(None): functions framed within current regulations.
p.(None): 16. Comparator (Product): A research or commercialized product (for example, active control) or placebo
p.(None): used as a reference in a clinical study.
p.(None): 17. Confidentiality: Failure to disclose to others - unless they are authorized personnel - information that
p.(None): is the property of the sponsor or the identity of a subject.
p.(None): 18. Informed Consent: The process by which a subject voluntarily confirms their desire to
p.(None): participate in a particular study, after being informed about all the relevant aspects so that your
p.(None): Decision regarding your participation be free and responsible. Informed consent is
p.(None): document through a written, signed and dated “Informed Consent Form”.
p.(None): 19. Contract: Written, dated and signed agreement between two persons or more parties involved, which establishes any
p.(None): arrangement on the delegation and distribution of work and obligations for the development of an investigation and, if
p.(None): If necessary, on financial matters. The protocol can serve as the basis for a contract.
p.(None): 20. Quality Control (CC): The techniques and operational activities carried out within the system of
p.(None): quality assurance to verify that the quality requirements of the
p.(None): activities related to the study.
p.(None): 21. Compliance (in relation to studies): Attachment to all requirements related to the study,
p.(None): Good Clinical Practice (BPC) requirements and applicable regulatory requirements.
p.(None): 22. Source Data: All information in original records and certified copies of the original records of
p.(None): clinical findings, observations or other activities in
p.(None): Page 64 of 164
p.(None): Republic of El Salvador
...
p.(None): 59. Level of compliance with the BPC: The level of compliance of the center with the Principles of the BPC, as
p.(None): Evaluate the (National) Surveillance Authority of compliance with the PCBs.
p.(None): Page 70 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): 60. Opinion (in relation to CEIS): The trial and / or advice provided by a CEIS.
p.(None): 61. Contract Research Organization (ICO)
p.(None): ["ContractResearchOrganization" (CRO)]: Person or organization (commercial, academic or otherwise) hired by the
p.(None): Sponsor to perform one or more of the sponsor's duties and functions related to the study.
p.(None): 62. Sponsor: Individual, company, institution or organization responsible for initiating, administering / controlling
p.(None): and / or fund a clinical study.
p.(None): 63. Sponsor-Researcher: Individual who initiates and conducts, alone or with others, a health study
p.(None): and under whose immediate direction the product under investigation is administered (or delivered to, or used) by the
p.(None): subject. The term does not include any person other than an individual (that is, does not include a person
p.(None): corporation or agency). The obligations of a sponsor-researcher include both those of a sponsor
p.(None): like those of a researcher.
p.(None): 64. Standard Operating Procedures (POE) ["Standard OperatingProcedures
p.(None): (SOPs) ”]: Detailed and written instructions to achieve uniformity in the execution of a specific function.
p.(None): 65. Research medicinal product (PMI): Pharmaceutical form of an active ingredient or placebo
p.(None): that is being tested or used as a reference in a health study, including a product with an authorization of
p.(None): marketing when used or conditioned (formulated or packaged) in a different way than
p.(None): approved or when used to obtain more information about a previously approved use.
p.(None): 66. CPB (National) Compliance Monitoring Program: A particular program established by a country
p.(None): to monitor compliance with Good Clinical Practices within its territory, through inspections.
p.(None): 67. Research protocol: Document describing the object (s), design, methodology,
p.(None): statistical considerations and organization of a study. Generally, the protocol also provides
p.(None): background and rationale for the study, but these could be provided in other documents
p.(None): Page 71 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): referenced in the protocol. In the BPC guidelines, the term protocol refers to the protocol and the
p.(None): amendments to the protocol.
p.(None): 68. Adverse Drug Reaction (RAM): These are all harmful and unintentional responses to a product
p.(None): medicinal, related to any dose. The phrase ‘answers… to a medicinal product’ means that a
p.(None): causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, that is, that
p.(None): The relationship cannot be ruled out. With regard to medicinal products on the market: a response to
p.(None): a drug that is harmful and unintentional, and that occurs with doses normally used in humans to
p.(None): prophylaxis, diagnosis or treatment of diseases, or for modification of physiological function (see the Guide to
...
p.(None): Information about
p.(None): 1. Promoter information
p.(None): 2. Participating researchers
p.(None): 3. Realization centers
p.(None): 4. General Aspects
p.(None): 4.1. Preclinical and clinical history that supports the rational of the study
p.(None): 4.2. Justification
p.(None): 4.3. Main goal
p.(None): 4.4. Secondary objectives
p.(None): 4.5. Phase Study: I-II-III-IV
p.(None): 4.6. Kind of investigation
p.(None): 4.7. Design (parallel, crosslinking, etc.)
p.(None): 4.8. Sample's size calculation
p.(None): 5. Population to study
p.(None): 5.1. Type (patients, healthy volunteers or others)
p.(None): 5.2. Inclusion criteria
p.(None): 5.3. Exclusion criteria
p.(None): 5.4. Groups to compare
p.(None): 5.5. Demographic aspects
p.(None): 5.6. Prognostic Criteria
p.(None): 5.7. Stage of the disease
p.(None): 5.8. Treatment response measure
p.(None): 5.9. Associated disease
p.(None): 5.10. Similarity of patients with the general population
p.(None): 6. Compared treatments
p.(None): 6.1. Drug proposed as intervention
p.(None): 6.2. Dose selection
p.(None): 6.3. Dose (fixed, flexible, route of administration)
p.(None): 6.4. Treatments, (Treatments) attached (standardized, allowed, prohibited)
p.(None): 6.5. Treatment duration
p.(None): 6.6. Information of lot number, formulation, etc.
p.(None): Not included or provided
p.(None): Inappropriate
p.(None): Suitable
p.(None): Very suitable
p.(None): Page 84 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Information about
p.(None): 6.7. Drug recognized as Standard treatment
p.(None): 6.8. Justified placebo use
p.(None): 6.9. Masking
p.(None): 7. Details of the experimental design
p.(None): 7.1. Checked
p.(None): 7.2. Controls: active-inactive
p.(None): 7.3. Concurrent-historical
p.(None): 7.4. Assignment of Treatment with random distribution
p.(None): 7.5. Cleaning-stratification period
p.(None): 7.6. Periodicity of visits, laboratory exam, evaluations
p.(None): 7.7. Start and end of treatment
p.(None): 8. Data collection and analysis
p.(None): 8.1. Measures used to evaluate the objectives
p.(None): 8.2. Record of response variables
p.(None): 8.3. Observers (constants, variables)
p.(None): 8.4. Collection method (normalized)
p.(None): 8.5. Evaluation of incomplete or lost data
p.(None): 8.6. Evaluation of the degree of compliance Treatment
p.(None): 8.7. Statistical tests to apply
p.(None): 8.8. Intention to treat analysis
p.(None): 9. Adverse effects (EA)
p.(None): 9.1. Subjective (reported spontaneously or with directed questions)
p.(None): 9.2. Identification criteria
p.(None): 9.3. Classification and evaluation of the Same
p.(None): 10. Controls to minimize bias
p.(None): 10.1. Impartial (blind) observers
p.(None): 10.2. Patients are unaware of the treatment received (blind)
p.(None): Not included or provided
p.(None): Inappropriate
p.(None): Suitable
p.(None): Very suitable
p.(None): Page 85 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Information about
p.(None): 10.3 Impartial assessor (blind)
p.(None): 10.4 Blind statistical analysis (does not identify groups)
p.(None): Not included or provided
p.(None): Inappropriate
p.(None): Suitable
p.(None): Very suitable
p.(None): 11. Individual Registration Sheet
p.(None): IV.- EVALUATION OF THE PATIENT INFORMATION SHEET
p.(None): Information about
p.(None): 1. Copy of the investigation protocol summary
p.(None): 2. Objective to be achieved with the study and treatment
p.(None): 3. Methodology to follow
p.(None): 4. Proposed treatment and placebo if any
p.(None): 5. Expected benefits of the proposed method for the participant
p.(None): 6. Expected benefits of the proposed method for society
p.(None): 7. Risks and inconveniences arising from the investigation
p.(None): 8. Possible adverse events
p.(None): 9. Risks and benefits of alternative methods to that proposed
p.(None): 10. Risks and benefits of non-participation in the study
p.(None): 11. Voluntary nature of participation
p.(None): 12. Right not to participate and to withdraw freely from the study without prejudice of any kind
p.(None): 13. Right to expand information as per participant's need
p.(None): 14. Confidentiality of the data obtained and its scope
p.(None): 15. Damage insurance and compensation guarantee for
p.(None): Not included or provided
p.(None): Poorly suited
p.(None): Adequate
p.(None): Very suitable
p.(None): Page 86 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Information about
p.(None): injury or death of the participant
p.(None): 16. Researcher responsible for informing the subject at any time during the study
p.(None): 17. Reference place for health care
p.(None): 18. The degree to which your medical care will be covered during the study, in case of any inconvenience
p.(None): 19. Ethics committee that evaluated the research
p.(None): 20. If you will receive any compensation or gift for your participation
p.(None): 21. Understanding the information
p.(None): 22. Information on the subject's access to the product under test, if it is effective from the
p.(None): completion of the investigation and until its commercialization, and if it will be delivered free of charge or
p.(None): I would have to pay
p.(None): for him
...
Orphaned Trigger Words
p.(None): operation of standard work procedures ”3, and also mentioned in the guidelines
p.(None): contained in B.O. 09/21/11 - Resolution 1480/11-MS - Approving the Guide for Research with Human Beings, in
p.(None): Argentina4.
p.(None): Operational guidelines for the operation of a research ethics committee dictated by WHO
p.(None): They refer: “The Ethics Committees must publicly indicate the operational procedures that determine the authority
p.(None): under which the committee is established, the functions and tasks of the Ethics Committees, the requirements of its members,
p.(None): the terms and conditions of appointments, offices, secretariat structure, procedures
p.(None): internal, and quorum requirements. Ethics Committees must act in accordance with their procedures
p.(None): written operations ”5. Glossaries of research ethics define Procedures
p.(None): Standardized operations such as written procedures, detailed for the uniform development of
p.(None): a function6.
p.(None): The procedures differ from the policies in that they are practical, detailed, specific and specific tactics.
p.(None): detailed directives that allow implementing a policy. Written operating procedures are needed because they are
p.(None): requirement to evaluate the proper functioning of a committee, and are the reference used to instruct and remember. Yes
p.(None): well on many occasions institutions can work without written procedures, that is not so effective
p.(None): not desirable. The procedures are not only necessary to meet requirements and be decorative, but must arrive
p.(None): to be a comprehensive and practical description of the different functions of the research ethics committee. The
p.(None): Results of having them would be:
p.(None): - Establish consistency in how situations are handled
p.(None): - Promote a reduction of errors
p.(None): - Provide clarity about responsibility in the distribution of tasks
p.(None): 3 BOE 33, Saturday, February 7, 2004. MINISTRY OF HEALTH AND CONSUMPTION, 2316 ROYAL DECREE 223/2004, of February 6,
p.(None): with which clinical trials with medications are regulated.
p.(None): 4. Opinion of the commissions, bill of clinical investigations with medicines, products
p.(None): doctors, dental products, biological products, gene therapy and cell therapy. The commissions of
p.(None): Social Action and Public Health and General Legislation of the Argentine Republic.
p.(None): 5 Operational guides for ethics committees that evaluate biomedical research, World Health Organization,
p.(None): 2000
p.(None): 6 Definition of terms. General Glossary Course of Introduction to Research Ethics, Bioethics Network
p.(None): Latin American
p.(None): Page 2 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): - Help faster and better training of new committee members
p.(None): - Provide a partial defense against complaints arising from an alleged unequal treatment in determinations
p.(None): of the committees.
p.(None): Within this framework, it is necessary to establish harmonized procedures for Good Clinical Practices defined for
p.(None): our country, which can serve as a basis for both regulatory agencies and researchers, Committees of
p.(None): Ethics, Universities and Companies.
p.(None): Page 3 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): 2. OBJECTIVES
p.(None): 2.1 GENERAL
p.(None): - Standardize the operational procedures of the National Committee for Health Research Ethics (CNEIS) and
p.(None): Local Committee for Health Research (CLEIS) of El Salvador, to guarantee quality in the
p.(None): Documentary and administrative operation, and comply with international guidelines and Good Practice Guide
p.(None): Clinics
p.(None): 2.2 SPECIFIC
p.(None): - Standardize the procedures for the review of ethical considerations of health research.
p.(None): - Establish a guide for an appropriate induction of the new members of the Committees.
p.(None): - Optimize processes for decision making.
p.(None): - Establish inter-institutional procedures for the integral evaluation of Clinical Trials.
p.(None): 3. SCOPE
p.(None): This manual applies to the entire Regulation of Clinical Trials that are carried out in El
p.(None): Salvador and is evaluated inter-institutionally between the National Directorate of Medicines, National Committee
p.(None): of Ethics of Health Research and the Higher Council of Public Health.
p.(None): 4. LEGAL BASES
p.(None): - Constitution of the Republic Art. 68, 69.
p.(None): - Law on the Rights and Duties of Patients Art. 5 literal c), Art. 9 literal L), Art. 16, 17 and 18.
p.(None): - Medicines Law Art. 2, 29, 66, 68 74 b).
p.(None): - Health Code Art. 7 and 14
p.(None): - General Regulations of the Medicines Law Art. 34, 85
p.(None): - Technical Regulations of the American Center for Pharmaceutical Products. Medicines
p.(None): Page 4 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): of Human Use. Sanitary Registration Requirements. RTCA 11.03.59: 11.
p.(None): - American Central Technical Regulations. Pharmaceutical products. Drug Stability Studies for Use
p.(None): Human. RTCA 11.01.04: 10.
p.(None): - American Central Technical Regulations. Pharmaceutical products. Labeling of Pharmaceutical Products for Use
p.(None): Human. RTCA 11.01.02: 04.
...
p.(None): - Investigator's commitment to good clinical practices.
p.(None): - Certificate of Good Manufacturing Practices (BPM) of the manufacturer or Certificate of BPM
p.(None): issued by the Local Regulatory Authority. Applies if the product is not registered.
p.(None): - Primary and secondary packaging arts of the product or products to be used in the clinical study, which
p.(None): contain the lot numbers and the date of manufacture and expiration.
p.(None): - Other materials (Promotional, patient card, questionnaires, etc.).
p.(None): - Copy of the certificate of authorization of operation of the Health establishment where the
p.(None): Clinical Study, issued by the Higher Council of Public Health.
p.(None): - Copy of the updated payment of the operating annuity of the establishment of
p.(None): health where the clinical study will take place.
p.(None): Page 9 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Recognitions of documents related to Clinical Research
p.(None): The National Committee for Health Research Ethics, the National Directorate of Medicines and the Superior Council
p.(None): Public Health, may officially recognize relevant decisions, reports or information from trials
p.(None): Clinics of drug regulatory agencies that have been certified level IV by the Organization
p.(None): Pan American Health (PAHO), as well as by health authorities of the United States of America, Canada,
p.(None): Australia, Switzerland, Japan and by the European Medicines Agency (EMA) and other countries that have
p.(None): specific regulation for the regulation of Clinical Trials.
p.(None): In the case of drug research protocols that require evaluation in beings
p.(None): human, its review will be applicable regardless of the primary origin of the application, be it from the sector
p.(None): National, foreign, public or private.
p.(None): In compliance with the Constitution of the Republic of El Salvador, Article 68.- A Higher Council of Public Health
p.(None): will ensure the health of the people. It will consist of the same number of representatives of the Medical, Dental,
p.(None): Chemist - Pharmacist, Veterinarian, Clinical Laboratory, Psychology, Nursing and others at the level of
p.(None): Degree that the Higher Council of Public Health has qualified to have its respective board; will have a
p.(None): president and a secretary of appointment of the executive body. The law will determine your organization.
p.(None): The exercise of professions that are immediately related to the health of the people will be monitored
p.(None): by legal bodies formed by academics belonging to each profession. These organisms will have
p.(None): power to suspend the professional members of the guild under their control, when exercising their
p.(None): profession with manifest immorality or disability. The suspension of professionals may be resolved by the agencies
p.(None): competent in accordance with due process.
p.(None): Page 10 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
...
p.(None): Clinical Practices according to the previous condition is as follows:
p.(None): CPB compliance review in studies already initiated
p.(None): Duty
p.(None): International pharmaceutical companies US $ 900.00
p.(None): National pharmaceutical companies US $ 600.00 Non-organizations
p.(None): non-governmental
p.(None): profit and foreign companies or universities
p.(None): $ 600.00
p.(None): Page 13 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): DESCRIPTION OF THE PROCEDURE 1
p.(None): Every person / institution / body that will submit a research project must submit it to
p.(None): ethical evaluation considering next steps:
p.(None): No. ACTIVITIES
p.(None): Download the documents for the identification of the fulfillment of prerequisites to the submission of projects of
p.(None): research at the following address: http://www.cneis.org.sv/ section Download documents:
p.(None): http://www.cneis.org.sv/descarga-de-documentos/
p.(None): in which you will find the following information:
p.(None): 1 1. Guide to Good Clinical Practices.
p.(None): 2. Good Clinical Practices Verification Guide.
p.(None): 3. User Guide for the Presentation of Clinical Research Protocols of the Directorate
p.(None): National Medicines.
p.(None): 4. Application Form for evaluation of clinical research protocols in humans.
p.(None): Request Authorization Letter from the authority of the center or centers
p.(None): health (includes hospitals, Minister of Health, Regional Directors of Health in the case of Units
p.(None): Community Family Health
p.(None): two
p.(None): located, private clinics) for conducting the study within
p.(None): the installations. It includes knowledge of the head of the hospital service, if applicable.
p.(None): PERSON IN CHARGE
p.(None): Sponsor / Researchers
p.(None): Principal investigator / team of researchers
p.(None): 3 Prepare Letter of intent of the researcher on the study. Investigator
p.(None): principal
p.(None): Page 14 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): No. ACTIVITIES
p.(None): Print protocol in its original version, with an edition date when the original is written in another language;
p.(None): Protocol translated into Spanish,
p.(None): with edition date and 4 printed copies and an electronic copy.
p.(None): 4
p.(None): Any protocol, independent of its type, must include the section “Ethical considerations”.
p.(None): Consult by telephone or in person with the Assistant of the National Ethics Committee of the
p.(None): Health Research, telephone 2561-2520, CSSP Facilities, building N ° 2, second level, on
p.(None): 5 the fulfillment of requirements for filling out the request for evaluation of medicines to be used
p.(None): in research protocols,
p.(None): as well as the requirements and identification of the payment of tariff or exemption thereof.
p.(None): PERSON IN CHARGE
p.(None): Principal investigator
p.(None): Principal investigator
p.(None): Page 15 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): PROCESS DIAGRAM - PROCEDURE 1
p.(None): PROCEDURE 1
p.(None): REVIEW OF REQUIREMENTS FOR SUBMISSION OF RESEARCH PROJECTS OR PROTOCOLS
p.(None): Sponsor/
p.(None): Researchers
p.(None): Principal investigator/
p.(None): team of researchers
p.(None): Start
p.(None): Download documents to identify compliance with prerequisites
p.(None): http://www.cneis.org.sv/
p.(None): Request authorization letter from the authority of the
p.(None): or health centers
p.(None): Prepare Investigator Letter of Intent
p.(None): about the study
p.(None): Print protocol in its original version, with an edition date when the original is written in another language;
...
p.(None): PROCEDURE 3: DETERMINATION OF THE TYPE OF RESEARCH PROJECT
p.(None): OBJECTIVE: To determine the type of evaluation that the research protocols will receive according to their
p.(None): features.
p.(None): RESPONSIBLE:
p.(None): - Administrative Assistant of the CNEIS.
p.(None): - Technician in charge of Monitoring Clinical Trials
p.(None): - National Committee for Health Research Ethics.
p.(None): - National Directorate of Medicines
p.(None): MATERIALS:
p.(None): - Research protocols.
p.(None): - Guide for identification of a clinical trial (ANNEX 4).
p.(None): EVALUATION MECHANISMS:
p.(None): - Evaluation that requires full: corresponds to projects that involve risks beyond the minimum for
p.(None): research subjects and, therefore, should be evaluated by the majority of the members and be discussed in
p.(None): full. The necessary quorum is half plus one, respecting multidisciplinarity.
p.(None): - Expedited evaluation: corresponds to projects that carry minimal ethical risks for the subjects of
p.(None): investigation and therefore, can be evaluated by two or three members of the Committee without discussion
p.(None): of the full. As well as studies of importance to Public Health, during national emergencies.
p.(None): The two main criteria that an expedited review must meet are:
p.(None): - The study does not involve more than what is considered minimum irrigation
p.(None): Page 19 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): - The study must fit into one or more of the following categories defined by CNEIS itself:
p.(None): ➢ Data collection through non-invasive procedures commonly used in clinical practice.
p.(None): ➢ Studies involving materials already collected, which may be data or samples
p.(None): ➢ Review of the periodic report of a study previously approved by the CIS and that is no longer enrolling new
p.(None): subjects, either that there are no additional risks identified or that it is limited only to data analysis.
p.(None): ➢ Review of minor amendments.
p.(None): Projects that do not require evaluation: corresponds to projects whose purpose is the evaluation of a
...
p.(None): proposed (group of patients, family support,
p.(None): 5
p.(None): representatives of community organizations,
p.(None): specialists, statistician, specialist in research methodology, others according to their expertise).
p.(None): This consultation will be an input for the final resolution. This procedure must be performed within the
p.(None): defined period for evaluation.
p.(None): CNEIS members
p.(None): President of CNEIS
p.(None): CNEIS
p.(None): Expert Advisory Committee
p.(None): Page 23 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): Develop the session for the protocol discussion of
p.(None): 5 according to the final resolution guide and establish the corresponding final opinion.
p.(None): The plenary by consensus decides the resolution as follows:
p.(None): Approved without restrictions (ASR)
p.(None): 6
p.(None): Evaluated with observations and request for amendments (FI =
p.(None): Information is missing)
p.(None): Not approved (PRT = Protocol rejected for technical and ethical reasons)
p.(None): CNEIS Reviewers
p.(None): CNEIS Secretary
p.(None): NOTE:
p.(None): The Researcher must inform the National Committee of Health Research Ethics when the Study will begin
p.(None): Clinician authorized by the CNEIS, also must inform when the Clinical Study has finished as
p.(None): established in procedure 14 of this manual.
p.(None): Page 24 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): PROCEDURE 5. ELABORATION OF THE RESOLUTION ACT OF A RESEARCH PROJECT
p.(None): OBJECTIVE: Standardize the preparation of the minutes and the memorandums of notification, evaluation
p.(None): of the research projects that have been submitted to the Committee and the National Directorate of Medicines (in case
p.(None): of a clinical study).
p.(None): RESPONSIBLE:
p.(None): - Secretary of the CNEIS
p.(None): - Administrative assistant
p.(None): MATERIALS:
p.(None): - Guide for the preparation of the resolution document (ANNEX 7)
p.(None): - Notification format for researchers. (ANNEX 8)
p.(None): DESCRIPTION OF THE PROCEDURE 5
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): Prepare the resolution document containing the opinion, which
p.(None): will be signed by the President and the Secretary, placing the
p.(None): one
p.(None): correlative number established by the Committee, using the
p.(None): guide to the minutes of resolution.
p.(None): It clearly identifies the Evaluation Committee, as well as the evaluated research project, the
p.(None): investigator
p.(None): responsible, the place where the recruitment of
p.(None): two
p.(None): patients, the final opinion of the evaluation and the declaration
p.(None): of conflict of interest of the members of the Committee in case it occurs.
p.(None): CNEIS Secretary
p.(None): CNEIS Secretary
p.(None): Page 25 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): Keep the minutes in the Committee file, together with the
p.(None): 3
p.(None): Related documentation.
p.(None): Prepare the memorandum following the notification format for researchers, specifying the respective
p.(None): number the
p.(None): 4
p.(None): Informed consent document approved, sealed and
p.(None): signed on each of its pages.
p.(None): Communicate to the investigator, clearly the times of delivery of information or notification to the CNEIS, which must meet
p.(None): in the cases of (delivery of continuity reports, security reports or adverse events, and all
p.(None): the tracking documents; as well as the validity period of the approval of the research protocol.
p.(None): 5 Information delivery times:
p.(None): ✓ Serious Adverse Events, EAS: first 24 hours.
p.(None): ✓ Serious unrelated adverse events: one week.
p.(None): ✓ Non-serious internal adverse events associated and not associated with the study: three weeks.
p.(None): ✓ Safety and continuity reports: quarterly, semi-annually and annually.
p.(None): Validity of approval of the research protocol: one year.
p.(None): CNEIS administrative assistant
p.(None): CNEIS administrative assistant
p.(None): CNEIS Reviewers
p.(None): Page 26 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): PROCEDURE 6. EVALUATION MEETING WITH THE INVESTIGATOR
p.(None): OBJECTIVE: Standardize the development of meetings convened with researchers, in order to
p.(None): obtain more technical, methodological and ethical information on the protocols presented, in those investigations in
p.(None): which are necessary opinions of external consultants and those in which it is necessary to deepen in
p.(None): aspects of the protocol.
p.(None): RESPONSIBLE:
p.(None): - National Committee for Health Research Ethics
p.(None): - National Directorate of Medicines
p.(None): - Principal investigator
p.(None): MATERIALS:
p.(None): - Notice of call to principal investigators
p.(None): - Power Point presentation
p.(None): - Written protocol
p.(None): DESCRIPTION OF THE PROCEDURE 6
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): Define if it is necessary to invite the principal investigator, if the study meets one or more of the following
p.(None): terms:
p.(None): ✓ Research that poses a high security risk
p.(None): ✓ Research involving vulnerable populations
p.(None): one
p.(None): ✓ Investigations that are related to the field of
p.(None): genetics.
p.(None): ✓ Research involving little known or complex methodologies
p.(None): CNEIS full reviewers
p.(None): Page 27 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): ✓ That during the appeal process it is considered to listen to the principal investigator.
p.(None): Send invitation to the principal investigator, requesting to make a presentation of the project to the committee and
p.(None): answer your
p.(None): 2 questions. The invitation must be made within a maximum period of 21 business days, from the receipt of
p.(None): the request for evaluation of the study protocol.
p.(None): Make the presentation to the Committee in full and answer the
p.(None): 3 questions that arise from committee members and / or experts invited by the Committee.
...
p.(None): There is a certain degree of responsibility when managing adverse events. When there is no sponsor
p.(None): externally, the research authority of the institution in charge of the project will fulfill the role of the sponsor. The
p.(None): Principal investigator (IP) or chief investigator (IJ) has full responsibility for conducting the study. In
p.(None): A Multicentre study, the IP has coordinated responsibilities to report adverse events to the CNEIS and the
p.(None): DNM In the case of studies of products already registered in the DNM that evaluate a new, new indication
p.(None): concentration if it is higher than the one already registered, new dosage or new dosage form for the purpose of
p.(None): registry; All studies of pharmacokinetics, bioavailability and bioequivalence will also be reported to
p.(None): CNFV Any IP / IJ that you have accepted to upload
p.(None): Page 32 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): with the areas of Pharmacovigilance, delegated by the sponsor, you must take both responsibilities, those of the IP and
p.(None): those of the sponsor.
p.(None): Serious Adverse Event (EAS) or Serious Drug Adverse Reaction (Serious RAM)
p.(None): Any unfavorable occurrence that at any dose:
p.(None): (a) results in death,
p.(None): (b) life threatening, requires patient hospitalization or prolongation of existing hospitalization,
p.(None): (c) results in persistent or significant disability / disability, or is a congenital anomaly / defect
p.(None): of birth
p.(None): Which EAS to report?
p.(None): - The management and reporting of arrangements for EAS must be implemented in all trials. In the agreements
p.(None): at the beginning of the trial, it should be established that EAS are defined as related to the disease and that, therefore,
p.(None): They are not subject to an expedited report. EAS management and reporting procedures must be clearly
p.(None): defined in the protocol.
p.(None): It is recommended that an Independent Data Monitoring Committee (CIMD) be installed so that on a regular basis
p.(None): data security reviews are made throughout the trial and when necessary, and recommend
p.(None): Sponsor continue, modify or end the trial. Again, this procedure must be defined in the
p.(None): protocol.
p.(None): The confidentiality and adherence of the data must be maintained both in your record and in your report.
p.(None): During rehearsal
p.(None): - For each EA an evaluation of the seriousness, the causality and the expectation must be made. The
p.(None): Responsibility for this evaluation is of the IP; and when there is
p.(None): Page 33 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): several, as in multicentric studies, the responsibility will fall on all IPs. It is appropriate that each IP
p.(None): in each site evaluate each event, before reporting it to the central IP. It must be specified in the protocol of
p.(None): clinical trial and use local POEs, and will take responsibility for determining and reporting each of the events at
p.(None): Sponsor and central IP, simultaneously. When you need to report expeditiously, this procedure assumes
p.(None): The responsibility for the initial determination and reporting to the central IP.
p.(None): Seriousness Assessment
p.(None): - The term seriousness is based on the evolution of the patient / event or action criterion. It is different from
p.(None): "Severity", which is used to refer to the intensity of a specific event.
p.(None): Causality Assessment
p.(None): - Most adverse events and adverse reactions to drugs that occur in a study, whether serious or not,
p.(None): they are expected to be toxicities due to the drug used in the study. The causation assignment must be made
p.(None): by the researcher responsible for the care of the participants, using the definitions shown in the
p.(None): following picture:
p.(None): Relationship Description
p.(None): Not related
p.(None): Unlikely
p.(None): Possible
p.(None): There is no evidence of any causal relationship.
p.(None): There is little evidence to suggest that there is a causal relationship (eg the event did not occur within a while
p.(None): reasonable after the medication was administered in the trial). There is no other reasonable explanation for the
p.(None): event (Ex. The clinical condition of the participant, other concomitant treatment, etc.).
p.(None): There is some evidence that suggests a causal relationship (eg because the event occurred within a while
p.(None): reasonable after administered on
p.(None): Page 34 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Relationship Description
p.(None): medication under study). However, the influence of other factors may have contributed to the event (eg.
p.(None): clinical condition of the patient, other concomitant treatments, etc.).
p.(None): There is evidence that suggests a causal relationship and there seems to be no influence
p.(None): Probable
p.(None): Definitive
p.(None): Cannot be evaluated
p.(None): of other factors.
p.(None): There is clear evidence of a causal relationship and any influence of other contributing factors may be
p.(None): discarded
p.(None): There is insufficient or incomplete evidence to make a clinical trial of causal relationship.
p.(None): All serious adverse events (EAS) should be reported immediately except those EAS that the
p.(None): protocol or other document (for example, Researcher's Brochure) identify that they do not need an immediate report.
p.(None): Immediate reports should be followed by detailed written reports.
p.(None): All local investigators must report any EAS or SUSAR, as required by the Committee on
p.(None): Local, National Research Ethics and the competent authority.
p.(None): It is necessary that all EAS and SUSAR be notified in physical and digital format (Email, CD or Memory
p.(None): USB)
p.(None): The CNEIS, must send all the information of EAS and / or SUSAR to the DNM, so that it carries out the evaluation and the
p.(None): corresponding tracking. If the EAS and / or SUSAR is related to the investigational drug, the DNM has the
p.(None): authority to suspend the prescription, dispensation and supply of investigational drugs, as
p.(None): established in article 74 of the Medicines Law, in order to control the sanitary surveillance of medicines.
p.(None): The CNEIS must send to the CNFV the results of the Clinical Trials of the medications that are
p.(None): they are registered with the DNM, regarding security and
p.(None): Page 35 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): effectiveness to compare them with the safety assessment contained in the Periodic Safety Reports
p.(None): (IPS) and Risk Management Plans (PGR).
p.(None): For all those Clinical Trials that have been carried out in El Salvador, the CNFV may request the data from the CNEIS
p.(None): obtained from the clinical study.
p.(None): DESCRIPTION OF THE PROCEDURE 8
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): When an EAS occurs, RAM would be, RAM would not be unexpected or SUSAR in El Salvador, the researcher
p.(None): shall
p.(None): inform the National Ethics Committee to the National Directorate
p.(None): one
p.(None): of Medicines and the National Pharmacovigilance Center
p.(None): (CNFV) within the first 24 hours from the knowledge by the principal investigator.
p.(None): For EAS and SUSAR:
p.(None): Prepare the report of serious adverse events (EAS) and SUSAR using the form; classified according to Dictionary
p.(None): doctor for systems regulatory activities (MedRA) and the form for reporting adverse events.
p.(None): For RAM Serious or Not Serious for Medications in
p.(None): 2 research that already have a Health Registry, the researcher must report the RAM
p.(None): Serious, through the following ways:
p.(None): - Through the filling of the RAM Suspicion Notification Sheet. (Annex 8)
p.(None): - Or, the online electronic format filling: E-REPORTING:
p.(None): http://cnfv.salud.sv/hoja-ram-esavi-electronica-en-linea/
p.(None): Sponsor /
p.(None): Principal investigator
p.(None): Sponsor / Principal Investigator
p.(None): Page 36 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): If there is any doubt about causation, the local investigator
p.(None): You must inform the study coordinating center, who
p.(None): 3 will notify the Principal Investigator. Pharmaceutical companies and / or other clinicians
p.(None): they must be interrogated to advise, in some cases.
p.(None): After receiving the EAS and SUSAR report, the CNEIS and DNM must be called for discussion and
p.(None): New case analysis of EAS and SUSAR, within the first 72 hours.
p.(None): The CNFV will be convened in cases where there are Serious or Non-Serious RAM for product studies already
p.(None): registered in the DNM as established in this manual.
p.(None): 5
p.(None): In the case of the Pre-Marketing studies, the CNFV
p.(None): technical support will only be provided to decide whether there is a causal relationship or not in a Serious Adverse Event or
p.(None): Serious Drug Adverse Reaction.
...
p.(None): CNEIS administrative assistant
p.(None): Technician in charge of Monitoring Clinical Trials.
p.(None): Page 36 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): PROCEDURE 10. REPORT OF AMENDMENTS
p.(None): OBJECTIVE: To homogenize the procedure for receiving substantial or minor amendments, to studies authorized during
p.(None): the development of the same, sent to the CNEIS
p.(None): or to the CEIS.
p.(None): RESPONSIBLE:
p.(None): - Sponsor
p.(None): - Principal investigator
p.(None): - CNEIS / CEIS
p.(None): - National Directorate of Medicines
p.(None): MATERIALS:
p.(None): - Description of the amendment and amendment report. (ANNEX 10A and 10B).
p.(None): - Reasons for the proposed amendment.
p.(None): - Copy of the proposed changes to the protocol or any other document, demonstrating what was written before and
p.(None): after.
p.(None): - Data supporting the amendment, including any changes to the risk-benefit analysis.
p.(None): TYPES OF AMENDMENT:
p.(None): An amendment to the research project may be substantial or minor (not substantial).
p.(None): Substantial amendment: A substantial amendment may be defined as an amendment to the protocol or to any
p.(None): Another substantial document, which can affect to a significant degree:
p.(None): - The safety or physical or mental integrity of the subjects in the study
p.(None): - The scientific value of the study
p.(None): - Conducting or administering the study
p.(None): Page 37 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): - The quality or safety of any medicinal product under investigation used in the trial.
p.(None): Substantial amendments may be:
p.(None): Amendments related to the protocol
p.(None): - Purpose of the essay
p.(None): - Trial design
p.(None): - Recruitment procedure
p.(None): - Measures of effectiveness
p.(None): - Sample calendar
p.(None): - Added or subtracted from exams or measures
p.(None): - Number of participants
p.(None): - Age range of participants
p.(None): - Inclusion criteria
p.(None): - Exclusion criteria
p.(None): - Security monitoring
p.(None): - Duration of exposure to the medicinal product under investigation
p.(None): - Change of dose of the medicinal product under investigation
p.(None): - Comparator change
p.(None): - Amendments to other study documentation
p.(None): - Participant information sheet
p.(None): - Informed consent
p.(None): - Questionnaires
p.(None): - Invitation card
p.(None): - Letters to the Chief or Principal Investigator, and other clinicians
p.(None): - Information sheets for relatives or caregivers
p.(None): - The file of the Medicinal Product in Research (PMI)
p.(None): - Amendments related to trial arrangements
p.(None): - Change the Principal Investigator or add new ones (this means: researchers who
p.(None): direct the research in each center)
p.(None): Page 38 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): - Change in the coordinating researcher
p.(None): - Change in the study site or add new sites
p.(None): - Change of sponsor or legal representative
p.(None): - Change of the definition of completion of the study
p.(None): - Change in PMI provider
p.(None): Minor (non-substantial) amendment: A minor amendment can be defined as a change in the details of the study that does not
p.(None): it will have significant implications for the participants in it, or for its management, administration or value
p.(None): scientific.
p.(None): Minor amendments can be:
p.(None): - Corrections of typographical errors in the study documents
p.(None): - Minor clarifications to the protocol
p.(None): - Changes in the research team (apart from changes to the Chief or Principal Investigator)
p.(None): - Extension of the study beyond the period specified in the application form
p.(None): - Changes in financing arrangements
p.(None): - Changes in the documentation used by the research team to record the study data (Ex.
p.(None): Case Report Forms)
p.(None): - Changes in logistics arrangements for storage or transport of samples
p.(None): - Inclusion of new sites in studies exempt from “site specific determination” (SSA).
p.(None): It is necessary that all Amendment Reports be notified in physical and digital format (Email, CD or
p.(None): Pen drive).
p.(None): Page 39 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): DESCRIPTION OF THE PROCEDURE 10
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): Determine if the amendment is substantial or not. Taking into account the format information of
p.(None): amendments
p.(None): Substantial for clinical trials of medicinal products
p.(None): 1 under investigation (PMI) and deliver notification format and description of the amendment, together
p.(None): with all updated documentation, such as consent forms or protocols.
p.(None): Send amendment to both the CNEIS and the Center or Unit
p.(None): 2 of Research that authorized the study, before the amendment takes action.
p.(None): Reception and notification of amendment.
p.(None): Deliver to CNEIS and DNM in next session for
p.(None): 3
p.(None): respective review and authorization in next session, prior
p.(None): to the implementation of the amendment.
p.(None): Analyze the amendments, classify the type of amendment as substantial or less.
p.(None): In cases of substantial amendments, it must be ruled whether it is approved or rejected by the National Directorate of
p.(None): Medications and the National Ethics Committee of the
p.(None): 6
p.(None): Health Research, preparing approval certificate
p.(None): before being implemented.
p.(None): In the case of minor amendments, it will be read and sent to file with all the information
p.(None): of the protocol, providing a copy to the DNM.
p.(None): Sponsor / Principal Investigator
p.(None): Sponsor / Principal Investigator
...
p.(None): 4
p.(None): according to exposed information, and prepare notification
p.(None): Administrative Assistant and
p.(None): Page 45 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): of results.
p.(None): Send to the DNM all periodic reports of research progress or continuity.
p.(None): Analyze and update information in Logs of
p.(None): 5
p.(None): tracing.
p.(None): Send notification to principal investigator and CSSP supervisory team. A copy of the notification must be
p.(None): 6
p.(None): filed next to the project information of
p.(None): investigation
p.(None): Technician in charge of Monitoring Clinical Trials.
p.(None): Administrative and Technical Assistant in charge of Monitoring Clinical Trials
p.(None): Administrative assistant
p.(None): Page 46 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): PROCEDURE 13: AUDIT OF GOOD CLINICAL PRACTICES TO RESEARCH CENTERS
p.(None): OBJECTIVES: Define the mechanism and criteria for carrying out the audits of PCBs to all parties
p.(None): involved in clinical research with the purpose of monitoring compliance with them.
p.(None): RESPONSIBLE:
p.(None): - Sponsor
p.(None): - Principal investigator
p.(None): - National Committee for Health Research Ethics
p.(None): - CSSP CSSP Audit Team
p.(None): MATERIALS:
p.(None): - Checklist of requirements for compliance with good clinical practices. (annex 14).
p.(None): DESCRIPTION OF THE PROCEDURE 13
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): Identify the studies that will be inspected according to the following criteria:
p.(None): The importance of proof for decision making
p.(None): 1 regulatory
p.(None): - The nature of the study
p.(None): - The vulnerability of the subjects
p.(None): - The irregularities of the data
p.(None): - The complaints
p.(None): National Committee for Health Research Ethics and National Directorate of Medicines
p.(None): Page 47 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): Request in writing to the CSSP the Audit of one or more research centers, attaching information
p.(None): about him
p.(None): protocol, the modifications, the form of the
p.(None): two
p.(None): authorization with knowledge of the cause, samples of
p.(None): data collection notebooks (FRC), study reports, reports of serious adverse events, etc.
p.(None): Prepare the audit plan for the center and the study to be audited, in agreement with the CNEIS,
p.(None): specifying specific source documents and centers to visit.
p.(None): Note: When planning the Audit, the supervisor must understand the scientific objectives, the
p.(None): criteria of
p.(None): 3
p.(None): inclusion and exclusion, concomitant medications
p.(None): allowed and not allowed, visits and analytical procedures required, any special requirements
p.(None): for handling or storage of the test article, and known information about the medication
p.(None): of the essay, as well as its profile of adverse events.
p.(None): Request information from the CNEIS about irregularities of data or special matters of interest that the
p.(None): DNM,
p.(None): 4
p.(None): during the internal examination of the marketing application
p.(None): (or presentation of the protocol).
p.(None): Inform the clinical investigator in advance, the date of the
p.(None): visit, to ensure that it is present and can access the study records in the
p.(None): moment of
p.(None): 5
p.(None): Audit. When an Audit is announced, the inspector
p.(None): inform the clinical investigator of the documents that must be at hand for the Audit and the
p.(None): installations
p.(None): CNEIS DNM
p.(None): CSSP Audit Team
p.(None): CSSP Audit Team
p.(None): CSSP Audit Team
p.(None): Page 48 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): that will be visited, if relevant.
p.(None): Hold a meeting with the principal investigator at the beginning of the Audit and present their official identification and
p.(None): Any official notice that may be requested. Explain the nature and scope of the Audit, and summarize
p.(None): briefly the methods and procedures that will be used to carry it out.
p.(None): Request information on:
p.(None): - Screening and income of patients to study
p.(None): - Obtaining informed consent
p.(None): 6 - Collection and analysis of study data
p.(None): - Registration, transcription and notification of data to the sponsor
p.(None): - The reception, return and administration of the test drug
p.(None): Other interviews can be conducted with the key study staff and, if relevant, with the subjects
p.(None): of the study, during the Audit and as situations arise that merit it.
p.(None): Determine if the test activities were carried out according to the protocol, to the requirements
p.(None): regulatory
p.(None): 7 applicable and to the BPC, and verify that the data was recorded and notified accurately,
p.(None): using the checklist
p.(None): Identify the study records through an inventory of
p.(None): 8
p.(None): the same. This will be done before the review begins.
p.(None): CSSP Audit Team
p.(None): CSSP Audit Team
p.(None): CSSP Audit Team
p.(None): Page 49 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): exhaustive records of specific subjects. You can facilitate this task by first having someone
p.(None): that you are familiar with the study documents and explain your organization and
p.(None): Location. The inspector will then check, at a minimum, that there is a case file for each subject
p.(None): registered in the center. Other essential documents will also be considered, for example, the approvals of the
p.(None): Ethics Committee, records of receipt of trial medications, others.
p.(None): Compare the copy of the protocol provided by the CNEIS and the clinical investigator's file protocol,
p.(None): to determine if there are differences in what refers to:
p.(None): - The selection of subjects (inclusion and exclusion criteria)
p.(None): - The number of subjects
p.(None): - The frequency and nature of the observations of the subjects
p.(None): 9
p.(None): - The dosage
p.(None): - The route of administration
p.(None): - The frequency of administration
p.(None): - Masking procedures
p.(None): - If there are differences, determine if they were documented by protocol modifications and if they are
p.(None): approved in accordance with the applicable regulatory requirements.
p.(None): Compare the original source data of the records of
p.(None): 10 the subjects with the data collection notebooks or the final report for the sponsor, in order
p.(None): to verify that
p.(None): CSSP Audit Team
p.(None): CSSP Audit Team
p.(None): Page 50 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): Source data has been fully and accurately notified. Select a representative sample of the
p.(None): subjects recruited at intervals, at the beginning, in the middle and at the end of the study. However, if a
p.(None): significant problem in a particular area (for example, not taking the test medication as required),
p.(None): audit this particular aspect of the study in all subjects. Identify source data that supports the following
p.(None): fundamental points:
p.(None): Were there subjects and went to the visits as notified? Subjects admitted to the study or those who
p.(None): completed,
p.(None): Did they meet the inclusion or exclusion criteria of the protocol?
p.(None): Regarding the dose and frequency of administration, did the subjects receive the
p.(None): trial medication according to the protocol?
p.(None): Were the significant assessment criteria data fully and correctly obtained and notified, with
p.(None): according to the protocol?
p.(None): Were adverse events reported to the sponsor and the regulatory authority?
p.(None): Review the study records of each subject to verify the correct administration of the dose in what is
p.(None): refers to the quantity, frequency, duration and route of administration.
p.(None): 11 In addition, examine the shipping and distribution records of the drug to reconstruct the route of
p.(None): distribution of the test drug and check the dates of receipt, the quantity and the
p.(None): medication identity of
p.(None): CSSP Audit Team
p.(None): Page 51 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): test, and to compare the use of the test drug with the amounts sent and returned to the promoter at the end of
p.(None): study. If unused supplies are not returned to the sponsor, the supervisor will verify that the
p.(None): Alternative provision was handled appropriately and documented. The supervisor will verify that the medication
p.(None): of the test was kept under appropriate conditions.
p.(None): Conclude the Audit by making its final comments to the clinical investigator. The supervisor will explain and comment
p.(None): The results of the visit. The results will be described in what
p.(None): 12 regarding its nature and scope (that is, how many records were reviewed and to what extent). The
p.(None): Results must be strictly objective, based on the records and information available
p.(None): during the audit.
p.(None): Thoroughly document the Audit, both during its completion and after its conclusion. The
p.(None): only tangible results of an audit are the written report and
p.(None): 13 supervisor notes. When serious breaches are observed, the
p.(None): legal or administrative sanctions against the clinical investigator will be based on the documented results of
p.(None): the auditory.
p.(None): Prepares the narrative report of the supervision in which the results of it are detailed, explaining the reason for
p.(None): the Audit, for example, if it was systematic or if it was performed with
p.(None): 14 a special purpose. It will also describe the scope of supervision, for example, if it was limited to one
p.(None): succinct review of the records to address a specific issue or if it was an exhaustive audit of the
p.(None): study completion To the
p.(None): CSSP Audit Team
p.(None): CSSP Audit Team
p.(None): CSSP Audit Team
p.(None): Page 52 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): No. RESPONSIBLE ACTIVITIES
p.(None): Describe the scope of supervision, the report will indicate which records were considered and the number of
p.(None): documents or medical records that were considered in relation to the number of study subjects. The
p.(None): The report will also include the name of the trial drug, the study sponsor, the title and number of the
p.(None): protocol, the dates of the study and the number of subjects. Mention by name the individuals who performed
...
p.(None): PROCEDURE 16. RESEARCH OF THE ARCHIVES OF THE CNEIS
p.(None): OBJECTIVE: To comply with the requirement of Good Clinical Practices for CEIS (in section 3.5.1), which
p.(None): requires keeping all relevant records (written procedures, member lists, lists of
p.(None): membership of members and their occupation, documents submitted, minutes of meetings and correspondence) by a
p.(None): three-year period after completing the study and making them available at the time the
p.(None): regulatory authority (s) request them.
p.(None): RESPONSIBLE:
p.(None): - Members of the Health Research Ethics Committee (CNEIS)
p.(None): FILE CONTENT:
p.(None): The files (sources of printed, magnetic or electronic data) must include, at least:
p.(None): - Procedures manual: regulations, operational guides, manuals, national and / or international standards,
p.(None): technical documents, the procedures manual with their respective annexes, the applicable regulatory texts.
p.(None): - List of identification and curriculum vitae of each member of the CNEIS, updated.
p.(None): - Financial records (fee income, operating expenses), summary of expenses, and forms of
p.(None): consumption and order, or monthly expense.
p.(None): - Minutes of meetings of the Committee, listed consecutively by year.
p.(None): - Reports of CNEIS decisions. Approval Minutes and reports of rejection and suspension ordered
p.(None): correlatively, foliated per year.
p.(None): - Reports of serious adverse events and reports of the Independent Data Monitoring Committees (CSSP),
p.(None): backed by CNEIS analysis reports.
p.(None): - Correspondence received (documentation sent by investigators, correspondence exchanged
p.(None): with them and other actors).
p.(None): - Correspondence dispatched by the CNEIS.
p.(None): Page 60 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): - Protocols evaluated, with all the documentation analyzed, Minutes of Approval, copy of follow-up reports,
p.(None): reports and amendments.
p.(None): - Documents submitted by the project sponsor.
p.(None): - Periodic reports on the study and the final report. Protocol in its different versions, manual of the
p.(None): Investigator, Informed Consent, Researcher Resume, Minutes of Approval or Rejection,
p.(None): reports and correspondence ordered by correlative date. It is an obligation that each protocol is protected in a
p.(None): file identified with the title, the code, the name of the sponsoring institution, the name of the researcher
p.(None): and the place or center where the investigation is carried out, as well as the start and end date.
p.(None): - It will be the responsibility of the CNEIS to keep the test files for a period of 3 years, from the
p.(None): completion of it, leaving a record in the corresponding Database. Later it will pass the archives of
p.(None): the essays will go to the general archive of the Higher Council of Public Health.
p.(None): Page 61 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): 10. GLOSSARY
p.(None): 1. Approval (in relation to the CNEIS): The affirmative decision of the Health Research Ethics Committee that
p.(None): The clinical study was reviewed and can be conducted in the institution within the guidelines established by the
p.(None): CEIS, the institution, Good Clinical Practice (BPC) and the applicable regulatory requirements.
p.(None): 2. Quality Assurance (CA): All planned and systematic actions that are established to
p.(None): ensure that the study is being carried out and that the data is generated, documented (recorded) and
p.(None): reported in compliance with Good Clinical Practice (BPC) and regulatory requirements
p.(None): applicable.
p.(None): 3. Randomization: The process of assigning the subjects of a study to the treatment groups
p.(None): or control using chance to determine subjects, in order to reduce bias.
p.(None): 4. Audit: A systematic and independent review of related activities and documents
p.(None): with the study to determine if the activities evaluated were performed and the data were recorded,
p.(None): analyzed and reported accurately according to the protocol, Standard Operating Procedures of the
p.(None): Sponsor (POE), Good Clinical Practice (BPC) and applicable regulatory requirements.
p.(None): 5. Study Data Audit: A comparison of the source data and records associated with the
p.(None): intermediate or final report to determine if the source data were accurately reported, establish
p.(None): if the studies were carried out according to the protocol and the applicable PCBs, obtain information
p.(None): additional not provided in the report, and establish whether procedures were used to obtain the data
p.(None): They could invalidate them.
p.(None): 6. Authority of Surveillance (National) of the Compliance of the BPC: A body of norms, established within a
p.(None): country, which has the responsibility of monitoring the compliance of the PCBs within its territory and of carrying out
p.(None): other functions related to the PCBs, as determined nationally, in the case of El Salvador this
p.(None): entity is the Higher Council of Public Health.
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p.(None): National Committee for Health Research Ethics
p.(None): 7. Regulatory Authorities: Refers to the authority responsible for the regulation of investigations and
p.(None): medicines. They can be agencies that have the power to regulate. In the guidelines of Good Practice
p.(None): Clinic of the International Harmonization Conference, the term Regulatory Authorities includes the
p.(None): authorities that review the submitted clinical data and those that carry out inspections. Sometimes it
p.(None): refers to these organizations as competent authorities.
p.(None): 8. Well-being (of the study subjects): The physical and mental integrity of the subjects participating in a study
p.(None): in health.
p.(None): 9. Good Clinical Practices (PCB): A standard for design, conduction, realization, monitoring,
p.(None): audit, registration, analysis and report of clinical studies that provides a guarantee that the data and
p.(None): the reported results are credible and accurate and that rights are protected,
p.(None): integrity and confidentiality of the subjects of the study.
p.(None): 10. Center where the study is carried out: Place (s) where the activities related to the
p.(None): study.
p.(None): 11. Subject Identification Code: A unique identifier that the investigator assigns to each subject of the study
p.(None): to protect its identity, and that is used instead of the name of the subject when the investigator reports events
p.(None): Adverse and / or some other data related to the study.
p.(None): 12. Coordinating Committee: A committee that can be organized by the sponsor to coordinate the conduct of a
p.(None): Multicentre study.
p.(None): 13. Ethics Committee of Clinical / Health Research (CEIC / CEIS) of an institution: Autonomous entity within
p.(None): of a Hospital, University or institution dedicated to research, whose objective is to ensure the protection of the
p.(None): dignity and rights of the people who participate as research subjects *.
p.(None): 14. Independent Data Monitoring Committee (CIMD) (Data Monitoring and Security Council, Monitoring Committee,
p.(None): Data Monitoring Committee): An independent data monitoring committee that the sponsor can
p.(None): establish to evaluate the progress of a health study in intervals, the data
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p.(None): National Committee for Health Research Ethics
p.(None): safety and critical points for the evaluation of effectiveness, and recommend to the sponsor if it should
p.(None): continue, modify or stop a study.
p.(None): 15. National Committee for Health Research Ethics (CNEIS): Governing body of the ethical framework for research in
p.(None): health in El Salvador, whose main objective is to protect the rights of the human beings who participate as
p.(None): research subjects and among whose functions is the accreditation of local committees, to develop their
p.(None): functions framed within current regulations.
p.(None): 16. Comparator (Product): A research or commercialized product (for example, active control) or placebo
p.(None): used as a reference in a clinical study.
p.(None): 17. Confidentiality: Failure to disclose to others - unless they are authorized personnel - information that
p.(None): is the property of the sponsor or the identity of a subject.
p.(None): 18. Informed Consent: The process by which a subject voluntarily confirms their desire to
p.(None): participate in a particular study, after being informed about all the relevant aspects so that your
p.(None): Decision regarding your participation be free and responsible. Informed consent is
p.(None): document through a written, signed and dated “Informed Consent Form”.
p.(None): 19. Contract: Written, dated and signed agreement between two persons or more parties involved, which establishes any
p.(None): arrangement on the delegation and distribution of work and obligations for the development of an investigation and, if
p.(None): If necessary, on financial matters. The protocol can serve as the basis for a contract.
p.(None): 20. Quality Control (CC): The techniques and operational activities carried out within the system of
p.(None): quality assurance to verify that the quality requirements of the
p.(None): activities related to the study.
p.(None): 21. Compliance (in relation to studies): Attachment to all requirements related to the study,
p.(None): Good Clinical Practice (BPC) requirements and applicable regulatory requirements.
p.(None): 22. Source Data: All information in original records and certified copies of the original records of
p.(None): clinical findings, observations or other activities in
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p.(None): National Committee for Health Research Ethics
p.(None): a health study necessary for the reconstruction and evaluation of the study. The source data is contained in
p.(None): source documents (original records or certified copies).
p.(None): 23. Hospital departments and services: Direct patient care units in hospitals
p.(None): o Health units, where the subjects to be included in the studies will be identified and recruited.
p.(None): 24. Serious deviation: It is defined as any violation of the correct conditions and principles of the BPC, in
p.(None): relationship with the essay, or the disrespect for the protocol of that essay or its amendments. It is considered "serious" that
p.(None): deviation that can significantly affect the safety or physical (or mental) integrity of the subjects in the
p.(None): study, or its scientific value.
p.(None): It is the responsibility of the sponsor to determine the impact of the deviation on the scientific value of the trial. Yes
p.(None): someone is not sure how to do it, you should ask for advice from the competent authority, the sponsor or the
p.(None): CEIS.
p.(None): 25. Hospital Management: Instance that, in his position as legal representative of the Hospital, will consider whether
p.(None): the institution and / or the person proposing the study will respect hospital regulations, as well as
p.(None): the confidentiality of the data, and if they may have the right to access the data and the hospital patients.
p.(None): 26. Documentation: All records, in any form (including, but not limited to records
p.(None): written, electronic, magnetic, optical and scanner, X-rays and electrocardiograms, etc.) that describe or record
p.(None): the methods, conduction and / or results of a study, the factors that affect a study and the actions taken.
p.(None): 27. Essential Documents: Documents that individually and collectively allow an evaluation of the conduct of
p.(None): a study, and the quality of general data.
p.(None): 28. Source Documents: Original documents, data and records (eg hospital records, sheets
p.(None): clinics, lab notes, memoranda, subjects diaries or evaluation checklists,
p.(None): pharmacy delivery records, recorded data of automated instruments, copies or
p.(None): certified transcripts after verifying that they are exact copies,
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p.(None): National Committee for Health Research Ethics
p.(None): microfiche, photographic negatives, magnetic media or microfilm, X-rays, subjects' files and
p.(None): records kept in pharmacies, in laboratories and in the medical-technical departments involved
p.(None): in the health study).
p.(None): 29. Amendment to the Protocol: Amendments are changes made to a research study, after having
p.(None): obtained a favorable opinion from the ethical point of view of the corresponding CNEIS and the authorization of
p.(None): a regulatory body (unit or research center or others that apply). They can be made to the protocol, to
p.(None): other essential documents and other aspects of the study development. All protocols of
p.(None): study must have clearly written the version number and date, in order to maintain an adequate record and
p.(None): audit; and any amendment must match the date and version number.
p.(None): 30. Clinical Study / Trial (RCT): Any research conducted in humans with the intention of discovering or
p.(None): verify the clinical, pharmacological and / or any other pharmaco-dynamic effects of the product (s) in
p.(None): investigation; and / or identify any adverse reaction to research product (s); and / or to study
p.(None): the absorption, distribution, metabolism and excretion of product (s) under investigation, in order to verify
p.(None): its safety and / or effectiveness.
p.(None): 31. Report of a Clinical Study: A written description of a study of any therapeutic agent,
p.(None): prophylactic or diagnostic performed in humans, in which the clinical and statistical description,
p.(None): Presentations and analyzes are fully integrated into a single report (see International Conference Guide
p.(None): of Harmonization for the Structure and Content of the Clinical Study Reports).
p.(None): 32. Clinical Study, Intermediate Report (“InterimAnalysis”): A report of intermediate results and its
p.(None): evaluation based on analyzes performed during the course of a study.
p.(None): 33. Blind / Masking Study: Procedure in which one or more parts of the study are unaware
p.(None): the assignment (s) to the treatment. Simple blind study generally refers to the fact that the
p.(None): subject (s) do not know the assignment and double blind study refers to the subject (s),
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p.(None): National Committee for Health Research Ethics
p.(None): Researcher (s), monitor and in some cases the analyst, do not know the allocation to treatment.
p.(None): 34. Multicenter Study: A health study conducted according to a single protocol but in more than
p.(None): a place and, therefore, made by more than one researcher.
p.(None): 35. Non-clinical study: Biomedical studies not performed in humans.
p.(None): 36. Adverse Event (EA): Any adverse medical occurrence in a patient or subject of an investigation
p.(None): in health to whom a pharmaceutical product was administered and which does not necessarily have a
p.(None): causal relationship with this treatment.
p.(None): 37. Adverse Event (EA): It is any unfavorable medical outcome that occurs in a patient or a
p.(None): subject of a clinical trial, who has been given a medicinal product, and who does not necessarily
p.(None): I would have a causal relationship with this treatment. An EA can therefore be any sign
p.(None): unfavorable and unintended (including an abnormal finding on a laboratory test), symptom or disease
p.(None): time period associated with the use of a medicinal product under investigation (PMI), whether it is considered related or not
p.(None): to the PMI.
p.(None): 38. Adverse Reaction (RA): Any unfavorable and unintended response to a PMI, at a certain dose of
p.(None): administration. All EAs, judged as such by the reporting investigator or the sponsor,
p.(None): they qualify as an adverse reaction, as long as they have a reasonable causal relationship to a medicinal product. The
p.(None): Reasonable causal expression means that it converges in general with evidence or argument that suggests a
p.(None): causal relationship
p.(None): 39. Unexpected Adverse Reaction: It is an RA that, by its nature or severity, is not consistent with the information
p.(None): existing about the product, for example, in the researcher's manual for a product under investigation not
p.(None): marketed or in the summary of the product characteristics (CPR) of a product
p.(None): marketed It is also considered unexpected RA when the outcome of an adverse reaction is not consistent.
p.(None): with the existing information about the product. The side effects documented in the Report Form
p.(None): from
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p.(None): National Committee for Health Research Ethics
p.(None): Cases (FRC) that occur in a more severe form than anticipated, are also considered unexpected.
p.(None): 40. Serious Adverse Event (EAS) or Serious Drug Adverse Reaction (Serious RAM): any unfavorable occurrence
p.(None): the course and in the context of an investigation on a diagnostic product or procedure or
p.(None): Therapeutic resulting in death, life threatening, requires hospitalization or prolongation of
p.(None): Existing hospitalization, resulting in persistent or significant disability or disability, is an anomaly
p.(None): congenital or birth defect or is medically significant according to medical criteria. The above is
p.(None): applies without the presumed existence of a causal link between the application of the product or treatment
p.(None): and the adverse event.
p.(None): 41. Adverse Drug Reaction (ADR): harmful and unintentional response to a medicinal product related to
p.(None): any dose In clinical experience before the approval of a new medicinal product or its
p.(None): new uses, particularly when the therapeutic dose cannot be established, should be considered
p.(None): adverse drug reaction to any reaction that involves a causal relationship between a medicinal product and
p.(None): an adverse event as a reasonable possibility, that is, that the relationship cannot be ruled out.
p.(None): 42. Adverse Reaction Serious Unexpected Suspected (RASIS / SUSAR): Any suspected adverse reaction related to
p.(None): a PMI, which is unexpected and serious. The medical trial should be exercised to decide if an EA / RA is serious in
p.(None): other important situations other than those stated. EA / RA that are not immediately threatening to
p.(None): life or not result in death or hospitalization, but they need interventions to prevent one or more
p.(None): outcomes of the above, must also be considered as serious.
p.(None): 43. Investigator's Brochure [IB]: A compilation of clinical and non-clinical data on
p.(None): the research product (s) that is (are) relevant for the study of the product (s) in the
p.(None): research in humans.
p.(None): 44. Case Report Form (FRC) [“Case ReportForm” (CRF)]: A printed, optical or
p.(None): electronic, designed to record all the
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p.(None): National Committee for Health Research Ethics
p.(None): information required in the protocol to be reported to the sponsor about each subject of the study.
p.(None): 45. Audit / supervision: The action of the regulatory authority (s) to carry out an official review of the
p.(None): documents, facilities, records and any other resource that the authority (ies) considers to be related
p.(None): with the study in health and that can be located in the place where the study is carried out, in the facilities of the
p.(None): sponsor and / or contract research organization (ICO) or other sites than the authority (s)
p.(None): Regulatory (s) considered appropriate.
p.(None): 46. Inspector / supervisor: A person conducting inspections of the study on behalf of the Authority of
p.(None): (National) Surveillance of Compliance with the BPC.
p.(None): 47. Institution (medical): Any public or private entity, agency or dental medical facility where they are conducted
p.(None): Health studies
p.(None): 48. Basic, pre-clinical or fundamental research: It is the experimental or technical work that is carried out
p.(None): primarily to acquire new knowledge of the underlying phenomenon and observable facts, without an application
p.(None): particular or use established. It can be divided into pure basic research and oriented basic research. In
p.(None): This type of research study subjects are cells, tissues, molecules and / or experimental animals. East
p.(None): type of research is carried out mainly within a specialized laboratory
p.(None): 49. Clinical Research: Patient oriented research. Research conducted with subjects
p.(None): humans (or with material of human origin, such as tissues, specimens, and cognitive phenomena) to
p.(None): which the researcher interacts directly with human subjects. It also includes studies
p.(None): epidemiological and behavioral studies and results research and research in services of
p.(None): Health.
p.(None): 50. Process research or evaluation of health systems (or research in health services or
p.(None): operational research): Field of research that examines the impact of the organization, financing and
p.(None): administration of health care services in the delivery, quality, costs, access and results of these
p.(None): services. In this type of research the subject of study are the processes or relationships within the
p.(None): health institutions.
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p.(None): National Committee for Health Research Ethics
p.(None): 51. Public health research: Whose subject of research are the communities.
p.(None): 52. Health research: “Process of obtaining systematic knowledge and technologies that can be
p.(None): used to improve the health of individuals and groups. Provides basic information about health status
p.(None): and population disease; seeks to develop instruments for the prevention, cure and relief of the effects of
p.(None): diseases; and strives to plan better approaches for individual and community health services. ”
p.(None): 53. Researcher: Person responsible for conducting a health study at the site where the
p.(None): study. If a study is conducted by a group of individuals, the researcher is the responsible leader.
p.(None): of the group and will be called principal investigator.
p.(None): 54. Coordinating Investigator: A researcher, in a Multicenter study, who is assigned the responsibility of
p.(None): coordinate the researchers in the different participating centers.
p.(None): 55. Researcher / Institution: Expression that means “The researcher and / or the Institution, when
p.(None): stipulate the applicable regulatory requirements ”.
p.(None): 56. Head of the Unit / Research Center: Personnel responsible and designated in their hospital function as the
p.(None): Manager of the Research Units / Centers and responsible for compliance with the development standards of
p.(None): health research with human subjects, as well as standard operating procedures.
p.(None): 57. Monitoring: The act of monitoring the process of a health study and ensuring that it is conducted,
p.(None): Registered and reported in accordance with the protocol, Standard Operating Procedures (SOP), Good Practice
p.(None): Clinic (BPC) and the applicable regulatory requirements.
p.(None): 58. Monitoring, Report of: A written report from the monitor to the sponsor, according to the SOPs of the
p.(None): sponsor, after each visit to the study site and / or any other communication related to the study.
p.(None): 59. Level of compliance with the BPC: The level of compliance of the center with the Principles of the BPC, as
p.(None): Evaluate the (National) Surveillance Authority of compliance with the PCBs.
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p.(None): National Committee for Health Research Ethics
p.(None): 60. Opinion (in relation to CEIS): The trial and / or advice provided by a CEIS.
p.(None): 61. Contract Research Organization (ICO)
p.(None): ["ContractResearchOrganization" (CRO)]: Person or organization (commercial, academic or otherwise) hired by the
p.(None): Sponsor to perform one or more of the sponsor's duties and functions related to the study.
p.(None): 62. Sponsor: Individual, company, institution or organization responsible for initiating, administering / controlling
p.(None): and / or fund a clinical study.
p.(None): 63. Sponsor-Researcher: Individual who initiates and conducts, alone or with others, a health study
p.(None): and under whose immediate direction the product under investigation is administered (or delivered to, or used) by the
p.(None): subject. The term does not include any person other than an individual (that is, does not include a person
p.(None): corporation or agency). The obligations of a sponsor-researcher include both those of a sponsor
p.(None): like those of a researcher.
p.(None): 64. Standard Operating Procedures (POE) ["Standard OperatingProcedures
p.(None): (SOPs) ”]: Detailed and written instructions to achieve uniformity in the execution of a specific function.
p.(None): 65. Research medicinal product (PMI): Pharmaceutical form of an active ingredient or placebo
p.(None): that is being tested or used as a reference in a health study, including a product with an authorization of
p.(None): marketing when used or conditioned (formulated or packaged) in a different way than
p.(None): approved or when used to obtain more information about a previously approved use.
p.(None): 66. CPB (National) Compliance Monitoring Program: A particular program established by a country
p.(None): to monitor compliance with Good Clinical Practices within its territory, through inspections.
p.(None): 67. Research protocol: Document describing the object (s), design, methodology,
p.(None): statistical considerations and organization of a study. Generally, the protocol also provides
p.(None): background and rationale for the study, but these could be provided in other documents
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p.(None): National Committee for Health Research Ethics
p.(None): referenced in the protocol. In the BPC guidelines, the term protocol refers to the protocol and the
p.(None): amendments to the protocol.
p.(None): 68. Adverse Drug Reaction (RAM): These are all harmful and unintentional responses to a product
p.(None): medicinal, related to any dose. The phrase ‘answers… to a medicinal product’ means that a
p.(None): causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, that is, that
p.(None): The relationship cannot be ruled out. With regard to medicinal products on the market: a response to
p.(None): a drug that is harmful and unintentional, and that occurs with doses normally used in humans to
p.(None): prophylaxis, diagnosis or treatment of diseases, or for modification of physiological function (see the Guide to
p.(None): the International Harmonization Conference for the Management of Clinical Safety Data: Definitions and Standards of
p.(None): an Immediate Report).
p.(None): 69. Unexpected Drug Adverse Reaction: Adverse reaction whose nature or severity is not
p.(None): consistent with the applicable product information (for example, that contained in the Researcher's Brochure
p.(None): for an unapproved research product, or packaging insert / summary of product characteristics
p.(None): approved) (see the Guide to the International Harmonization Conference for Data Management of
p.(None): Clinical Safety: Definitions and Standards of an Immediate Report).
p.(None): 70. Original Medical Record: See source documents. In this document, "subject", "individual" and "person" are
p.(None): They use with the same meaning.
p.(None): 71. Legally Accepted Representative: Individual, legal representative or other body authorized under the laws
p.(None): applicable to accept, on behalf of a probable candidate, his participation in the health study.
p.(None): 72. Applicable Regulatory Requirement (s): Any law (s) and regulation (s) that govern
p.(None): Conducting health studies of research products.
p.(None): 73. Site Where the Study is Performed: The place (s) where the related activities are carried out
p.(None): With the study.
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p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): 74. Sub-researcher: Any individual member of the health study group, appointed and supervised by the
p.(None): researcher to perform critical procedures related to the study and / or make important decisions
p.(None): related to it (for example, associates, residents, research fellow).
p.(None): 75. Subject of the Study: Individual who participates in a health study, either as a recipient of the
p.(None): product (s) under investigation or as a control. In this document, "subject", "individual" and "person" are used
p.(None): With the same meaning.
p.(None): 76. Vulnerable (or Vulnerated) Subjects: Individuals whose desire to participate in a health study may be
p.(None): influenced by the expectation, justified or not, of the benefits associated with your participation, or of a
p.(None): revenge on the part of the superior members of a hierarchy in case of refusing to participate. By
p.(None): For example, the members of a group with a hierarchical structure, such as that made up of medical students,
p.(None): dentistry, chemical-drug-biological and nursing, subordinate hospital and laboratory personnel,
p.(None): employees of the pharmaceutical industry, members of the armedXforces and people who are
p.(None): detained / detained Other vulnerable (or violated) subjects include patients with diseases
p.(None): incurable, people in nursing homes, unemployed or homeless, patients in emergency situations,
p.(None): ethnicXminority groups, homeless people, nomads, refugees, minors and those who cannot give their
p.(None): consent.
p.(None): 77. Impartial Witness: A person independent of the study, who cannot be influenced in bad faith
p.(None): by the personnel involved in the study, who is present in the process of obtaining the
p.(None): informed consent if the subject or the representative of the legally accepted subject does not know how to read, and who reads the
p.(None): "Informed Consent Form" and any other written information provided to the subject.
p.(None): to. Research Unit / Research Center: In-hospital entity responsible for: Promoting and
p.(None): develop research in the hospital Train hospital staff who request it in methodology
p.(None): of research, to develop research with internal validity, technically evaluate, support the
p.(None): Page 73 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): logistics, register, monitor and monitor the development of studies carried out in the institution.
p.(None): 78. Compliance Monitoring of the BPC: Periodic Audit of any of the parties involved in the
p.(None): conducting a health study (for example, the CNEIS of researchers, sponsors, etc.), for the purpose
p.(None): to verify compliance with the PCBs and the corresponding regulations.
p.(None): Page 74 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): 11. ANNEXES
p.(None): ANNEX 1. GUIDE TO DEVELOP THE LETTER OF INTENTIONS OF A RESEARCHER / RESEARCH TEAM
p.(None): ON THE LETTER OF INTENTION:
p.(None): You must enter:
p.(None): 1. APPLICANT RESEARCHER: Name, position, institution. The sponsoring company defines who the
p.(None): Principal investigator in the cases there are several research centers and researchers.
p.(None): 2. SPONSOR: Indicate the entity that finances and promotes the study.
p.(None): 3. TITLE OF THE PROTOCOL: If the title is very extensive, try to summarize it in a few words.
p.(None): 4. PURPOSE: Indicate the main objective of the study (only one).
p.(None): 5. MAIN EVALUATION PARAMETER (End Point): Indicate the chosen variable as the best expression
p.(None): of objective evaluation.
p.(None): 6. DESIGN: Indicate the methodology to be used: comparative study or not, randomized or not, blind
p.(None): or open, parallel / cross groups, case / control, cohorts, transversal, etc.
p.(None): 7. POPULATION AND NUMBER OF PARTICIPANTS: Indicate the origin of the sample (patients of an institution,
p.(None): healthyXvolunteers from a community, etc.) and the number of volunteers planned. In the case of animals
p.(None): laboratory, indicate species and number.
p.(None): 8. DURATION OF THE STUDY: Time during which the participant will remain in the study.
...
p.(None): Researcher's brochure (Legal documents must be submitted in Spanish or with your
p.(None): respective
p.(None): 2 translation, in accordance with Salvadoran notarial legislation; in the case of documents
p.(None): coming from
p.(None): abroad, must be presented apostilled or consularized, in original and copy for confrontation.)
p.(None): 3 Four copies of the full study protocol in Spanish and one electronic copy
p.(None): Information on the insurance policy for the research subject granted by the sponsor, specifying
p.(None): 4 the applicability mechanism in El Salvador
p.(None): 5 Curriculum of the principal investigator and co-investigators.
p.(None): 6 Proof of payment of tariff
p.(None): 7 Payment method of the researcher in El Salvador (attach a copy of the contract)
p.(None): 8 Letter of authorization from the center or centers where the study will be carried out
p.(None): 9 Investigator's commitment to good clinical practices
p.(None): Certificate of Good Manufacturing Practices (BPM) of the manufacturer or Certificate of BPM issued by the
p.(None): 10 Local Regulatory Authority. Applies if the product is not registered.
p.(None): Primary and secondary packaging of the product or products to be used in the clinical study with its
p.(None): label of
p.(None): 11 identification, containing storage conditions and lot numbers and expiration date.
p.(None): Stability studies in accordance with the provisions of RTCA 11.01.04.10 Products
p.(None): Pharmacists
p.(None): 12 Stability Studies of Medicines for Human Use
p.(None): 13 Other materials (Promotional, patient card, questionnaires, etc.)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS) (ES P ACIO
p.(None): EXCLUS IVO CNEIS) (ES P ACIO
p.(None): EXCLUS IVO CNEIS) (ES P ACIO
p.(None): EXCLUS IVO CNEIS) (ES P ACIO
p.(None): EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): (ES P ACIO EXCLUS IVO CNEIS)
p.(None): THE FOLLOWING BOXES ARE NOT FOR USE OR FICIAL. (EXCLUSIVE CNEIS SPACE)
p.(None): 11. FINAL OPINION
p.(None): 11.1 RECEIVED DATE:
p.(None): 11.3 PROCESS RESULT:
p.(None): 11.5 SIGNATURE AND SEAL:
p.(None): Approved Denied
p.(None): 11.2 No. ASSIGNED CNEIS: 11.4 No. APPROVAL DATE:
p.(None): Page 77 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): NATIONAL COMMITTEE OF ETHICS OF HEALTH RESEARCH
p.(None): APPLICATION FOR EVALUATION OF CLINICAL RESEARCH PROTOCOLS IN HUMAN BEINGS
p.(None): 1. DATA OF THE PRO TO CO LO
p.(None): APPLICATION FILLING INSTRUCTION
p.(None): 1.1 PROTOCOL No: Protocol number, as
p.(None): appears in the protocol
p.(None): 1.2 VERSION: Version of
p.(None): protocol that is subject to authorization
p.(None): 1.3 DATE: Date of
p.(None): version of the protocol to authorize
p.(None): 1.4 TITLE OF THE PROTOCOL: Full title, as it appears in the
p.(None): protocol
p.(None): 1.5 NUMBER OF CENTERS: Full name of the centers
p.(None): research where the study will take place
p.(None): 2. CO-INFENTIFIED INFORMATION
...
p.(None): Products to use in research.
p.(None): 8.1.7 MANUFACTURER'S NAME Establishment authorized to perform all
p.(None): operations that involve product manufacturing
p.(None): Pharmacists
p.(None): 8.1.8 COUNTRY OF ORIGIN Country where the
p.(None): medicine. In the event that more than one laboratory is involved in manufacturing, the country of origin is that in which
p.(None): performs the manufacture of at least the bulk medicine.
p.(None): 9. SIGNATURES AND SEAL S
p.(None): 9.1 RESEARCHER'S SIGNATURE: Signature of the principal investigator, responsible
p.(None): of clinical research.
p.(None): 9.2 SEAL OF THE MAIN RESEARCHER: Seal of the principal investigator, responsible for the
p.(None): clinical research.
p.(None): Name, signature and seal of the sponsor. When not applicable, the name, signature and seal of the representative must go
p.(None): 9.3 SIGNATURE OF THE SPONSOR OR ITS REPRESENTATIVE:
p.(None): from the sponsor, Contract Research Center or to whom the sponsor has delegated this function.
p.(None): Page 78 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 3 IDENTIFYING A CLINICAL TRIAL
p.(None): What is a clinical trial of a medicinal product?
p.(None): This algorithm and the footnotes to the table will help you answer this question. Please start in the column
p.(None): A and follow the instructions. There is additional information in the notes.
p.(None): A B C D
p.(None): AND
p.(None): Clinical trial of a medicinal product
p.(None): A non-interventional clinical trial?
p.(None): Is it a medicinal product (PM)? If you answer no to all the questions in column A, the activity is not
p.(None): a clinical trial of a PM. If you answer yes to any of the questions, go to column B.
p.(None): A.1 Is it a
p.(None): substance * or
p.(None): combination of substances presented as having
p.(None): properties of
p.(None): treatment or
p.(None): disease prevention in humans?
p.(None): A.2 Does the function of
p.(None): Is it not a medicinal product?
p.(None): If you answer yes to the questions in column B, the activity is not a clinical trial of a PM.
p.(None): If you answer no to this question, go to column C.
p.(None): B.1 Are you only administering any of the following substances?
p.(None): • Complete human blood **
p.(None): • Human blood cells
p.(None): • Human plasma
p.(None): • Fabrics, except one
p.(None): What effects of the medication are you looking for?
p.(None): If you answer not all the questions in column C, the activity is not a clinical trial. If yes
p.(None): to any of the questions, go to column D.
p.(None): C.1 To discover or verify / compare its clinical effects?
p.(None): C.2 To discover or verify / compare its pharmacological effects? (Ex. Pharmacodynamics)
p.(None): C.3 To identify or verify / compare your
p.(None): Why do you look for these effects?
p.(None): If you answer no to all
p.(None): questions in column D, the activity is not a clinical trial. If yes to
p.(None): Any of the questions below, go to column E.
p.(None): D.1 To determine or verify / compare the effectiveness of the medicine? vii
p.(None): Why do you look for these effects?
p.(None): If you answer yes to all questions, the activity is a non-interventionist essay.
p.(None): If the answers from columns A, B, C and D brought it to column E, and
p.(None): Answer no to any of these questions, the activity is a clinical trial.
p.(None): E.1 Is this a study of one or more medicinal products, which have market authorization in the
p.(None): region?
p.(None): E.2 Are the products prescribed in the usual way they are registered?
p.(None): E.3 Is the assignment of any patient involved in the
p.(None): Page 79 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): A B C D
p.(None): AND
p.(None): Is the substance like medicine?
p.(None): Ex. Can it be administered to human beings, either with a view to restoring, correcting or
p.(None): modify physiological functions, exerting a pharmacological, immunological or metabolic action;
p.(None): or to make a
p.(None): Medical diagnostic; or is it
p.(None): administered in another way, for a medical purpose?
p.(None): A.3 Is it an active substance in a form
p.(None): pharmaceutical?
p.(None): medicinal product with somatic cells ***
p.(None): • A food product (including dietary supplements) not presented as a medication
p.(None): • A cosmetic product
p.(None): +
p.(None): • A medical device
p.(None): adverse reactions?
p.(None): C.4 Study or verify / compare its absorption, distribution, metabolism or
p.(None): excretion?
p.(None): D.2 To determine, verify or
p.(None): compare the
p.(None): medication safety?
p.(None): study of a particular therapeutic strategy, falls within the current practice and does not
p.(None): decide in a protocol, in an advanced clinical trial? viii
p.(None): E.4 Is the decision to prescribe a particular medicinal product,
p.(None): clearly separated from the decision to include the patient in the study?
p.(None): E.5 Do not apply to patients included in the study other than
p.(None): those that apply in current practice?
p.(None): E.6 Will epidemiological methods be used to analyze data coming out of this study?
p.(None): * Substance is any material, regardless of its origin (human, animal, plant or chemical), which is administered to a
p.(None): human being.
p.(None): ** This does not include derivatives of human blood, human cells and human plasma that involves a process of
p.(None): manufacture.
p.(None): *** Somatic cell therapy medicinal products use live somatic cells of human (or animal) origin,
p.(None): whose biological characteristics have been manipulated to obtain a
p.(None): Page 80 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): therapeutic, diagnostic or preventive effect (in humans), through metabolic, pharmacological and
p.(None): immunological
p.(None): Any product ingested that is not a medicine is seen as food. A food cannot be classified as
p.(None): a medicine, unless it contains one or more ingredients generally seen as for a medical purpose or
p.(None): medicinal.
p.(None): + A "cosmetic product" means any substance or preparation with the intention of putting it in contact
p.(None): with various external parts of the human body (epidermis, hair system, nails, lips, and external genital organs),
p.(None): or in teeth and mucous membranes of the oral cavity, with exclusive or main views of cleaning, perfume
p.(None): or protect them in good condition, changes in appearance or correct body odors.
p.(None): Vii Efficacy is the concept of scientifically proving whether - and to what extent - a medicine is capable of
p.(None): diagnose, prevent or treat a disease.
p.(None): Viii The assignment of patients to a treatment group randomly and planned by a trial protocol
p.(None): Clinical cannot be considered as clinical practice.
p.(None): Page 81 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 4A. ASSESSMENT GUIDE FOR A HEALTH RESEARCH PROJECT
p.(None): INSTRUCTIVE:
p.(None): This instrument must be used by each of the members of the CNEIS, during the review of the
p.(None): documentation. It is a guide to review the formal, methodological and ethical aspects of the study. I know
p.(None): recommends that each evaluator mark with an “X” or write in the blank, as appropriate.
p.(None): Once the deliberation is finished, the secretary will complete the form that includes all the opinions
p.(None): and those that were filled individually will be removed.
p.(None): DATE APPLICATION DATE FIRST
p.(None): EVALUATION
p.(None): SECOND EVALUATION DATE
p.(None): DATE RESOLUTION (APPROVAL / REJECTION)
p.(None): LIST OF ELEMENTS TO EVALUATE IN A HEALTH RESEARCH PROTOCOL
p.(None): I.- IDENTIFICATION:
p.(None): Code
p.(None): Protocol Title
p.(None): Page 82 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): II.- EVALUATION OF THE SUMMARY OF THE PROJECT
p.(None): Little bit
p.(None): Information on Not recorded
p.(None): adequate
p.(None): Adequate
p.(None): Very suitable
p.(None): 1. Promoter
p.(None): 2. Research title
p.(None): 3. Type of investigation
p.(None): 4. Place of performance
p.(None): 5. Authority responsible for the institution of realization
p.(None): 6. Other study centers
p.(None): 7. Responsible researcher
p.(None): 8. Drug or Method to investigate. Information on manufacturing, expiration, registration
p.(None): 9. Stage or phase of the study
p.(None): 10. Objective of the study: efficacy, toxicity, dose, etc.
p.(None): 11. Design: random, double blind, etc.
p.(None): 12. Disease under study
p.(None): 13. Inclusion criteria
p.(None): 14. Exclusion criteria
p.(None): 15. Number of patients
p.(None): 16. Duration of the study
p.(None): 17. Schedule of realization
p.(None): 18. Financial responsible and damage insurance
p.(None): 19. Ethical considerations
p.(None): Page 83 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): III.- METHODOLOGICAL EVALUATION OF THE RESEARCH PROTOCOL
p.(None): Information about
p.(None): 1. Promoter information
p.(None): 2. Participating researchers
p.(None): 3. Realization centers
p.(None): 4. General Aspects
p.(None): 4.1. Preclinical and clinical history that supports the rational of the study
p.(None): 4.2. Justification
p.(None): 4.3. Main goal
p.(None): 4.4. Secondary objectives
p.(None): 4.5. Phase Study: I-II-III-IV
p.(None): 4.6. Kind of investigation
p.(None): 4.7. Design (parallel, crosslinking, etc.)
p.(None): 4.8. Sample's size calculation
p.(None): 5. Population to study
p.(None): 5.1. Type (patients, healthyXvolunteers or others)
p.(None): 5.2. Inclusion criteria
p.(None): 5.3. Exclusion criteria
p.(None): 5.4. Groups to compare
p.(None): 5.5. Demographic aspects
p.(None): 5.6. Prognostic Criteria
p.(None): 5.7. Stage of the disease
p.(None): 5.8. Treatment response measure
p.(None): 5.9. Associated disease
p.(None): 5.10. Similarity of patients with the general population
p.(None): 6. Compared treatments
p.(None): 6.1. Drug proposed as intervention
p.(None): 6.2. Dose selection
p.(None): 6.3. Dose (fixed, flexible, route of administration)
p.(None): 6.4. Treatments, (Treatments) attached (standardized, allowed, prohibited)
p.(None): 6.5. Treatment duration
p.(None): 6.6. Information of lot number, formulation, etc.
p.(None): Not included or provided
p.(None): Inappropriate
p.(None): Suitable
p.(None): Very suitable
p.(None): Page 84 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Information about
p.(None): 6.7. Drug recognized as Standard treatment
p.(None): 6.8. Justified placebo use
p.(None): 6.9. Masking
p.(None): 7. Details of the experimental design
p.(None): 7.1. Checked
p.(None): 7.2. Controls: active-inactive
p.(None): 7.3. Concurrent-historical
p.(None): 7.4. Assignment of Treatment with random distribution
p.(None): 7.5. Cleaning-stratification period
p.(None): 7.6. Periodicity of visits, laboratory exam, evaluations
p.(None): 7.7. Start and end of treatment
p.(None): 8. Data collection and analysis
p.(None): 8.1. Measures used to evaluate the objectives
p.(None): 8.2. Record of response variables
p.(None): 8.3. Observers (constants, variables)
p.(None): 8.4. Collection method (normalized)
p.(None): 8.5. Evaluation of incomplete or lost data
p.(None): 8.6. Evaluation of the degree of compliance Treatment
p.(None): 8.7. Statistical tests to apply
p.(None): 8.8. Intention to treat analysis
p.(None): 9. Adverse effects (EA)
p.(None): 9.1. Subjective (reported spontaneously or with directed questions)
p.(None): 9.2. Identification criteria
p.(None): 9.3. Classification and evaluation of the Same
p.(None): 10. Controls to minimize bias
p.(None): 10.1. Impartial (blind) observers
p.(None): 10.2. Patients are unaware of the treatment received (blind)
p.(None): Not included or provided
p.(None): Inappropriate
p.(None): Suitable
p.(None): Very suitable
p.(None): Page 85 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Information about
p.(None): 10.3 Impartial assessor (blind)
p.(None): 10.4 Blind statistical analysis (does not identify groups)
p.(None): Not included or provided
p.(None): Inappropriate
p.(None): Suitable
p.(None): Very suitable
p.(None): 11. Individual Registration Sheet
p.(None): IV.- EVALUATION OF THE PATIENT INFORMATION SHEET
p.(None): Information about
p.(None): 1. Copy of the investigation protocol summary
p.(None): 2. Objective to be achieved with the study and treatment
p.(None): 3. Methodology to follow
p.(None): 4. Proposed treatment and placebo if any
p.(None): 5. Expected benefits of the proposed method for the participant
p.(None): 6. Expected benefits of the proposed method for society
p.(None): 7. Risks and inconveniences arising from the investigation
p.(None): 8. Possible adverse events
p.(None): 9. Risks and benefits of alternative methods to that proposed
p.(None): 10. Risks and benefits of non-participation in the study
p.(None): 11. Voluntary nature of participation
p.(None): 12. Right not to participate and to withdraw freely from the study without prejudice of any kind
p.(None): 13. Right to expand information as per participant's need
p.(None): 14. Confidentiality of the data obtained and its scope
p.(None): 15. Damage insurance and compensation guarantee for
p.(None): Not included or provided
p.(None): Poorly suited
p.(None): Adequate
p.(None): Very suitable
p.(None): Page 86 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Information about
p.(None): injury or death of the participant
p.(None): 16. Researcher responsible for informing the subject at any time during the study
p.(None): 17. Reference place for health care
p.(None): 18. The degree to which your medical care will be covered during the study, in case of any inconvenience
p.(None): 19. Ethics committee that evaluated the research
p.(None): 20. If you will receive any compensation or gift for your participation
p.(None): 21. Understanding the information
p.(None): 22. Information on the subject's access to the product under test, if it is effective from the
p.(None): completion of the investigation and until its commercialization, and if it will be delivered free of charge or
p.(None): I would have to pay
p.(None): for him
p.(None): 23. Information on the subject's access to the product being tested, if it is effective and after its
p.(None): marketing, and if it will be delivered to you for free or you would have to pay for it
p.(None): 24. In the case of people over 12 and under 18, there is an Informed Assent Form
p.(None): 25. Dissemination and right to know the results (mechanism or form as you will know them)
p.(None): 26. There is a safeguard of the data, limitations and consequences of its breach
p.(None): Not included or provided
p.(None): Poorly suited
p.(None): Adequate
p.(None): Very suitable
p.(None): Page 87 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): V.- EVALUATION OF INFORMED CONSENT
p.(None): Information about
p.(None): 1. Identification: date and place for signatures
p.(None): 2. Name and surname of the participant, legal representative or witness
p.(None): 3. Research title
p.(None): 4. Statement of reading the information sheet and understanding of it
p.(None): 5. Statement of having been able to ask any question freely
p.(None): 6. Statement of having received sufficient information
p.(None): 7. Statement of having been informed by an investigator whose first and last name is recorded
p.(None): 8. Statement that your participation is voluntary and competent
p.(None): 9. Statement of understanding that you can withdraw without prejudice
p.(None): 10. Expression of free conformity
p.(None): 11. In the case of people over 12 years of age and under 18, there is an Informed Assent Form (AI).
p.(None): 12. Date of edition of the Informed Consent (CI) version
p.(None): Not included or provided
p.(None): Poorly suited
p.(None): Adequate
p.(None): Very suitable
p.(None): Page 88 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): INVESTIGATIONS WITH PEOPLE WHO SUFFER MENTAL AFFECTIONS OR BEHAVIOR DISORDERS
p.(None): Observations:
p.(None): Criteria YES NO
p.(None): The objective of the research seeks to obtain knowledge applicable to the health of this type of people
p.(None): Informed Consent is adapted to your ability to nod
p.(None): There is no risk of mandatory participation
p.(None): The risk-benefit ratio is acceptable.
p.(None): The benefits are superior to the treatments currently available
p.(None): The support of a family member, director or legal guardian is considered in the decision
p.(None): INVESTIGATIONS WITH PARTICIPATION OF PRISONERS
p.(None): Criteria YES NO Comments:
p.(None): The study does not deprive of medications with therapeutic or prophylactic effects, if you have a
p.(None): disease or risk of contracting it
p.(None): The principle of voluntariness is fulfilled
p.(None): Page 89 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): RESEARCH WITH PARTICIPATION OF PERSONS OF ETHNIC COMMUNITIES, MINORITY GROUPS OR VULNERED COMMUNITIES
p.(None): IN HUMAN RIGHTS
p.(None): Criteria YES NO Comments
p.(None): The study does not discriminate against any other community
p.(None): The objective seeks to obtain knowledge applicable to that community
p.(None): Enough information from that community is reported
p.(None): The community is informed of the conduct of the study
p.(None): Informed Consent is adapted to the culture of that community
p.(None): Questions to the researcher, by the members of the National Research Ethics Committee in
p.(None): Health (CNEIS), and complementary information:
p.(None): SAW. GENERAL CONCLUSIONS OF THE ETHICAL ASSESSMENT
p.(None): Information about 0 1 2
p.(None): 3
p.(None): 1. Relevance and extension of the information provided
p.(None): 2. Form of data collection in relation to objectives, statistical analysis and scientific efficiency
p.(None): 3. Potential to extract information with the least exposure of the subjects
p.(None): 4. Justification of the predictable risks and inconveniences with the benefits for the subject
p.(None): 5. Justification of the predictable risks and inconveniences with the benefits for society
p.(None): 6. Adaptation of the researcher to the proposed project according to experience in the subject
p.(None): 7. Adequacy of the place of performance, considering the resources available
p.(None): Page 90 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Information about 0 1 2
p.(None): 3
p.(None): 8. Adequacy of medical supervision and follow-up of subjects
p.(None): 9. Adequacy of forecasts to monitor the course of the investigation
p.(None): 10. Adequacy of the information to be
p.(None): provided to the patient, representatives, witnesses, etc.
p.(None): 11. Means to give information and obtain consent
p.(None): 12. Assurance that participants will have all the information during the investigation
p.(None): relevant available
p.(None): 13. Forecasts to answer the questions and requirements of the participants during the study
p.(None): 14. Health care forecast in case of adverse effect and the degree to which it will be provided
p.(None): 15. Plan to provide the best treatment tested to the subjects, at the end of the investigation
p.(None): 16. Plan to provide the best proven treatment to the community, at the end of the investigation
p.(None): 17. Compensation and compensation provisions for damages
p.(None): 18. Investigator's liability insurance
p.(None): 19. Confidentiality requirements
p.(None): Maximum score 57 points.
p.(None): Page 91 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 4B ETHICAL EVALUATION GUIDE FOR RESEARCH PROTOCOLS DIFFERENT FROM CLINICAL TRIALS
p.(None): Principle analysis Adequate Not applicable
p.(None): Inadequate AUTONOMY
p.(None): Protection of confidentiality Obtaining
p.(None): consent / assent, voluntariness, information, understanding
p.(None): Substitution decisions (legal representative) BENEFIT
p.(None): Risk / benefit ratio Risk not exceeding the minimum NO MALEFICENCE
p.(None): Correct methodology: plausible hypothesis, justification and objectives, sample size
p.(None): Clinical equiponderance: interventions are considered equal in efficacy and safety Suitability
p.(None): of the researcher (training experience, sufficient time for the study) Safety clauses
p.(None): Suitability of research site / facilities JUSTIFICIA
p.(None): Equitable selection of subjects Compensation for damages
p.(None): Social utility
p.(None): Access to interventions
p.(None): VULNERABILITY
p.(None): Vulnerable, discriminated populations have been identified,
p.(None): Page 92 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Principle analysis Adequate Not applicable
p.(None): Inadequate
p.(None): which?
p.(None): Individual guarantees of vulnerability protection are completed
p.(None): The expected results suppose a direct benefit for the participants
p.(None): CONSEQUENCES ANALYSIS
p.(None): For the study subjects
p.(None): For society (responds to the health needs and problems of the country)
p.(None): Page 93 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 4C GUIDE FOR FINAL RESOLUTION
p.(None): At this stage, the important thing is that there is sufficient deliberation for each of the criteria. It's not about
p.(None): Mark the number of people who agree or disagree with the criteria. Only in particular cases, should
p.(None): record if one of the members did not agree with the opinion of the rest and the discussion was exhausted. In case of no
p.(None): If there is agreement, it will be convenient to suspend the discussion and resume it in an upcoming session.
p.(None): Definitions of the numbers in this guide:
p.(None): 1. Evaluate a treatment, intervention or theory that will improve health and well-being, or knowledge.
p.(None): The justification is the scarcity of resources and avoid exploitation. Scientific knowledge is evaluated, the
p.(None): citizen level understanding of social values.
p.(None): 2. The study has a clear hypothesis, uses accepted scientific principles and methods - which
p.(None): they include statistical techniques— to produce reliable and valid data.
p.(None): 3. In the selection of subjects or participants, people or populations are not selected
p.(None): stigmatized, or violated for risky investigations, while the most favored are offered
p.(None): participate in investigations of more beneficial potential (The principle of Distributive Justice is fulfilled).
p.(None): 4. Potential risks and damages are minimized, maximizing potential benefits so that
p.(None): the risks to the subjects are proportional to the benefits and to the society (Respect
p.(None): by the principle of No Maleficence / Charity).
p.(None): 5. The evaluation was carried out with the participation of members outside the investigation, stating whether or not they exist
p.(None): existence of conflict of interest. It fulfills the commitment to render public account. There is independence
p.(None): Intellectual, economic and all kinds of researchers.
p.(None): 6. Informed Consent is clear and understandable. Describe the purpose, its risks and benefits
p.(None): potential, the existing alternatives. Secure the
p.(None): Page 94 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): understanding and willingness to make decisions about participation in research (Principle of
p.(None): Autonomy).
p.(None): 7. Respect for people is guaranteed in the sense of: the possibility of allowing them to leave
p.(None): of the investigation, the protection of your privacy through confidentiality, the provision of information about
p.(None): of risks or benefits discovered in the course of the investigation, the provision of information about
p.(None): results of clinical research, continuous monitoring of well-being (Respect for Autonomy and Charity).
p.(None): 8. It is stated in the Informed Consent that the Sponsoring Institution, backed by the policy
p.(None): insurance, covers 100% of expenses for medical treatment for health recovery, due to damage
p.(None): directly related to the study, freeing the subject and his legal representatives from expenses, and the
p.(None): institution where research is carried out.
p.(None): Page 95 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Social value or
p.(None): Scientific validity
p.(None): Equitable selection
p.(None): Risk Reason
p.(None): Decision Criteria
p.(None): Independent evaluation
p.(None): Informed consent
p.(None): Respect for
p.(None): Compensation for damages
p.(None): Members present
p.(None): one
p.(None): scientific
p.(None): 1 2
p.(None): of the subjects
p.(None): 3
p.(None): favorable profit
p.(None): 4
p.(None): (Declaration of conflict of interest)
p.(None): 5
p.(None): meets requirements
p.(None): 6
p.(None): the subjects
p.(None): 7 8
p.(None): two
p.(None): 3
p.(None): 4
p.(None): 5
p.(None): 6
p.(None): 7
p.(None): 8
p.(None): Total
p.(None): Page 96 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Resolution:
p.(None): Evaluation No. Date I II
p.(None): III
p.(None): Observation
p.(None): Approved without restrictions (ASR)
p.(None): Evaluated with observations and request for amendments (FI)
p.(None): Not approved (RCT)
p.(None): Page 97 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 5A REQUIREMENTS FOR THE DEVELOPMENT OF AN INFORMED CONSENT (CI)
p.(None): Informed Consent is a communicative and deliberative process within the relationship between the researcher and the
p.(None): Subject or potential research participant, where joint decisions and agreements are made +. The
p.(None): form is a documentary support that guarantees that the most relevant information has been offered by the
p.(None): researcher, and received and understood by the Research participant Subject, and allows to verify if there is
p.(None): acceptance or rejection of the proposal.
p.(None): Any informed consent form must include - expressed in understandable language - two parts:
p.(None): Information for the Research Subject and Informed Consent Form.
p.(None): - Information for the Research Subject
p.(None): The written information document is a written summary of the minimum information that must be communicated to
p.(None): the person to comply with the substantive ethical principle of Informed Consent. This information document
p.(None): It will be the basis or guide for verbal explanation and discussion of the study with the Subject or his legal representative. I know
p.(None): recognizes that this document will not be the only source of information that the Subject will receive in the process of
p.(None): Informed consent.
p.(None): Information content:
p.(None): a) That the study involves an investigation (study title).
p.(None): b) The purpose of the study.
p.(None): c) The treatment (or intervention) under study and the probability of randomization to treatment or
p.(None): procedure, where applicable.
p.(None): d) The procedures to follow in the study, including all invasive procedures.
p.(None): + Bravo M, Zunino M.E., Document on “Informed Consent”, CEC SSMS, 2002 and Fernández M., L., Consent
p.(None): informed in clinical practice, 2002.
p.(None): Page 98 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): e) The responsibilities of the Subject.
p.(None): f) Those aspects of the study that are experimental.
p.(None): g) The reasonably foreseeable risks and inconveniences for the Subject and, where relevant, for the embryo,
p.(None): Fetus or nursing child.
p.(None): h) Reasonably expected benefits. When no clinical benefit is intended for the Subject, it should be
p.(None): informed of it.
p.(None): i) Alternative procedures or treatments that may exist for the Subject, and its risks and benefits
p.(None): potentials of importance
p.(None): j) The compensation and / or treatment available to the Subject, in the case of damages related to the study.
p.(None): k) Advance payment arrangement, if any, to the Subject participating in the study (for phase I and II studies).
p.(None): l) That the participation of the Subject in the study is voluntary and that the Subject may refuse their participation or
p.(None): abandon a study without penalty or loss of benefits to which you would otherwise have been entitled.
p.(None): m) That the monitor (s), auditor (s), the Ethics Committee and the regulatory authorities will have free
p.(None): access to the original clinical history of the Subject, for the verification of the procedures and / or data of the
p.(None): study, without violating the right to confidentiality of the Subject, as allowed by law and
p.(None): relevant regulations; and that, by signing the Informed Consent form, the Subject or his representative
p.(None): Legally acceptable is authorizing such access.
p.(None): n) That the documents that identify the Subject will be confidential and, as allowed by law and
p.(None): Relevant regulations will not be publicly available. If the results of the study are published, the identity of the
p.(None): Subject will be confidential.
p.(None): o) That the Subject or his legal representative will be informed at all times if new information is available that
p.(None): may be relevant to the subject's decision to continue participating in the study.
p.(None): p) The people to contact for additional information about the study and the
p.(None): Rights of the Subjects of the study, and / or in case of damages related to the study [Researcher
p.(None): principal, co-investigator, data from
p.(None): Page 99 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Health Research Ethics Committee (CEIS) with stamp, date of evaluation and signature of the President].
p.(None): q) The foreseeable circumstances and / or the reasons under which the participation of the
p.(None): Subject in the study.
p.(None): r) The expected duration of the Subject's participation in the study.
p.(None): s) The approximate number of subjects involved in the study.
p.(None): t) In the case of minors, the assent of the minor (s) and the identity of the legal guardian that
p.(None): Sign the Consent.
p.(None): The instrument or form must meet the following requirements:
p.(None): - Must be prepared thinking of a Research Subject, healthy or ill, and not the editor of a magazine
p.(None): scientific The translation from English or another language into Spanish must be adapted to the subject's language and not
p.(None): literal translation.
p.(None): - The contents must be organized in headings.
p.(None): - It must be written with short sentences, using a separate point to separate the sentences.
p.(None): - It must be written in simple words, avoiding the use of technicalities and numerical probabilistic expressions.
p.(None): - If possible, drawings must be included.
p.(None): - The design must be attractive.
p.(None): - Its extension should not be more than 2 pages.
p.(None): - We must evaluate or validate the readability and ease of understanding of the text (with people outside the field of
p.(None): healthcare professionals).
p.(None): Informed Consent Form
p.(None): The Informed Consent Form is the document that the person or their legal representative and the
p.(None): witness (if applicable) will sign and date, to leave with it documented evidence or proof that the Subject
p.(None): has received sufficient information about the study, the research product and its rights as
p.(None): Subject of Research and who wishes to participate freely and voluntarily in the study.
p.(None): If the Subject is illiterate, the signature can be replaced by the fingerprint, but in these
p.(None): Page 100 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Cases must include 2 witnesses.
p.(None): In cases where the Research Subjects are between 12 and 18 years old, in addition to the consent of the parents or
p.(None): Legal representatives, a Assent Form must be included, which must also be signed by the minor.
p.(None): Page 101 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 5B BASIC STRUCTURE MODEL OF THE INFORMATION DOCUMENT FOR THE RESEARCH SUBJECT AND FORM
p.(None): OF INFORMED CONSENT
p.(None): I-General Information
p.(None): 1- [Study Title]
p.(None): 2- [Protocol Number] 3- [Sponsor / Address]
p.(None): 4- [Principal Investigator]
p.(None): 5- [Telephone]
p.(None): 6- [Participating Centers / Address] 7-. [Introduction]
p.(None): II-Specific information (from the study)
p.(None): 8- [Purpose of the Study] 9- [Background]
p.(None): 10- [Study Duration]
p.(None): 11- [Expected Number of Participating Subjects] 12- [Exclusions]
p.(None): 13- [Study Design]
p.(None): 14- [Study Treatment]
p.(None): 15- [Study Procedures]
p.(None): 16- [Additional / optional studies (Sub-studies)] 17- [Possible Risks and Discomforts]
p.(None): 18- [Precautions]
p.(None): 19- [Women of Fertile Age] 20- [Possible Benefits]
p.(None): III Rights of the person
p.(None): 21- [Notification of New Findings] 22- [Treatment Alternatives]
p.(None): Page 102 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): 23- [Options at the end of the Study] 24- [Confidentiality]
p.(None): 25- [Payment per Participation] 26- [Costs]
p.(None): 27- [Compensation for Damages or Injuries Related to the Study] 28- [Voluntary Participation and Retirement]
p.(None): 29- [Questions / Contacts]
p.(None): IV-Consent to participate
p.(None): 30- [General Information]
p.(None): 31- [Subject Consent Statement] 32- [Additional Declarations]
p.(None): 33- [Signature Requirements]
p.(None): Page 103 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 5C CHECKLIST OF INFORMATION DOCUMENT REQUIREMENTS FOR THE SUBJECT OF
p.(None): RESEARCH AND INFORMED CONSENT FORM
p.(None): Protocol No .:
p.(None): Is required:
p.(None): Statement that the study involves research
p.(None): Explanation of the purpose of the investigation
p.(None): Study treatment (s) and probability of randomization for each treatment
p.(None): Expected duration of the person's participation
p.(None): Description of the procedures to follow, including all invasive procedures
p.(None): Responsibilities of the person
p.(None): Identification of any procedures that are experimental
p.(None): Details of any aspect of the study that is experimental
p.(None): Description of any reasonably unforeseen risks or discomforts for the person and, when
p.(None): applicable, an embryo, fetus or nursing child
p.(None): When there is no intended clinical benefit for the subject, the person should be aware of it.
p.(None): Description of any benefits reasonably expected for the person or for others
p.(None): Disclosure of specific alternate procedures or treatment appropriate to the person, and their benefits and
p.(None): potential potential risks
p.(None): Any anticipated expenses for the person while participating in the study
p.(None): Proportional advance payment, if any, for the person to participate in the study
p.(None): Explain the conditions under which the researcher can exclude people from the study without their
p.(None): consent
p.(None): Inform the person about who will have access to their medical records (monitor, auditor, JRI,
p.(None): regulatory authorities) to verify the procedures and data of the study, and that the
p.(None): confidentiality to the extent permitted by applicable laws and regulations. If the study results
p.(None): are published, the identity of the person will remain confidential information
p.(None): By signing the Informed Consent Form, the person provides access to their records
p.(None): doctors
p.(None): That the subject's medical records will be kept under strict confidentiality, and will be
p.(None): Page 104 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): protected by applicable local and federal regulations, and will not be made public knowledge
p.(None): Compensation and / or treatment (s) available to the person in the case of a study related injury
p.(None): People to communicate with:
p.(None): For questions about the study
p.(None): For questions about the rights of the person under investigation
p.(None): In the case of a research related injury
p.(None): Statement that participation is voluntary and that the person may withdraw from the study at
p.(None): any time without being punished or losing the benefits to which the person has anyway
p.(None): right
p.(None): Statement of the anticipated circumstances under which the investigator may suspend the
p.(None): participation of the person without the consent of the person
p.(None): Additional costs for the person that may arise from participation in the study
p.(None): The person - or the person's representative - will be notified in a timely manner if new ones develop
p.(None): significant findings during the course of the investigation, which may affect the disposition of
p.(None): the person to continue participating
p.(None): Approximate number of people
p.(None): Consequences of the withdrawal of the person and the procedures at the time of termination
p.(None): Statement that the treatment or procedures may involve risks to the person (or to the person
p.(None): embryo, fetus or nursing child) that are currently unforeseen
p.(None): Page 105 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 6 MINUTES FOR RESOLUTION OF A RESEARCH PROJECT
p.(None): Institution:
p.(None): ACT N °: / EVALUATION ACT
p.(None): HEALTH STUDY PROTOCOL Nº ..........
p.(None): On ……………, on ……. Days of the month of …… del. , H. Committee Committee
p.(None): of Health Research Ethics ………………………………… .., with the assistance of its permanent members:
p.(None): [full name, position on the Committee (chairman, secretary, permanent member, alternate member and the
p.(None): profession of each)] ………………………………………………………………, have reviewed the documents submitted by
p.(None): ..........................., Principal Investigator, namely:
p.(None): 1. Protocol ".................", version ...................
p.(None): 2. Protocol ".................", Spanish version of ....................
p.(None): 3. Investigator Brochure ......
p.(None): 4. Informed Consent Form of the Protocol "...........", Spanish version, ...................
p.(None): 5. The curriculum vitae of ........................................ In addition, to know Background
p.(None): exposed by .................. in the session of the day .............., has considered that the sponsored clinical study
p.(None): by ................, (does not present ethical objections) (presents the following observations):
p.(None): 1) The members of the Committee declared (Having or not having a conflict of interest).
p.(None): 2) The design conforms to the standards of Research in Human Beings.
p.(None): 3) The benefit ratio was considered acceptable.
p.(None): 4) The informed consent form meets the requirements.
p.(None): 5) The medical treatment necessary for the recovery of the health of the participants is guaranteed due to
p.(None): Adverse effects directly related to the study. Expenses that will be canceled by in a
p.(None): 100%, at no cost to the participant in the research or to the center or establishment (full name of the
p.(None): center where the study will be conducted) .............., backed by the coverage of
p.(None): Sure, Policy No. ................ of ............, effective from ......... to ... ........, under the responsibility
p.(None): by name
p.(None): full and legal representative of the institution responsible for sponsorship in the country where the study is conducted).
p.(None): 6) Payment is guaranteed for ................. of the participants and ........
p.(None): 7) The curriculum background of the Principal Investigator guarantees the execution of the study within
p.(None): ethically acceptable frameworks.
p.(None): 8) Observations and recommendations
p.(None): Consequently, the Health Research Ethics Committee of ……………………………… .. approves (rejects)
p.(None): unanimity (most of its members)
p.(None): Name and signatures of the president and secretary
p.(None): DC.
p.(None): • Principal investigator.
p.(None): • Institution.
p.(None): • C.E.I.S. Secretariat
p.(None): Page 106 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 7 NOTIFICATION FOR THE MAIN RESEARCHER
p.(None): Institution………………..
p.(None): Health Research Ethics Committee MEMORAND Nº: /
p.(None): ANT .: Minutes of the Council of the Health Research Ethics Committee of ..................
p.(None): MAT .: Submit Evaluation Report .............
p.(None): Date,
p.(None): SR., Dr ................... (Name, position, institution) MAIN RESEARCHER
p.(None): PRESENT.
p.(None): Of our consideration:
p.(None): Attachment I send to you, Informed Consent, final version of. (Date)
p.(None): signed and stamped, and Evaluation Act No. ...... of (date) .........., which certifies that the Board of Ethics Committee
p.(None): of Research in Health of (institution), DICTAMEN the research protocol called “...................”,
p.(None): sponsored by ..................., to perform in ..................., dependent on ... ...
p.(None): We ask you to inform this Committee about the start of the study and inform, within the deadlines
p.(None): established [within the first 24 hours the related serious adverse events, one week the
p.(None): serious unrelated adverse events, three weeks for internal non-serious adverse events], events
p.(None): associated and not associated with the study, quarterly reports and annual safety and continuity reports, the
p.(None): evidence of benefit, rejection of the participation of subjects, the number of subjects enrolled and / or
p.(None): any important antecedents observed during the execution of the investigation, as well as the amendments and
p.(None): deviations, in a timely manner.
p.(None): Page 107 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): In addition, it is reported that the duration of the project approval is one year, extendable according to
p.(None): communication and official request.
p.(None): Say hello,
p.(None): …………………………………………. ..........................................
p.(None): Secretary- President
p.(None): Health Research Ethics Committee
p.(None): DC
p.(None): • Mr., Dr. ………… .............., Principal Investigator.
p.(None): • C.E.I.S. Secretariat
p.(None): Page 108 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 8 SERIOUS ADVERSE EVENTS REPORT FORM
p.(None): Please send via FAX, within the first 24 hours after the event notification.
p.(None): Patient Initials …………………………………………
p.(None): ... ... ................
p.(None): Hospital Registry of
p.(None): patient .............. ……………… ..… ...............
p.(None): Treating doctor. …………………………………………
p.(None): …………….… .........
p.(None): Patient ID:
p.(None): Date of birth:
p.(None): d d m mm aaa Hospital …………………………………………………
p.(None): ………… ..… .............
p.(None): Report Type Test Arm Sex Height
p.(None): Weight
p.(None): 1 = Initial 2 = Interim 3 = Final
p.(None): 1 = 1 =
p.(None): 2 = Male
p.(None): .
p.(None): 2 =
p.(None): Female cm kg
p.(None): Date of last treatment administered prior to EAS
p.(None): d d m mm a a
p.(None): Was the treatment under study at the full dose, according to the protocol, before the event?
p.(None): 0 = No, specify …………………………………… ...
p.(None): 1 = Yes
p.(None): Why is the event considered serious? (Choose the most serious)
p.(None): Where did the EAS occur?
p.(None): Page 109 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Why is the event considered serious? (Choose the most serious)
p.(None): Where did the EAS occur?
p.(None): 1 = It resulted in death 2 = Threatened life
p.(None): 3 = Required hospitalization or prolongation of existing hospitalization
p.(None): 4 = It resulted in permanent disability / significant disability 5 = It resulted in congenital anomaly / birth defect
p.(None): 6 = Another important medical event
p.(None): 1 = Hospital
p.(None): 2 = Outpatient clinic
p.(None): 3 = House
p.(None): 4 = Hospice
p.(None): 5 = Other,
p.(None): specify …………………………………………… ..
p.(None): Briefly, describe the EAS (Include relevant symptoms, body part, relevant laboratory tests and
p.(None): treatment received). Continue on a separate sheet, if necessary.
p.(None): Page 110 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): EAS Details
p.(None): EAS Status
p.(None): Serious Adverse Event Name:
p.(None): Name
p.(None): EAS duration (dd mmm yy)
p.(None): Date of appearance
p.(None): 1 = Solved
p.(None): 2 = Solved with sequels
p.(None): 3 = Persists
p.(None): 4 = It got worse
p.(None): 5 = Fatal
p.(None): 6 = Not evaluable
p.(None): Expected
p.(None): 1 = Expected *
p.(None): 2 = Not expected
p.(None): Date of resolution
p.(None): Grade
p.(None): Or check here if it persists
p.(None): * Was the event one of those listed in the protocol, as an undesirable effect recognized for medication in the
p.(None): test? See protocol page.
p.(None): Trial treatment
p.(None): Trial drugs
p.(None): which was
p.(None): Date
p.(None): Happening
p.(None): Causal Relationship of the event
p.(None): 1 = Definitive
p.(None): Action taken
p.(None): 0 = None 1 = Dose Reduction
p.(None): receiving the patient when the EAS started
p.(None): Total daily dose
p.(None): start of the most recent cycle
p.(None): (dd mmm yy)
p.(None): at present?
p.(None): 0 = No
p.(None): 1 = Yes
p.(None): End date (dd mmm yy)
p.(None): 2 = Probable
p.(None): 3 = Possible
p.(None): 4 =
p.(None): Unlikely 5 = No
p.(None): related 6 = No
p.(None): evaluable
p.(None): 2 = Delayed treatment 3 = Delayed and reduced treatment 4 = Permanently suspended treatment
p.(None): Page 111 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Patient number in the study
p.(None): Other treatments at the time of the event (Include concomitant medication, radiotherapy, surgery, palliative care).
p.(None): Continue on a separate sheet, if necessary. Exclude therapy administered for the management of EAS.
p.(None): Action taken
p.(None): Treatment
p.(None): Give the generic name of the drugs / treatment given in the last 30 days
p.(None): Total daily dose
p.(None): Route of Administration
p.(None): 1 = Oral 2 = Intravenous 3 = Subcutaneous 4 = Other (specify)
p.(None): Start Date (dd mmm yy)
p.(None): Currently happening?
p.(None): 0 = No
p.(None): 1 = Yes
p.(None): End date (dd mmm yy)
p.(None): 0 = None 1 = Dose reduction 2 = Delayed treatment 3 = Delayed and reduced treatment 4 = Treatment
p.(None): permanently suspended
p.(None): Page 112 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): Other relevant information that facilitates the evaluation
p.(None): (Include medical history, drug or alcohol abuse, family history, special research findings, etc.)
p.(None): Was this event expected from the point of view of the patient's medical history?
p.(None): 0 = No
p.(None): 1 = Yes
p.(None): Additional Information:
p.(None): Authorized Health Professional Firm
p.(None): ………………………………………………………….
p.(None): .
p.(None): Contact phone number
p.(None): …………………………………………………………
p.(None): …… ..
p.(None): Name
p.(None): ……………………………………………………
p.(None): ...
p.(None): Report date
p.(None): d d m mm a a
p.(None): OFFICIAL USE ONLY
p.(None): Was the EAS drug related?
p.(None): Yes No Event No
p.(None): Was the event unexpected? Yes No Comments:
p.(None): Was the event a RASIS / SUSAR?
p.(None): Shipping Date Form
p.(None): Date of introduction in the
p.(None): If not
p.(None): d d m mm a a
p.(None): database d d m mm a a
p.(None): Code
...
p.(None): etc.
p.(None): It refers to the given treatment (trial or other)
p.(None): Other comments
p.(None): Results of the Blind survey (when applicable)
p.(None): This section is optional, it is only filled if it is relevant (eg due to disagreement on causation, concomitant medication
p.(None): also suspicious, etc.).
p.(None): Provide details, if the Blind survey was performed
p.(None): Page 119 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 9B SECURITY REPORTS COVER
...
p.(None): If not
p.(None): Summary of Changes
p.(None): Briefly summarize the main changes proposed in this amendment, with a language
p.(None): Understandable for a layman. Explain the purpose of the changes and their meaning for the study. In
p.(None): Page 124 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): In the case of a modified amendment, indicate the modifications that have been made.
p.(None): If the amendment significantly alters the study design or methodology, or may otherwise affect
p.(None): The scientific value of the study must include supporting scientific information (or attach it separately).
p.(None): Indicate whether additional scientific criticism has been obtained or not.
p.(None): Any other relevant information
p.(None): Those who apply can indicate any specific ethical problem related to the amendment, which is desired
p.(None): the opinion of the CEIS.
p.(None): List of attached documents
p.(None): Document Version Date
p.(None): Statement
p.(None): I confirm that the information in this format is accurate and I assume full responsibility for it.
p.(None): I consider it reasonable that the proposed amendment should be implemented. Signature of the Chief Investigator
p.(None): ……. ………………………………
p.(None): Name …….………………………………
p.(None): Date of submission …………………………………….
p.(None): Page 125 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 10B SUBSTANTIAL AMENDMENT FORMAT FOR CLINICAL PRODUCT TESTS
p.(None): RESEARCH MEDICINALS (PMI)
p.(None): NOTIFICATION OF A SUBSTANCIAL AMENDMENT TO A CLINICAL TRIAL OF A MEDICINAL PRODUCT FOR HUMAN USE, DIRECTED
p.(None): TO THE HEALTH RESEARCH ETHICS COMMITTEE AND THE COMPETENT AUTHORITY.
p.(None): For official use:
p.(None): Date of receipt of the request: Date:
p.(None): Basis for non-acceptance / negative opinion:
p.(None): Start date of the procedure: Authorization / positive opinion:
p.(None): Registration number of the corresponding CEIS: Withdrawal of the application of the amendment
p.(None): Competent authority for the study: Date:
p.(None): To be filled out by the applicant:
p.(None): This form must be submitted to the corresponding CNEIS, for the opinion on a substantial amendment, and then must
p.(None): present to the competent authority, when applicable.
p.(None): Page 126 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): A. TYPE OF NOTIFICATION
p.(None): A.1 Notification for an opinion of the CNEIS:
p.(None): A.2 Notification to the competent authority:
p.(None): A.3 Information notification only *:
p.(None): A.3.1 To the CNEIS:
p.(None): A.3.2 To the competent authority:
p.(None): B. TEST IDENTIFICATION:
p.(None): B.1 Does the substantial amendment concern several trials involving PMI? If not
p.(None): B.1.1 If the answer is yes, repeat this section as many times as necessary
p.(None): B.2 Full title of the essay:
p.(None): B.3 Sponsor's code number for the protocol, version and date:
p.(None): C. IDENTIFICATION OF THE SPONSOR RESPONSIBLE FOR THE APPLICATION
p.(None): C.1 Sponsor
p.(None): C.1.1 Organization:
p.(None): C.1.2 Name of the contact person:
p.(None): C.1.3 Address:
p.(None): C.1.4 Telephone number:
p.(None): C.1.5 Fax number:
p.(None): C.1.6 E-mail:
p.(None): C.2 Legal Representative of the sponsor in the country, for the purpose of the trial (if different from the sponsor)
p.(None): * For substantial amendments, only notify when the competent authority (CA) has determined
p.(None): previously (eg quality data). The sponsor must not only submit the amendment to the CA, but also inform the
p.(None): CEIS that has notified, marking "for information only". Similarly, the sponsor must inform the CA of
p.(None): any notification of a substantial amendment that was previously determined by the CEIS (eg Sites for
p.(None): study completion).
p.(None): Page 127 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): C.2.1 Organization:
p.(None): C.2.2 Name of the contact person:
p.(None): C.2.3 Address:
p.(None): C.2.4 Telephone number:
p.(None): C.2.5 Fax number:
p.(None): C.2.6 E-mail:
p.(None): D. IDENTIFICATION OF THE APPLICANT (Check the appropriate box)
p.(None): D.1 Request to the CEIS
p.(None): D.1.1 Sponsor
p.(None): D.1.2 Legal Representative of the sponsor
p.(None): D.1.3 Person or organization authorized to make the application
p.(None): D.1.4 Researcher in charge of the application, when applicable:
p.(None): D.1.4.1. Study coordinator (for multicentric studies):
p.(None): D.1.4.2. Principal investigator (for single-center trials):
p.(None): D.1.5 Complete
p.(None): D.1.5.1 Organization:
p.(None): D.1.5.2 Name:
p.(None): D.1.5.3 Address:
p.(None): D.1.5.4 Telephone number:
p.(None): D.1.5.5 Fax number:
p.(None): D.1.5.6 E-mail:
p.(None): D.2 Request to the competent authority
p.(None): D.2.1 Sponsor
p.(None): D.2.2 Legal Representative of the sponsor
p.(None): D.2.3 Person or organization authorized by the sponsor to make the application
p.(None): D.2.4 Complete
p.(None): D.2.4.1 Organization:
p.(None): D.2.4.2 Name:
p.(None): Page 128 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): D.2.4.3 Address:
p.(None): D.2.4.4 Telephone number:
p.(None): D.2.4.5 Fax number:
p.(None): D.2.4.6. E-mail:
p.(None): E. IDENTIFICATION OF THE SUBSTANTIAL AMENDMENT
p.(None): E.1 Sponsor's code number for the substantial amendment, version and date for the clinical trial
p.(None): concerning:
p.(None): E.2 Substantial amendment type
p.(None): E.2.1 Amendment to the informed consent information Yes
p.(None): Do not
p.(None): E.2.2 Amendment to the protocol
p.(None): If not
p.(None): E.2.3 Amendment to other attached documents, in the initial application form
p.(None): If not
p.(None): E.2.3.1 If yes, specify:
p.(None): E.2.4 Amendment to other documents or information Yes No
p.(None): E.2.4.1 If yes, specify:
...
p.(None): H.3.6 State the name of the previous coordinating researcher:
p.(None): H.4 Change of the principal investigator at an existing site (provide details about the new principal investigator)
p.(None): H.4.1 First name
p.(None): H.4.2 Middle name (if applicable)
p.(None): H.4.3 Surname
p.(None): H.4.4 Qualification (Dr. ...)
p.(None): H.4.5 Professional Management:
p.(None): H.4.6 State the name of the previous principal investigator:
p.(None): I. CHANGE OF INSTRUCTIONS TO THE COMPETENT AUTHORITY, FOR FEEDBACK TO THE SPONSOR
p.(None): I.1 Change of electronic contact for application feedback Yes
p.(None): Do not
p.(None): If yes, provide the new email in which you wish to receive feedback:
p.(None): Page 132 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): J. LIST OF DOCUMENTS ADDED TO THE NOTIFICATION FORM
p.(None): Please submit only relevant documents and / or explanatory references to those already submitted (when applicable). Make
p.(None): Clear references to any change of the separate pages, and submit old and new texts. Check the box
p.(None): appropriate
p.(None): J.1 Declaration letter of the type of amendment and the reason (s)
p.(None): J.2 Summary of proposed amendments
p.(None): J.3 List of modified documents (identity, version, date)
p.(None): J.4 Pages with the previous and new words (if applicable)
p.(None): J.5 Supporting information
p.(None): J.6 Copy of initial application form, with amendment data highlighted
p.(None): J.7 Comments on any new aspect of the amendment
p.(None): K. APPLICANT'S SIGNATURE
p.(None): K.1 I confirm that [I confirm in the name of the sponsor that]:
p.(None): The information given in this document is correct, that the test will be conducted according to the protocol, the
p.(None): national regulation and the principles of Good Clinical Practices; and it is reasonable that the
p.(None): proposed amendment.
p.(None): K.2 Application for the Clinical Research Ethics Committee:
p.(None): K.2.1 Signature:
p.(None): K.2.2 Name:
p.(None): K.2.3 Date:
p.(None): Page 133 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): K.3. Application for the competent authority:
p.(None): K.3.1 Signature:
p.(None): K.3.2 Name:
p.(None): K.3.3 Date:
p.(None): Page 134 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 11 NOTIFICATION OF SERIOUS DEVIATIONS
p.(None): Sponsor:
p.(None): Date on which the deviation was identified:
...
p.(None): FOR STUDIES THAT WILL CONTINUE INCLUDING PARTICIPANTS, ATTACH A COPY OF THE LAST INFORMED CONSENT APPROVED
p.(None): CERTIFICATIONS
p.(None): Signature of the Principal Investigator
p.(None): Date
p.(None): Sponsor Signature (if applicable)
p.(None): Date
p.(None): Signature of the monitor (if applicable)
p.(None): Date
p.(None): Page 139 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 13A NOTIFICATION OF FINALIZATION OF A CLINICAL TRIAL OF A RESEARCH MEDICINAL PRODUCT
p.(None): (ECA-PMI)
p.(None): This notification must be delivered within the first 90 days after the end of a trial.
p.(None): clinical, or within the first 15 days, if the completion was premature.
p.(None): Date received by the authority:
p.(None): To be filled by the applicant:
p.(None): Protocol identification
p.(None): Title:
p.(None): Approval date:
p.(None): Sponsor Protocol Number:
p.(None): Applicant Identification
p.(None): B.1. Sponsor ID
p.(None): 1. Name of the sponsor:
p.(None): 2. Name of the legal representative of the sponsor in the country:
p.(None): 3. Address:
p.(None): 4. Telephone / Fax:
p.(None): 5. E-mail:
p.(None): B.2. Investigators Identification
p.(None): 1. Name of the principal investigator:
p.(None): 2. If there are several sites, cite the names of the responsible researchers per site:
p.(None): Study Completion
p.(None): The study ends on the country site: Completion date:
p.(None): Page 140 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
...
p.(None): training program and dates. Source: Curriculum Vitae
p.(None): Page 144 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): MEDICAL CARE FOR PARTICIPATING STUDENTS
p.(None): Appropriate medical care is provided to the person in case of an adverse event, including values
p.(None): of clinically significant laboratory, related to the study. Source: Protocol
p.(None): There is an authorization letter from the authority of the health center (it includes
p.(None): hospitals, Community Family Health Units, clinics) to carry out the study within
p.(None): the installations. It includes knowledge of the head of the hospital service, if applicable.
p.(None): The researcher must seek through prior agreements with the sponsor the
p.(None): continuity of treatment to research subjects once their
p.(None): Participation in the study if your interruption jeopardizes your safety within the frameworks
p.(None): applicable regulators. Source: procedures described in the research protocol.
p.(None): AUTHORIZATION OF THE ETHICAL CONSIDERATIONS OF THE RESEARCH
p.(None): Before starting a study, the researcher / institution must have the
p.(None): favorable approval / opinion, written and dated, of the CNEIS / CEIS study protocol, the
p.(None): Informed consent form, updates, recruitment procedures
p.(None): of subjects (for example, announcements) and any other written information that will be provided to
p.(None): YES NO Comments:
p.(None): YES NO Comments:
p.(None): Page 145 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): persons
p.(None): COMPLIANCE WITH THE PROTOCOL YES NO Comments:
p.(None): The researcher / institution must conduct the study in accordance with the protocol agreed with the
p.(None): sponsor and favorable approval / opinion of the CNEIS / CEIS and, if necessary, by the authorities
p.(None): Regulatory
p.(None): The investigator or the person designated by the investigator must document and explain any
p.(None): deviation from the approved protocol, except for changes involving only logistic or administrative aspects
p.(None): of the study (for example, change of monitors, change of telephone number).
p.(None): RESEARCH PRODUCTS YES NO Comments:
p.(None): The product delivery records are available to the study site, the inventory on the site, the use
p.(None): in each subject and the return to the sponsor or alternate disposition of the unused medicine
p.(None): The product (s) are stored as specified by the sponsor and in accordance with the
p.(None): applicable regulatory requirements The researcher or a person designated by the researcher / institution must
p.(None): explain the correct use of the product under investigation to each subject and must verify at appropriate intervals
p.(None): for the study, that each subject is following the instructions appropriately.
p.(None): ASSIGNMENT PROCESSES
p.(None): RANDOM AND OPENING OF THE BLIND
p.(None): The researcher must follow the procedures
p.(None): YES NO Comments:
p.(None): Page 146 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): randomization of the study, if any, and you should ensure that the code only
p.(None): open in accordance with the protocol. If the study is blind, the researcher must document and
p.(None): Quickly explain to the sponsor any premature breaking of the code (for example,
p.(None): accidental breakage, breakdown by a serious adverse event) of the product under investigation.
p.(None): PROGRESS REPORTS YES NO Comments:
p.(None): The researcher must submit to the CNEIS / CEIS written summaries of the study status in
p.(None): annual or more frequently if requested
p.(None): The researcher must immediately submit written reports to the sponsor, the CNEIS / CEIS and,
p.(None): when applicable, to the institution about any significant change that affects the conduct of the study and / or
p.(None): increase the risks for the subjects
p.(None): SAFETY REPORTS YES NO Comments:
p.(None): The researcher must comply with the applicable regulatory requirements
p.(None): related to the report of
p.(None): unexpected serious adverse drug reactions
p.(None): For reported deaths, the investigator must provide the sponsor and the
p.(None): CNEIS / CEIS any additional information requested (for example, autopsy reports and medical reports
p.(None): from
...
p.(None): required for the performance of its work.
p.(None): Second: During his work he will have accessXtoXinformation with character
p.(None): confidential that should not be used for outside purposes.
p.(None): The parties that sign this agreement must comply with it in full and comply with the provisions of this
p.(None): Confidentiality Agreement sign two copies of it with the same tenor and equal validity in legal force.
p.(None): Given in San Salvador on the 20th day of the month of XXX of the XXXX year.
p.(None): PRESIDENT NAME
p.(None): Page 151 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 17. DECLARATION OF ABSENCE OF CONFLICTS OF INTEREST
p.(None): Declaration of Absence of Conflicts of Interest
p.(None): In the course of performing your duties as under this agreement, you will have
p.(None): accessXtoXinformation owned by the National Committee for Health Research Ethics. You agree to try
p.(None): this information as confidential (hereinafter as "information")
p.(None): I,
p.(None): I compromise to:
p.(None): a) Not to use the information for any other purpose than to fulfill my obligations under this agreement; Y
p.(None): b) Not disclose or provide the information to any third party who does not have a working relationship and
p.(None): Confidentiality in it and to use the information properly.
p.(None): It will not relate to any obligation of confidentiality and will not use it until you are clearly not
p.(None): able to demonstrate that any part of the information:
p.(None): a) It was known by you before any disclosure or discovery by the National Ethics Committee of
p.(None): Health Research, or:
p.(None): b) It was public domain at the time of discovery by the National Committee for Health Research Ethics,
p.(None): or:
p.(None): c) It has become part of the public domain, or:
p.(None): d) It has been available to you by a third party without abuse of trust or of the obligations of
p.(None): Confidentiality to the National Committee for Health Research Ethics.
p.(None): I promise not to communicate the deliberations and results of the team of
p.(None): Page 152 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): in which it participates, as well as the resulting recommendations
p.(None): and / or the decisions of the National Committee for Health Research Ethics to third parties, except as
p.(None): explicitly agreed the National Committee for Health Research Ethics.
p.(None): You will perform your responsibilities exclusively in your capacity as a
p.(None): of the National Committee of Ethics of Health Research. Signing this
p.(None): agreement, you confirm that you have no financial interest and / or other relationship with the parties, which:
p.(None): a) They could have a commercial interest created by obtaining access to any part of the referred information
p.(None): previously and / or:
p.(None): b) You may have an interest created in the result of the appreciation of the products, in which you will participate
p.(None): but it will not limit parties such as the producer that has been evaluated or from competent producers.
p.(None): I accept the provisions and conditions contained in this document and for the record, I sign this document:
p.(None): Name:
p.(None): Entity:
p.(None): Date:
p.(None): Firm:
p.(None): Page 153 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): ANNEX 18 EXTERNAL EXPERTS
p.(None): 1. OBJECTIVES
p.(None): Establish the criteria for the integration and operation of the Committees of External Experts to guarantee the
p.(None): quality in the documentary and administrative functioning, and comply with international guidelines for the process of
p.(None): decision making of the National Committee for Health Research Ethics.
p.(None): 2. REACH
p.(None): Understand the performance guidelines of professionals hired as External Experts of the National Committee of
p.(None): Health Research Ethics, from your contract for evaluation to the delivery of reports and opinions by
p.(None): part of the Committee of External Experts, in addition to providing guidance to the ethics committees of the
p.(None): research (CNEIS / CEIS) on which organizations depend to examine and monitor the ethics of the
p.(None): research, as well as researchers who design and carry out health research studies.
p.(None): 3. PRIOR REQUIREMENTS
p.(None): Application filed by the National Committee for Health Research Ethics in which it applies
p.(None): conformation of the Committee of External Experts as technical-scientific evaluators that issue an opinion
p.(None): based on your judgment and experience, on certain topics.
p.(None): 4. DESCRIPTION
p.(None): RESPONSIBLE DESCRIPTION
p.(None): The CNEIS may establish and approve by resolution the Committees of External Experts it deems necessary. The
p.(None): Committees will be composed of External Experts and CNEIS officials, with adequate training and experience,
p.(None): which may be permanent or temporary.
p.(None): The CNEIS will establish the organizational structure of the Committees of External Experts in the resolutions of
p.(None): appointment.
p.(None): CREATION OF EXTERNAL EXPERTS COMMITTEES
p.(None): Page 154 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): RESPONSIBLE DESCRIPTION
p.(None): The Committees of External Experts will have a document that will define at least the following elements: objective
p.(None): and scope, composition, designation of the leader, secretariat, declaration of absence of conflict of interest,
...
p.(None): It was shaped.
p.(None): Each Committee of External Experts held at the institution must have established the following:
p.(None): - Name of the leader External Expert
p.(None): - Name of the secretary of the Committee of External Experts
p.(None): - Name of External Experts
p.(None): - Sessions to celebrate
p.(None): - Calls
p.(None): - Quorums
p.(None): - Minutes
p.(None): - Validity
p.(None): To hold the meetings in order to solve a problem in the Committees of External Experts, you must:
p.(None): - Define the Agenda to be developed or the objective of the Committee meeting.
p.(None): - Convene the participants and the guests attaching the agenda to be developed, the objective of the
p.(None): Committee and the purpose of the meeting.
p.(None): - Indicate in the call the information or reports necessary to present during the activity.
p.(None): - Develop the scheduled meeting or activity at the appointed time.
p.(None): - Verify the approval of the previous minutes and the follow-up to commitments of the previous minutes when applicable.
p.(None): - Prepare the attendance record.
p.(None): - Raise Minutes of the results of the development of the agenda highlighting as a priority:
p.(None): - The topics discussed
p.(None): Page 158 of 164
p.(None): Republic of El Salvador
p.(None): National Committee for Health Research Ethics
p.(None): RESPONSIBLE DESCRIPTION
p.(None): - The decisions made
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| abuse | Victim of Abuse |
| access | Access to Social Goods |
| access to information | Access to information |
| age | Age |
| armed forces | Soldier |
| authority | Relationship to Authority |
| autonomy | Impaired Autonomy |
| blind | visual impairment |
| child | Child |
| cioms | cioms guidelines |
| cognitive | Cognitive Impairment |
| criminal | criminal |
| dependent | Dependent |
| detained | person in detention center |
| disability | Mentally Disabled |
| drug | Drug Usage |
| embryo | embryo |
| emergencies | patients in emergency situations |
| emergency | Public Emergency |
| employees | employees |
| ethnic | Ethnicity |
| ethnic minority | ethnic minority |
| family | Motherhood/Family |
| fertile | of childbearing age/fertile |
| fetus | Fetus/Neonate |
| healthy volunteers | Healthy People |
| homeless | Homeless Persons |
| ill | ill |
| illiterate | Literacy |
| influence | Drug Usage |
| language | Linguistic Proficiency |
| manipulated | Manipulable |
| minor | Youth/Minors |
| minority | Racial Minority |
| nomads | nomad |
| occupation | Occupation |
| opinion | philosophical differences/differences of opinion |
| parents | parents |
| party | political affiliation |
| placebo | participants in a control group |
| property | Property Ownership |
| single | Marital Status |
| substance | Drug Usage |
| unemployed | Unemployment |
| volunteers | Healthy People |
| vulnerability | vulnerable |
| vulnerable | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| drug | ['influence', 'substance'] |
| healthy volunteers | ['volunteers'] |
| influence | ['drug', 'substance'] |
| substance | ['drug', 'influence'] |
| volunteers | ['healthyXvolunteers'] |
| vulnerability | ['vulnerable'] |
| vulnerable | ['vulnerability'] |
Trigger Words
capacity
consent
ethics
justice
protect
protection
risk
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input