Republic of El Salvador
National Committee for Health Research Ethics
MINISTRY OF HEALTH SUPERIOR COUNCIL OF PUBLIC HEALTH
NATIONAL COMMITTEE OF ETHICS OF HEALTH RESEARCH
STANDARD OPERATING PROCEDURES MANUAL FOR HEALTH RESEARCH ETHICS COMMITTEES
AUGUST 2015
Republic of El Salvador
National Committee for Health Research Ethics
CATALOG SHEET
2015 Ministry of Health
All rights reserved. The partial or total reproduction of this work is allowed, provided that the
source and not for sale or other commercial purpose.
The official documentation of the Ministry of Health can be consulted through:
http://asp.salud.gob.sv/regulacion/default.asp
“STANDARD OPERATING PROCEDURES MANUAL FOR HEALTH RESEARCH ETHICS COMMITTEES”
Printing:
Edition and Distribution Ministry of Health
Vice Ministry of Health of Health Policies Higher Council of Public Health
Arce Street No. 827, San Salvador. Telephone: 22 05 70 00 Official page: http://www.salud.gob.sv
Graphic project design:
Diagramming:
Printed in El Salvador by:
Ministry of Health. Vice Ministry of Health Policies. Higher Council of Public Health. Direction of
Regulation and Legislation in Health. National Committee for Health Research Ethics. San Salvador, El Salvador.
AC
ADDITION
Republic of El Salvador
National Committee for Health Research Ethics
Following the maturity and implementation of all procedures established in the Manual of
Standard Procedures of the National Committee for Health Research Ethics, the following have been performed
Addenda (August 2017)
- Legal bases were updated
- The responsibilities section was added
- The Review and Update and Acronyms section was moved to the beginning of the Manual.
- In procedure 1; The section of all documents to be submitted by the Investigator was placed.
- In procedure 2; the tariffs of the Good Clinical Practice Audits were added.
- In procedure 3; the responsibility of the Technician in charge of Clinical Trials Monitoring was added
- In procedure 4; The following note was added: The Investigator must inform the Committee
National Health Research Ethics when the Clinical Study authorized by the
CNEIS, likewise, must inform when the Clinical Study has finished as established in the
procedure 14 of this manual.
- In procedure 5; the responsibility of the Technician in charge of Clinical Trials Monitoring was added
- In procedure 8; the interaction between the National Committee for Health Research Ethics was added,
the National Pharmacovigilance Center, the Higher Council of Public Health and the National Directorate of
Medicines. Likewise, notification contacts were added, flowchart of the process to be followed in case of
EAS report // RAM. The times established for the EAS // RAM report were added.
- In procedure 10; the responsibility of the Technician in charge of Clinical Trials Monitoring was added
Republic of El Salvador
National Committee for Health Research Ethics
- In procedure 13; the word "Request" was removed from the name of the procedure.
- Annex 1 and 2 were updated and uniform. Annex 2 Request for Evaluation of Clinical Research Protocols in
Humans.
- The interinstitutional macroprocess was modified.
- Organizational chart of the National Committee for Health Research Ethics was prepared.
- Explanatory notes of the Clinical Trials Regulation were added.
Republic of El Salvador
National Committee for Health Research Ethics
TECHNICAL TEAM
Authors:
Dr. Mario Ernesto Soriano Lima
President, National Committee of Health Research Ethics CSSP-MINSAL
Dr. David Torres
Vice President, National Committee for Health Research Ethics CSSP-MINSAL
Lic. Yeny Acosta
Secretary, National Committee for Health Research Ethics CSSP-MINSAL
Reviewers and update team
Ing. Tito Orlando Llanes Vocal
Dr. Gerardo Antonio Godoy Vocal
Lic. Miriam Irene Meléndez Vocal
Lic. Aydeé Rivera of Vocal Stop
Lic. María Delsy Menjívar Vocal Licda. Sonia Siciliano de Serpas Vocal Licda. Katia
Orbelina Sermeño Vocal
Lic. Amanda Isabel Garcia Vocal Licda. Patricia Lissette Mira Gómez Vocal Dr. Melvyn
Alfredo Rogel Hernández Vocal
Ms. Ángela de Rivas Administrative Assistant
Republic of El Salvador
National Committee for Health Research Ethics
CONTENT
Addenda
3
1. Introduction
one
2. Objectives
4
2.1 General
4
2.2 Specific
4
3. Legal Bases
4
4. Responsibilities
5
5. Review and Update
6
6. Organization chart of the National Committee for Health Research Ethics 6
7. Acronyms
7
8. Procedures - Description of Procedures
8
Procedure 1: Presentation of Research Projects or Protocols for Evaluation.
8
Documentation to be submitted by the researcher
8
In compliance with the Constitution of the Republic of El Salvador, Art. 68.- 10
Description of Procedure 1
14
Process Diagram - Procedure 1 16
Procedure 2: Receipt of a Health Research Project or Protocol 17
Description of Procedure 2
17
Procedure 3: Determination of the Type of Research Project 19
Description of Procedure 3
twenty
Procedure 4: Evaluation of the Protocols
22
Description of Procedure 4
22
Procedure 5. Preparation of the Resolution Document of a Research Project 25
Description of Procedure 5
25
Procedure 6. Evaluation Meeting With Researcher 27
Description of Procedure 6
27
Procedure 7. Appeal Review
29
Description of Procedure 7
29
Procedure 8. Report of Adverse Events in Clinical Trials 31
Description of Procedure 8
36
Procedure 9. Security Report
35
Republic of El Salvador
National Committee for Health Research Ethics
Description of Procedure 9
35
Procedure 10. Report of Amendments
37
Description of Procedure 10
40
Procedure 11. Report of Serious Deviations from Study 42
Description of Procedure 11
43
Procedure 12. Periodic Report on Research Progress or Continuity 45
Description of Procedure 12
Four. Five
Procedure 13: Audit of Good Clinical Practices to Research Centers 47
Description of Procedure 13
47
Procedure 14. Receipt of Notification of Completion of a Study 56
Description of Procedure 14
56
Procedure 15. Receipt of Final Report to Cneis 58
Description of Procedure 15
58
Procedure 16. Backup of the Cneis 60 Archives
9. Glossary
62
10. Annexes
75
Annex 1. Guide to Prepare the Letter of Intent of a Researcher / Research Team
75
Annex 2 Request for Evaluation of Clinical Research Protocols in Human Beings 76 Annex 3 Identifying a
Clinical Trial 79
Annex 4a. Evaluation Guide for a Health Research Project 82
Annex 4b Guide for Ethical Evaluation of Research Protocols Different from Clinical Trials
92
Annex 4c Guide for Final Resolution
94
Annex 5a Requirements for the Elaboration of an Informed Consent (Ci) 98
Annex 5b Basic Structure Model of the Information Document for the Research Subject and Form
Informed Consent 102
Annex 5c Checklist of Requirements of the Information Document for the Subject of Investigation and
Informed Consent Form 104
Annex 6 Record of Resolution of a Research Project 106
Annex 7 Notification For Principal Investigator 107
Annex 8 Report Form for Serious Adverse Events 109
Annex 9a Security Report. Clinical Trials of Medicinal Products in Research (Pmi)
115
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National Committee for Health Research Ethics
Notes: Guide to Complete the List of Semi-Annual Security Reports and the Tabulated Summary
118
Annex 9b Cover of Security Reports 120
Annex 10a Substantial Amendment Notification for Non-Medicinal Products Clinical Studies
123
Annex 10b Substantial Amendments Format for Clinical Trials of Research Medicinal Products (PMI)
126
Annex 11 Notification of Serious Deviations
135
Annex 12 Continuity Report
136
Annex 13a Notification of Completion of a Clinical Trial of a Medicinal Product in Research (ECA-PMI)
140
Annex 13b Notification of Completion of a Study that Does Not Involve Medicinal Products in Research
142
Annex 14. Checklist of Requirements for Compliance with Good Clinical Practices.
144
Annex 15. Inter-institutional Macroprocess for Authorization and Follow-up of Clinical Trials
149
Annex 16. Confidentiality Agreement
151
Annex 17. Declaration of Absence of Conflicts of Interest 152
Annex 18 External Experts
154
Annex 19 Format for Presentation of Research Protocols 162
11. Bibliography
164
Republic of El Salvador
National Committee for Health Research Ethics
1. INTRODUCTION
The Health Research Ethics Committee (CEIS) 1, according to UNESCO, is a group of people (a president and
members) who meet for the purpose of “Protecting human beings who participate in research such as
research subjects, aimed at obtaining biological, biomedical, behavioral and
epidemiological, susceptible of being generalized. ”
The Committee is a structure formed by individuals, with two main functions: ethics, which allows them
make decisions and verdicts on the Research Protocols they evaluate, and the administrative that
allows them to function quickly and be effective in responding to requests, by taking care of the
documentation that is essential to follow up on regulatory provisions. The function
Administrative committee could be considered as essential, but at the same time accessory. Essential, because without
she, no matter how good ethical decisions are taken, the procedures cannot be carried out in an orderly manner and
reproducible; and accessory, because the priority would be more focused on the ability of members to protect
Rights of subjects undergoing biomedical research.
For the proper functioning of the CEIS, one of the most widespread documents on the operation of the CEIS,
denominated Functional Guide of a Scientific Ethical Committee (CEC), disseminated by the PAHO / WHO Bioethics Unit of the
Universidad de Chile, mentions that the Procedures Manual must be found in the Archives of every CEC
Operational 1. Likewise, in the document of Good Clinical Practices-Document of the Americas,
prepared and promoted by the Pan American Health Organization, in Article 3.4 of Procedures says: “The
CEI / CRI must fulfill its functions according to written standards ”2. In the Spanish Royal Decree 223/2004 of the Ministry
of Health and Consumption, in its article 14, literal 2, it is mentioned that “the Clinical Research Ethics Committees
they must elaborate and follow for their
1 * In general, we will talk about “Health Research Ethics Committee”, instead of “Ethics Committee of
Clinical Research ”, which has dominated until recently. This is due to the trend that seeks to modify
the very nature of these committees, so that they are increasingly broad and inclusive. However,
because it is something that is in process and in many official documents it follows
Speaking of "clinical research", both expressions can be found in this document.
1 Mile L., Operational guides for the operation of a CEC. University of Chile, Bioethics Unit, PAHO / WHO.
2 Good Clinical Practices-Document of the Americas, Pan American Health Organization, 2005.
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operation of standard work procedures ”3, and also mentioned in the guidelines
contained in B.O. 09/21/11 - Resolution 1480/11-MS - Approving the Guide for Research with Human Beings, in
Argentina4.
Operational guidelines for the operation of a research ethics committee dictated by WHO
They refer: “The Ethics Committees must publicly indicate the operational procedures that determine the authority
under which the committee is established, the functions and tasks of the Ethics Committees, the requirements of its members,
the terms and conditions of appointments, offices, secretariat structure, procedures
internal, and quorum requirements. Ethics Committees must act in accordance with their procedures
written operations ”5. Glossaries of research ethics define Procedures
Standardized operations such as written procedures, detailed for the uniform development of
a function6.
The procedures differ from the policies in that they are practical, detailed, specific and specific tactics.
detailed directives that allow implementing a policy. Written operating procedures are needed because they are
requirement to evaluate the proper functioning of a committee, and are the reference used to instruct and remember. Yes
well on many occasions institutions can work without written procedures, that is not so effective
not desirable. The procedures are not only necessary to meet requirements and be decorative, but must arrive
to be a comprehensive and practical description of the different functions of the research ethics committee. The
Results of having them would be:
- Establish consistency in how situations are handled
- Promote a reduction of errors
- Provide clarity about responsibility in the distribution of tasks
3 BOE 33, Saturday, February 7, 2004. MINISTRY OF HEALTH AND CONSUMPTION, 2316 ROYAL DECREE 223/2004, of February 6,
with which clinical trials with medications are regulated.
4. Opinion of the commissions, bill of clinical investigations with medicines, products
doctors, dental products, biological products, gene therapy and cell therapy. The commissions of
Social Action and Public Health and General Legislation of the Argentine Republic.
5 Operational guides for ethics committees that evaluate biomedical research, World Health Organization,
2000
6 Definition of terms. General Glossary Course of Introduction to Research Ethics, Bioethics Network
Latin American
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- Help faster and better training of new committee members
- Provide a partial defense against complaints arising from an alleged unequal treatment in determinations
of the committees.
Within this framework, it is necessary to establish harmonized procedures for Good Clinical Practices defined for
our country, which can serve as a basis for both regulatory agencies and researchers, Committees of
Ethics, Universities and Companies.
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2. OBJECTIVES
2.1 GENERAL
- Standardize the operational procedures of the National Committee for Health Research Ethics (CNEIS) and
Local Committee for Health Research (CLEIS) of El Salvador, to guarantee quality in the
Documentary and administrative operation, and comply with international guidelines and Good Practice Guide
Clinics
2.2 SPECIFIC
- Standardize the procedures for the review of ethical considerations of health research.
- Establish a guide for an appropriate induction of the new members of the Committees.
- Optimize processes for decision making.
- Establish inter-institutional procedures for the integral evaluation of Clinical Trials.
3. SCOPE
This manual applies to the entire Regulation of Clinical Trials that are carried out in El
Salvador and is evaluated inter-institutionally between the National Directorate of Medicines, National Committee
of Ethics of Health Research and the Higher Council of Public Health.
4. LEGAL BASES
- Constitution of the Republic Art. 68, 69.
- Law on the Rights and Duties of Patients Art. 5 literal c), Art. 9 literal L), Art. 16, 17 and 18.
- Medicines Law Art. 2, 29, 66, 68 74 b).
- Health Code Art. 7 and 14
- General Regulations of the Medicines Law Art. 34, 85
- Technical Regulations of the American Center for Pharmaceutical Products. Medicines
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of Human Use. Sanitary Registration Requirements. RTCA 11.03.59: 11.
- American Central Technical Regulations. Pharmaceutical products. Drug Stability Studies for Use
Human. RTCA 11.01.04: 10.
- American Central Technical Regulations. Pharmaceutical products. Labeling of Pharmaceutical Products for Use
Human. RTCA 11.01.02: 04.
- American Central Technical Regulations. Pharmaceutical products. Medicines for Human Use. Good Practices of
Manufacturing for the Pharmaceutical Industry. RTCA 11.03.42: 07.
-     Pharmaceutical products. Medicines for Human Use. Bioequivalence and Interchangeability. RTS
11.02.01: 16.
- Salvadoran Technical Regulations RTS 11.02.02: 16. Pharmaceutical products. Medicines for Human Use.
Pharmacovigilance
- Guide to Good Clinical Practices (Document of the Americas).
- Guide of Verification of Good Clinical Practices in Health Establishments.
- Guidelines for Good Clinical Practices in Establishments in which Research or
Clinical Trials (Adaptation of the Harmonized Tripartite Guide of the International Harmonization Conference
ICHE 6R1).
5. RESPONSIBILITIES
- CNEIS: Responsible for contributing to safeguard the dignity, rights, security and welfare of all
and current and potential research participants. As well as in charge of receiving,
evaluate, approve / not approve or observe a research protocol.
- DNM: Responsible for evaluating approving / denying / observing clinical research protocols,
approval of the importation of the medicinal product under investigation, monitoring and supervision of the trials
clinical (EAS, SUSAR, Amendments to the protocol, Reports, support in PCB Audits, in others)
- CSSP: Responsible for executing Good Clinical Practice Inspections.
- CNFV: Responsible for Pharmacovigilance of studies of products already registered in the DNM that
evaluate a new indication, new concentration if it is higher than the one already registered, new dosage or new
pharmaceutical form with
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registration purpose; All studies of pharmacokinetics, bioavailability and bioequivalence. The CNFV, provides
technical support to decide whether there is a causal relationship or not in a Serious Adverse Event or Adverse Reaction
Medication and for those Pre-marketing medications; in the case of post-marketing medications
Provides technical analysis according to your specialty.
6. REVIEW AND UPDATE
This Manual will be reviewed every three years, from its publication for its update and also
will be reviewed and updated when there is a significant change in the development of the processes
established in this document.
7. ORGANIGRAM OF THE NATIONAL COMMITTEE OF ETHICS OF HEALTH RESEARCH
Ministry of Health
(MINSAL)
Higher Public Health Council (CSSP)
National Committee of
Ethics of the
Health Research (CNEIS)
National Directorate of
Medicines
(DNM)
Local Committees of Health Research Ethics
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Presidency of the
CNEIS
Administrative assistant
DNM representatives
PCB auditors
Vice President CNEIS
CNEIS Vocal Secretary
8. ACRONYMS
- BPC: Good Clinical Practices
- CEIC / CEIS: Local Committee for Clinical Health Research Ethics
- CNEIC / CNEIS: National Ethics Committee for Clinical Health Research
- CNFV: National Pharmacovigilance Center
- CRO / OIC: Contract Research Organization
- CSSP: Higher Council of Public Health
- DNM: National Directorate of Medicines
- EAS: Serious Adverse Event
- ECC: Controlled clinical trial
- IP: Principal Investigator
- IJ: Chief Researcher
- MINSAL: Ministry of Health
- PMI: Medicinal product under investigation
- POE: Standard operating procedure
- PRET: Protocol rejected for ethical and technical reasons
- SUSAR: Suspected Unexpected Serious Adverse Events
- UES: University of El Salvador
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9. PROCEDURES - DESCRIPTION OF PROCEDURES
PROCEDURE 1: PRESENTATION OF RESEARCH PROJECTS OR PROTOCOLS FOR EVALUATION.
OBJECTIVE: To facilitate researchers to present their research protocols to the National Committee
of Health Research Ethics (CNEIS) and the National Directorate of Medicines (DNM) for case studies
clinical.
RESPONSIBLE:
- Sponsor / research team / principal investigator.
- Assistant to the National Committee for Health Research Ethics.
- Delegated staff of the National Directorate of Medicines.
SUPPORT MATERIAL
- Document of Good Clinical Practices: Document of the Americas, Guidelines for Good
Clinical Practices
- Guide for the elaboration of the clinical trial protocol ”,“ how to develop research protocols
in health".
- Guide of Verification of Good Clinical Practices in Health Establishments.
- Operation Manual of the National Committee for Health Research Ethics.
- Standard operating procedures manual of the CNEIS.
- User Guide for the Presentation of Clinical Research Protocols of the National Directorate of
Medicines
DOCUMENTATION TO BE PRESENTED BY THE RESEARCHER
The protocols submitted to the CNEIS evaluation must be accompanied by the following documentation,
duly completed in printed format:
- Application Form for evaluation of clinical research protocols in humans (Annex 2)
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- Letter requesting evaluation of the protocol addressed to the ethics committee (original or copy).
- Complete original protocol of the study in Spanish, containing original informed consent,
Informed assent (if applicable) and investigator's brochure (Legal documents must be submitted in
Spanish or with their respective translation, in accordance with Salvadoran notarial legislation; in the case of
documents from abroad, must be presented apostilled or consularized, in original and copy
for confrontation.)
- Four copies of the full protocol of the study in Spanish and one copy in electronic.
- Report (summary) of pre-clinical phase I and Phase II studies when applicable.
- Information on the insurance policy for the research subject granted by the sponsor, specifying the
Applicability mechanism in El Salvador.
- Curriculum vitae of the principal investigator and co-investigators.
- Proof of payment of tariff.
- Payment method of the researcher in El Salvador (attach a copy of the contract).
- Letter of authorization from the center or centers where the study will be carried out.
- Investigator's commitment to good clinical practices.
- Certificate of Good Manufacturing Practices (BPM) of the manufacturer or Certificate of BPM
issued by the Local Regulatory Authority. Applies if the product is not registered.
- Primary and secondary packaging arts of the product or products to be used in the clinical study, which
contain the lot numbers and the date of manufacture and expiration.
- Other materials (Promotional, patient card, questionnaires, etc.).
- Copy of the certificate of authorization of operation of the Health establishment where the
Clinical Study, issued by the Higher Council of Public Health.
- Copy of the updated payment of the operating annuity of the establishment of
health where the clinical study will take place.
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Recognitions of documents related to Clinical Research
The National Committee for Health Research Ethics, the National Directorate of Medicines and the Superior Council
Public Health, may officially recognize relevant decisions, reports or information from trials
Clinics of drug regulatory agencies that have been certified level IV by the Organization
Pan American Health (PAHO), as well as by health authorities of the United States of America, Canada,
Australia, Switzerland, Japan and by the European Medicines Agency (EMA) and other countries that have
specific regulation for the regulation of Clinical Trials.
In the case of drug research protocols that require evaluation in beings
human, its review will be applicable regardless of the primary origin of the application, be it from the sector
National, foreign, public or private.
In compliance with the Constitution of the Republic of El Salvador, Article 68.- A Higher Council of Public Health
will ensure the health of the people. It will consist of the same number of representatives of the Medical, Dental,
Chemist - Pharmacist, Veterinarian, Clinical Laboratory, Psychology, Nursing and others at the level of
Degree that the Higher Council of Public Health has qualified to have its respective board; will have a
president and a secretary of appointment of the executive body. The law will determine your organization.
The exercise of professions that are immediately related to the health of the people will be monitored
by legal bodies formed by academics belonging to each profession. These organisms will have
power to suspend the professional members of the guild under their control, when exercising their
profession with manifest immorality or disability. The suspension of professionals may be resolved by the agencies
competent in accordance with due process.
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The Higher Council of Public Health will know and resolve the appeals that are brought against the
resolutions pronounced by the organizations referred to in the previous paragraph.
And in compliance with Art. 14. Literal d) Of the Health Code which details that:
The powers of the Board are:
d) Authorize prior favorable report of the respective Supervisory Board, the opening and
operation of clinical biological laboratories, radiological cabinets, hospitals, clinics
social assistance, optical cabinets, denture laboratories.
In reference to the above it is necessary that:
<< The Health establishment where the Clinical Study will be carried out, is authorized by the Council
Senior Public Health >>
PAYMENT OF TARIFFS (requirement N ° 6, Annex 3):
It represents the right that every research project receives the evaluation of ethical considerations according to
international and harmonized guidelines for the country, Audit of Good Clinical Practices, review of
Addenda, adverse effects, modifications and other processes related to the execution of the investigation.
Payment of fees for the ethical evaluation of first-time investigations with molecules, procedures
invasive clinics, blood sample management or biological tissue collection for genetic analysis, is the
next:
TYPE OF ORGANIZATION TARIFFS
International pharmaceutical companies. $ 2,400.00
National pharmaceutical companies US $ 1,600.00 Non-organizations
nonprofit government and of
foreign universities
US $ 1,100.00
Local private universities US $ 400.00 Without sponsorship
and state sources: the case will be evaluated to exempt the payment
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TYPE OF ORGANIZATION TARIFFS
ANNUAL RENEWAL OF THE STUDY AND
BPC COMPLIANCE REVIEW
DUTY
International pharmaceutical companies US $ 1,100.00
National pharmaceutical companies US $ 733.33 Non-organizations
non-governmental
profit and foreign companies or universities
US $ 566.67
Local private universities US $ 133.33 The
case for
State sources
determine whether or not to proceed to exempt the payment.
Studies other than clinical trials or the previous classification will pay the following fees:
TYPE OF ORGANIZATION TARIFFS
International pharmaceutical companies. $ 1,500.00
National pharmaceutical companies US $ 1,000.00 Non-organizations
nonprofit government and of
foreign universities
$ 500.00
Local private universities US $ 400.00 Without sponsorship
and state sources: the case will be evaluated to exempt the payment
ANNUAL RENEWAL OF STUDIES DIFFERENT FROM CLINICAL TRIALS
DUTY
International pharmaceutical companies. $ 500.00
National pharmaceutical companies US $ 333.33 Organizations not
nonprofit government and of
foreign universities
US $ 166.67
Local private universities US $ 133.33 Without sponsorship
and state sources: the case will be evaluated to exempt the payment
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In the case of investigations already initiated with molecules, invasive clinical procedures, sample handling
blood or biological tissue collection for genetic analysis, which have not received an initial audit,
CNEIS will indicate audit of studies already initiated. The payment of tariffs for the execution of Good Audits
Clinical Practices according to the previous condition is as follows:
CPB compliance review in studies already initiated
Duty
International pharmaceutical companies US $ 900.00
National pharmaceutical companies US $ 600.00 Non-organizations
non-governmental
profit and foreign companies or universities
$ 600.00
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DESCRIPTION OF THE PROCEDURE 1
Every person / institution / body that will submit a research project must submit it to
ethical evaluation considering next steps:
No. ACTIVITIES
Download the documents for the identification of the fulfillment of prerequisites to the submission of projects of
research at the following address: http://www.cneis.org.sv/ section Download documents:
http://www.cneis.org.sv/descarga-de-documentos/
in which you will find the following information:
1 1. Guide to Good Clinical Practices.
2. Good Clinical Practices Verification Guide.
3. User Guide for the Presentation of Clinical Research Protocols of the Directorate
National Medicines.
4. Application Form for evaluation of clinical research protocols in humans.
Request Authorization Letter from the authority of the center or centers
health (includes hospitals, Minister of Health, Regional Directors of Health in the case of Units
Community Family Health
two
located, private clinics) for conducting the study within
the installations. It includes knowledge of the head of the hospital service, if applicable.
PERSON IN CHARGE
Sponsor / Researchers
Principal investigator / team of researchers
3 Prepare Letter of intent of the researcher on the study. Investigator
principal
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No. ACTIVITIES
Print protocol in its original version, with an edition date when the original is written in another language;
Protocol translated into Spanish,
with edition date and 4 printed copies and an electronic copy.
4
Any protocol, independent of its type, must include the section “Ethical considerations”.
Consult by telephone or in person with the Assistant of the National Ethics Committee of the
Health Research, telephone 2561-2520, CSSP Facilities, building N ° 2, second level, on
5 the fulfillment of requirements for filling out the request for evaluation of medicines to be used
in research protocols,
as well as the requirements and identification of the payment of tariff or exemption thereof.
PERSON IN CHARGE
Principal investigator
Principal investigator
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PROCESS DIAGRAM - PROCEDURE 1
PROCEDURE 1
REVIEW OF REQUIREMENTS FOR SUBMISSION OF RESEARCH PROJECTS OR PROTOCOLS
Sponsor/
Researchers
Principal investigator/
team of researchers
Start
Download documents to identify compliance with prerequisites
http://www.cneis.org.sv/
Request authorization letter from the authority of the
or health centers
Prepare Investigator Letter of Intent
about the study
Print protocol in its original version, with an edition date when the original is written in another language;
Protocol translated into Spanish, with edition date and 3 hard copies and one electronic copy.
Consult by telephone or in person with the Assistant of the Committee, on compliance with requirements for
the filling of the medication evaluation request to be used in research protocols
The end
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PROCEDURE 2: RECEPTION OF A HEALTH RESEARCH PROJECT OR PROTOCOL
OBJECTIVE: To facilitate the reception of the research protocols submitted to the National Ethics Committee of
Health Research (CNEIS) and the National Directorate of Medicines (DNM) for the latter to carry out the
respective evaluation.
RESPONSIBLE:
- Administrative Assistant of the CNEIS.
MATERIALS:
- Application for Evaluation of Clinical Research Protocols in Human Beings (ANNEX 2)
- Document reception form (ANNEX 3).
- Electronic file for registration and storage of research projects.
DESCRIPTION OF PROCEDURE 2
No. ACTIVITIES
Receipt of letter of intent and documents according to request guide for evaluation of protocols for
investigation.
one
Tool to use:
Application for Protocol Evaluation.
PERSON IN CHARGE
CNEIS administrative assistant
Review Request for Evaluation of Research Protocols
Clinic in Human Beings, previous verification of the voucher
two
of payment of tariffs according to type of investigation and according to source
financing, if at least one of the requirements is not met
CNEIS administrative assistant
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No. ACTIVITIES
From the list, the study will not be received and the reasons will be explained to the researcher.
PERSON IN CHARGE
Enter the electronic file of study reception in which you must enter the date of receipt, name of the study,
name of
principal investigator, and observations if applicable, assigning a
3
identification code of each project. The code must
register as follows: CNEIS-year-correlative number of
according to reception.
Leave written record of studies that have not been received
4 due to lack of compliance with requirements and provide guidance to the researcher to complete the reception
of the study.
CNEIS administrative assistant
CNEIS administrative assistant
File the documents received for entry into the agenda of the next session of the committee.
5
Notify via email the Technician in charge of Clinical Trials Follow-up.
CNEIS administrative assistant
Send a printed and electronic copy of those studies to the National Directorate of Medicines
related to medicines, narcotic drugs, psychotropics, precursors, substances and products
chemicals, cosmetic products and aggregates, natural medicinal products, independently
6 of the study phase described in the protocol, during the three business days of receiving the protocol; with the
purpose of verifying the aspects related to the Regulations of the National Directorate of Medicines, in
in terms of production, marketing, subtraction, waste, expiration and all those
related procedures
CNEIS administrative assistant
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PROCEDURE 3: DETERMINATION OF THE TYPE OF RESEARCH PROJECT
OBJECTIVE: To determine the type of evaluation that the research protocols will receive according to their
features.
RESPONSIBLE:
- Administrative Assistant of the CNEIS.
- Technician in charge of Monitoring Clinical Trials
- National Committee for Health Research Ethics.
- National Directorate of Medicines
MATERIALS:
- Research protocols.
- Guide for identification of a clinical trial (ANNEX 4).
EVALUATION MECHANISMS:
- Evaluation that requires full: corresponds to projects that involve risks beyond the minimum for
research subjects and, therefore, should be evaluated by the majority of the members and be discussed in
full. The necessary quorum is half plus one, respecting multidisciplinarity.
- Expedited evaluation: corresponds to projects that carry minimal ethical risks for the subjects of
investigation and therefore, can be evaluated by two or three members of the Committee without discussion
of the full. As well as studies of importance to Public Health, during national emergencies.
The two main criteria that an expedited review must meet are:
- The study does not involve more than what is considered minimum irrigation
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- The study must fit into one or more of the following categories defined by CNEIS itself:
➢ Data collection through non-invasive procedures commonly used in clinical practice.
➢ Studies involving materials already collected, which may be data or samples
➢ Review of the periodic report of a study previously approved by the CIS and that is no longer enrolling new
subjects, either that there are no additional risks identified or that it is limited only to data analysis.
➢ Review of minor amendments.
Projects that do not require evaluation: corresponds to projects whose purpose is the evaluation of a
program, in which its purpose is not to produce new, generalizable knowledge, but its
knowledge is relevant only to a specific person or program.
DESCRIPTION OF THE PROCEDURE 3
No. RESPONSIBLE ACTIVITIES
Assistant
Present to the plenary the investigation protocols and their
one
full documentation.
CNEIS administrative
Read the list of summaries of the projects of which
two
Review requested.
CNEIS Secretary
Decide the type of evaluation, according to the evaluation mechanisms and the President assigns the persons
Who
3
will carry out the expedited evaluations and those that require
full.
CNEIS,
Chairman of the Committee
Deliver electronic or printed versions of the protocols to
4
the members of the committee for evaluation of the protocols,
CNEIS Technical Assistant
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No. RESPONSIBLE ACTIVITIES
reporting in the minutes the name of the people to whom the protocols have been delivered.
Notifies the Technician in charge of the follow-up of Clinical Trials, for updating databases of
assignments of investigation protocols of Committee staff.
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PROCEDURE 4: EVALUATION OF PROTOCOLS
OBJECTIVE: Define the steps to follow and participants in the evaluation of research protocols
clinical and / or scientific.
RESPONSIBLE:
- National Committee for Health Research Ethics (CNEIS).
- National Directorate of Medicines.
- Consultative committee of independent experts.
MATERIALS:
- Research protocols.
- “Evaluation guide for a health research project” (ANNEX 4A, 4B and 4C)
- Requirements for elaboration of an informed consent, model of the basic structure of the IC and list
of verification of requirements of the information document (ANNEX 5A, 5B and 5C)
DESCRIPTION OF THE PROCEDURE 4
No. RESPONSIBLE ACTIVITIES
Members of the
1 Read the protocol and its annexes
CNEIS
Record the observations in writing on the form
two
corresponding evaluation.
CNEIS members
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Send the completed evaluation form to the secretary of the committee in the stipulated time.
In the case of full evaluations, in the span of
four to ten weeks, each member of the committee and the
3 DNM must send the relevant results and comments electronically to the committee secretary.
In the case of expedited evaluations, within seven days, send the committee secretary the
relevant results and comments electronically.
Define the session in which each protocol will be discussed,
4 according to the reception of comments and the evaluation period.
In the case of clinical trials that, due to their complexity or specialty, are required to consult a
Advisory Committee of Independent Experts, the President of the CNEIS in agreement with the other members thereof,
will invite members of groups directly involved in the type of project through official mechanisms
proposed (group of patients, family support,
5
representatives of community organizations,
specialists, statistician, specialist in research methodology, others according to their expertise).
This consultation will be an input for the final resolution. This procedure must be performed within the
defined period for evaluation.
CNEIS members
President of CNEIS
CNEIS
Expert Advisory Committee
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No. RESPONSIBLE ACTIVITIES
Develop the session for the protocol discussion of
5 according to the final resolution guide and establish the corresponding final opinion.
The plenary by consensus decides the resolution as follows:
Approved without restrictions (ASR)
6
Evaluated with observations and request for amendments (FI =
Information is missing)
Not approved (PRT = Protocol rejected for technical and ethical reasons)
CNEIS Reviewers
CNEIS Secretary
NOTE:
The Researcher must inform the National Committee of Health Research Ethics when the Study will begin
Clinician authorized by the CNEIS, also must inform when the Clinical Study has finished as
established in procedure 14 of this manual.
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PROCEDURE 5. ELABORATION OF THE RESOLUTION ACT OF A RESEARCH PROJECT
OBJECTIVE: Standardize the preparation of the minutes and the memorandums of notification, evaluation
of the research projects that have been submitted to the Committee and the National Directorate of Medicines (in case
of a clinical study).
RESPONSIBLE:
- Secretary of the CNEIS
-    Administrative assistant
MATERIALS:
- Guide for the preparation of the resolution document (ANNEX 7)
- Notification format for researchers. (ANNEX 8)
DESCRIPTION OF THE PROCEDURE 5
No. RESPONSIBLE ACTIVITIES
Prepare the resolution document containing the opinion, which
will be signed by the President and the Secretary, placing the
one
correlative number established by the Committee, using the
guide to the minutes of resolution.
It clearly identifies the Evaluation Committee, as well as the evaluated research project, the
investigator
responsible, the place where the recruitment of
two
patients, the final opinion of the evaluation and the declaration
of conflict of interest of the members of the Committee in case it occurs.
CNEIS Secretary
CNEIS Secretary
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No. RESPONSIBLE ACTIVITIES
Keep the minutes in the Committee file, together with the
3
Related documentation.
Prepare the memorandum following the notification format for researchers, specifying the respective
number the
4
Informed consent document approved, sealed and
signed on each of its pages.
Communicate to the investigator, clearly the times of delivery of information or notification to the CNEIS, which must meet
in the cases of (delivery of continuity reports, security reports or adverse events, and all
the tracking documents; as well as the validity period of the approval of the research protocol.
5 Information delivery times:
✓ Serious Adverse Events, EAS: first 24 hours.
✓ Serious unrelated adverse events: one week.
✓ Non-serious internal adverse events associated and not associated with the study: three weeks.
✓ Safety and continuity reports: quarterly, semi-annually and annually.
Validity of approval of the research protocol: one year.
CNEIS administrative assistant
CNEIS administrative assistant
CNEIS Reviewers
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PROCEDURE 6. EVALUATION MEETING WITH THE INVESTIGATOR
OBJECTIVE: Standardize the development of meetings convened with researchers, in order to
obtain more technical, methodological and ethical information on the protocols presented, in those investigations in
which are necessary opinions of external consultants and those in which it is necessary to deepen in
aspects of the protocol.
RESPONSIBLE:
- National Committee for Health Research Ethics
- National Directorate of Medicines
-    Principal investigator
MATERIALS:
- Notice of call to principal investigators
-    Power Point presentation
- Written protocol
DESCRIPTION OF THE PROCEDURE 6
No. RESPONSIBLE ACTIVITIES
Define if it is necessary to invite the principal investigator, if the study meets one or more of the following
terms:
✓ Research that poses a high security risk
✓ Research involving vulnerable populations
one
✓ Investigations that are related to the field of
genetics.
✓ Research involving little known or complex methodologies
CNEIS full reviewers
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No. RESPONSIBLE ACTIVITIES
✓ That during the appeal process it is considered to listen to the principal investigator.
Send invitation to the principal investigator, requesting to make a presentation of the project to the committee and
answer your
2 questions. The invitation must be made within a maximum period of 21 business days, from the receipt of
the request for evaluation of the study protocol.
Make the presentation to the Committee in full and answer the
3 questions that arise from committee members and / or experts invited by the Committee.
The Committee will deliberate and resolve according to the arguments and
4
analysis.
Send the approval or rejection report within 7 days
5 business, counting from the day of the presentation made by the researcher.
CNEIS administrative assistant
Principal investigator
CNEIS and DNM in
full
CNEIS administrative assistant
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PROCEDURE 7. APPEAL REVIEW
OBJECTIVE: Standardize the processing of appeal letters of rejected resolutions.
MATERIALS:
- Letter of appeal, in which the necessary technical or scientific arguments are described.
- Document that includes changes.
RESPONSIBLE:
- Sponsor
- Researchers
- CNEIS administrative assistant
- Secretary of the CNEIS
DESCRIPTION OF THE PROCEDURE 7
No. RESPONSIBLE ACTIVITIES
Prepare and send appeals within 30 days
1 after delivery of the rejection or cancellation resolution of the protocol.
Receive the appeal, after verification of compliance with the following criteria:
two
Within the established period
Appeal arguments clear and justified
Sponsor / Principal Investigator
CNEIS administrative assistant
Analyze and discuss the appeal in the full Committee,
3
preparing the minutes with the new comments
CNEIS in full Secretariat
Prepare final resolution and send response to appeal
4
Within 30 business days after delivery of the
Assistant Secretary
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No. RESPONSIBLE ACTIVITIES
appeal, addressed to the principal investigator, the sponsor and the institution where it has been raised
Perform the investigation.
File reply sent, along with all documents
5
related to the research project
CNEIS administrative
CNEIS administrative assistant
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PROCEDURE 8. REPORT OF ADVERSE EVENTS IN CLINICAL TRIALS
OBJECTIVE: Standardize reports and records of adverse events that occurred to ensure the safety of
Study participants, for compliance with Good Clinical Practices.
RESPONSIBLE:
- Sponsor
-    Principal investigator
-    Administrative assistant
- Chairman of the committee
- Member of the CNEIS
- National Pharmacovigilance Center
- Specialist Physician of the National Directorate of Medicines
- Lead Inspector of the Higher Council of Public Health
- Technician in charge of Monitoring Clinical Trials
MATERIALS:
- Report of serious adverse events (EAS) and SUSAR using the form (ANNEX 8).
REQUIREMENT:
- All EAS and SUSAR must be presented in Spanish.
CONTACTS FOR NOTIFICATION OF ADVERSE EVENTS CNEIS
Email: cneiselsalvador@cssp.gob.sv
Phone: 25612520
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DNM
Mail: assay.clinicos@medicamentos.gob.sv
Telephone: 2522-5000
CNFV
Email: cnfv.elsalvador@gmail.com
Telephone: 2522-5056
Download site to RAM report form:
http://cnfv.salud.sv/alertas-nacionales-de-seguridad/
Types of adverse effects (AD):
EA classification
Adverse events can be classified into different categories:
- Adverse Event (EA)
- Adverse reaction (RA)
- Unexpected adverse reaction (RAI)
- Serious Adverse Event (EAS) or Serious Adverse Reaction (RAS)
- Serious Adverse Reaction Suspected (RASS)
- Adverse Reaction Serious Unexpected Suspected (RASIS / SUSAR)
RESPONSIBILITIES
There is a certain degree of responsibility when managing adverse events. When there is no sponsor
externally, the research authority of the institution in charge of the project will fulfill the role of the sponsor. The
Principal investigator (IP) or chief investigator (IJ) has full responsibility for conducting the study. In
A Multicentre study, the IP has coordinated responsibilities to report adverse events to the CNEIS and the
DNM In the case of studies of products already registered in the DNM that evaluate a new, new indication
concentration if it is higher than the one already registered, new dosage or new dosage form for the purpose of
registry; All studies of pharmacokinetics, bioavailability and bioequivalence will also be reported to
CNFV Any IP / IJ that you have accepted to upload
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with the areas of Pharmacovigilance, delegated by the sponsor, you must take both responsibilities, those of the IP and
those of the sponsor.
Serious Adverse Event (EAS) or Serious Drug Adverse Reaction (Serious RAM)
Any unfavorable occurrence that at any dose:
(a) results in death,
(b) life threatening, requires patient hospitalization or prolongation of existing hospitalization,
(c) results in persistent or significant disability / disability, or is a congenital anomaly / defect
of birth
Which EAS to report?
- The management and reporting of arrangements for EAS must be implemented in all trials. In the agreements
at the beginning of the trial, it should be established that EAS are defined as related to the disease and that, therefore,
They are not subject to an expedited report. EAS management and reporting procedures must be clearly
defined in the protocol.
It is recommended that an Independent Data Monitoring Committee (CIMD) be installed so that on a regular basis
data security reviews are made throughout the trial and when necessary, and recommend
Sponsor continue, modify or end the trial. Again, this procedure must be defined in the
protocol.
The confidentiality and adherence of the data must be maintained both in your record and in your report.
During rehearsal
- For each EA an evaluation of the seriousness, the causality and the expectation must be made. The
Responsibility for this evaluation is of the IP; and when there is
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several, as in multicentric studies, the responsibility will fall on all IPs. It is appropriate that each IP
in each site evaluate each event, before reporting it to the central IP. It must be specified in the protocol of
clinical trial and use local POEs, and will take responsibility for determining and reporting each of the events at
Sponsor and central IP, simultaneously. When you need to report expeditiously, this procedure assumes
The responsibility for the initial determination and reporting to the central IP.
Seriousness Assessment
- The term seriousness is based on the evolution of the patient / event or action criterion. It is different from
"Severity", which is used to refer to the intensity of a specific event.
Causality Assessment
- Most adverse events and adverse reactions to drugs that occur in a study, whether serious or not,
they are expected to be toxicities due to the drug used in the study. The causation assignment must be made
by the researcher responsible for the care of the participants, using the definitions shown in the
following picture:
Relationship Description
Not related
Unlikely
Possible
There is no evidence of any causal relationship.
There is little evidence to suggest that there is a causal relationship (eg the event did not occur within a while
reasonable after the medication was administered in the trial). There is no other reasonable explanation for the
event (Ex. The clinical condition of the participant, other concomitant treatment, etc.).
There is some evidence that suggests a causal relationship (eg because the event occurred within a while
reasonable after administered on
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Relationship Description
medication under study). However, the influence of other factors may have contributed to the event (eg.
clinical condition of the patient, other concomitant treatments, etc.).
There is evidence that suggests a causal relationship and there seems to be no influence
Probable
Definitive
Cannot be evaluated
of other factors.
There is clear evidence of a causal relationship and any influence of other contributing factors may be
discarded
There is insufficient or incomplete evidence to make a clinical trial of causal relationship.
All serious adverse events (EAS) should be reported immediately except those EAS that the
protocol or other document (for example, Researcher's Brochure) identify that they do not need an immediate report.
Immediate reports should be followed by detailed written reports.
All local investigators must report any EAS or SUSAR, as required by the Committee on
Local, National Research Ethics and the competent authority.
It is necessary that all EAS and SUSAR be notified in physical and digital format (Email, CD or Memory
USB)
The CNEIS, must send all the information of EAS and / or SUSAR to the DNM, so that it carries out the evaluation and the
corresponding tracking. If the EAS and / or SUSAR is related to the investigational drug, the DNM has the
authority to suspend the prescription, dispensation and supply of investigational drugs, as
established in article 74 of the Medicines Law, in order to control the sanitary surveillance of medicines.
The CNEIS must send to the CNFV the results of the Clinical Trials of the medications that are
they are registered with the DNM, regarding security and
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effectiveness to compare them with the safety assessment contained in the Periodic Safety Reports
(IPS) and Risk Management Plans (PGR).
For all those Clinical Trials that have been carried out in El Salvador, the CNFV may request the data from the CNEIS
obtained from the clinical study.
DESCRIPTION OF THE PROCEDURE 8
No. RESPONSIBLE ACTIVITIES
When an EAS occurs, RAM would be, RAM would not be unexpected or SUSAR in El Salvador, the researcher
shall
inform the National Ethics Committee to the National Directorate
one
of Medicines and the National Pharmacovigilance Center
(CNFV) within the first 24 hours from the knowledge by the principal investigator.
For EAS and SUSAR:
Prepare the report of serious adverse events (EAS) and SUSAR using the form; classified according to Dictionary
doctor for systems regulatory activities (MedRA) and the form for reporting adverse events.
For RAM Serious or Not Serious for Medications in
2 research that already have a Health Registry, the researcher must report the RAM
Serious, through the following ways:
- Through the filling of the RAM Suspicion Notification Sheet. (Annex 8)
- Or, the online electronic format filling: E-REPORTING:
http://cnfv.salud.sv/hoja-ram-esavi-electronica-en-linea/
Sponsor /
Principal investigator
Sponsor / Principal Investigator
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No. RESPONSIBLE ACTIVITIES
If there is any doubt about causation, the local investigator
You must inform the study coordinating center, who
3 will notify the Principal Investigator. Pharmaceutical companies and / or other clinicians
they must be interrogated to advise, in some cases.
After receiving the EAS and SUSAR report, the CNEIS and DNM must be called for discussion and
New case analysis of EAS and SUSAR, within the first 72 hours.
The CNFV will be convened in cases where there are Serious or Non-Serious RAM for product studies already
registered in the DNM as established in this manual.
5
In the case of the Pre-Marketing studies, the CNFV
technical support will only be provided to decide whether there is a causal relationship or not in a Serious Adverse Event or
Serious Drug Adverse Reaction.
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
reported by the investigator within a period not exceeding 15 business days.
They analyze the report and request audit programming from
6 BPC in follow-up of the EAS and SUSAR reported within the first 72 hours.
Expose to the committee those persistent, fatal EAS and SUSAR
7
or not expected.
Perform BPC audit in a period of 10 days
8
Skilful
Sponsor / Local Researcher, Principal Investigator
CNEIS administrative assistant
Y
Technician in charge of Clinical Trials Follow-up
CNEIS and DNM
Vocal
CSSP CSSP Audit Team
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No. RESPONSIBLE ACTIVITIES
Once the audit is completed, the Lead Auditor sends an audit report to the CNEIS in 10 business days.
They receive a report from BPC in follow-up of the EAS and SUSAR, analyze and evaluate to define the relationship with
the study and the
9 relevance of its continuity.
CNEIS notifies the investigator about decisions made.
Analyze and archive EAS and SUSAR tracking records and update Logbook.
10
Notify the CNEIS Administrative Assistant about the update of the information.
11 Analyze and update information in Tracking Logs.
Send a copy of all EAS and SUSAR reports to the Management
12
National Medicines.
CNEIS and DNM
Technician in charge of Clinical Trials Follow-up
Technician in charge of
Follow-up of Clinical Trials.
CNEIS administrative assistant
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TIMES ESTABLISHED FOR THE REPORT:
1. EAS, Serious RAM, Not Serious Unexpected RAM or SUSAR (National), will be reported in the first 24 hours from
of knowledge by the principal investigator.
2. In the case of the SUSAR International, the investigator must send a quarterly report (every three
months) to the CNEIS with the research molecule, during the first five (5) business days of the following
trimester. Said report must be presented in Spanish and with a summary sheet of the SUSAR case.
3. Report of non-serious EA or non-serious National and International RAM, the investigator must report to the CNEIS
semiannually (every 6 months).
Once the information has been received in the CNEIS, it must report to the CNFV.
4. In reference to EAS not related to medications, they must be reported within 72 hours of
knowledge by the principal investigator.
5. In the case of expected national EAs, they must be reported semiannually (every 6 months).
6. In the case of expected international EAS, they must be reported annually or earlier if the duration of the
protocol is less than one year.
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FLOW OF NOTIFICATION, EVALUATION AND MONITORING OF EAS, SUSAR and RAM Serious
Principal investigator/
team of researchers
Administrative Assistant of the CNEIS and Technician in charge of the Clinical Trials Follow-up
CNEIS and DNM
CNEIS member
CSSP
BPC Auditor Team
CNFV
Start
Researcher notifies the CNEIS, DNM. (CNFV) in the first 24 hours after knowledge by the researcher
prinpal
Prepare the report of serious adverse events (EAS) and SUSAR using the form.
Fill out the form for RAM Serious or Not Serious for Medicines according to formats established by the CNFV
one
Responsible for convening the CNEIS, CSSP and DNM for the discussion and analysis of the new case of EAS, within the
first 72 hours
File EAS tracking records and update Adverse Events Log
Serious / SUSAR RAM Serious or not Serious
They analyze the report and request CPB inspection programming in pursuit of the EAS reported within
The first 72 hours.
two
• Receive report from BPC in follow-up of the EAS.
• Receive a report from the CNFV in case a Serious RAM has been reported
CNEIS:
Notify the investigator about decisions made.
Expose to the committee those persistent EAS and SUSAR, fatal or unexpected.
Prepare inspection and submit EAS follow-up report within 10 business days.
one
The CNFV will be convened in cases where there are Serious or Non-Serious RAM for studies of
Products already registered in the DNM as established in this manual.
The CNFV will issue a report to the CNEIS and the DNM of the process carried out on the RAM Serious or not Serious
reported by the researcher.
two
The end
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PROCEDURE 9. SECURITY REPORT
OBJECTIVE: Standardize the procedure to report annually (or as requested), to the authorities
competent and to the CNEIS, the accumulated adverse events, while a health study is being carried out.
RESPONSIBLE:
- Sponsor
- Researchers.
- Assistant of the CNEIS.
MATERIALS:
- Security report. Clinical trials of medicinal products under investigation (PMI) (ANNEX 9A and 9B).
It is necessary that all Security Reports be notified in physical and digital format (Email, CD or
Pen drive).
DESCRIPTION OF THE PROCEDURE 9
No. RESPONSIBLE ACTIVITIES
Determine if the Clinical Trial corresponds to a Product
Medicinal in Research (PMI-ECA) —including the
one
gene therapy—, or other care research of the
Health.
Include information about the protocol, contact information, all information about the effects that are not
classified
two
as serious, related to the period (every 6 months and
annual report), according to the safety report.
Deliver a copy, using the cover and the guide for
3
Preparation of the safety report.
Sponsor / Principal Investigator
Sponsor / Principal Investigator
Sponsor / Researcher
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No. RESPONSIBLE ACTIVITIES
principal
Receive the documents according to the formats and file with all the documents related to the study.
4
Notifies the Technician in charge of the Clinical Trials Follow-up of the DNM.
Analyze and update information in Logs of
5
tracing.
CNEIS administrative assistant
Technician in charge of Monitoring Clinical Trials.
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PROCEDURE 10. REPORT OF AMENDMENTS
OBJECTIVE: To homogenize the procedure for receiving substantial or minor amendments, to studies authorized during
the development of the same, sent to the CNEIS
or to the CEIS.
RESPONSIBLE:
- Sponsor
-    Principal investigator
- CNEIS / CEIS
- National Directorate of Medicines
MATERIALS:
- Description of the amendment and amendment report. (ANNEX 10A and 10B).
- Reasons for the proposed amendment.
- Copy of the proposed changes to the protocol or any other document, demonstrating what was written before and
after.
- Data supporting the amendment, including any changes to the risk-benefit analysis.
TYPES OF AMENDMENT:
An amendment to the research project may be substantial or minor (not substantial).
Substantial amendment: A substantial amendment may be defined as an amendment to the protocol or to any
Another substantial document, which can affect to a significant degree:
- The safety or physical or mental integrity of the subjects in the study
- The scientific value of the study
- Conducting or administering the study
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- The quality or safety of any medicinal product under investigation used in the trial.
Substantial amendments may be:
Amendments related to the protocol
- Purpose of the essay
- Trial design
- Recruitment procedure
- Measures of effectiveness
- Sample calendar
- Added or subtracted from exams or measures
-    Number of participants
- Age range of participants
-    Inclusion criteria
-    Exclusion criteria
- Security monitoring
- Duration of exposure to the medicinal product under investigation
- Change of dose of the medicinal product under investigation
- Comparator change
- Amendments to other study documentation
- Participant information sheet
-    Informed consent
- Questionnaires
-    Invitation card
- Letters to the Chief or Principal Investigator, and other clinicians
- Information sheets for relatives or caregivers
- The file of the Medicinal Product in Research (PMI)
- Amendments related to trial arrangements
- Change the Principal Investigator or add new ones (this means: researchers who
direct the research in each center)
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- Change in the coordinating researcher
- Change in the study site or add new sites
- Change of sponsor or legal representative
- Change of the definition of completion of the study
- Change in PMI provider
Minor (non-substantial) amendment: A minor amendment can be defined as a change in the details of the study that does not
it will have significant implications for the participants in it, or for its management, administration or value
scientific.
Minor amendments can be:
- Corrections of typographical errors in the study documents
- Minor clarifications to the protocol
- Changes in the research team (apart from changes to the Chief or Principal Investigator)
- Extension of the study beyond the period specified in the application form
- Changes in financing arrangements
- Changes in the documentation used by the research team to record the study data (Ex.
Case Report Forms)
- Changes in logistics arrangements for storage or transport of samples
- Inclusion of new sites in studies exempt from “site specific determination” (SSA).
It is necessary that all Amendment Reports be notified in physical and digital format (Email, CD or
Pen drive).
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DESCRIPTION OF THE PROCEDURE 10
No. RESPONSIBLE ACTIVITIES
Determine if the amendment is substantial or not. Taking into account the format information of
amendments
Substantial for clinical trials of medicinal products
1 under investigation (PMI) and deliver notification format and description of the amendment, together
with all updated documentation, such as consent forms or protocols.
Send amendment to both the CNEIS and the Center or Unit
2 of Research that authorized the study, before the amendment takes action.
Reception and notification of amendment.
Deliver to CNEIS and DNM in next session for
3
respective review and authorization in next session, prior
to the implementation of the amendment.
Analyze the amendments, classify the type of amendment as substantial or less.
In cases of substantial amendments, it must be ruled whether it is approved or rejected by the National Directorate of
Medications and the National Ethics Committee of the
6
Health Research, preparing approval certificate
before being implemented.
In the case of minor amendments, it will be read and sent to file with all the information
of the protocol, providing a copy to the DNM.
Sponsor / Principal Investigator
Sponsor / Principal Investigator
CNEIS administrative assistant
CNEIS DNM
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No. RESPONSIBLE ACTIVITIES
Assistant
Notify the investigator of the authorization, observation or
7
Denial of the reported amendment.
CNEIS administrative
TIMES FOR REVISION OF AMENDMENTS:
- In the case of substantial amendments, they must be reviewed within a period of 15 business days, from
of the notification by the Administrative Assistant of the CNEIS.
- In the case of non-substantial amendments, they must be reviewed within a period of 7 business days, starting from
the notification by the Administrative Assistant of the CNEIS.
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PROCEDURE 11. REPORT OF SERIOUS DEVIATIONS OF THE STUDY
OBJECTIVE: Standardize the procedure for notification of serious deviations from Good Clinical Practices (PCB) or
of the approved study protocol.
RESPONSIBLE:
- Sponsor
-    Principal investigator
- CSSP Audit Team
- CNEIS
MATERIALS:
- Summary of deviations, including justification, according to notification format. (ANNEX 11)
It is necessary that all Reports of Serious Deviations in the Study be notified in physical and digital format
(Email, CD or USB Memory).
The CNEIS must send all reports of deviations related to the clinical study to the DNM, so that it
carry out the corresponding evaluations.
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DESCRIPTION OF THE PROCEDURE 11
No. RESPONSIBLE ACTIVITIES
Continuously monitor the conduct of the clinical trial and
1 identify any deviation from the established and approved protocol.
Determine the impact that the deviation will have on the
2 subjects / patients of the trial and / or the scientific integrity of the study.
Sponsor and Principal investigator should analyze and discuss the section of the BPC or the
protocol that
has violated, and how this impacts the subject / participant and / or
3
in the scientific integrity of the essay.
Similarly, initiate the implementation of any immediate security measures that are required.
Collect all available information and evidence and complete the deviation notification format
would. East
form, accompanied by evidence supporting the
4
notification, must be sent to the CNEIS and the DNM within
of the period of 7 days after the deviation has been identified.
Convene the principal investigator for full review of the
5 essay and general systems of administration and processes, evaluating the extent of the
deviation.
Plan and implement corrective actions with the study team, through a formal action plan
corrective of
6 the deviation. This must be sent to the CNEIS within 3 days of the evaluation meeting.
between the CNEIS and the principal investigator.
Principal investigator. Sponsor.
CNEIS, DNM
Sponsor / Principal Investigator
Sponsor, principal investigator
Principal Investigator, Supervisor of the Higher Council of Public Health
CNEIS, DNM,
principal investigator
Sponsor / Principal Investigator
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No. RESPONSIBLE ACTIVITIES
File the corrective action plan with all the
7 information on the research project and notify the Technician in charge of the Monitoring of Tests
Clinics
Analyze and update information in Logs of
8
tracing.
CNEIS administrative assistant
Technician in charge of Monitoring Clinical Trials.
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PROCEDURE 12. PERIODIC REPORT OF PROGRESS IN RESEARCH OR CONTINUITY
OBJECTIVES: Homogenize the procedure for receiving the periodic progress report on the investigation, or request
of renewal of the ethical evaluation.
RESPONSIBLE:
- Sponsor
-    Principal investigator
- National Committee for Health Research Ethics
MATERIALS:
- Continuity Report (ANNEX 12)
DESCRIPTION OF THE PROCEDURE 12
No. RESPONSIBLE ACTIVITIES
Prepare continuity report with the information
related to:
one
- Start of inclusion of study subjects
- Completion of data collection
Request renewal of ethical authorization when the period
2 of validity of the project has ended and it has not ended for different reasons.
Receive the continuity report and notify the Technician in charge of Clinical Trials Follow-up.
3
Include in the agenda of the next CNEIS meeting, to
Review and analysis.
Sponsor / Principal Investigator
Sponsor / Principal Investigator
Administrative assistant
Fully evaluate the continuity report and deliver an opinion
4
according to exposed information, and prepare notification
Administrative Assistant and
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No. RESPONSIBLE ACTIVITIES
of results.
Send to the DNM all periodic reports of research progress or continuity.
Analyze and update information in Logs of
5
tracing.
Send notification to principal investigator and CSSP supervisory team. A copy of the notification must be
6
filed next to the project information of
investigation
Technician in charge of Monitoring Clinical Trials.
Administrative and Technical Assistant in charge of Monitoring Clinical Trials
Administrative assistant
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PROCEDURE 13: AUDIT OF GOOD CLINICAL PRACTICES TO RESEARCH CENTERS
OBJECTIVES: Define the mechanism and criteria for carrying out the audits of PCBs to all parties
involved in clinical research with the purpose of monitoring compliance with them.
RESPONSIBLE:
- Sponsor
-    Principal investigator
- National Committee for Health Research Ethics
- CSSP CSSP Audit Team
MATERIALS:
- Checklist of requirements for compliance with good clinical practices. (annex 14).
DESCRIPTION OF THE PROCEDURE 13
No. RESPONSIBLE ACTIVITIES
Identify the studies that will be inspected according to the following criteria:
The importance of proof for decision making
1 regulatory
- The nature of the study
- The vulnerability of the subjects
- The irregularities of the data
-    The complaints
National Committee for Health Research Ethics and National Directorate of Medicines
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No. RESPONSIBLE ACTIVITIES
Request in writing to the CSSP the Audit of one or more research centers, attaching information
about him
protocol, the modifications, the form of the
two
authorization with knowledge of the cause, samples of
data collection notebooks (FRC), study reports, reports of serious adverse events, etc.
Prepare the audit plan for the center and the study to be audited, in agreement with the CNEIS,
specifying specific source documents and centers to visit.
Note: When planning the Audit, the supervisor must understand the scientific objectives, the
criteria of
3
inclusion and exclusion, concomitant medications
allowed and not allowed, visits and analytical procedures required, any special requirements
for handling or storage of the test article, and known information about the medication
of the essay, as well as its profile of adverse events.
Request information from the CNEIS about irregularities of data or special matters of interest that the
DNM,
4
during the internal examination of the marketing application
(or presentation of the protocol).
Inform the clinical investigator in advance, the date of the
visit, to ensure that it is present and can access the study records in the
moment of
5
Audit. When an Audit is announced, the inspector
inform the clinical investigator of the documents that must be at hand for the Audit and the
installations
CNEIS DNM
CSSP Audit Team
CSSP Audit Team
CSSP Audit Team
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No. RESPONSIBLE ACTIVITIES
that will be visited, if relevant.
Hold a meeting with the principal investigator at the beginning of the Audit and present their official identification and
Any official notice that may be requested. Explain the nature and scope of the Audit, and summarize
briefly the methods and procedures that will be used to carry it out.
Request information on:
- Screening and income of patients to study
- Obtaining informed consent
6 - Collection and analysis of study data
- Registration, transcription and notification of data to the sponsor
- The reception, return and administration of the test drug
Other interviews can be conducted with the key study staff and, if relevant, with the subjects
of the study, during the Audit and as situations arise that merit it.
Determine if the test activities were carried out according to the protocol, to the requirements
regulatory
7 applicable and to the BPC, and verify that the data was recorded and notified accurately,
using the checklist
Identify the study records through an inventory of
8
the same. This will be done before the review begins.
CSSP Audit Team
CSSP Audit Team
CSSP Audit Team
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No. RESPONSIBLE ACTIVITIES
exhaustive records of specific subjects. You can facilitate this task by first having someone
that you are familiar with the study documents and explain your organization and
Location. The inspector will then check, at a minimum, that there is a case file for each subject
registered in the center. Other essential documents will also be considered, for example, the approvals of the
Ethics Committee, records of receipt of trial medications, others.
Compare the copy of the protocol provided by the CNEIS and the clinical investigator's file protocol,
to determine if there are differences in what refers to:
- The selection of subjects (inclusion and exclusion criteria)
- The number of subjects
- The frequency and nature of the observations of the subjects
9
- The dosage
- The route of administration
- The frequency of administration
- Masking procedures
- If there are differences, determine if they were documented by protocol modifications and if they are
approved in accordance with the applicable regulatory requirements.
Compare the original source data of the records of
10 the subjects with the data collection notebooks or the final report for the sponsor, in order
to verify that
CSSP Audit Team
CSSP Audit Team
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No. RESPONSIBLE ACTIVITIES
Source data has been fully and accurately notified. Select a representative sample of the
subjects recruited at intervals, at the beginning, in the middle and at the end of the study. However, if a
significant problem in a particular area (for example, not taking the test medication as required),
audit this particular aspect of the study in all subjects. Identify source data that supports the following
fundamental points:
Were there subjects and went to the visits as notified? Subjects admitted to the study or those who
completed,
Did they meet the inclusion or exclusion criteria of the protocol?
Regarding the dose and frequency of administration, did the subjects receive the
trial medication according to the protocol?
Were the significant assessment criteria data fully and correctly obtained and notified, with
according to the protocol?
Were adverse events reported to the sponsor and the regulatory authority?
Review the study records of each subject to verify the correct administration of the dose in what is
refers to the quantity, frequency, duration and route of administration.
11 In addition, examine the shipping and distribution records of the drug to reconstruct the route of
distribution of the test drug and check the dates of receipt, the quantity and the
medication identity of
CSSP Audit Team
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No. RESPONSIBLE ACTIVITIES
test, and to compare the use of the test drug with the amounts sent and returned to the promoter at the end of
study. If unused supplies are not returned to the sponsor, the supervisor will verify that the
Alternative provision was handled appropriately and documented. The supervisor will verify that the medication
of the test was kept under appropriate conditions.
Conclude the Audit by making its final comments to the clinical investigator. The supervisor will explain and comment
The results of the visit. The results will be described in what
12 regarding its nature and scope (that is, how many records were reviewed and to what extent). The
Results must be strictly objective, based on the records and information available
during the audit.
Thoroughly document the Audit, both during its completion and after its conclusion. The
only tangible results of an audit are the written report and
13 supervisor notes. When serious breaches are observed, the
legal or administrative sanctions against the clinical investigator will be based on the documented results of
the auditory.
Prepares the narrative report of the supervision in which the results of it are detailed, explaining the reason for
the Audit, for example, if it was systematic or if it was performed with
14 a special purpose. It will also describe the scope of supervision, for example, if it was limited to one
succinct review of the records to address a specific issue or if it was an exhaustive audit of the
study completion To the
CSSP Audit Team
CSSP Audit Team
CSSP Audit Team
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No. RESPONSIBLE ACTIVITIES
Describe the scope of supervision, the report will indicate which records were considered and the number of
documents or medical records that were considered in relation to the number of study subjects. The
The report will also include the name of the trial drug, the study sponsor, the title and number of the
protocol, the dates of the study and the number of subjects. Mention by name the individuals who performed
important functions in the study, as well as to those who provided information during the supervision.
The most important part of the report is the description of the results of the supervision. The inspector
describe in detail each of the significant results. This description will be specific and quantify the
which was observed based on the total number of records examined. The supervision observations will be
objective and the report will include, as evidence, copies of the records obtained to document the results
objectionable All tests must have all numbered pages and the report will refer specifically to
they.
The report will include a comment of the final interview with the clinical investigator, in which the
Results of supervision. The response of the clinical investigator to the observations will be recorded.
Finally, said report will be sent to the National Committee for Health Research Ethics.
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No. RESPONSIBLE ACTIVITIES
Receive audit report from BPC for subsequent programming in the CNEIS agenda and notifies the
Technical
Responsible for the Follow-up of Clinical Trials.
fifteen
Evaluate audit results of Good Clinical Practices, and make a decision of the full prior notification to the
investigator.
Notify the Principal Investigator about the results and findings of the Good Practice Audit
Clinics, the proceeding of the investigation, also provides time for the correction of disagreements, in case
They exist.
NOTE: in accordance with the findings found in the Audit of Good Clinical Practices, the Committee
National
16
Health Research Ethics, will notify the
Researcher and sponsor proceeding from Clinical Research.
If in 60 days the investigator has not corrected the observations resulting from the Good Audit
Clinical Practices, the National Committee for Health Research Ethics has the power to cancel the study
clinical.
17 Analyze and update information in Tracking Logs.
CNEIS Administrative Assistant
CNEIS DNM
National Committee for Health Research Ethics
Technician in charge of Monitoring Clinical Trials.
EXPLANATORY NOTES:
1. The time established to plan, execute and finalize an Audit of Good Clinical Practices
It is 60 business days.
2. The investigator may previously request an audit of Good Clinical Practices, before starting the
Clinical study.
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3. The National Health Research Ethics Committee will evaluate and determine depending on the type
of research study, if the health establishment where the Clinical Study is intended to be carried out will
prior audit of Good Clinical Practices prior to the development of the research study.
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PROCEDURE 14. RECEIPT OF NOTIFICATION OF COMPLETION OF A STUDY
OBJECTIVES: Homogenize the reception of the report of the completion of a study.
RESPONSIBLE:
- Sponsor
-    Principal investigator
- Secretary of the CNEIS
- National Committee for Health Research Ethics
MATERIALS:
- Notification of completion of a Clinical Trial of a Medicinal Product in Research (ANNEX 13A) and that no
It involves medicinal products. (ANNEX 13B)
DESCRIPTION OF THE PROCEDURE 14
No. RESPONSIBLE ACTIVITIES
Complete the notification format of a clinical trial or study that does not involve products
medicinal, clearly describing the reasons for project completion:
1 - The essay has ended in a research center and / or in all participating centers, within or
outside of El Salvador.
- Early or premature completion.
- The essay does not start
Sponsor / Principal Investigator
2 Notify the completion of a study to the CNEIS within the Sponsors /
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No. RESPONSIBLE ACTIVITIES
first 90 days after the end of the project, or within the first 15 days after there is
terminated prematurely, and sent to CNEIS and sponsor.
Receive notification and place on agenda point for
3
session next to notification
Review in full grounds of completion, verifying that the information on the grounds is complete and give income
4
to be placed next to the complete file of the
draft.
Prepare notification of completion format review
5 and sending to principal investigator, sponsor and National Directorate of Medicines.
Principal investigator
Administrative Assistant of the National Committee for Health Research Ethics
CNEIS DNM
Administrative Assistant of the National Committee for Health Research Ethics
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PROCEDURE 15. RECEIPT OF FINAL REPORT TO CNEIS
OBJECTIVE: Feedback from committee members by verifying that the
study appropriately, being able to assess the results thereof and using the results obtained in
benefit of the institution / subjects of the institution.
RESPONSIBLE:
- Sponsor
-    Principal investigator
- Health Research Ethics Committee (CNEIS)
MATERIALS:
- Final investigation report
DESCRIPTION OF THE PROCEDURE 15
No. RESPONSIBLE ACTIVITIES
Prepare summary of the final investigation report
within the first 3 months after the end of
one
process of analysis and interpretation of information
Collected in the project.
Incorporate the following information in the report:
• If the objectives were achieved
• Main findings
two
• Arrangements for publication or dissemination of the
research, including any feedback to participants.
Review in full final report verifying that the
3
information about the motives is complete and give
Sponsor / Principal Investigator
Sponsor / Principal Investigator
CNEIS DNM
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No. RESPONSIBLE ACTIVITIES
income to be placed next to the complete project file.
Prepare notification of report review and delivery to
4 principal investigator, sponsor and National Directorate of Medicines
CNEIS administrative assistant
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PROCEDURE 16. RESEARCH OF THE ARCHIVES OF THE CNEIS
OBJECTIVE: To comply with the requirement of Good Clinical Practices for CEIS (in section 3.5.1), which
requires keeping all relevant records (written procedures, member lists, lists of
membership of members and their occupation, documents submitted, minutes of meetings and correspondence) by a
three-year period after completing the study and making them available at the time the
regulatory authority (s) request them.
RESPONSIBLE:
- Members of the Health Research Ethics Committee (CNEIS)
FILE CONTENT:
The files (sources of printed, magnetic or electronic data) must include, at least:
- Procedures manual: regulations, operational guides, manuals, national and / or international standards,
technical documents, the procedures manual with their respective annexes, the applicable regulatory texts.
- List of identification and curriculum vitae of each member of the CNEIS, updated.
- Financial records (fee income, operating expenses), summary of expenses, and forms of
consumption and order, or monthly expense.
- Minutes of meetings of the Committee, listed consecutively by year.
- Reports of CNEIS decisions. Approval Minutes and reports of rejection and suspension ordered
correlatively, foliated per year.
- Reports of serious adverse events and reports of the Independent Data Monitoring Committees (CSSP),
backed by CNEIS analysis reports.
- Correspondence received (documentation sent by investigators, correspondence exchanged
with them and other actors).
- Correspondence dispatched by the CNEIS.
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- Protocols evaluated, with all the documentation analyzed, Minutes of Approval, copy of follow-up reports,
reports and amendments.
- Documents submitted by the project sponsor.
- Periodic reports on the study and the final report. Protocol in its different versions, manual of the
Investigator, Informed Consent, Researcher Resume, Minutes of Approval or Rejection,
reports and correspondence ordered by correlative date. It is an obligation that each protocol is protected in a
file identified with the title, the code, the name of the sponsoring institution, the name of the researcher
and the place or center where the investigation is carried out, as well as the start and end date.
- It will be the responsibility of the CNEIS to keep the test files for a period of 3 years, from the
completion of it, leaving a record in the corresponding Database. Later it will pass the archives of
the essays will go to the general archive of the Higher Council of Public Health.
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10. GLOSSARY
1. Approval (in relation to the CNEIS): The affirmative decision of the Health Research Ethics Committee that
The clinical study was reviewed and can be conducted in the institution within the guidelines established by the
CEIS, the institution, Good Clinical Practice (BPC) and the applicable regulatory requirements.
2. Quality Assurance (CA): All planned and systematic actions that are established to
ensure that the study is being carried out and that the data is generated, documented (recorded) and
reported in compliance with Good Clinical Practice (BPC) and regulatory requirements
applicable.
3. Randomization: The process of assigning the subjects of a study to the treatment groups
or control using chance to determine subjects, in order to reduce bias.
4. Audit: A systematic and independent review of related activities and documents
with the study to determine if the activities evaluated were performed and the data were recorded,
analyzed and reported accurately according to the protocol, Standard Operating Procedures of the
Sponsor (POE), Good Clinical Practice (BPC) and applicable regulatory requirements.
5. Study Data Audit: A comparison of the source data and records associated with the
intermediate or final report to determine if the source data were accurately reported, establish
if the studies were carried out according to the protocol and the applicable PCBs, obtain information
additional not provided in the report, and establish whether procedures were used to obtain the data
They could invalidate them.
6. Authority of Surveillance (National) of the Compliance of the BPC: A body of norms, established within a
country, which has the responsibility of monitoring the compliance of the PCBs within its territory and of carrying out
other functions related to the PCBs, as determined nationally, in the case of El Salvador this
entity is the Higher Council of Public Health.
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7. Regulatory Authorities: Refers to the authority responsible for the regulation of investigations and
medicines. They can be agencies that have the power to regulate. In the guidelines of Good Practice
Clinic of the International Harmonization Conference, the term Regulatory Authorities includes the
authorities that review the submitted clinical data and those that carry out inspections. Sometimes it
refers to these organizations as competent authorities.
8. Well-being (of the study subjects): The physical and mental integrity of the subjects participating in a study
in health.
9. Good Clinical Practices (PCB): A standard for design, conduction, realization, monitoring,
audit, registration, analysis and report of clinical studies that provides a guarantee that the data and
the reported results are credible and accurate and that rights are protected,
integrity and confidentiality of the subjects of the study.
10. Center where the study is carried out: Place (s) where the activities related to the
study.
11. Subject Identification Code: A unique identifier that the investigator assigns to each subject of the study
to protect its identity, and that is used instead of the name of the subject when the investigator reports events
Adverse and / or some other data related to the study.
12. Coordinating Committee: A committee that can be organized by the sponsor to coordinate the conduct of a
Multicentre study.
13. Ethics Committee of Clinical / Health Research (CEIC / CEIS) of an institution: Autonomous entity within
of a Hospital, University or institution dedicated to research, whose objective is to ensure the protection of the
dignity and rights of the people who participate as research subjects *.
14. Independent Data Monitoring Committee (CIMD) (Data Monitoring and Security Council, Monitoring Committee,
Data Monitoring Committee): An independent data monitoring committee that the sponsor can
establish to evaluate the progress of a health study in intervals, the data
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safety and critical points for the evaluation of effectiveness, and recommend to the sponsor if it should
continue, modify or stop a study.
15. National Committee for Health Research Ethics (CNEIS): Governing body of the ethical framework for research in
health in El Salvador, whose main objective is to protect the rights of the human beings who participate as
research subjects and among whose functions is the accreditation of local committees, to develop their
functions framed within current regulations.
16. Comparator (Product): A research or commercialized product (for example, active control) or placebo
used as a reference in a clinical study.
17. Confidentiality: Failure to disclose to others - unless they are authorized personnel - information that
is the property of the sponsor or the identity of a subject.
18. Informed Consent: The process by which a subject voluntarily confirms their desire to
participate in a particular study, after being informed about all the relevant aspects so that your
Decision regarding your participation be free and responsible. Informed consent is
document through a written, signed and dated “Informed Consent Form”.
19. Contract: Written, dated and signed agreement between two persons or more parties involved, which establishes any
arrangement on the delegation and distribution of work and obligations for the development of an investigation and, if
If necessary, on financial matters. The protocol can serve as the basis for a contract.
20. Quality Control (CC): The techniques and operational activities carried out within the system of
quality assurance to verify that the quality requirements of the
activities related to the study.
21. Compliance (in relation to studies): Attachment to all requirements related to the study,
Good Clinical Practice (BPC) requirements and applicable regulatory requirements.
22. Source Data: All information in original records and certified copies of the original records of
clinical findings, observations or other activities in
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a health study necessary for the reconstruction and evaluation of the study. The source data is contained in
source documents (original records or certified copies).
23. Hospital departments and services: Direct patient care units in hospitals
o Health units, where the subjects to be included in the studies will be identified and recruited.
24. Serious deviation: It is defined as any violation of the correct conditions and principles of the BPC, in
relationship with the essay, or the disrespect for the protocol of that essay or its amendments. It is considered "serious" that
deviation that can significantly affect the safety or physical (or mental) integrity of the subjects in the
study, or its scientific value.
It is the responsibility of the sponsor to determine the impact of the deviation on the scientific value of the trial. Yes
someone is not sure how to do it, you should ask for advice from the competent authority, the sponsor or the
CEIS.
25. Hospital Management: Instance that, in his position as legal representative of the Hospital, will consider whether
the institution and / or the person proposing the study will respect hospital regulations, as well as
the confidentiality of the data, and if they may have the right to access the data and the hospital patients.
26. Documentation: All records, in any form (including, but not limited to records
written, electronic, magnetic, optical and scanner, X-rays and electrocardiograms, etc.) that describe or record
the methods, conduction and / or results of a study, the factors that affect a study and the actions taken.
27. Essential Documents: Documents that individually and collectively allow an evaluation of the conduct of
a study, and the quality of general data.
28. Source Documents: Original documents, data and records (eg hospital records, sheets
clinics, lab notes, memoranda, subjects diaries or evaluation checklists,
pharmacy delivery records, recorded data of automated instruments, copies or
certified transcripts after verifying that they are exact copies,
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microfiche, photographic negatives, magnetic media or microfilm, X-rays, subjects' files and
records kept in pharmacies, in laboratories and in the medical-technical departments involved
in the health study).
29. Amendment to the Protocol: Amendments are changes made to a research study, after having
obtained a favorable opinion from the ethical point of view of the corresponding CNEIS and the authorization of
a regulatory body (unit or research center or others that apply). They can be made to the protocol, to
other essential documents and other aspects of the study development. All protocols of
study must have clearly written the version number and date, in order to maintain an adequate record and
audit; and any amendment must match the date and version number.
30. Clinical Study / Trial (RCT): Any research conducted in humans with the intention of discovering or
verify the clinical, pharmacological and / or any other pharmaco-dynamic effects of the product (s) in
investigation; and / or identify any adverse reaction to research product (s); and / or to study
the absorption, distribution, metabolism and excretion of product (s) under investigation, in order to verify
its safety and / or effectiveness.
31. Report of a Clinical Study: A written description of a study of any therapeutic agent,
prophylactic or diagnostic performed in humans, in which the clinical and statistical description,
Presentations and analyzes are fully integrated into a single report (see International Conference Guide
of Harmonization for the Structure and Content of the Clinical Study Reports).
32. Clinical Study, Intermediate Report (“InterimAnalysis”): A report of intermediate results and its
evaluation based on analyzes performed during the course of a study.
33. Blind / Masking Study: Procedure in which one or more parts of the study are unaware
the assignment (s) to the treatment. Simple blind study generally refers to the fact that the
subject (s) do not know the assignment and double blind study refers to the subject (s),
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Researcher (s), monitor and in some cases the analyst, do not know the allocation to treatment.
34. Multicenter Study: A health study conducted according to a single protocol but in more than
a place and, therefore, made by more than one researcher.
35. Non-clinical study: Biomedical studies not performed in humans.
36. Adverse Event (EA): Any adverse medical occurrence in a patient or subject of an investigation
in health to whom a pharmaceutical product was administered and which does not necessarily have a
causal relationship with this treatment.
37. Adverse Event (EA): It is any unfavorable medical outcome that occurs in a patient or a
subject of a clinical trial, who has been given a medicinal product, and who does not necessarily
I would have a causal relationship with this treatment. An EA can therefore be any sign
unfavorable and unintended (including an abnormal finding on a laboratory test), symptom or disease
time period associated with the use of a medicinal product under investigation (PMI), whether it is considered related or not
to the PMI.
38. Adverse Reaction (RA): Any unfavorable and unintended response to a PMI, at a certain dose of
administration. All EAs, judged as such by the reporting investigator or the sponsor,
they qualify as an adverse reaction, as long as they have a reasonable causal relationship to a medicinal product. The
Reasonable causal expression means that it converges in general with evidence or argument that suggests a
causal relationship
39. Unexpected Adverse Reaction: It is an RA that, by its nature or severity, is not consistent with the information
existing about the product, for example, in the researcher's manual for a product under investigation not
marketed or in the summary of the product characteristics (CPR) of a product
marketed It is also considered unexpected RA when the outcome of an adverse reaction is not consistent.
with the existing information about the product. The side effects documented in the Report Form
from
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Cases (FRC) that occur in a more severe form than anticipated, are also considered unexpected.
40. Serious Adverse Event (EAS) or Serious Drug Adverse Reaction (Serious RAM): any unfavorable occurrence
the course and in the context of an investigation on a diagnostic product or procedure or
Therapeutic resulting in death, life threatening, requires hospitalization or prolongation of
Existing hospitalization, resulting in persistent or significant disability or disability, is an anomaly
congenital or birth defect or is medically significant according to medical criteria. The above is
applies without the presumed existence of a causal link between the application of the product or treatment
and the adverse event.
41. Adverse Drug Reaction (ADR): harmful and unintentional response to a medicinal product related to
any dose In clinical experience before the approval of a new medicinal product or its
new uses, particularly when the therapeutic dose cannot be established, should be considered
adverse drug reaction to any reaction that involves a causal relationship between a medicinal product and
an adverse event as a reasonable possibility, that is, that the relationship cannot be ruled out.
42. Adverse Reaction Serious Unexpected Suspected (RASIS / SUSAR): Any suspected adverse reaction related to
a PMI, which is unexpected and serious. The medical trial should be exercised to decide if an EA / RA is serious in
other important situations other than those stated. EA / RA that are not immediately threatening to
life or not result in death or hospitalization, but they need interventions to prevent one or more
outcomes of the above, must also be considered as serious.
43. Investigator's Brochure [IB]: A compilation of clinical and non-clinical data on
the research product (s) that is (are) relevant for the study of the product (s) in the
research in humans.
44. Case Report Form (FRC) [“Case ReportForm” (CRF)]: A printed, optical or
electronic, designed to record all the
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information required in the protocol to be reported to the sponsor about each subject of the study.
45. Audit / supervision: The action of the regulatory authority (s) to carry out an official review of the
documents, facilities, records and any other resource that the authority (ies) considers to be related
with the study in health and that can be located in the place where the study is carried out, in the facilities of the
sponsor and / or contract research organization (ICO) or other sites than the authority (s)
Regulatory (s) considered appropriate.
46. ​​Inspector / supervisor: A person conducting inspections of the study on behalf of the Authority of
(National) Surveillance of Compliance with the BPC.
47. Institution (medical): Any public or private entity, agency or dental medical facility where they are conducted
Health studies
48. Basic, pre-clinical or fundamental research: It is the experimental or technical work that is carried out
primarily to acquire new knowledge of the underlying phenomenon and observable facts, without an application
particular or use established. It can be divided into pure basic research and oriented basic research. In
This type of research study subjects are cells, tissues, molecules and / or experimental animals. East
type of research is carried out mainly within a specialized laboratory
49. Clinical Research: Patient oriented research. Research conducted with subjects
humans (or with material of human origin, such as tissues, specimens, and cognitive phenomena) to
which the researcher interacts directly with human subjects. It also includes studies
epidemiological and behavioral studies and results research and research in services of
Health.
50. Process research or evaluation of health systems (or research in health services or
operational research): Field of research that examines the impact of the organization, financing and
administration of health care services in the delivery, quality, costs, access and results of these
services. In this type of research the subject of study are the processes or relationships within the
health institutions.
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51. Public health research: Whose subject of research are the communities.
52. Health research: “Process of obtaining systematic knowledge and technologies that can be
used to improve the health of individuals and groups. Provides basic information about health status
and population disease; seeks to develop instruments for the prevention, cure and relief of the effects of
diseases; and strives to plan better approaches for individual and community health services. ”
53. Researcher: Person responsible for conducting a health study at the site where the
study. If a study is conducted by a group of individuals, the researcher is the responsible leader.
of the group and will be called principal investigator.
54. Coordinating Investigator: A researcher, in a Multicenter study, who is assigned the responsibility of
coordinate the researchers in the different participating centers.
55. Researcher / Institution: Expression that means “The researcher and / or the Institution, when
stipulate the applicable regulatory requirements ”.
56. Head of the Unit / Research Center: Personnel responsible and designated in their hospital function as the
Manager of the Research Units / Centers and responsible for compliance with the development standards of
health research with human subjects, as well as standard operating procedures.
57. Monitoring: The act of monitoring the process of a health study and ensuring that it is conducted,
Registered and reported in accordance with the protocol, Standard Operating Procedures (SOP), Good Practice
Clinic (BPC) and the applicable regulatory requirements.
58. Monitoring, Report of: A written report from the monitor to the sponsor, according to the SOPs of the
sponsor, after each visit to the study site and / or any other communication related to the study.
59. Level of compliance with the BPC: The level of compliance of the center with the Principles of the BPC, as
Evaluate the (National) Surveillance Authority of compliance with the PCBs.
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60. Opinion (in relation to CEIS): The trial and / or advice provided by a CEIS.
61. Contract Research Organization (ICO)
["ContractResearchOrganization" (CRO)]: Person or organization (commercial, academic or otherwise) hired by the
Sponsor to perform one or more of the sponsor's duties and functions related to the study.
62. Sponsor: Individual, company, institution or organization responsible for initiating, administering / controlling
and / or fund a clinical study.
63. Sponsor-Researcher: Individual who initiates and conducts, alone or with others, a health study
and under whose immediate direction the product under investigation is administered (or delivered to, or used) by the
subject. The term does not include any person other than an individual (that is, does not include a person
corporation or agency). The obligations of a sponsor-researcher include both those of a sponsor
like those of a researcher.
64. Standard Operating Procedures (POE) ["Standard OperatingProcedures
(SOPs) ”]: Detailed and written instructions to achieve uniformity in the execution of a specific function.
65. Research medicinal product (PMI): Pharmaceutical form of an active ingredient or placebo
that is being tested or used as a reference in a health study, including a product with an authorization of
marketing when used or conditioned (formulated or packaged) in a different way than
approved or when used to obtain more information about a previously approved use.
66. CPB (National) Compliance Monitoring Program: A particular program established by a country
to monitor compliance with Good Clinical Practices within its territory, through inspections.
67. Research protocol: Document describing the object (s), design, methodology,
statistical considerations and organization of a study. Generally, the protocol also provides
background and rationale for the study, but these could be provided in other documents
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referenced in the protocol. In the BPC guidelines, the term protocol refers to the protocol and the
amendments to the protocol.
68. Adverse Drug Reaction (RAM): These are all harmful and unintentional responses to a product
medicinal, related to any dose. The phrase ‘answers… to a medicinal product’ means that a
causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, that is, that
The relationship cannot be ruled out. With regard to medicinal products on the market: a response to
a drug that is harmful and unintentional, and that occurs with doses normally used in humans to
prophylaxis, diagnosis or treatment of diseases, or for modification of physiological function (see the Guide to
the International Harmonization Conference for the Management of Clinical Safety Data: Definitions and Standards of
an Immediate Report).
69. Unexpected Drug Adverse Reaction: Adverse reaction whose nature or severity is not
consistent with the applicable product information (for example, that contained in the Researcher's Brochure
for an unapproved research product, or packaging insert / summary of product characteristics
approved) (see the Guide to the International Harmonization Conference for Data Management of
Clinical Safety: Definitions and Standards of an Immediate Report).
70. Original Medical Record: See source documents. In this document, "subject", "individual" and "person" are
They use with the same meaning.
71. Legally Accepted Representative: Individual, legal representative or other body authorized under the laws
applicable to accept, on behalf of a probable candidate, his participation in the health study.
72. Applicable Regulatory Requirement (s): Any law (s) and regulation (s) that govern
Conducting health studies of research products.
73. Site Where the Study is Performed: The place (s) where the related activities are carried out
With the study.
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74. Sub-researcher: Any individual member of the health study group, appointed and supervised by the
researcher to perform critical procedures related to the study and / or make important decisions
related to it (for example, associates, residents, research fellow).
75. Subject of the Study: Individual who participates in a health study, either as a recipient of the
product (s) under investigation or as a control. In this document, "subject", "individual" and "person" are used
With the same meaning.
76. Vulnerable (or Vulnerated) Subjects: Individuals whose desire to participate in a health study may be
influenced by the expectation, justified or not, of the benefits associated with your participation, or of a
revenge on the part of the superior members of a hierarchy in case of refusing to participate. By
For example, the members of a group with a hierarchical structure, such as that made up of medical students,
dentistry, chemical-drug-biological and nursing, subordinate hospital and laboratory personnel,
employees of the pharmaceutical industry, members of the armed forces and people who are
detained / detained Other vulnerable (or violated) subjects include patients with diseases
incurable, people in nursing homes, unemployed or homeless, patients in emergency situations,
ethnic minority groups, homeless people, nomads, refugees, minors and those who cannot give their
consent.
77. Impartial Witness: A person independent of the study, who cannot be influenced in bad faith
by the personnel involved in the study, who is present in the process of obtaining the
informed consent if the subject or the representative of the legally accepted subject does not know how to read, and who reads the
"Informed Consent Form" and any other written information provided to the subject.
to. Research Unit / Research Center: In-hospital entity responsible for: Promoting and
develop research in the hospital Train hospital staff who request it in methodology
of research, to develop research with internal validity, technically evaluate, support the
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logistics, register, monitor and monitor the development of studies carried out in the institution.
78. Compliance Monitoring of the BPC: Periodic Audit of any of the parties involved in the
conducting a health study (for example, the CNEIS of researchers, sponsors, etc.), for the purpose
to verify compliance with the PCBs and the corresponding regulations.
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11. ANNEXES
ANNEX 1. GUIDE TO DEVELOP THE LETTER OF INTENTIONS OF A RESEARCHER / RESEARCH TEAM
ON THE LETTER OF INTENTION:
You must enter:
1. APPLICANT RESEARCHER: Name, position, institution. The sponsoring company defines who the
Principal investigator in the cases there are several research centers and researchers.
2. SPONSOR: Indicate the entity that finances and promotes the study.
3. TITLE OF THE PROTOCOL: If the title is very extensive, try to summarize it in a few words.
4. PURPOSE: Indicate the main objective of the study (only one).
5. MAIN EVALUATION PARAMETER (End Point): Indicate the chosen variable as the best expression
of objective evaluation.
6. DESIGN: Indicate the methodology to be used: comparative study or not, randomized or not, blind
or open, parallel / cross groups, case / control, cohorts, transversal, etc.
7. POPULATION AND NUMBER OF PARTICIPANTS: Indicate the origin of the sample (patients of an institution,
healthy volunteers from a community, etc.) and the number of volunteers planned. In the case of animals
laboratory, indicate species and number.
8. DURATION OF THE STUDY: Time during which the participant will remain in the study.
9. CENTERS, RESEARCHERS AND COLLABORATORS: Institutions where participants will be recruited, where
Samples will be analyzed, when applicable. Name and affiliation of co-researchers and collaborators
main.
10. Make clear the place, means and procedure to contact the responsible person (telephone numbers,
email and postal address).
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ANNEX 2 APPLICATION FOR EVALUATION OF CLINICAL RESEARCH PROTOCOLS IN HUMAN BEINGS
NATIONAL COMMITTEE OF ETHICS OF HEALTH RESEARCH
APPLICATION FOR EVALUATION OF CLINICAL RESEARCH PROTOCOLS IN HUMAN BEINGS
FILL THE RMULAR PHONE TO MACHINE OR ELECTRONIC PHASE WITHOUT BUT NOR OR COOLING NES. DO NOT LEAVE SPACE IN
WHITE
1. DATA OF THE PRO TO CO LO
1.1 PRO NO CO LO:
1.2 VERSION: 1.3 DATE:
1.4 TITLE OF THE PRO TO CO LO:
1.5 CENTER NUMBER S:
2.1 VERSION:
2. CO-INFENTIFIED INFORMATION
2.2 DATE (DAY / MONTH / YEAR):
3. O TRO S DO CUMENTO S
3.1 VERSION
3.2 DATE (DAY / MONTH / YEAR)
3.3 DO NOT MBRE:
4. INVESTIGATED MAIN R
4.1 NO MBRES AND LAST NAME:
4.4 NIT NUMBER:
4.2 EXACT ADDRESS OF THE RESEARCH SITE:
4.3 DUI NUMBER:
5. SUB-INVESTED RES
4.5 No. OF J.V.P.M .:
4.6 CO RREO:
4.7 NUMBER OF CO NTACT PHONE:
5.1 NO MBRES AND LAST NAME:
5.4 NIT NUMBER:
5.2 EXACT ADDRESS OF THE RESEARCH SITE:
5.5 No. OF J.V.P.M .:
5.6 CO RREO:
5.3 DUI NUMBER:
5.7 PHONE NO OF
CONTACT :
6. RESEARCH DATA
6.1 CO MITÉ OF ETHICS IN RESEARCH:
6.2 RINED PATTER R:
6.6 TELEPHONE NO
RINED PATTER R:
6.3 PERSON OF CO NTACT (NSPO RESPO):
6.7 NON-PERSONAL PHONE NUMBER OF CO NTACTO:
6.4 RESEARCH CENTER:
6.8 NON CENTER TELEPHONE
6.5 RESEARCH PHASE:
6.9 No. OF PATIENTS TO INCLUDE
IN THE
STUDY IN EL SALVADO R:
7. SPECIAL COURT SITUATION TO THE SEA IN ACCOUNT
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NATIONAL COMMITTEE OF ETHICS OF HEALTH RESEARCH
APPLICATION FOR EVALUATION OF CLINICAL RESEARCH PROTOCOLS IN HUMAN BEINGS
FILL THE RMULAR PHONE TO MACHINE OR ELECTRONIC PHASE WITHOUT BUT NOR OR COOLING NES. DO NOT LEAVE SPACE IN
WHITE
8. LIST OF PRO DUCT S TO BE USED IN THE CLINICAL TRIAL
8.1 PRO DUCT S IN RESEARCH: (Fill in with the s c a s illa s)
8 .1.1 N OM B R E D EL P R OD UC TO
one
two
3
4
5
8 .1.2 P R IN C IP IO A C TIVO
8 .1.3 F OR M A
F A R M A C ÉUTIC A
/  PRESENTATION
/  QUANTITY
8 .1.4 LAST NAME OR BATCH
8 .1.5 F EC HA D E
EXP GO TO CONDITION OR
EXPIRATION
8 .1.6
CONDITIONS OF
STORAGE
8 .1.7
NAME OF
MAKER
8 .1.8 P A ÍS D E OR IGEN
9. SIGNATURES AND SEAL S
I DECLARE AND JURY Q EU WHAT IS PRO DUCT S LISTED S, WILL BE USED S EXCLUSIVELY IN THE PRO
RESEARCH AREA MENTION NOTHING PREVIOUSLY RENT, PO R WH EU I ACCEPT, SEAL AND SIGNATURE.
THE RESEARCHER WAS CO MPRO METE TO COMPLY WITH THE GOOD CLINICAL PRACTICES AND INFO RMAR PERIÓ
DICAMENTLY TO THE NATIONAL HEALTH RESEARCH ETHICS COMMITTEE; FROM THE BEGINNING TO THE END OF THE
INVESTIGATION.
9.1 SIGNATURE OF THE INVESTIGATOR: 9.2 SEAL OF THE MAIN RESEARCHER:
9.3 SIGNATURE OF THE SPONSOR OR ITS
REPRESENTATIVE
10. OJ CUMENTO S Q UE MUST ACO MPAÑAR SO LICITUD
NO DO CUMENTATION
PRESENTS THE REQUIREMENT (EXCLUSIVE SPACE CNEIS)
YES NO DOES NOT APPLY
1 Request for evaluation of the protocol addressed to the ethics committee (original or copy).
Full original protocol of the study in Spanish, containing original informed consent and
Researcher's brochure (Legal documents must be submitted in Spanish or with your
respective
2 translation, in accordance with Salvadoran notarial legislation; in the case of documents
coming from
abroad, must be presented apostilled or consularized, in original and copy for confrontation.)
3 Four copies of the full study protocol in Spanish and one electronic copy
Information on the insurance policy for the research subject granted by the sponsor, specifying
4 the applicability mechanism in El Salvador
5 Curriculum of the principal investigator and co-investigators.
6 Proof of payment of tariff
7 Payment method of the researcher in El Salvador (attach a copy of the contract)
8 Letter of authorization from the center or centers where the study will be carried out
9 Investigator's commitment to good clinical practices
Certificate of Good Manufacturing Practices (BPM) of the manufacturer or Certificate of BPM issued by the
10 Local Regulatory Authority. Applies if the product is not registered.
Primary and secondary packaging of the product or products to be used in the clinical study with its
label of
11 identification, containing storage conditions and lot numbers and expiration date.
Stability studies in accordance with the provisions of RTCA 11.01.04.10 Products
Pharmacists
12 Stability Studies of Medicines for Human Use
13 Other materials (Promotional, patient card, questionnaires, etc.)
(ES P ACIO EXCLUS IVO CNEIS)
(ES P ACIO EXCLUS IVO CNEIS)
(ES P ACIO EXCLUS IVO CNEIS)
(ES P ACIO EXCLUS IVO CNEIS)
(ES P ACIO EXCLUS IVO CNEIS)
(ES P ACIO EXCLUS IVO CNEIS)
(ES P ACIO EXCLUS IVO CNEIS)
(ES P ACIO EXCLUS IVO CNEIS)
(ES P ACIO EXCLUS IVO CNEIS)
(ES P ACIO EXCLUS IVO CNEIS)
(ES P ACIO EXCLUS IVO CNEIS)
(ES P ACIO EXCLUS IVO CNEIS)
(ES P ACIO EXCLUS IVO CNEIS)
(ES P ACIO EXCLUS IVO CNEIS)
(ES P ACIO EXCLUS IVO CNEIS)
(ES P ACIO EXCLUS IVO CNEIS)
(ES P ACIO EXCLUS IVO CNEIS)
(ES P ACIO EXCLUS IVO CNEIS)
(ES P ACIO EXCLUS IVO CNEIS)
(ES P ACIO EXCLUS IVO CNEIS)
(ES P ACIO EXCLUS IVO CNEIS)
(ES P ACIO EXCLUS IVO CNEIS)
(ES P ACIO EXCLUS IVO CNEIS)
(ES P ACIO EXCLUS IVO CNEIS)
(ES P ACIO EXCLUS IVO CNEIS)
(ES P ACIO EXCLUS IVO CNEIS)
(ES P ACIO EXCLUS IVO CNEIS)
(ES P ACIO EXCLUS IVO CNEIS)
(ES P ACIO EXCLUS IVO CNEIS)
(ES P ACIO EXCLUS IVO CNEIS)
(ES P ACIO EXCLUS IVO CNEIS) (ES P ACIO
EXCLUS IVO CNEIS) (ES P ACIO
EXCLUS IVO CNEIS) (ES P ACIO
EXCLUS IVO CNEIS) (ES P ACIO
EXCLUS IVO CNEIS)
(ES P ACIO EXCLUS IVO CNEIS)
(ES P ACIO EXCLUS IVO CNEIS)
(ES P ACIO EXCLUS IVO CNEIS)
(ES P ACIO EXCLUS IVO CNEIS)
THE FOLLOWING BOXES ARE NOT FOR USE OR FICIAL. (EXCLUSIVE CNEIS SPACE)
11. FINAL OPINION
11.1 RECEIVED DATE:
11.3 PROCESS RESULT:
11.5 SIGNATURE AND SEAL:
Approved Denied
11.2 No. ASSIGNED CNEIS: 11.4 No. APPROVAL DATE:
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NATIONAL COMMITTEE OF ETHICS OF HEALTH RESEARCH
APPLICATION FOR EVALUATION OF CLINICAL RESEARCH PROTOCOLS IN HUMAN BEINGS
1. DATA OF THE PRO TO CO LO
APPLICATION FILLING INSTRUCTION
1.1 PROTOCOL No: Protocol number, as
appears in the protocol
1.2 VERSION: Version of
protocol that is subject to authorization
1.3 DATE: Date of
version of the protocol to authorize
1.4 TITLE OF THE PROTOCOL: Full title, as it appears in the
protocol
1.5 NUMBER OF CENTERS: Full name of the centers
research where the study will take place
2. CO-INFENTIFIED INFORMATION
2.1 VERSION: Version of
informed consent submitted to authorization
2.2 DATE: Date of
informed consent submitted to authorization
3. O TRO S DO CUMENTO S (Promotional, patient cards, questionnaires, etc.)
3.1 VERSION: Version number
of the document to be authorized
3.2 DATE (DAY / MONTH / YEAR): Date of the document to be authorized
3.3 NAME: Name of the document
to be authorized
4. INVESTIGATED MAIN R
4.1 NAMES AND SURNAMES: Full name of the
principal investigator.
4.2 EXACT ADDRESS OF THE SITE
INVESTIGATION
Research site address, approved by the CSSP.
4.3 DUI NUMBER: Investigator DUI Number
principal
4.4 NIT NUMBER: NIT number of the researcher
principal
4.5 No. OF J.V.P.M .: Number of J.V.P.M. of the
principal investigator.
4.6 MAIL: Email
of the principal investigator
4.7 CONTACT PHONE Contact phone (cellular or landline) of the
principal investigator.
5. SUB-INVESTED RES
4.1 NAMES AND SURNAMES: Full name and surname of the
underinvestigators
4.2 EXACT ADDRESS OF THE SITE
INVESTIGATION
Research site address, approved by the CSSP.
4.3 DUI NUMBER: DUI number of the
underinvestigators
4.4 NIT NUMBER: NIT Number of the NIT
underinvestigators
4.5 No. OF J.V.P.M .: Number of J.V.P.M.
of the sub-researchers
4.6 MAIL: Email
of the sub-researchers
4.7 CONTACT PHONE Contact phone (cellular or landline) of the
underinvestigators
6. DATA OF THE INVESTIGATION
6.1 RESEARCH ETHICS COMMITTEE: Name of the Research Ethics Committee that approved the
protocol. (Local or Independent Committee of the
country of origin or National, attach copy)
6.2 SPONSOR: Name of the sponsor of the
clinical study.
6.3 CONTACT PERSON (RESPONSIBLE): authorization process.
6.4 RESEARCH CENTER: Name of the Research Center to be carried out
administrative procedures charge. If not
Exist, place N / A (Not Applicable).
6.5 RESEARCH PHASE: Research phase to which it belongs
the present clinical study (II, II-a, II-b, III, IV).
6.6 SPONSOR PHONE: Sponsor contact phone number.
6.7 CONTACT PERSON PHONE: Contact person's telephone.
6.8 CENTER PHONE Center telephone number
Investigation.
6.9 No. OF PATIENTS TO INCLUDE IN THE STUDY IN EL SALVADOR:
Number of patients planned to be recruited in the present clinical study in El Salvador.
7. SPECIAL COURT SITUATION TO THE SEA IN ACCOUNT
Comments or special situations deemed necessary to take into account for the authorization of the protocol.
8. DATA S OF THE PRO DUCT IN RESEARCH
8.1 PRODUCT NAME: Name of the products to be used in the
investigation.
8.1.2 ACTIVE PRINCIPLE: Name of the active principals
To use in research.
8.1.3 PHARMACEUTICAL FORM / PRESENTATION / QUANTITY:
Pharmaceutical form, presentation and quantity of the products to be used in the investigation.
8.1.4 BATCH NUMBER: Any combination of letters,
numbers or symbols used to identify a lot.
Date placed on the primary and secondary packaging material of a product, to indicate the date until
8.1.5 EXPIRATION OR EXPIRATION DATE:
which the product is expected to meet the quality specifications. This date is set for each lot.
8.1.6 STORAGE CONDITIONS: Recommended temperature for storing and transporting the
Products to use in research.
8.1.7 MANUFACTURER'S NAME Establishment authorized to perform all
operations that involve product manufacturing
Pharmacists
8.1.8 COUNTRY OF ORIGIN Country where the
medicine. In the event that more than one laboratory is involved in manufacturing, the country of origin is that in which
performs the manufacture of at least the bulk medicine.
9. SIGNATURES AND SEAL S
9.1 RESEARCHER'S SIGNATURE: Signature of the principal investigator, responsible
of clinical research.
9.2 SEAL OF THE MAIN RESEARCHER: Seal of the principal investigator, responsible for the
clinical research.
Name, signature and seal of the sponsor. When not applicable, the name, signature and seal of the representative must go
9.3 SIGNATURE OF THE SPONSOR OR ITS REPRESENTATIVE:
from the sponsor, Contract Research Center or to whom the sponsor has delegated this function.
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ANNEX 3 IDENTIFYING A CLINICAL TRIAL
What is a clinical trial of a medicinal product?
This algorithm and the footnotes to the table will help you answer this question. Please start in the column
A and follow the instructions. There is additional information in the notes.
A B C D
AND
Clinical trial of a medicinal product
A non-interventional clinical trial?
Is it a medicinal product (PM)? If you answer no to all the questions in column A, the activity is not
a clinical trial of a PM. If you answer yes to any of the questions, go to column B.
A.1 Is it a
substance * or
combination of substances presented as having
properties of
treatment or
disease prevention in humans?
A.2 Does the function of
Is it not a medicinal product?
If you answer yes to the questions in column B, the activity is not a clinical trial of a PM.
If you answer no to this question, go to column C.
B.1 Are you only administering any of the following substances?
• Complete human blood **
• Human blood cells
• Human plasma
• Fabrics, except one
What effects of the medication are you looking for?
If you answer not all the questions in column C, the activity is not a clinical trial. If yes
to any of the questions, go to column D.
C.1 To discover or verify / compare its clinical effects?
C.2 To discover or verify / compare its pharmacological effects? (Ex. Pharmacodynamics)
C.3 To identify or verify / compare your
Why do you look for these effects?
If you answer no to all
questions in column D, the activity is not a clinical trial. If yes to
Any of the questions below, go to column E.
D.1 To determine or verify / compare the effectiveness of the medicine? vii
Why do you look for these effects?
If you answer yes to all questions, the activity is a non-interventionist essay.
If the answers from columns A, B, C and D brought it to column E, and
Answer no to any of these questions, the activity is a clinical trial.
E.1 Is this a study of one or more medicinal products, which have market authorization in the
region?
E.2 Are the products prescribed in the usual way they are registered?
E.3 Is the assignment of any patient involved in the
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A B C D
AND
Is the substance like medicine?
Ex. Can it be administered to human beings, either with a view to restoring, correcting or
modify physiological functions, exerting a pharmacological, immunological or metabolic action;
or to make a
Medical diagnostic; or is it
administered in another way, for a medical purpose?
A.3 Is it an active substance in a form
pharmaceutical?
medicinal product with somatic cells ***
• A food product (including dietary supplements) not presented as a medication
• A cosmetic product
+
• A medical device
adverse reactions?
C.4 Study or verify / compare its absorption, distribution, metabolism or
excretion?
D.2 To determine, verify or
compare the
medication safety?
study of a particular therapeutic strategy, falls within the current practice and does not
decide in a protocol, in an advanced clinical trial? viii
E.4 Is the decision to prescribe a particular medicinal product,
clearly separated from the decision to include the patient in the study?
E.5 Do not apply to patients included in the study other than
those that apply in current practice?
E.6 Will epidemiological methods be used to analyze data coming out of this study?
* Substance is any material, regardless of its origin (human, animal, plant or chemical), which is administered to a
human being.
** This does not include derivatives of human blood, human cells and human plasma that involves a process of
manufacture.
*** Somatic cell therapy medicinal products use live somatic cells of human (or animal) origin,
whose biological characteristics have been manipulated to obtain a
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therapeutic, diagnostic or preventive effect (in humans), through metabolic, pharmacological and
immunological
 Any product ingested that is not a medicine is seen as food. A food cannot be classified as
a medicine, unless it contains one or more ingredients generally seen as for a medical purpose or
medicinal.
+ A "cosmetic product" means any substance or preparation with the intention of putting it in contact
with various external parts of the human body (epidermis, hair system, nails, lips, and external genital organs),
or in teeth and mucous membranes of the oral cavity, with exclusive or main views of cleaning, perfume
or protect them in good condition, changes in appearance or correct body odors.
Vii Efficacy is the concept of scientifically proving whether - and to what extent - a medicine is capable of
diagnose, prevent or treat a disease.
Viii The assignment of patients to a treatment group randomly and planned by a trial protocol
Clinical cannot be considered as clinical practice.
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ANNEX 4A. ASSESSMENT GUIDE FOR A HEALTH RESEARCH PROJECT
INSTRUCTIVE:
This instrument must be used by each of the members of the CNEIS, during the review of the
documentation. It is a guide to review the formal, methodological and ethical aspects of the study. I know
recommends that each evaluator mark with an “X” or write in the blank, as appropriate.
Once the deliberation is finished, the secretary will complete the form that includes all the opinions
and those that were filled individually will be removed.
DATE APPLICATION DATE FIRST
EVALUATION
SECOND EVALUATION DATE
DATE RESOLUTION (APPROVAL / REJECTION)
LIST OF ELEMENTS TO EVALUATE IN A HEALTH RESEARCH PROTOCOL
I.- IDENTIFICATION:
Code
Protocol Title
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II.- EVALUATION OF THE SUMMARY OF THE PROJECT
Little bit
Information on Not recorded
adequate
Adequate
Very suitable
1. Promoter
2. Research title
3. Type of investigation
4. Place of performance
5. Authority responsible for the institution of realization
6. Other study centers
7. Responsible researcher
8. Drug or Method to investigate. Information on manufacturing, expiration, registration
9. Stage or phase of the study
10. Objective of the study: efficacy, toxicity, dose, etc.
11. Design: random, double blind, etc.
12. Disease under study
13. Inclusion criteria
14. Exclusion criteria
15. Number of patients
16. Duration of the study
17. Schedule of realization
18. Financial responsible and damage insurance
19. Ethical considerations
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III.- METHODOLOGICAL EVALUATION OF THE RESEARCH PROTOCOL
Information about
1. Promoter information
2. Participating researchers
3. Realization centers
4. General Aspects
4.1. Preclinical and clinical history that supports the rational of the study
4.2. Justification
4.3. Main goal
4.4. Secondary objectives
4.5. Phase Study: I-II-III-IV
4.6. Kind of investigation
4.7. Design (parallel, crosslinking, etc.)
4.8. Sample's size calculation
5. Population to study
5.1. Type (patients, healthy volunteers or others)
5.2. Inclusion criteria
5.3. Exclusion criteria
5.4. Groups to compare
5.5. Demographic aspects
5.6. Prognostic Criteria
5.7. Stage of the disease
5.8. Treatment response measure
5.9. Associated disease
5.10. Similarity of patients with the general population
6. Compared treatments
6.1. Drug proposed as intervention
6.2. Dose selection
6.3. Dose (fixed, flexible, route of administration)
6.4. Treatments, (Treatments) attached (standardized, allowed, prohibited)
6.5. Treatment duration
6.6. Information of lot number, formulation, etc.
Not included or provided
Inappropriate
Suitable
Very suitable
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Information about
6.7. Drug recognized as Standard treatment
6.8. Justified placebo use
6.9. Masking
7. Details of the experimental design
7.1. Checked
7.2. Controls: active-inactive
7.3. Concurrent-historical
7.4. Assignment of Treatment with random distribution
7.5. Cleaning-stratification period
7.6. Periodicity of visits, laboratory exam, evaluations
7.7. Start and end of treatment
8. Data collection and analysis
8.1. Measures used to evaluate the objectives
8.2. Record of response variables
8.3. Observers (constants, variables)
8.4. Collection method (normalized)
8.5. Evaluation of incomplete or lost data
8.6. Evaluation of the degree of compliance Treatment
8.7. Statistical tests to apply
8.8. Intention to treat analysis
9. Adverse effects (EA)
9.1. Subjective (reported spontaneously or with directed questions)
9.2. Identification criteria
9.3. Classification and evaluation of the Same
10. Controls to minimize bias
10.1. Impartial (blind) observers
10.2. Patients are unaware of the treatment received (blind)
Not included or provided
Inappropriate
Suitable
Very suitable
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Information about
10.3 Impartial assessor (blind)
10.4 Blind statistical analysis (does not identify groups)
Not included or provided
Inappropriate
Suitable
Very suitable
11. Individual Registration Sheet
IV.- EVALUATION OF THE PATIENT INFORMATION SHEET
Information about
1. Copy of the investigation protocol summary
2. Objective to be achieved with the study and treatment
3. Methodology to follow
4. Proposed treatment and placebo if any
5. Expected benefits of the proposed method for the participant
6. Expected benefits of the proposed method for society
7. Risks and inconveniences arising from the investigation
8. Possible adverse events
9. Risks and benefits of alternative methods to that proposed
10. Risks and benefits of non-participation in the study
11. Voluntary nature of participation
12. Right not to participate and to withdraw freely from the study without prejudice of any kind
13. Right to expand information as per participant's need
14. Confidentiality of the data obtained and its scope
15. Damage insurance and compensation guarantee for
Not included or provided
Poorly suited
Adequate
Very suitable
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Information about
injury or death of the participant
16. Researcher responsible for informing the subject at any time during the study
17. Reference place for health care
18. The degree to which your medical care will be covered during the study, in case of any inconvenience
19. Ethics committee that evaluated the research
20. If you will receive any compensation or gift for your participation
21. Understanding the information
22. Information on the subject's access to the product under test, if it is effective from the
completion of the investigation and until its commercialization, and if it will be delivered free of charge or
I would have to pay
for him
23. Information on the subject's access to the product being tested, if it is effective and after its
marketing, and if it will be delivered to you for free or you would have to pay for it
24. In the case of people over 12 and under 18, there is an Informed Assent Form
25. Dissemination and right to know the results (mechanism or form as you will know them)
26. There is a safeguard of the data, limitations and consequences of its breach
Not included or provided
Poorly suited
Adequate
Very suitable
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V.- EVALUATION OF INFORMED CONSENT
Information about
1. Identification: date and place for signatures
2. Name and surname of the participant, legal representative or witness
3. Research title
4. Statement of reading the information sheet and understanding of it
5. Statement of having been able to ask any question freely
6. Statement of having received sufficient information
7. Statement of having been informed by an investigator whose first and last name is recorded
8. Statement that your participation is voluntary and competent
9. Statement of understanding that you can withdraw without prejudice
10. Expression of free conformity
11. In the case of people over 12 years of age and under 18, there is an Informed Assent Form (AI).
12. Date of edition of the Informed Consent (CI) version
Not included or provided
Poorly suited
Adequate
Very suitable
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INVESTIGATIONS WITH PEOPLE WHO SUFFER MENTAL AFFECTIONS OR BEHAVIOR DISORDERS
Observations:
Criteria YES NO
The objective of the research seeks to obtain knowledge applicable to the health of this type of people
Informed Consent is adapted to your ability to nod
There is no risk of mandatory participation
The risk-benefit ratio is acceptable.
The benefits are superior to the treatments currently available
The support of a family member, director or legal guardian is considered in the decision
INVESTIGATIONS WITH PARTICIPATION OF PRISONERS
Criteria YES NO Comments:
The study does not deprive of medications with therapeutic or prophylactic effects, if you have a
disease or risk of contracting it
The principle of voluntariness is fulfilled
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RESEARCH WITH PARTICIPATION OF PERSONS OF ETHNIC COMMUNITIES, MINORITY GROUPS OR VULNERED COMMUNITIES
IN HUMAN RIGHTS
Criteria YES NO Comments
The study does not discriminate against any other community
The objective seeks to obtain knowledge applicable to that community
Enough information from that community is reported
The community is informed of the conduct of the study
Informed Consent is adapted to the culture of that community
Questions to the researcher, by the members of the National Research Ethics Committee in
Health (CNEIS), and complementary information:
SAW. GENERAL CONCLUSIONS OF THE ETHICAL ASSESSMENT
Information about 0 1 2
3
1. Relevance and extension of the information provided
2. Form of data collection in relation to objectives, statistical analysis and scientific efficiency
3. Potential to extract information with the least exposure of the subjects
4. Justification of the predictable risks and inconveniences with the benefits for the subject
5. Justification of the predictable risks and inconveniences with the benefits for society
6. Adaptation of the researcher to the proposed project according to experience in the subject
7. Adequacy of the place of performance, considering the resources available
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Information about 0 1 2
3
8. Adequacy of medical supervision and follow-up of subjects
9. Adequacy of forecasts to monitor the course of the investigation
10. Adequacy of the information to be
provided to the patient, representatives, witnesses, etc.
11. Means to give information and obtain consent
12. Assurance that participants will have all the information during the investigation
relevant available
13. Forecasts to answer the questions and requirements of the participants during the study
14. Health care forecast in case of adverse effect and the degree to which it will be provided
15. Plan to provide the best treatment tested to the subjects, at the end of the investigation
16. Plan to provide the best proven treatment to the community, at the end of the investigation
17. Compensation and compensation provisions for damages
18. Investigator's liability insurance
19. Confidentiality requirements
Maximum score 57 points.
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ANNEX 4B ETHICAL EVALUATION GUIDE FOR RESEARCH PROTOCOLS DIFFERENT FROM CLINICAL TRIALS
Principle analysis Adequate Not applicable
Inadequate AUTONOMY
Protection of confidentiality Obtaining
consent / assent, voluntariness, information, understanding
Substitution decisions (legal representative) BENEFIT
Risk / benefit ratio Risk not exceeding the minimum NO MALEFICENCE
Correct methodology: plausible hypothesis, justification and objectives, sample size
Clinical equiponderance: interventions are considered equal in efficacy and safety Suitability
of the researcher (training experience, sufficient time for the study) Safety clauses
Suitability of research site / facilities JUSTIFICIA
Equitable selection of subjects Compensation for damages
Social utility
Access to interventions
VULNERABILITY
Vulnerable, discriminated populations have been identified,
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Principle analysis Adequate Not applicable
Inadequate
which?
Individual guarantees of vulnerability protection are completed
The expected results suppose a direct benefit for the participants
CONSEQUENCES ANALYSIS
For the study subjects
For society (responds to the health needs and problems of the country)
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ANNEX 4C GUIDE FOR FINAL RESOLUTION
At this stage, the important thing is that there is sufficient deliberation for each of the criteria. It's not about
Mark the number of people who agree or disagree with the criteria. Only in particular cases, should
record if one of the members did not agree with the opinion of the rest and the discussion was exhausted. In case of no
If there is agreement, it will be convenient to suspend the discussion and resume it in an upcoming session.
Definitions of the numbers in this guide:
1. Evaluate a treatment, intervention or theory that will improve health and well-being, or knowledge.
The justification is the scarcity of resources and avoid exploitation. Scientific knowledge is evaluated, the
citizen level understanding of social values.
2. The study has a clear hypothesis, uses accepted scientific principles and methods - which
they include statistical techniques— to produce reliable and valid data.
3. In the selection of subjects or participants, people or populations are not selected
stigmatized, or violated for risky investigations, while the most favored are offered
participate in investigations of more beneficial potential (The principle of Distributive Justice is fulfilled).
4. Potential risks and damages are minimized, maximizing potential benefits so that
the risks to the subjects are proportional to the benefits and to the society (Respect
by the principle of No Maleficence / Charity).
5. The evaluation was carried out with the participation of members outside the investigation, stating whether or not they exist
existence of conflict of interest. It fulfills the commitment to render public account. There is independence
Intellectual, economic and all kinds of researchers.
6. Informed Consent is clear and understandable. Describe the purpose, its risks and benefits
potential, the existing alternatives. Secure the
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understanding and willingness to make decisions about participation in research (Principle of
Autonomy).
7. Respect for people is guaranteed in the sense of: the possibility of allowing them to leave
of the investigation, the protection of your privacy through confidentiality, the provision of information about
of risks or benefits discovered in the course of the investigation, the provision of information about
results of clinical research, continuous monitoring of well-being (Respect for Autonomy and Charity).
8. It is stated in the Informed Consent that the Sponsoring Institution, backed by the policy
insurance, covers 100% of expenses for medical treatment for health recovery, due to damage
directly related to the study, freeing the subject and his legal representatives from expenses, and the
institution where research is carried out.
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Social value or
Scientific validity
Equitable selection
Risk Reason
Decision Criteria
Independent evaluation
Informed consent
Respect for
Compensation for damages
Members present
one
scientific
1 2
of the subjects
3
favorable profit
4
(Declaration of conflict of interest)
5
meets requirements
6
the subjects
7 8
two
3
4
5
6
7
8
Total
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Resolution:
Evaluation No. Date I II
III
Observation
Approved without restrictions (ASR)
Evaluated with observations and request for amendments (FI)
Not approved (RCT)
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ANNEX 5A REQUIREMENTS FOR THE DEVELOPMENT OF AN INFORMED CONSENT (CI)
Informed Consent is a communicative and deliberative process within the relationship between the researcher and the
Subject or potential research participant, where joint decisions and agreements are made +. The
form is a documentary support that guarantees that the most relevant information has been offered by the
researcher, and received and understood by the Research participant Subject, and allows to verify if there is
acceptance or rejection of the proposal.
Any informed consent form must include - expressed in understandable language - two parts:
Information for the Research Subject and Informed Consent Form.
- Information for the Research Subject
The written information document is a written summary of the minimum information that must be communicated to
the person to comply with the substantive ethical principle of Informed Consent. This information document
It will be the basis or guide for verbal explanation and discussion of the study with the Subject or his legal representative. I know
recognizes that this document will not be the only source of information that the Subject will receive in the process of
Informed consent.
Information content:
a) That the study involves an investigation (study title).
b) The purpose of the study.
c) The treatment (or intervention) under study and the probability of randomization to treatment or
procedure, where applicable.
d) The procedures to follow in the study, including all invasive procedures.
+ Bravo M, Zunino M.E., Document on “Informed Consent”, CEC SSMS, 2002 and Fernández M., L., Consent
informed in clinical practice, 2002.
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e) The responsibilities of the Subject.
f) Those aspects of the study that are experimental.
g) The reasonably foreseeable risks and inconveniences for the Subject and, where relevant, for the embryo,
Fetus or nursing child.
h) Reasonably expected benefits. When no clinical benefit is intended for the Subject, it should be
informed of it.
i) Alternative procedures or treatments that may exist for the Subject, and its risks and benefits
potentials of importance
j) The compensation and / or treatment available to the Subject, in the case of damages related to the study.
k) Advance payment arrangement, if any, to the Subject participating in the study (for phase I and II studies).
l) That the participation of the Subject in the study is voluntary and that the Subject may refuse their participation or
abandon a study without penalty or loss of benefits to which you would otherwise have been entitled.
m) That the monitor (s), auditor (s), the Ethics Committee and the regulatory authorities will have free
access to the original clinical history of the Subject, for the verification of the procedures and / or data of the
study, without violating the right to confidentiality of the Subject, as allowed by law and
relevant regulations; and that, by signing the Informed Consent form, the Subject or his representative
Legally acceptable is authorizing such access.
n) That the documents that identify the Subject will be confidential and, as allowed by law and
Relevant regulations will not be publicly available. If the results of the study are published, the identity of the
Subject will be confidential.
o) That the Subject or his legal representative will be informed at all times if new information is available that
may be relevant to the subject's decision to continue participating in the study.
p) The people to contact for additional information about the study and the
Rights of the Subjects of the study, and / or in case of damages related to the study [Researcher
principal, co-investigator, data from
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Health Research Ethics Committee (CEIS) with stamp, date of evaluation and signature of the President].
q) The foreseeable circumstances and / or the reasons under which the participation of the
Subject in the study.
r) The expected duration of the Subject's participation in the study.
s) The approximate number of subjects involved in the study.
t) In the case of minors, the assent of the minor (s) and the identity of the legal guardian that
Sign the Consent.
The instrument or form must meet the following requirements:
- Must be prepared thinking of a Research Subject, healthy or ill, and not the editor of a magazine
scientific The translation from English or another language into Spanish must be adapted to the subject's language and not
literal translation.
- The contents must be organized in headings.
- It must be written with short sentences, using a separate point to separate the sentences.
- It must be written in simple words, avoiding the use of technicalities and numerical probabilistic expressions.
- If possible, drawings must be included.
- The design must be attractive.
- Its extension should not be more than 2 pages.
- We must evaluate or validate the readability and ease of understanding of the text (with people outside the field of
healthcare professionals).
Informed Consent Form
The Informed Consent Form is the document that the person or their legal representative and the
witness (if applicable) will sign and date, to leave with it documented evidence or proof that the Subject
has received sufficient information about the study, the research product and its rights as
Subject of Research and who wishes to participate freely and voluntarily in the study.
If the Subject is illiterate, the signature can be replaced by the fingerprint, but in these
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Cases must include 2 witnesses.
In cases where the Research Subjects are between 12 and 18 years old, in addition to the consent of the parents or
Legal representatives, a Assent Form must be included, which must also be signed by the minor.
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ANNEX 5B BASIC STRUCTURE MODEL OF THE INFORMATION DOCUMENT FOR THE RESEARCH SUBJECT AND FORM
OF INFORMED CONSENT
I-General Information
1- [Study Title]
2- [Protocol Number] 3- [Sponsor / Address]
4- [Principal Investigator]
5- [Telephone]
6- [Participating Centers / Address] 7-. [Introduction]
II-Specific information (from the study)
8- [Purpose of the Study] 9- [Background]
10- [Study Duration]
11- [Expected Number of Participating Subjects] 12- [Exclusions]
13- [Study Design]
14- [Study Treatment]
15- [Study Procedures]
16- [Additional / optional studies (Sub-studies)] 17- [Possible Risks and Discomforts]
18- [Precautions]
19- [Women of Fertile Age] 20- [Possible Benefits]
III Rights of the person
21- [Notification of New Findings] 22- [Treatment Alternatives]
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23- [Options at the end of the Study] 24- [Confidentiality]
25- [Payment per Participation] 26- [Costs]
27- [Compensation for Damages or Injuries Related to the Study] 28- [Voluntary Participation and Retirement]
29- [Questions / Contacts]
IV-Consent to participate
30- [General Information]
31- [Subject Consent Statement] 32- [Additional Declarations]
33- [Signature Requirements]
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ANNEX 5C CHECKLIST OF INFORMATION DOCUMENT REQUIREMENTS FOR THE SUBJECT OF
RESEARCH AND INFORMED CONSENT FORM
Protocol No .:
Is required:
Statement that the study involves research
Explanation of the purpose of the investigation
Study treatment (s) and probability of randomization for each treatment
Expected duration of the person's participation
Description of the procedures to follow, including all invasive procedures
Responsibilities of the person
Identification of any procedures that are experimental
Details of any aspect of the study that is experimental
Description of any reasonably unforeseen risks or discomforts for the person and, when
applicable, an embryo, fetus or nursing child
When there is no intended clinical benefit for the subject, the person should be aware of it.
Description of any benefits reasonably expected for the person or for others
Disclosure of specific alternate procedures or treatment appropriate to the person, and their benefits and
potential potential risks
Any anticipated expenses for the person while participating in the study
Proportional advance payment, if any, for the person to participate in the study
Explain the conditions under which the researcher can exclude people from the study without their
consent
Inform the person about who will have access to their medical records (monitor, auditor, JRI,
regulatory authorities) to verify the procedures and data of the study, and that the
confidentiality to the extent permitted by applicable laws and regulations. If the study results
are published, the identity of the person will remain confidential information
By signing the Informed Consent Form, the person provides access to their records
doctors
That the subject's medical records will be kept under strict confidentiality, and will be
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protected by applicable local and federal regulations, and will not be made public knowledge
Compensation and / or treatment (s) available to the person in the case of a study related injury
People to communicate with:
For questions about the study
For questions about the rights of the person under investigation
In the case of a research related injury
Statement that participation is voluntary and that the person may withdraw from the study at
any time without being punished or losing the benefits to which the person has anyway
right
Statement of the anticipated circumstances under which the investigator may suspend the
participation of the person without the consent of the person
Additional costs for the person that may arise from participation in the study
The person - or the person's representative - will be notified in a timely manner if new ones develop
significant findings during the course of the investigation, which may affect the disposition of
the person to continue participating
Approximate number of people
Consequences of the withdrawal of the person and the procedures at the time of termination
Statement that the treatment or procedures may involve risks to the person (or to the person
embryo, fetus or nursing child) that are currently unforeseen
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ANNEX 6 MINUTES FOR RESOLUTION OF A RESEARCH PROJECT
Institution:
ACT N °: / EVALUATION ACT
HEALTH STUDY PROTOCOL Nº ..........
On ……………, on ……. Days of the month of …… del. , H. Committee Committee
of Health Research Ethics ………………………………… .., with the assistance of its permanent members:
[full name, position on the Committee (chairman, secretary, permanent member, alternate member and the
profession of each)] ………………………………………………………………, have reviewed the documents submitted by
..........................., Principal Investigator, namely:
1. Protocol ".................", version ...................
2. Protocol ".................", Spanish version of ....................
3. Investigator Brochure ......
4. Informed Consent Form of the Protocol "...........", Spanish version, ...................
5. The curriculum vitae of ........................................ In addition, to know Background
exposed by .................. in the session of the day .............., has considered that the sponsored clinical study
by ................, (does not present ethical objections) (presents the following observations):
1) The members of the Committee declared (Having or not having a conflict of interest).
2) The design conforms to the standards of Research in Human Beings.
3) The benefit ratio was considered acceptable.
4) The informed consent form meets the requirements.
5) The medical treatment necessary for the recovery of the health of the participants is guaranteed due to
Adverse effects directly related to the study. Expenses that will be canceled by in a
100%, at no cost to the participant in the research or to the center or establishment (full name of the
center where the study will be conducted) .............., backed by the coverage of
Sure, Policy No. ................ of ............, effective from ......... to ... ........, under the responsibility
by name
full and legal representative of the institution responsible for sponsorship in the country where the study is conducted).
6) Payment is guaranteed for ................. of the participants and ........
7) The curriculum background of the Principal Investigator guarantees the execution of the study within
ethically acceptable frameworks.
8) Observations and recommendations
Consequently, the Health Research Ethics Committee of ……………………………… .. approves (rejects)
unanimity (most of its members)
Name and signatures of the president and secretary
DC.
• Principal investigator.
• Institution.
• C.E.I.S. Secretariat
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ANNEX 7 NOTIFICATION FOR THE MAIN RESEARCHER
Institution………………..
Health Research Ethics Committee MEMORAND Nº: /
ANT .: Minutes of the Council of the Health Research Ethics Committee of ..................
MAT .: Submit Evaluation Report .............
Date,
SR., Dr ................... (Name, position, institution) MAIN RESEARCHER
PRESENT.
Of our consideration:
Attachment I send to you, Informed Consent, final version of. (Date)
signed and stamped, and Evaluation Act No. ...... of (date) .........., which certifies that the Board of Ethics Committee
of Research in Health of (institution), DICTAMEN the research protocol called “...................”,
sponsored by ..................., to perform in ..................., dependent on ... ...
We ask you to inform this Committee about the start of the study and inform, within the deadlines
established [within the first 24 hours the related serious adverse events, one week the
serious unrelated adverse events, three weeks for internal non-serious adverse events], events
associated and not associated with the study, quarterly reports and annual safety and continuity reports, the
evidence of benefit, rejection of the participation of subjects, the number of subjects enrolled and / or
any important antecedents observed during the execution of the investigation, as well as the amendments and
deviations, in a timely manner.
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In addition, it is reported that the duration of the project approval is one year, extendable according to
communication and official request.
Say hello,
…………………………………………. ..........................................
Secretary- President
Health Research Ethics Committee
DC
• Mr., Dr. ………… .............., Principal Investigator.
• C.E.I.S. Secretariat
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ANNEX 8 SERIOUS ADVERSE EVENTS REPORT FORM
Please send via FAX, within the first 24 hours after the event notification.
Patient Initials …………………………………………
... ... ................
Hospital Registry of
patient .............. ……………… ..… ...............
Treating doctor. …………………………………………
…………….… .........
Patient ID:
Date of birth:
d d m mm aaa Hospital …………………………………………………
………… ..… .............
Report Type Test Arm Sex Height
Weight
1 = Initial 2 = Interim 3 = Final
1 = 1 =
2 = Male
.
2 =
Female cm kg
Date of last treatment administered prior to EAS
d d m mm a a
Was the treatment under study at the full dose, according to the protocol, before the event?
0 = No, specify …………………………………… ...
1 = Yes
Why is the event considered serious? (Choose the most serious)
Where did the EAS occur?
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Why is the event considered serious? (Choose the most serious)
Where did the EAS occur?
1 = It resulted in death 2 = Threatened life
3 = Required hospitalization or prolongation of existing hospitalization
4 = It resulted in permanent disability / significant disability 5 = It resulted in congenital anomaly / birth defect
6 = Another important medical event
1 = Hospital
2 = Outpatient clinic
3 = House
4 = Hospice
5 = Other,
specify …………………………………………… ..
Briefly, describe the EAS (Include relevant symptoms, body part, relevant laboratory tests and
treatment received). Continue on a separate sheet, if necessary.
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EAS Details
EAS Status
Serious Adverse Event Name:
Name
EAS duration (dd mmm yy)
Date of appearance
1 = Solved
2 = Solved with sequels
3 = Persists
4 = It got worse
5 = Fatal
6 = Not evaluable
Expected
1 = Expected *
2 = Not expected
Date of resolution
Grade
Or check here if it persists
* Was the event one of those listed in the protocol, as an undesirable effect recognized for medication in the
test? See protocol page.
Trial treatment
Trial drugs
which was
Date
Happening
Causal Relationship of the event
1 = Definitive
Action taken
0 = None 1 = Dose Reduction
receiving the patient when the EAS started
Total daily dose
start of the most recent cycle
(dd mmm yy)
at present?
0 = No
1 = Yes
End date (dd mmm yy)
2 = Probable
3 = Possible
4 =
Unlikely 5 = No
related 6 = No
evaluable
2 = Delayed treatment 3 = Delayed and reduced treatment 4 = Permanently suspended treatment
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Patient number in the study
Other treatments at the time of the event (Include concomitant medication, radiotherapy, surgery, palliative care).
Continue on a separate sheet, if necessary. Exclude therapy administered for the management of EAS.
Action taken
Treatment
Give the generic name of the drugs / treatment given in the last 30 days
Total daily dose
Route of Administration
1 = Oral 2 = Intravenous 3 = Subcutaneous 4 = Other (specify)
Start Date (dd mmm yy)
Currently happening?
0 = No
1 = Yes
End date (dd mmm yy)
0 = None 1 = Dose reduction 2 = Delayed treatment 3 = Delayed and reduced treatment 4 = Treatment
permanently suspended
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Other relevant information that facilitates the evaluation
(Include medical history, drug or alcohol abuse, family history, special research findings, etc.)
Was this event expected from the point of view of the patient's medical history?
0 = No
1 = Yes
Additional Information:
Authorized Health Professional Firm
………………………………………………………….
.
Contact phone number
…………………………………………………………
…… ..
Name
……………………………………………………
...
Report date
d d m mm a a
OFFICIAL USE ONLY
Was the EAS drug related?
Yes No Event No
Was the event unexpected? Yes No Comments:
Was the event a RASIS / SUSAR?
Shipping Date Form
Date of introduction in the
If not
d d m mm a a
database d d m mm a a
Code
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Form reviewed by
(Firm)                            ……………………………………
………
Review by a clinician (Signature) ……………………………………
...
Date
d d m mm a a
Date
d d m mm a a
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ANNEX 9A SECURITY REPORT. CLINICAL TRIALS OF MEDICINAL RESEARCH PRODUCTS (PMI)
Full name of the essay Short title
Research product (s) under investigation (PMI) Sponsor
CEIS that approved the study Principal investigator Trial start date
Trial end date Target number of subjects for the entire trial
Contact details for the person making the notification
Name Address Telephone Fax
E-mail
Date of this notification
Security information in the reported period
Number of subjects included during the period under review
How many patients have been included since the start of the trial
Number of EAS observed
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About the study
Period covered by the report: a
Insert the “gram flow” of the study
RANDOM
ARM A
ARM B
Sample size
Number of patients included
Start date of patient inclusion Estimated closing date
Results to evaluate
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Subject ID
Body system (See APPENDIX,
at the end of this Annex)
Reference Case Number
country
Date of birth
Sex
PMI dose
Date of treatment
EA Appearance Date
Adverse reaction Evolution Comments
Unmasking results (when applicable)
QT001
Online list of the Safety Report of the trial
Summary Summary and tabulation of the essay
Body system / Medical term Arm A Arm B
Total
Gastrointestinal (11) 1 0
one
Nausea, vomiting and diarrhea 1 0
one
Patient Safety Statement
Report of the Independent Data Monitoring Committee (if applicable)
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NOTES: GUIDE TO COMPLETE THE LIST OF SEMESTER SECURITY REPORTS AND THE SUMMARY TABULATED
Comment field
Subject ID Patient number in the trial
Body systems classified according to the Common Toxicity Criteria (Version 3.0)
1. Allergy / Immunology
2. Hearing / Ear
3. Blood / Bone Marrow
4. Cardiac Arrhythmia
5. Cardiac in General
6. Coagulation
7. Constitutional Symptoms
8. Death
9. Dermatology / Skin
10. Endocrine
11. Gastrointestinal
12. Growth and Development
Body system
13. Hemorrhage / Bleeding
14. Hepatobiliary / Pancreas
15. Infection
16. Lymphatic
17. Metabolic / Laboratory
18. Skeletal muscle / soft tissues
19. Neurology
20. Eyepiece / Visual
21. Pain
22. Pulmonary / Upper respiratory tract
23. Renal / Genitourinary
24. Secondary Malignancy
25. Sexual / Reproductive Function
26. Intra-operative Surgery / Injuria 27. Syndromes
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Comment field
28. Vascular
29. Other
Case reference number
country
This is a number that uniquely identifies the AES event This refers to the country where the case occurred
Date of birth Date of birth (day-month-year) Sex F = female M = male
PMI dose in mg
Date the patient started the event-related cycle (day-month-year)
Date of treatment
EA Appearance Date
Adverse reaction
Evolution
Date symptoms started (day-month-year)
Describe the symptoms that the patient experienced during the event manifestation, event progression, exams,
etc.
It refers to the given treatment (trial or other)
Other comments
Results of the Blind survey (when applicable)
This section is optional, it is only filled if it is relevant (eg due to disagreement on causation, concomitant medication
also suspicious, etc.).
Provide details, if the Blind survey was performed
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ANNEX 9B SECURITY REPORTS COVER
CLINICAL TRIAL OF MEDICINAL RESEARCH PRODUCT (PMI) SECURITY REPORT TO THE ETHICS COMMITTEE
CORRESPONDING RESEARCH
Please indicate what type (s) of Security Report (s) you wish to notify with this COVER (check all that
correspond). Use a different sheet for each clinical trial.
Expedited report of a serious adverse local reaction (RASIS)
Notify only the RASIS occurred in the sites within El Salvador
6 month security report
Include a global list of all RASIS related to the medicinal product under investigation and that have
occurred in the reported period
Annual Security Report
Include a global list of all suspected or expected serious local adverse reactions (RASS)
related to the PMI and that have occurred in the reported period
Other
For example, reports from the Data Monitoring Committee or other security review Full title of the study:
Research sponsor: Name of principal / chief investigator:
Name of the corresponding CEIS:
CEIS evaluation report number:
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Contact details of the person making the notification
Name:
Address:
Phone:
Fax:
E-mail:
Date of notification: Signature:
List of attached documents
Please list each report submitted with this notification (insert rows, as required).
1. RASIS expedited (only in El Salvador)
Report Number of
Trial site
sponsor / reference
Date RASIS was first reported to the sponsor
Is this a 7 or 15 day report?
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2. Other reports
Type of report Date of report
Recognition of receipt by the corresponding CEIS (please insert the name):
CEIS [] received the current report:
Signature: Name:
CEIS position:
Date:
Sign the original to be returned only to the sponsor (or who submits the report).
The copy must remain for information in the CNEIS.
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ANNEX 10A SUBSTANCIAL AMENDMENT NOTICE FOR CLINICAL STUDIES THAT ARE NOT OF MEDICINAL PRODUCTS
For use in all cases of research other than clinical trials with PMI.
It must be completed legibly and so that people who lack knowledge can understand it
doctors and / or specialized. It must be submitted for authorization to the corresponding CEIS and notify the Center or
Research unit.
Details of the Principal Investigator:
Name Address:
Telephone: E-mail: Fax:
Full title of the study:
Name of the corresponding CEIS: Reference number of the CEIS: Start date of the study: Protocol reference
(if applicable), current version and date:
Amendment number and date:
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Type of amendment (indicate all that apply in bold)
(a) Amendment to the information previously given to the CNEIS in the Application Form Yes No
If yes, refer to the application section to the CNEIS ("Summary of Changes")
(b) Amendment to the protocol
If not
If yes, submit the revised protocol with a new version number and date, noting the changes clearly,
or document a list of changes and the two texts (the previous one and the revised one).
(c) Amendment to the information sheet and informed consent (s) for the participants, or any other
study support document
If not
If yes, submit all revised documents with new version numbers and dates, noting changes in form
evident.
Is this a modified version of an amendment previously notified to the CNEIS and gives an unfavorable opinion?
If not
Summary of Changes
Briefly summarize the main changes proposed in this amendment, with a language
Understandable for a layman. Explain the purpose of the changes and their meaning for the study. In
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In the case of a modified amendment, indicate the modifications that have been made.
If the amendment significantly alters the study design or methodology, or may otherwise affect
The scientific value of the study must include supporting scientific information (or attach it separately).
Indicate whether additional scientific criticism has been obtained or not.
Any other relevant information
Those who apply can indicate any specific ethical problem related to the amendment, which is desired
the opinion of the CEIS.
List of attached documents
Document Version Date
Statement
I confirm that the information in this format is accurate and I assume full responsibility for it.
I consider it reasonable that the proposed amendment should be implemented. Signature of the Chief Investigator
……. ………………………………
Name   …….………………………………
Date of submission …………………………………….
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ANNEX 10B SUBSTANTIAL AMENDMENT FORMAT FOR CLINICAL PRODUCT TESTS
RESEARCH MEDICINALS (PMI)
NOTIFICATION OF A SUBSTANCIAL AMENDMENT TO A CLINICAL TRIAL OF A MEDICINAL PRODUCT FOR HUMAN USE, DIRECTED
TO THE HEALTH RESEARCH ETHICS COMMITTEE AND THE COMPETENT AUTHORITY.
For official use:
Date of receipt of the request: Date:
Basis for non-acceptance / negative opinion:
Start date of the procedure: Authorization / positive opinion:
Registration number of the corresponding CEIS: Withdrawal of the application of the amendment
Competent authority for the study: Date:
To be filled out by the applicant:
This form must be submitted to the corresponding CNEIS, for the opinion on a substantial amendment, and then must
present to the competent authority, when applicable.
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A. TYPE OF NOTIFICATION
A.1 Notification for an opinion of the CNEIS:
A.2 Notification to the competent authority:
A.3 Information notification only *:
A.3.1 To the CNEIS:
A.3.2 To the competent authority:
B. TEST IDENTIFICATION:
B.1 Does the substantial amendment concern several trials involving PMI? If not
B.1.1 If the answer is yes, repeat this section as many times as necessary
B.2 Full title of the essay:
B.3 Sponsor's code number for the protocol, version and date:
C. IDENTIFICATION OF THE SPONSOR RESPONSIBLE FOR THE APPLICATION
C.1 Sponsor
C.1.1 Organization:
C.1.2 Name of the contact person:
C.1.3 Address:
C.1.4 Telephone number:
C.1.5 Fax number:
C.1.6 E-mail:
C.2 Legal Representative of the sponsor in the country, for the purpose of the trial (if different from the sponsor)
* For substantial amendments, only notify when the competent authority (CA) has determined
previously (eg quality data). The sponsor must not only submit the amendment to the CA, but also inform the
CEIS that has notified, marking "for information only". Similarly, the sponsor must inform the CA of
any notification of a substantial amendment that was previously determined by the CEIS (eg Sites for
study completion).
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C.2.1 Organization:
C.2.2 Name of the contact person:
C.2.3 Address:
C.2.4 Telephone number:
C.2.5 Fax number:
C.2.6 E-mail:
D. IDENTIFICATION OF THE APPLICANT (Check the appropriate box)
D.1 Request to the CEIS
D.1.1 Sponsor
D.1.2 Legal Representative of the sponsor
D.1.3 Person or organization authorized to make the application
D.1.4 Researcher in charge of the application, when applicable:
D.1.4.1. Study coordinator (for multicentric studies):
D.1.4.2. Principal investigator (for single-center trials):
D.1.5 Complete
D.1.5.1 Organization:
D.1.5.2 Name:
D.1.5.3 Address:
D.1.5.4 Telephone number:
D.1.5.5 Fax number:
D.1.5.6 E-mail:
D.2 Request to the competent authority
D.2.1 Sponsor
D.2.2 Legal Representative of the sponsor
D.2.3 Person or organization authorized by the sponsor to make the application
D.2.4 Complete
D.2.4.1 Organization:
D.2.4.2 Name:
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D.2.4.3 Address:
D.2.4.4 Telephone number:
D.2.4.5 Fax number:
D.2.4.6. E-mail:
E. IDENTIFICATION OF THE SUBSTANTIAL AMENDMENT
E.1 Sponsor's code number for the substantial amendment, version and date for the clinical trial
concerning:
E.2 Substantial amendment type
E.2.1 Amendment to the informed consent information Yes
Do not
E.2.2 Amendment to the protocol
If not
E.2.3 Amendment to other attached documents, in the initial application form
If not
E.2.3.1 If yes, specify:
E.2.4 Amendment to other documents or information Yes No
E.2.4.1 If yes, specify:
E.2.5 This amendment concerns urgent security measures, which have already been implemented
If not
E.2.6 This amendment is to notify a temporary suspension to the test Yes
Do not
E.2.7 This amendment is to request to restart the test Yes No
E.3 Reason for the substantial amendment:
E.3.1 Changes in the safety or integrity of the subjects, in the test Yes
Do not
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E.3.2 Changes in the interpretation of the relationship “scientific documents / test value”
If not
E.3.3 Changes in the quality of the PMI
If not
E.3.4 Changes in the conduct of trial administration Yes
Do not
E.3.5 Changes or addition of principal investigator (s) and / or coordinator researcher (s)
If not
E.3.6 Changes of sponsor, legal representative, applicant Yes
Do not
E.3.7 Changes / add site (s)
If not
E.3.8 Changes in the transfer of main tasks Yes
Do not
E.3.8.1 If yes, specify:
E.3.9 Other changes
If not
E.3.9.1 If yes, specify:
E.3.10 Other case
If not
E.3.10.1 If yes, specify:
E.4 INFORMATION ON THE TEMPORARY SUSPENSION OF THE TEST
E.4.1 Temporary suspension failure (YYYY / MM / DD)
E.4.2 The inclusion of patients has been suspended Yes No
E.4.3 The treatment has been suspended Yes No
E.4.4 Number of patients who are still receiving treatment, at the time of temporary suspension, in the
Substantial modification concerning the
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amendment:
E.4.5 What (s) is / are the reason (s) for temporary suspension?
E.4.5.1 Security
If not
E.4.5.2 Lack of effectiveness
If not
E.4.5.3 Other
If not
E.4.5.3.1 If yes, specify:
E.4.6 Briefly describe:
Justification for a temporary suspension to the trial (free text):
The proposed management of patients receiving treatment, at the time of suspension (free text):
The consequences of the temporary suspension for the evaluation of the results and the determinations of
overall risk / benefit for the medicinal product for research (free text):
F. REASONS FOR THE SUBSTANTIAL AMENDMENT (one or two sentences):
G. BRIEF DESCRIPTION OF THE CHANGES (free text):
H. CHANGE OF CLINICAL TRIAL RESEARCH SITES
H.1 Exchange rate
H.1.1 New site added
H.1.1.1 Principal Investigator (provide details)
H.1.1.1.1 First Name:
H.1.1.1.2 Middle Name (if applicable)
H.1.1.1.3 Surname
H.1.1.1.4 Qualifications (Dr. ...)
H.1.1.1.5 Professional Management
H.2 Removal of a research site
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H.2.1 Principal Investigator (provide details)
H.2.1.1 First Name
H.2.1.2 Middle name (if applicable)
H.2.1.3 Surname
H.2.1.4 Qualifications (Dr. ...)
H.2.1.5 Professional Management
H.3 Change of coordinating researcher (provide details of coordinating researcher)
H.3.1 First Name
H.3.2 Middle name (if applicable)
H.3.3 Surname
H.3.4 Qualification (Dr. ...)
H.3.5 Professional Management:
H.3.6 State the name of the previous coordinating researcher:
H.4 Change of the principal investigator at an existing site (provide details about the new principal investigator)
H.4.1 First name
H.4.2 Middle name (if applicable)
H.4.3 Surname
H.4.4 Qualification (Dr. ...)
H.4.5 Professional Management:
H.4.6 State the name of the previous principal investigator:
I. CHANGE OF INSTRUCTIONS TO THE COMPETENT AUTHORITY, FOR FEEDBACK TO THE SPONSOR
I.1 Change of electronic contact for application feedback Yes
Do not
If yes, provide the new email in which you wish to receive feedback:
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J. LIST OF DOCUMENTS ADDED TO THE NOTIFICATION FORM
Please submit only relevant documents and / or explanatory references to those already submitted (when applicable). Make
Clear references to any change of the separate pages, and submit old and new texts. Check the box
appropriate
J.1 Declaration letter of the type of amendment and the reason (s)
J.2 Summary of proposed amendments
J.3 List of modified documents (identity, version, date)
J.4 Pages with the previous and new words (if applicable)
J.5 Supporting information
J.6 Copy of initial application form, with amendment data highlighted
J.7 Comments on any new aspect of the amendment
K. APPLICANT'S SIGNATURE
K.1 I confirm that [I confirm in the name of the sponsor that]:
The information given in this document is correct, that the test will be conducted according to the protocol, the
national regulation and the principles of Good Clinical Practices; and it is reasonable that the
proposed amendment.
K.2 Application for the Clinical Research Ethics Committee:
K.2.1 Signature:
K.2.2 Name:
K.2.3 Date:
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K.3. Application for the competent authority:
K.3.1 Signature:
K.3.2 Name:
K.3.3 Date:
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ANNEX 11 NOTIFICATION OF SERIOUS DEVIATIONS
Sponsor:
Date on which the deviation was identified:
Individual or organization that committed the deviation:
Details of the study:
Title:
Principal Investigator / Chief:
Registration number (if applicable):
Number of CEIS Evaluation Minutes:
Date of ethical approval:
Details of the deviation, including the cause:
Details of the action taken:
Signature of the one who prepared the report: Date:
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ANNEX 12 CONTINUITY REPORT
CONTINUITY REPORT
Date of this report (day / month / year): Study number evaluated: Principal Investigator:
Protocol Title:
FEATURES
Sponsor: Financing: Yes No
Estimated project duration (months or years):
IMPORTANT DATES
Initial approval by the CEIS (day / month / year):
Last revision (day / month / year):
Inclusion of the first patient (day / month / year):
Closing date (day / month / year, when applicable):
Revisions of amendments and CEIS approval dates:
No. Date (day / month / year): No. Date (day / month / year): No. Date (day / month / year): No.
Date (day / month / year): No. Date (day / month / year): No. Date (day / month / year): No.
Date (day / month / year): No. Date (day / month / year):
CURRENT STATUS OF THE PROTOCOL
Open to inclusion of participants
Closed for inclusion, but some patients with active treatment
Closed for inclusion, but follow-up patients
Temporary suspension of the inclusion of participants
PRIMARY OBJECTIVES (Please summarize briefly the objectives of the study).
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CONTINUITY REPORT INCLUDING PATIENTS AND POSSIBILITY OF EVALUATION
Target number of subjects to include on your site: Total number of the study:
Number of subjects included to date on your site: Total number included to date: Number of subjects
Included since the last annual report (when applicable):
At this rate of inclusion, the target number of subjects on your site will be achieved:
Yes
Do not
If no, explain:
For studies closed to inclusion, but open for follow-up, indicate: Number of patients currently alive:
No. of patients who died
RESULTS OF THE STUDY (Please summarize all available information about toxicity, efficacy
expected or any other therapeutic efficacy. Attach a copy of the most recent Toxicity Summary Report for this
study).
Briefly summarize the results of the study to date. If they are not available, explain.
Have some participants voluntarily withdrawn from the study?
If not
If yes, specify the number and explain the reason:
Were some participants involuntarily removed from the study?
If not
If yes, specify the number and explain the cause:
Is there any significant new finding that may affect the willingness of the participants to continue in the
study?
If not
If yes, explain:
For corporate groups and consortium studies, attach a recent copy of the progress report
group set. If not available, explain the reason:
Is there a Data Monitoring Security Committee or other review committee for this protocol?
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Yes
Do not
CONTINUITY REPORT
If yes, attach a copy of the most recent report.
SERIOUS OR UNEXPECTED AND DEAD ADVERSE EVENTS IN THE STUDY (Please,
describe the type and frequency of any serious or unexpected adverse event (including deaths), as well as the
Actions performed in response. Indicate if the available results affect the relationship
risk / benefit Also, indicate your interpretation of the events, whether "related to the study" or "unrelated
to study ”).
Have serious or unexpected adverse events, and all deaths in the study, been reported at
CEIS? Yes
If not, explain.
Do not
Has the hospitalization rate changed since the last review by the CEIS? (when applicable) Yes
Do not
If yes, explain.
MAKE A LIST OF ALL PRESENTATIONS, SUMMARIES AND OTHER
PUBLICATIONS SUBMITTED UNTIL THE MOMENT (Please attach the relevant copies).
FUTURE PLANS
Briefly summarize the plans to continue this study.
If no participant has been included to date, indicate why this study should continue. For studies
corporate or consortiums, indicate plans to continue this study.
STATE REQUESTED FOR THIS PROTOCOL, BY THE RESEARCHER
That the study remains open to the inclusion of participants.
That the study be closed to the inclusion of participants, but that it remains open to follow-up.
On what date do you want this study closure to be effective (day / month / year):
Study completed (only one of the following two criteria is met):
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CONTINUITY REPORT
All data entries are completed, as is the analysis.
All subjects and future data collection and analysis have been transferred to a protocol of
long term follow up. Take note that it is the responsibility of the researcher to certify / document the transfer
of participants to a long-term follow-up study, and that the Informed Consent to
The long-term study must be obtained.
FOR STUDIES THAT WILL CONTINUE INCLUDING PARTICIPANTS, ATTACH A COPY OF THE LAST INFORMED CONSENT APPROVED
CERTIFICATIONS
Signature of the Principal Investigator
Date
Sponsor Signature (if applicable)
Date
Signature of the monitor (if applicable)
Date
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ANNEX 13A NOTIFICATION OF FINALIZATION OF A CLINICAL TRIAL OF A RESEARCH MEDICINAL PRODUCT
(ECA-PMI)
This notification must be delivered within the first 90 days after the end of a trial.
clinical, or within the first 15 days, if the completion was premature.
Date received by the authority:
To be filled by the applicant:
Protocol identification
Title:
Approval date:
Sponsor Protocol Number:
Applicant Identification
B.1. Sponsor ID
1. Name of the sponsor:
2. Name of the legal representative of the sponsor in the country:
3. Address:
4. Telephone / Fax:
5. E-mail:
B.2. Investigators Identification
1. Name of the principal investigator:
2. If there are several sites, cite the names of the responsible researchers per site:
Study Completion
The study ends on the country site: Completion date:
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The study ends at all sites in other countries:
Finish date:
This completion is premature:
If yes, write the date:
What causes premature completion of the study? Security
Lack of effectiveness
The study did not start Other
If you answered yes to any of the above, please add a brief summary freely.
Justification for premature completion of the study Number of patients included before completion Effects
in patients due to premature termination
Through my signature I state that the above is reliable.
F.
Name Date:
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ANNEX 13B NOTIFICATION OF FINALIZATION OF A STUDY THAT DOES NOT INVOLVE MEDICINAL PRODUCTS IN RESEARCH
This notification must be delivered within the first 90 days after the end of a clinical trial, or within
of the first 15 days, if the completion was premature.
Principal Investigator Identification
1. Name of the researcher:
2. Address:
3. Telephone / Fax:
4. E-mail:
Study Details
1. Name of the project:
2. Name of the sponsor:
3. Date of ethical approval:
4. Number of ethical approval minutes:
5. Name of the CEIS:
Study duration
1. Start date:
2. End date:
3. Was the completion premature?
Yes: If yes, go to section D
No: If no, go to section E
Circumstances of premature termination
Justification for premature completion:
Temporary stops
Is the study stoppage temporary? If yes, write the justification:
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Potential implications for subjects
Does stopping the study prematurely / temporarily have implications on the subjects included?
Please include the steps taken to counteract the implications:
Final report of the study
Is the summary of the final study report included? If not
If not, you have 12 months to deliver it
Statement
Name of researcher: Signature:
Date:
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ANNEX 14. CHECKLIST OF REQUIREMENTS FOR FULFILLMENT OF GOOD CLINICAL PRACTICES.
Criterion
RESEARCH COMPETENCES
Academic training in research, good clinical practices. You must provide evidence of those requirements to
through your updated Curriculum Vitae and / or any other relevant related documentation
The researcher is completely familiar with the proper use of the product in
investigation, as described in the protocol, current copy of the Investigator Brochure,
in product information and other relevant sources of information.
There is a dated and signed list of suitable persons to whom it has delegated tasks
significant related to the study, containing their names and functions that have been delegated to them
YES NO Comments:
ADEQUATE RESOURCES YES NO Comments:
The researcher must have sufficient time to conduct and properly complete the study within the
agreed period.
The researcher must have a sufficient number of qualified personnel and adequate facilities for the
expected duration of the study in order to conduct it appropriately and safely
Training of the research team should be documented including: name of each person trained,
training program and dates. Source: Curriculum Vitae
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MEDICAL CARE FOR PARTICIPATING STUDENTS
Appropriate medical care is provided to the person in case of an adverse event, including values
of clinically significant laboratory, related to the study. Source: Protocol
There is an authorization letter from the authority of the health center (it includes
hospitals, Community Family Health Units, clinics) to carry out the study within
the installations. It includes knowledge of the head of the hospital service, if applicable.
The researcher must seek through prior agreements with the sponsor the
continuity of treatment to research subjects once their
Participation in the study if your interruption jeopardizes your safety within the frameworks
applicable regulators. Source: procedures described in the research protocol.
AUTHORIZATION OF THE ETHICAL CONSIDERATIONS OF THE RESEARCH
Before starting a study, the researcher / institution must have the
favorable approval / opinion, written and dated, of the CNEIS / CEIS study protocol, the
Informed consent form, updates, recruitment procedures
of subjects (for example, announcements) and any other written information that will be provided to
YES NO Comments:
YES NO Comments:
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persons
COMPLIANCE WITH THE PROTOCOL YES NO Comments:
The researcher / institution must conduct the study in accordance with the protocol agreed with the
sponsor and favorable approval / opinion of the CNEIS / CEIS and, if necessary, by the authorities
Regulatory
The investigator or the person designated by the investigator must document and explain any
deviation from the approved protocol, except for changes involving only logistic or administrative aspects
of the study (for example, change of monitors, change of telephone number).
RESEARCH PRODUCTS YES NO Comments:
The product delivery records are available to the study site, the inventory on the site, the use
in each subject and the return to the sponsor or alternate disposition of the unused medicine
The product (s) are stored as specified by the sponsor and in accordance with the
applicable regulatory requirements The researcher or a person designated by the researcher / institution must
explain the correct use of the product under investigation to each subject and must verify at appropriate intervals
for the study, that each subject is following the instructions appropriately.
ASSIGNMENT PROCESSES
RANDOM AND OPENING OF THE BLIND
The researcher must follow the procedures
YES NO Comments:
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randomization of the study, if any, and you should ensure that the code only
open in accordance with the protocol. If the study is blind, the researcher must document and
Quickly explain to the sponsor any premature breaking of the code (for example,
accidental breakage, breakdown by a serious adverse event) of the product under investigation.
PROGRESS REPORTS YES NO Comments:
The researcher must submit to the CNEIS / CEIS written summaries of the study status in
annual or more frequently if requested
The researcher must immediately submit written reports to the sponsor, the CNEIS / CEIS and,
when applicable, to the institution about any significant change that affects the conduct of the study and / or
increase the risks for the subjects
SAFETY REPORTS YES NO Comments:
The researcher must comply with the applicable regulatory requirements
related to the report of
unexpected serious adverse drug reactions
For reported deaths, the investigator must provide the sponsor and the
CNEIS / CEIS any additional information requested (for example, autopsy reports and medical reports
from
egress)
TERMINATION OR SUSPENSION OF
STUDY
YES NO Comments:
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If the study is terminated or suspended prematurely for any reason, the
researcher / institution should inform quickly
to the people in the study, you must ensure appropriate treatment and follow-up for the people and,
when stipulated by regulatory requirements, you must inform the corresponding authorities by
written a detailed explanation of this suspension or termination
FINAL REPORT YES NO Comments:
At the end of the study, the researcher, when applicable, must inform the institution, the
Research / institution must provide the sponsor with all required reports, to the CNEIS / CEIS a
summary of the result of the study and to the regulatory authorities any report requested.
FINANCIAL ASPECTS YES NO Comments:
The financial aspects of the study should be documented in an agreement between the
Sponsor and researcher / institution. This document must be included in the presentation of the protocol. East
agreement must include evidence of acceptance / commitment of the institution / administration
hospital for the provision of facilities and services and the payments proposed by the sponsor
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ANNEX 15. INTERINSTITUTIONAL MACROPROCESS FOR AUTHORIZATION AND MONITORING OF CLINICAL TRIALS
CLINICAL STUDY REVIEW AND APPROVAL PROCESS
OBJECTIVE: To establish parameters for the documentary review of Clinical Trials among the National Ethics Committee of
Health Research (CNEIS), National Institute of Health (INS), National Directorate of Medicines and Council
Superior of Public Health, to contribute to the development of quality and consistency in the ethical evaluation of
research, as well as establishing mechanisms to ensure clear and efficient communication, to promote
Development of ethical evaluation.
RESEARCHER OR RESPONSIBLE
CNEIS
DNM
Start
Presents clinical study
Receive study
Distribute study to members of the CNEIS and
B refers to the DNM for
revision.
Receive and review protocol
Is the
protocol? Do not
Prepare protocol of observed or Not Approved protocol
Is the
protocol? Do not
Send observed or denied protocol resolution
Yes
TO
Prepare approval report of the clinical study
Yes
TO
Submit approval resolution
Receives Protocol Approval Act.
Forward Protocol Approval Minutes
The end
TO
Forward Certificate of observation or non-approval of the protocol
Receive observation or denial of research study
Notify the investigator
If it is observation, send documentation of correction of observations
Receive documents from
B rectification
observations
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CLINICAL STUDY FOLLOW-UP PROCESS
RESEARCHER OR RESPONSIBLE
CNEIS
DNM
CSSP
Start
Request approval of the importation of the medicine
TO
Submit documentation to correct observations
Review request for authorization to import the medicine
Was the importation of the medicine authorized?
No Notify comments
Yes A
Receive import authorization resolution of Special Visa
Delivery resolution of import authorization of Special Visa
Notifies start of clinical study
Receive notification
Request audit of Good Clinical Practices
Prepares audit of Good Clinical Practices based on Procedure 13 of the MPOE-CNEIS.
Execute Good Audit
C
Clinical Practices
Receive report and analyze results
Submit audit report of Good Clinical Practices
B
Receive notification of decision of the plenary for compliance with Good
Does it comply with Good Clinical Practices?
Notifies the plenary decision, result of the audit of Good Clinical Practices.
Clinical Practices No
B
Continues clinical study and submits reports based on the Standard Operating Procedures Manual of the National Committee
of Health Research Ethics
Forward Observations of the Audit of Good Clinical Practices
The end
Prepares an action plan to correct the findings of the audit of Good Clinical Practices
Presents an action plan to correct the findings of the Good Clinical Practice audit
Receive and review action plan in conjunction with CSSP and DNM
Request follow-up audit of Good Clinical Practices
Prepare and execute BPC tracking audit
Submit BPC follow-up audit report
C
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ANNEX 16. CONFIDENTIALITY AGREEMENT
CONFIDENTIALITY ACT
With the objective of guaranteeing the highest reliability in the labor relations between the parties and contributing to the
development and improvement of the missions that the National Committee for Health Research Ethics fulfills
Adopt this agreement.
On the one hand, in his capacity as Chairman of the National Ethics Committee of the
Health Research, Start Paseo General Escalón # 3551, San Salvador, El Salvador, Central America. For other
part: as
has accepted and has been authorized by his institution to collaborate as of the Committee
National Health Research Ethics.
Both parties reciprocally recognize their capacity and state that they have agreed to sign the precepts
established in this Confidentiality Agreement.
First: The National Committee for Health Research Ethics makes available to the Expert the information
required for the performance of its work.
Second: During his work he will have access to information with character
confidential that should not be used for outside purposes.
The parties that sign this agreement must comply with it in full and comply with the provisions of this
Confidentiality Agreement sign two copies of it with the same tenor and equal validity in legal force.
Given in San Salvador on the 20th day of the month of XXX of the XXXX year.
PRESIDENT NAME
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ANNEX 17. DECLARATION OF ABSENCE OF CONFLICTS OF INTEREST
Declaration of Absence of Conflicts of Interest
In the course of performing your duties as under this agreement, you will have
access to information owned by the National Committee for Health Research Ethics. You agree to try
this information as confidential (hereinafter as "information")
I,
I compromise to:
a) Not to use the information for any other purpose than to fulfill my obligations under this agreement; Y
b) Not disclose or provide the information to any third party who does not have a working relationship and
Confidentiality in it and to use the information properly.
It will not relate to any obligation of confidentiality and will not use it until you are clearly not
able to demonstrate that any part of the information:
a) It was known by you before any disclosure or discovery by the National Ethics Committee of
Health Research, or:
b) It was public domain at the time of discovery by the National Committee for Health Research Ethics,
or:
c) It has become part of the public domain, or:
d) It has been available to you by a third party without abuse of trust or of the obligations of
Confidentiality to the National Committee for Health Research Ethics.
I promise not to communicate the deliberations and results of the team of
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in which it participates, as well as the resulting recommendations
and / or the decisions of the National Committee for Health Research Ethics to third parties, except as
explicitly agreed the National Committee for Health Research Ethics.
You will perform your responsibilities exclusively in your capacity as a
of the National Committee of Ethics of Health Research. Signing this
agreement, you confirm that you have no financial interest and / or other relationship with the parties, which:
a) They could have a commercial interest created by obtaining access to any part of the referred information
previously and / or:
b) You may have an interest created in the result of the appreciation of the products, in which you will participate
but it will not limit parties such as the producer that has been evaluated or from competent producers.
I accept the provisions and conditions contained in this document and for the record, I sign this document:
Name:
Entity:
Date:
Firm:
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ANNEX 18 EXTERNAL EXPERTS
1. OBJECTIVES
Establish the criteria for the integration and operation of the Committees of External Experts to guarantee the
quality in the documentary and administrative functioning, and comply with international guidelines for the process of
decision making of the National Committee for Health Research Ethics.
2. REACH
Understand the performance guidelines of professionals hired as External Experts of the National Committee of
Health Research Ethics, from your contract for evaluation to the delivery of reports and opinions by
part of the Committee of External Experts, in addition to providing guidance to the ethics committees of the
research (CNEIS / CEIS) on which organizations depend to examine and monitor the ethics of the
research, as well as researchers who design and carry out health research studies.
3. PRIOR REQUIREMENTS
Application filed by the National Committee for Health Research Ethics in which it applies
conformation of the Committee of External Experts as technical-scientific evaluators that issue an opinion
based on your judgment and experience, on certain topics.
4. DESCRIPTION
RESPONSIBLE DESCRIPTION
The CNEIS may establish and approve by resolution the Committees of External Experts it deems necessary. The
Committees will be composed of External Experts and CNEIS officials, with adequate training and experience,
which may be permanent or temporary.
The CNEIS will establish the organizational structure of the Committees of External Experts in the resolutions of
appointment.
CREATION OF EXTERNAL EXPERTS COMMITTEES
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RESPONSIBLE DESCRIPTION
The Committees of External Experts will have a document that will define at least the following elements: objective
and scope, composition, designation of the leader, secretariat, declaration of absence of conflict of interest,
functions of the members, agenda, minutes and operating procedure including the quorum to meet, members with
right to vote and decision making.
The Committees of External Experts may be convened according to their schedule of meetings or under
justified circumstances, if extraordinary sessions are required to solve problems
specific.
The members of the Committees of External Experts cannot participate in work sessions if previously
have not deposited a declaration of absence of conflict of interest or if the last declaration of absence of
Conflict of interest dates back more than a year.
In case of absence of deposit of declaration of absence of conflict of interest, it is suspended
provisionally the participation of the members in the work of the Committee of External Experts, until the
situation regularize. Members declare at each meeting, the interests that could be considered as
harmful to their independence when the items on the agenda are informed.
The Committees of External Experts must submit to the CNEIS as a result of their work an individual report and a record
that contains the final decision voted, in correspondence with the terms described in the contract signed with the
CNEIS
The content of the report will include information regarding the start date of the evaluation, general information on the
object to be evaluated (product or institution), reason for the evaluation, description of the evaluation carried out,
recommendations, date of completion of the evaluation (expected and actual), name and signature of experts
involved
OPERATION OF THE COMMITTEES
The CNEIS External Experts are identified by means of IDENTIFICATION profiles
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RESPONSIBLE DESCRIPTION
specific knowledge for each particular situation.
If the required expertise is not available in the CNEIS, the Expert selection process is carried out
External
The CNEIS will have communication with the identified External Experts, through a formal written communication.
The selected External Experts must establish immediate communication with the CNEIS for the exercise of their
functions.
The External Expert, in the absence of a conflict of interest, must complete and sign a declaration of non-conflict of interest.
interests, where you express that you do not have any real, potential or obvious conflict of interest situation.
You will have 10 business days to send said declaration to the CNEIS.
The CNEIS Technical Committee will be responsible for the evaluation of the candidates for External Experts, and responsible for
Decide on their acceptance and participation in the activities assigned as Experts
External in the CNEIS.
The Technical Committee will base the selection of External Experts on the following elements:
- Suitability of the applicant in how much training and / or experience in the subject for which their
Expertise
- Declaration of no conflict of interest or its level of risk.
The CNEIS will not entrust activities to the External Experts if it has not signed a declaration of interests, which
It allows a priori control of the absence of conflict of interest.
The Technical Committee will assess the level of risk of conflicts of interest present, depending on the interests
declared and the professional universe of the expert (industry, academic or regulator).
As a result of the evaluation of the selected professionals, the CNEIS
EXTERNAL EXPERTS
CONFLICT OF INTERESTS
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RESPONSIBLE DESCRIPTION
propose the appointment of the Leading External Expert.
The CNEIS will require the External Experts to update the declarations of interests annually.
External Experts in the performance of their duties must update the declaration of interests for
own initiative when discovering a risk of conflict of interest in any of the phases of
evaluation or consciously deem to abstain and declare it immediately, in order to take action
relevant.
The External Expert may refrain from signing his statement if he consciously considers that he does not
You can carry out your activity because of the risk of impartiality or if you believe that your impartiality will be
doubt.
The CNEIS will file the documentation presented by the External Expert and the one generated in its selection process
(Call, conformity of the expert's labor entity, Curriculum Vitae, labor profile of the
External Expert, declaration of conflicts of interest and copy of the resolution of appointment), and will record the
External Experts appointed, with their qualification and professional experience, in the Registers of External Experts of the
CNEIS
The CNEIS establishes as a prerequisite to the use of the External Expert the signing of its commitment to
confidentiality, in relation to all the information that is given to you or that is generated in your work as an Expert
External.
The External Expert must sign a confidentiality agreement as a sign of their commitment in this regard.
The hiring and remuneration of the External Expert will be governed by the applicable regulations of the Procurement Law
and Public Administration Contracts (LACAP) and their contract time. The type of contract will be
liquidated as professional services, based on the payroll based on specialty, approved.
CONFIDENTIALITY D
HIRING
The period, number of meetings and duration of the Committees of External Experts MEETINGS
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RESPONSIBLE DESCRIPTION
they may differ due to the type or complexity of the investigation to be carried out and must be justified and defined by
the one who chairs it to be included in the minutes of installation of Committees of External Experts with a duration limit
3 months containing in them 6 meetings maximum to make an opinion and respond to the case for which
It was shaped.
Each Committee of External Experts held at the institution must have established the following:
- Name of the leader External Expert
- Name of the secretary of the Committee of External Experts
- Name of External Experts
- Sessions to celebrate
- Calls
- Quorums
- Minutes
- Validity
To hold the meetings in order to solve a problem in the Committees of External Experts, you must:
- Define the Agenda to be developed or the objective of the Committee meeting.
- Convene the participants and the guests attaching the agenda to be developed, the objective of the
Committee and the purpose of the meeting.
- Indicate in the call the information or reports necessary to present during the activity.
- Develop the scheduled meeting or activity at the appointed time.
- Verify the approval of the previous minutes and the follow-up to commitments of the previous minutes when applicable.
- Prepare the attendance record.
- Raise Minutes of the results of the development of the agenda highlighting as a priority:
-     The topics discussed
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RESPONSIBLE DESCRIPTION
- The decisions made
- Assigned tasks or commitments
- Record disagreements in decision making.
The draft of the minutes is sent by email to the members of the Committee that formed the meeting, with the
in order to make the observations or adjustments deemed pertinent.
Email comments, corrections and observations regarding the draft of the minutes submitted
by the Technical Secretary of the Committee.
The participants of the Committee of External Experts who have received the draft minutes will have three (3)
business days to make your comments, corrections and observations upon receipt of
draft of the minutes. If the previously established term has elapsed, no changes have been received against the
content of the minutes, it is understood that it is accepted and approved, then proceeds to
Sign the minutes.
Print and sign the committee minutes. The minutes of the Committees of External Experts are arranged to
consultation and will be kept on file according to the control records of each process.
In the event of a major cause, which prevents the continuity of a member hired as an External Expert, their
participation unless the Meeting of the Committee of the Committee has previously been held in the evaluation process
External experts.
The decision-making mechanism of the Committees of External Experts should take into account that
Each vote of the members of the Committee shall have the same percentage of decision and shall be placed in
the minutes of the meeting the votes with which said resolution was approved.
The individual reports that accompany the position of each Expert will be discussed
MECHANISM FOR DECISION MAKING
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RESPONSIBLE DESCRIPTION
External, they make a decision in consensus and present results by means of a document entered into by the designated link of the
Requesting Technical Unit, as Secretary.
The estimated time for the session will be one (1) day with the exception of those cases in which
need to infer more, or new base information is required for final resolution.
The Committee of External Experts in the execution of its activities will make use of the records established in each of
the technical areas of the Institution.
The CNEIS Committee of External Experts will deliver, as a result of the evaluation of each matter
treated, jointly a final report in correspondence with the particular terms of your contract and
according to the specified format.
The content of the report should include information regarding the start date of the evaluation, general information
of the object to be evaluated (product or institution), reason for the evaluation, description of the evaluation carried out,
recommendations, date of completion of the evaluation (expected and actual), name and signature of the Experts
External
The final report must be approved by the CNEIS, which will accept or deny, based on the fulfillment of the objectives
provided, the decision leaving it in writing in the minutes.
The Committee of External Experts will report to the CNEIS on the work done in the period of time of
operation, through a written report.
FINAL REPORTS
The report of the Committee of External Experts should be annulled, if it is detected that your declaration of
absence of conflict of interest. This implies reconsidering or annulling the decision in whose trial you had
Participation a member of the Committee.
VIOLATIONS AND SANCTIONS
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RESPONSIBLE DESCRIPTION
The condition of External Expert should be temporarily or permanently suspended if:
- Failure to comply with the working conditions previously accepted by the External Expert in a manner
repeated (non-attendance at meetings, delivery of their reports as planned, among others)
- Non-compliance is detected in relation to what is established in your confidentiality statement on the
documentation and information in charge.
The penalties will be criminal if the violation classifies the crimes of the current penal code.
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ANNEX 19 FORMAT OF PRESENTATION OF RESEARCH PROTOCOLS
DOCUMENT FORMAT
- The documents must be prepared in letter size paper, with exceptions described.
- Typeface and size for the text of the entire content of the document: Times New Roma 12. The text in the
Document content does not have a “bold”, “italic” or “underlined” format, unless indicated
On the contrary, as in titles, headings, words to be defined or words that precede two points.
- Paragraph spacing for the entire document is: 1.5 (except for tables or tools, use the
ideal spacing).
- The margins of the document should be: normal style (Sup .: 2.5 cm, Inf .: 2.5 cm, Left .: 3cm, Right .: 3 cm).
- The titles of the sections begin with a correlative number starting from 1. The title of the section is
aligned to the left and written in capital letters and in “bold” format, with no end point, since this is a Title.
- The titles of the sub sections and their derivatives begin with the correlative number of the title that they come from,
followed by a period and then starting from 1. The titles of the sub sections and their derivatives are
aligned its beginning to the left, below the first letter of the section that precedes it and they are written in
uppercase and in “bold” format, with no end point.
- Text that is not a title of sections or subsections is justified, and aligned at the beginning of the first
title letter or sub title, as appropriate.
- For explanatory footnotes, consecutive numbers are used in superscript format at the end
of the text and hyperlink to the footer of the corresponding sheet, in a text size of eight (8) dots.
- The text in tables has the same format as the rest of the document, except the headings
of columns in tables, these are always centered.
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- If you need to add extra spaces between paragraphs it can be done freely to improve the visualization of
sections of the document It is recommended that sections or subsections titles not be at the bottom of a page and the
rest of the content of these in the following; for that matter, add the necessary spaces so that the
Title of the section or subsection is on the next page along with their respective content.
- Whenever appropriate and to limit the size of the documentation, reference is made to the standards
applicable national or international technical and management.
- Likewise, you can use colors or other convenient formats, as long as they are
formal.
DOCUMENTS SUBMISSION
- It is requested to present all the documentation ordered according to the correlative index, ringed or
pasted, it will depend on the criteria of each researcher.
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12. BIBLIOGRAPHY
1. https://www.ich.org/products/guidelines.html
2. http://unesdoc.unesco.org/images/0013/001393/139309e.pdf Guide No 1: Creation of Bioethics Committees. UNESCO
3. http://www.nlm.nih.gov/nichsr/hta101/ta101014.html
4. http://www.suht.nhs.uk/index.cfm?articleid=2814
5. http://www3.imperial.ac.uk/clinicalresearchgovernanceoffice/standardoperating procedures
6. Council for International Organizations of Medical Sciences. International ethical guidelines for biomedical
research involving human subjects (CIOMS). Geneva, Switzerland: World Health Organization 2002 (consulted
2012 Dec 13). Available at http: // www. recerca.uab.es/ceeah/docs/CIOMS.pdf
7. Emanuel EJ, Wendler D, Grady C. What Makes Clinical Research Ethical? JAMA 2000; 283: 2701-2711.
8. An Instructional Guide for Peer Reviewers of Biomedical Manuscripts. Annals of Emergency Medicine
(accessed 2012 Dec 5). Available in
http://www3.us.elsevierhealth.com/extractor/graphics/em-acep/index.html. 13.
9. Practical guide to health research. Scientific and Technical Publication No. 620. Drafting of the protocol of
Research: Presentation of a research proposal. Washington, D.C: Pan American Organization of the
Health (PAHO) 2008 (accessed 2012 Dec 2). Available in
http://www.sld.cu/galerias/pdf/sitios/ rehabilitacion-bal / ops_protocolo.pdf. 14. Haynes RB, Mulrow CD, Huth EJ,
Altman DG, Gardner MJ. More Informative Abstracts Revisited. Ann Intern Med 1990; 113: 69-76. fifteen.
10. How to review the evidence: Systematic Identification and Review of the Scientific Literature. Canberra:
National Health and Medical Research Council (NHRMC) 2000 (accessed 2012 Dec 12).
Available at http://www.nhmrc.gov.au/_files_nhmrc/publications/ attachments / cp65.pdf.
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