0A4F4F9BD490A749D5437F821CF06DF1
Rules for the Regulation of Human Clinical Trials. Ministerial Accord SP-M-466- 2007
https://healthresearchweb.org/?action=download&file=GUA_EnsayosClinicos_Acuerdo_SPM4662007%5b1%5d.pdf
http://leaux.net/URLS/ConvertAPI Text Files/307F45F0242DA1C2B100F87BC6BEA911.en.txt
Examining the file media/Synopses/307F45F0242DA1C2B100F87BC6BEA911.html:
This file was generated: 2020-07-15 06:04:20
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Criminal Convictions
Searching for indicator prisoners:
(return to top)
p.(None): 20.2. There is an inability to communicate with the patient, due to confusion, lethargy, coma, among olros.
p.(None): 20.3. There is no sufficient time to obtain the consent of an authorized legal representative.
p.(None): A qualified physician, who has no participation in the study, should review and evaluate the
p.(None): silutation. The Report completes the case, including the independent physician's report. it must be presented to
p.(None): Research Ethics Committee for immediate review. It is imperative that the subject or his representative
p.(None): be notified, \ an p £ o ¢ łlo as possible. to give the consent of
p.(None): that the lralamîento be continued.
p.(None): Article 21. Subjects who cannot read or write. Participation is essential in these houses
p.(None): from an impartial witness during the study discussion. The consent of the subject can be expressed through the
p.(None): printing of the fingerprint on the original document, after ensuring that the subject has understood
p.(None): the content of the informed consent. It must also be accompanied by the fingerprint signature of the witness
p.(None): impartial.
p.(None): Article 22. Minors or disabled subjects, whose legal representative does not know how to read or
p.(None): scrlblr. In these situations, the participation of a witness also applies, both during the
p.(None): explanation of consent as during its signing.
p.(None): Article 23. Prisoners. The deprivation of freedom can affect the ability of this group of individuals to take
p.(None): a truly voluntary decision without coercion. For this reason, they are usually not included in studies.
p.(None): clinicians and, when a subject participating in a study is incarcerated, they are excluded from the study if their condition
p.(None): is not affected by this decision.
p.(None): An exception to this general principle are some life and death situations, when the subject could
p.(None): Benefit only from the treatment or when it comes to products that will be applied in the treatment
p.(None): of prevailing conditions in prisoners.
p.(None): A Committee on Ethics in Investigation that evaluates clinical studies on prisoners should take into account
p.(None): Among its Members, at least one prisoner or a representative of them with experience and capacity to
p.(None): I fulfilled] this function.
p.(None): zs.1. Research Presentation. Indicating at least, title of the investigation, name of the
p.(None): Researcher, telephone number and address where it will take place.
p.(None): 2s.z. Introduction. Indicating that it is an experimental study.
p.(None): 25.3. Purpose of the study. It must clearly indicate what will be the contributions that the study will reach
p.(None): Level lenlïfico and the objective (s) of the study.
p.(None): 25.4. Procedures to senum.
p.(None): study-related injury, without shifting that responsibility to health insurance or the
p.(None): state health services. The sponsor will cover the treatment ribs that the patient
p.(None): Anytime to recover from the injury, as long as the investigator adheres to protocol and Good Practice.
p.(None): Clinical practices in conducting the clinical trial.
p.(None): zs.1z. Confidentiality It must be specified that the confidentiality of the
p.(None): Pan-municipal subjects will be preserved and that no subject will be identified by name in the
p.(None): publication of the results of the study. Which regulatory authorities should be indicated. nationals remain
p.(None): Aulorized to review their clinical record in order to see the results of the study. This same
p.(None): Aulorization will apply to studio monitors, sponsor auditors and agency inspectors.
p.(None): regulators and representatives of the Research Ethics Committee in charge of the study.
p.(None): zs.13. Notification of new findings. The subject to their legal representative will be informed in due course of
p.(None): any new discoveries that occurred during the study that could alert your decision to
...
Political / nomad
Searching for indicator nomads:
(return to top)
p.(None): consider appropriate.
p.(None): 2.18. investigator. Person responsible for conducting a clinical study. If a study is conducted by
p.(None): a 9 group of individuals, the researcher is the leader responsible for the group and will be called the researcher
p.(None): principai.
p.(None): 2.40. Monitor. Professional trained with the necessary clinical competence, chosen by the sponsor, who will
p.(None): In charge of direct monitoring of the conduct of the trial. Serves as a link between the sponsor and
p.(None): the principal investigator, when they do not confer in the same person.
p.(None): 2.41. Investigation Organization by contract. Legal entity or organization (commercial, academic or other
p.(None): type) against by the employer to carry out one or more of the workings and functions of the related sponsor
p.(None): with the study.
p.(None): 2.42. Sponsor. Individual, company or ’entity, institution or organization
p.(None): responsible for the lniclb, completion, management and / or financing of a clinical trial.
p.(None): medicine, dentistry, chemical-biological-biological and in fermeria, personal
p.(None): Sub-ordinate of hospital and laboratory, employees of the pharmaceutical industry, members of the forces
p.(None): armed and people who are detained / detained. Olrog vulnerable subjects include patients with disease
p.(None): incurable people
p.(None): in asylums, unemployed or indigent. patients in emergency situations. ethnic minority groups, people
p.(None): homeless, nomads, refugees, minors and those who cannot consent.
p.(None): z.st. Impartial Testłgo. Independent study person, who cannot be influenced in bad faith by the
p.(None): personnel involved in the study, who are present in the process of obtaining informed consent.
p.(None): z.sz. Compassionate use. Use of a medicine or product in isolated patients, regardless of
p.(None): a clinical trial. Specialties are included
p.(None): tarmacêuticas for indications or conditions of use different from those aulorizadas, under the responsibility
p.(None): exclusively for a doctor who considers essential his
p.(None): utilization.
p.(None): CHAPTER II
p.(None): PROTECTION OF CLINICAL TRIAL SUBJECTS
p.(None): Article 3. Respect for the ethical postulates. Only a clinical investigation may be initiated,
p.(None): when THE GOVERNMENT has annulled the research protocol, considering that the final project
p.(None): meets all the requisites within which is the review and approval of an Ethics Committee in lnv
p.(None): accredited research independent of the interests of the investigation. Based on the benefits
p.(None): expected for the test subject and society justify the risks; likewise, only
p.(None): continue st compliance with this criterion is permanently monitored.
p.(None): Article S. The participation of the subjects in the investigation is voluntary. The participating subject in -a
p.(None): Research or its representative, may revoke your consent at any time, without expression
p.(None): of causes, without this deriving for him any liability or damage.
...
Political / political affiliation
Searching for indicator party:
(return to top)
p.(None): photographic. magnetic or microfilm media, x-rays, subject files and records kept in
p.(None): the pharmacy in the laboratories and in the medical-technical departments involved in the study. clinical).
p.(None): 2.11. Amendment to the protocol. A written description of a formal change or clarification of a protocol.
p.(None): 2.12. Clinical trial. All research or experimental evaluation of a substance, medicine or
p.(None): device, through its application to human beings, oriented towards one of the following lines:
p.(None): and. Show its pharmacodynamic effects or collect data regarding its absorption,
p.(None): distribution, metabolism and excretion in the
p.(None): human organism.
p.(None): b. Establish its efficacy for a specific therapeutic, prophylactic or diagnostic indication.
p.(None): c. Know the profile of your adverse reactions and establish your safety.
p.(None): The administration of the drug or medication to a single patient in the setting of the clinic is not considered a clinical trial.
p.(None): habitual medical practice for the sole purpose of obtaining a benefit for it. Medical practice and
p.(None): professional freedom of prescription of the doctor will not protect, in any case, clinical trials not
p.(None): ar ›Iorized, or the use of secret or undeclared remedies to the sanitary authority.
p.(None): 2.J 3. Open-blind clinical trial. It is the one in which the subject lants as the researcher knows the group of
p.(None): tralamienlo to which he has been assigned.
p.(None): 2.14. Clinical trial with third-party evaluation. It is one in which the subject, researcher and
p.(None): palroclnador, ignore the treatment received. To evaluate the response, a third person is used who
p.(None): the treatment each subject is receiving is unknown.
p.(None): 2.1s. It is cynical with crossed groups. It is the one in which the experimental and control treatments are
p.(None): administered to each individual in successive periods that have been determined randomly, to which
p.(None): allow each subject to be their
p.(None): 2.16. Clinical trial with parallel groups. It is one in which one or several groups of subjects are
p.(None): assigned to receive the experimental treatment at the same time as the other group receives the control treatment.
p.(None): 2.17. Controlled clinical trial. It is the one that establishes a comparison with a control group or tesligo. The
p.(None): randomized controlled clinical trial including at least two groups of volunteers,
p.(None): 2.1s. patient or healthy. whose assignment to an experimental or control treatment is carried out at random so that
p.(None): Neither the subject nor the doctor responsible for their selection or treatment can influence their assignment. So the
p.(None): Selection of subjects as the periods of treatment and follow-up should take place simultaneously in all
p.(None): groups. In the vast majority of cases it is the only scientifically valid way to assess efficacy and safety
p.(None): of a lerapêutica intervention.
p.(None): 2.19. Double-blind clinical trial. It is one in which both the subject and the researcher are unaware of the
p.(None): assignment to Nos treatment groups.
...
p.(None): Guatemala, THURSDAY, February 22, 2007
p.(None): 35.6. Written information to be provided to test subjects.
p.(None): 35.7. Approval report and follow-up of the trial by the Ethics Committee8 on Research duly
p.(None): accredited as appropriate.
p.(None): 35.8. When appropriate, declaration of conformity of the relevant authorities of the center where
p.(None): It will complete the test.
p.(None): Article 36. Procedure. THE COMMISSION will communicate in writing to the Researcher, sponsor and Ethics Committee8
p.(None): In Research, receipt of the application and complete documentation, as well as its subsequent authorization
p.(None): express.
p.(None): The following shall be subject to authorization: All clinical tests with a substance classified as a product in the
p.(None): clinical research; search for new therapeutic indications of an already registered substance.
p.(None): Article 37. Terms of authorization. During the first year of validity of this Agreement from
p.(None): of its publication in the Diario de Centro America, THE COMMISSION will rule on a clinical study in a
p.(None): no later than forty-five days after receipt of the request and complete documentation.
p.(None): During the second year of validity and subject to the raising of private funds from THE COMMISSION,
p.(None): This will have a term of thirty days. Within the aforementioned period, THE COMMISSION may request the information
p.(None): pertinent, make objections, checks and corresponding observations.
p.(None): In cases where additional information or clarifications are requested, once the new
p.(None): information that the interested party has presented in his case, the final resolution will be found within a plaza of
p.(None): 15 days from the receipt of the required information. This resolution will be notified to the
p.(None): Research Ethics, the researcher, the sponsor and any other party
p.(None): Article 46. Evaluation criteria for the use of the dispute. The Êtlca Committee on Research
p.(None): corresponding to evaluate the protocol, the investigator's brochure and the rest of the documentation that
p.(None): Accompany the application and it will issue its opinion taking into consideration the following questions:
p.(None): 46.1. Relevance of the clinical trial. taking into account the available knowledge.
p.(None): 46.2. Relevance of your design to obtain informed conclusions with the appropriate number of
p.(None): subjects in relation to the objective of the study.
p.(None): 46.3. Selection and withdrawal criteria for trial subjects, as well as the equitable selection of the
p.(None): show.
p.(None): 46.4 .. Justification of the foreseeable costs and inconveniences in relation to the expected benefits for
p.(None): the trial subjects, for other patients and for the community, taking into account the principle of
p.(None): protection of the test subjects developed in the elic postulates.
p.(None): 46.5. Justification of the control group either placebo to an active treatment.
p.(None): 46.6. Provisions for monitoring the trial.
p.(None): • s.7. Suitability of the researcher and his collaborators.
p.(None): 46.8. ldoneidad of the facilities.
p.(None): 46.9. Adequacy of written information for test subjects and the procedure for
p.(None): oblenciôn informed consent. and justification of research in disabled people
p.(None): to give your informed consent.
...
Searching for indicator political:
(return to top)
p.(None): Guołemolo, THURSDAY, February 22, 2007
p.(None): MIEfIG '¥' ERIO DE GAkŁfDP ziB> zCA ASEG ‘¥’ AND ICEA GOC7A
p.(None): DIAI2IO of CENTRO AMÉAÌCA
p.(None): NUMBER 25
p.(None): approval / favorable opinion of the study protocol, the capacity of the researcher (s) and
p.(None): adequate supply of the facilities, methods and material to be used in obtaining and documenting the
p.(None): informed consent of the subjects of the state.
p.(None): 2.8. Comparator (product). Research or marketed product used as reference for a trial
p.(None): clinical.
p.(None): .NsAvosmLlmcosE N'eUm N s. '
p.(None): FOR THE REGULATION OF THE
p.(None): 2.s. Informed consent. Process through which a subject voluntarily confirms his decision to
p.(None): participate in a particular school, voluntarily adopted by a person capable of giving
p.(None): consent after being
p.(None): MINISTERIAL AGREEMENT SP-M-466-2007
p.(None): THE PUBLIC HEALTH MINISTER
p.(None): AND CONSIDERING SOCIAL ASSISTANCE. '
p.(None): Oue the Political Constitution of the Republic recognizes that the enjoyment of health is a fundamental right of being
p.(None): without discrimination, and obliges the State to ensure it, developing through
p.(None): its institutions preventive actions. recovery and rehabilitation, in order to provide the habit before
p.(None): the most complex physical, mental and social well-being, also recognizing that the health of the inhabitants of the
p.(None): nation is a public good.
p.(None): CONSIDERING:
p.(None): That it is the competence and responsibility of the State regarding manufacturing. marketing, surveillance
p.(None): and control of pharmaceutical and related products to contribute to the existence of products
p.(None): safe, effective, quality, correctly identified and with appropriate information; understanding each other
p.(None): within this activity the authorization of clinical tests, which in order to be carried out
p.(None): must be evaluated by the Commission for the Evaluation of Clinical Trials, informed according to a Ministerial Agreement
p.(None): SP-M-2264-2004, in accordance with Article ninety four of the Regulations for Health Control
p.(None): of Medicines and Related Products; therefore, in compliance with the established, it is intended to make a
p.(None): technical proposal for the evaluation and approval of clinical trial protocols with drugs and all
p.(None): related to your development.
p.(None): SO:
p.(None): In exercise of the functions conferred on him by Articles 194 literal a) and g) of the Political Constitution of
p.(None): the Republic of Guatemala; and 27 literal m) of the Law of the Executive Organism, Decree number 114-97 of the
p.(None): Congress of the republic.
p.(None): AGREES:
p.(None): Issue the regulatory presenle:
p.(None): FOR THE REGULATION OF CLINICAL TRIALS IN HUMANS
p.(None): CHAPTER I
p.(None): GENERAL DISPOSITION
p.(None): 2.1. Accreditation. Declaration by means of the issuance of a certificate, in which the competent authority,
p.(None): auloriza the execution of activities of a Comilé de Élica in research, after having verified that
p.(None): he himself complies with all the requirements set out in the current regulations. ”
p.(None): z.2. Quality assurance. All those planned and symbolic actions that
p.(None): established to guarantee that the study is being carried out and that the data is generated.
p.(None): Documented (registered) and reported in c. implemented with the 6 Good Clinical Practice (PCB) and the
p.(None): applicable regulatory requirements.
p.(None): 8. Random Assignment. Process of assigning study subjects to treatment groups
p.(None): or control using chance to determine allocations to reduce bias.
p.(None): 2.4. Audit. A systematic and independent examination of related activities and documents
p.(None): with the study to determine if the evaluated activities were carried out and the data were recorded,
p.(None): analyzed and reported accurately according to protocol, standard operating procedures
p.(None): Sponsor's (POEs), Good Practice Clinics (BPC) and apiicabies regulatory requirements.
p.(None): 2.5. Good clinical practices (PCB). Standard for design, conduction, realization, monitoring,
p.(None): audit, registration, analysis and reporting of clinical studies that provides a guarantee that the data and
...
Political / vulnerable
Searching for indicator vulnerable:
(return to top)
p.(None): is harmful and unintentional and occurs at doses normally used in man for prophylaxis,
p.(None): dlagnôsllco or treatment
p.(None): from diseases to for modification of the łisiołógica function.
p.(None): specific hypothesis, the number of subjects is not predetermined in advance, but
p.(None): 2.47. Unexpected drug adverse reaction:
p.(None): adverse reaction whose
p.(None): It depends on the results that are obtained throughout it.
p.(None): 2.28. Simple clinical trial clergy. It is the one in which the subjects do not know the allocation to the group of
p.(None): treatment, but not the investigator.
p.(None): 2.29. Unlcêntrlco cylindrical test. It is that carried out by a single Investigator to a research team in
p.(None): a central dream.
p.(None): z.ao. Observational study. Analytical epidemiological study in which the researcher does not determine
p.(None): the allocation of the subjects to each group, but is limited to recording (observing) what happens in the
p.(None): reality.
p.(None): 2.31. Experimental assessment. It is that study in which an unauthorized substance is used as a specialty
p.(None): pharmaceutical or a pharmaceutical specialty is used under conditions of use other than those
p.(None): authorized; also is that
p.(None): Nature to severity does not correspond to the reference information on the product.
p.(None): 2.48. Subscriber subinves. Any individual member I from the designated and supervised clinical study group
p.(None): by the researcher at a site where the study is carried out to carry out the critical procedures
p.(None): related to the study and / or makes important decisions related to that.
p.(None): 2.50. Vulnerable subjectsG. Individuals whose desire to participate in clinical study may be influenced
p.(None): by the explanation, justified or not, of the benefits associated with their participation, or a
p.(None): revenge on the part of the members
p.(None): study in which subjects are assigned to one or more therapeutic intervention groups in a
p.(None): random, or is conditioned, directly or indirectly. the
p.(None): superiors of a hierarchy in order to refuse to participate.
p.(None): members of a group with a hierarchical structure, such as
p.(None): students of
p.(None): usual medical prescription process.
p.(None): z.1z. Adverse event (EA). Any unfavorable medical event that occurs in a patient or subject of
p.(None): a clinical investigation to whom a pharmaceutical product was administered and who does not necessarily have a relationship
p.(None): causal with that treatment. Therefore, an adverse event can be any unfavorable sign and not
p.(None): disabled (inducing an abnormal laboratory finding). Sloma or temporally associated disease
p.(None): with the use of a medicinal (research) product, whether or not related to it.
p.(None): 2.13. Serious Adverse Event (EAS) or Serious Adverse Drug Reaction (Serious RAM). Any event
p.(None): adverse or adverse reaction that, at any dose, produces death, threatens the life of the subject, makes
p.(None): necessary hospitalization or prolongation, causes permanent or significant disability or incapacity, or
p.(None): give rise to an abnormality or congenital mallormaciõn.
p.(None): 2.16. Case report form (FRC). Printed, optical or electronic document designed to
p.(None): record all the information required in the protocol to be reported to the sponsor on each subject of the
p.(None): study.
p.(None): 2.57. Inspection. Official review by a regulatory authority of documents, facilities, record and
p.(None): any other resource that the authorities consider is related to the clinical study and that may be
p.(None): located at the site where the study is carried out, at the facilities of the sponsor and / or the
p.(None): Investigative organization by contract (OIC) or at other sites than regulatory authorities
p.(None): consider appropriate.
p.(None): 2.18. investigator. Person responsible for conducting a clinical study. If a study is conducted by
p.(None): a 9 group of individuals, the researcher is the leader responsible for the group and will be called the researcher
p.(None): principai.
p.(None): 2.40. Monitor. Professional trained with the necessary clinical competence, chosen by the sponsor, who will
p.(None): In charge of direct monitoring of the conduct of the trial. Serves as a link between the sponsor and
p.(None): the principal investigator, when they do not confer in the same person.
p.(None): 2.41. Investigation Organization by contract. Legal entity or organization (commercial, academic or other
p.(None): type) against by the employer to carry out one or more of the workings and functions of the related sponsor
p.(None): with the study.
p.(None): 2.42. Sponsor. Individual, company or ’entity, institution or organization
p.(None): responsible for the lniclb, completion, management and / or financing of a clinical trial.
p.(None): medicine, dentistry, chemical-biological-biological and in fermeria, personal
p.(None): Sub-ordinate of hospital and laboratory, employees of the pharmaceutical industry, members of the forces
p.(None): armed and people who are detained / detained. Olrog vulnerable subjects include patients with disease
p.(None): incurable people
p.(None): in asylums, unemployed or indigent. patients in emergency situations. ethnic minority groups, people
p.(None): homeless, nomads, refugees, minors and those who cannot consent.
p.(None): z.st. Impartial Testłgo. Independent study person, who cannot be influenced in bad faith by the
p.(None): personnel involved in the study, who are present in the process of obtaining informed consent.
p.(None): z.sz. Compassionate use. Use of a medicine or product in isolated patients, regardless of
p.(None): a clinical trial. Specialties are included
p.(None): tarmacêuticas for indications or conditions of use different from those aulorizadas, under the responsibility
p.(None): exclusively for a doctor who considers essential his
p.(None): utilization.
p.(None): CHAPTER II
p.(None): PROTECTION OF CLINICAL TRIAL SUBJECTS
p.(None): Article 3. Respect for the ethical postulates. Only a clinical investigation may be initiated,
p.(None): when THE GOVERNMENT has annulled the research protocol, considering that the final project
p.(None): meets all the requisites within which is the review and approval of an Ethics Committee in lnv
p.(None): accredited research independent of the interests of the investigation. Based on the benefits
...
p.(None): All parties involved in an investigation into human beings will keep the strictest
p.(None): confidentiality. in such a way that the personal and family intimacy of the participating subjects in
p.(None): there.
p.(None): Likewise, appropriate measures should be taken to prevent access by unauthorized persons to
p.(None): Investigation data. The COMMISSION, the Research Ethics Committee that approved the protocol,
p.(None): The sponsor and national and / or international health regulatory agencies will have access to documents and
p.(None): regintros related to investigations when requested.
p.(None): 1 2 Guatemala, JU5VčS February 22, 2007 CENTRAL AMERICA JOURNAL
p.(None): ISSUE 25
p.(None): Article 6. All people have the right to receive a fair and equitable kato.
p.(None): In the extraordinary houses of Investigations without therapeutic purposes in minors and in the selection of the subjects
p.(None): ponlclpantas an una lnvoellgäcîón u •• •• d • b •• incapaceg o people
p.(None): - In the case of autonomous competition, the distributions will be taken equally, so that there is no
p.(None): groups exposed to ransom measures necessary to prevent impairment in their
p.(None): health and the possible exploitation of the elderly. All research with human subjects must have an approach
p.(None): these subjects.
p.(None): Valid science and design in a well-developed protocol, which guarantees quality
p.(None): of the study, in addition, the protection of vulnerable subjects, compensation and treatment for injuries to
p.(None): participants.
p.(None): Article 7. In vulnerable populations, investigations may only be carried out when they are of the highest interest.
p.(None): for your particular Galud. Investigations with said subjects can only be carried out when the
p.(None): all the following requirements:
p.(None): 7.1. Have sufficient scientific data and, in particular, pharmacological and toxicological tests
p.(None): in animals, which guarantee that the risks involved in the person in which it is carried out are admissible.
p.(None): 7.z. That the study is based on the available knowledge, the information sought, presumably,
p.(None): an advance in scientific knowledge about humans or to improve their health and design
p.(None): mlnlmlce the risks for the subjects participating in êl-.
p.(None): 7.z, That the foreseeable risks and inconveniences for the trial subjects have been weighted and are
p.(None): lower than the foreseeable benefits for each trial subject and future patients.
p.(None): Unless proven otherwise, it is presumed that the damage that affects the health of the person being tested, during the
p.(None): performance of the same and that they persist after the study is completed, have occurred as a consequence of the trial.
p.(None): The damages that affect the subjects after the end of their participation in the clinical trial must be analyzed.
p.(None): by the researcher to determine the link between the damage produced and the clinical trial.
p.(None): Article 11. For the electors of the liability regime provided for in this article, it shall be considered
p.(None): object of compensation all the expenses derlvados of the impairment in the health of the subject submitted to
p.(None): trial, as well as the economic damages that directly undermine such damage, provided that this is
p.(None): consequence of submission to the clinical trial. It will not be subject to compensation under the
...
Health / Cognitive Impairment
Searching for indicator impairment:
(return to top)
p.(None): continue st compliance with this criterion is permanently monitored.
p.(None): Article S. The participation of the subjects in the investigation is voluntary. The participating subject in -a
p.(None): Research or its representative, may revoke your consent at any time, without expression
p.(None): of causes, without this deriving for him any liability or damage.
p.(None): All parties involved in an investigation into human beings will keep the strictest
p.(None): confidentiality. in such a way that the personal and family intimacy of the participating subjects in
p.(None): there.
p.(None): Likewise, appropriate measures should be taken to prevent access by unauthorized persons to
p.(None): Investigation data. The COMMISSION, the Research Ethics Committee that approved the protocol,
p.(None): The sponsor and national and / or international health regulatory agencies will have access to documents and
p.(None): regintros related to investigations when requested.
p.(None): 1 2 Guatemala, JU5VčS February 22, 2007 CENTRAL AMERICA JOURNAL
p.(None): ISSUE 25
p.(None): Article 6. All people have the right to receive a fair and equitable kato.
p.(None): In the extraordinary houses of Investigations without therapeutic purposes in minors and in the selection of the subjects
p.(None): ponlclpantas an una lnvoellgäcîón u •• •• d • b •• incapaceg o people
p.(None): - In the case of autonomous competition, the distributions will be taken equally, so that there is no
p.(None): groups exposed to ransom measures necessary to prevent impairment in their
p.(None): health and the possible exploitation of the elderly. All research with human subjects must have an approach
p.(None): these subjects.
p.(None): Valid science and design in a well-developed protocol, which guarantees quality
p.(None): of the study, in addition, the protection of vulnerable subjects, compensation and treatment for injuries to
p.(None): participants.
p.(None): Article 7. In vulnerable populations, investigations may only be carried out when they are of the highest interest.
p.(None): for your particular Galud. Investigations with said subjects can only be carried out when the
p.(None): all the following requirements:
p.(None): 7.1. Have sufficient scientific data and, in particular, pharmacological and toxicological tests
p.(None): in animals, which guarantee that the risks involved in the person in which it is carried out are admissible.
p.(None): 7.z. That the study is based on the available knowledge, the information sought, presumably,
p.(None): an advance in scientific knowledge about humans or to improve their health and design
p.(None): mlnlmlce the risks for the subjects participating in êl-.
p.(None): 7.z, That the foreseeable risks and inconveniences for the trial subjects have been weighted and are
p.(None): lower than the foreseeable benefits for each trial subject and future patients.
p.(None): Unless proven otherwise, it is presumed that the damage that affects the health of the person being tested, during the
p.(None): performance of the same and that they persist after the study is completed, have occurred as a consequence of the trial.
p.(None): The damages that affect the subjects after the end of their participation in the clinical trial must be analyzed.
p.(None): by the researcher to determine the link between the damage produced and the clinical trial.
p.(None): Article 11. For the electors of the liability regime provided for in this article, it shall be considered
p.(None): object of compensation all the expenses derlvados of the impairment in the health of the subject submitted to
p.(None): trial, as well as the economic damages that directly undermine such damage, provided that this is
p.(None): consequence of submission to the clinical trial. It will not be subject to compensation under the
p.(None): liability provided for in this article, the damage suffered by the subject subject to the trial in their health when
p.(None): This is inhercnte to the pathology under study.
p.(None): CHAPTER III. INFORMED CONSENT
p.(None): Article 15. Informed consent process. The process for obtaining the informed consent of the
p.(None): Participating in a clinical trial is achieved with the following actions:
p.(None): 1s. 1. Elaboration of an informed consent document with all the elements and requirements
p.(None): established in the body of this provision.
p.(None): 1s. 2. Presentation of the content of the informed consent and procedure for its
p.(None): Obtained before the Comilê de Ética en Investigación, for approval.
p.(None): IN.3. Detailed explanation, in simple and understandable language for the subject or for Cu
p.(None): legal representative, what is the research, what are the risks and benefits and what are
p.(None): your rights to participate in the eCludio.
p.(None): 1g. 4. Discussion and answer to all the doubts and questions that the subject or his legal representative have.
p.(None): 1s. 5. . The participating subject or the legal representative, to give their consent to
...
Health / Comatose
Searching for indicator coma:
(return to top)
p.(None): 18.2. Subjects with mental disabilities. In the case of the incapable or in
p.(None): status of a legal representative, must give consent and sign the report
p.(None): on behalf of the participant, to whom the scope of the investigation must be explained, according to their
p.(None): understanding capacity.
p.(None): ISSUE 25
p.(None): 19.3.
p.(None): jg g 1g.5.
p.(None): CENTRAL AMERICA JOURNAL
p.(None): If from the essay relevant knowledge about the
p.(None): disease or cause of invasion. gives vital imoortancia to understand it. palliate it to cure it.
p.(None): If these knowledge cannot be obtained in any other way.
p.(None): If there are guarantees on the correct obtaining of informed consent, in accordance with the provisions of
p.(None): this regulation.
p.(None): Guatemolo, THURSDAY, February 22, 2007
p.(None): 25.10. Remuneration. It should be noted the expenses that patients received for expenses
p.(None): transportation, allmenlación, and others, where appropriate. Likewise, in studies that do not
p.(None): Therapeutic impact, amounts and how your participation will be rewarded.
p.(None): 25.11. Lions compensation. It must be clearly specified that the investigator will give medical care
p.(None): the participant who suffers some
p.(None): Article 20. Qualified emergencies: The following situations are considered:
p.(None): The immediate use of the product under study is essential to preserve the life of a patient.
p.(None): 20.2. There is an inability to communicate with the patient, due to confusion, lethargy, coma, among olros.
p.(None): 20.3. There is no sufficient time to obtain the consent of an authorized legal representative.
p.(None): A qualified physician, who has no participation in the study, should review and evaluate the
p.(None): silutation. The Report completes the case, including the independent physician's report. it must be presented to
p.(None): Research Ethics Committee for immediate review. It is imperative that the subject or his representative
p.(None): be notified, \ an p £ o ¢ łlo as possible. to give the consent of
p.(None): that the lralamîento be continued.
p.(None): Article 21. Subjects who cannot read or write. Participation is essential in these houses
p.(None): from an impartial witness during the study discussion. The consent of the subject can be expressed through the
p.(None): printing of the fingerprint on the original document, after ensuring that the subject has understood
p.(None): the content of the informed consent. It must also be accompanied by the fingerprint signature of the witness
p.(None): impartial.
p.(None): Article 22. Minors or disabled subjects, whose legal representative does not know how to read or
p.(None): scrlblr. In these situations, the participation of a witness also applies, both during the
p.(None): explanation of consent as during its signing.
p.(None): Article 23. Prisoners. The deprivation of freedom can affect the ability of this group of individuals to take
...
Health / Drug Usage
Searching for indicator drug:
(return to top)
p.(None): When the subject of the trial is not a person capable of giving his consent, the decision must be made by
p.(None): your legal representative after having been informed about all relevant aspects of it
p.(None): to take the "decision to participate. Informed sentiment is documented through a form of
p.(None): written, signed and dated informed consent.
p.(None): 2.10. Source documents. Original documents, data and records (for example, hospital records, sheets
p.(None): clinical, lab notes, memoranda, subject journals, or evaluation checklists,
p.(None): pharmacy delivery records, recorded data from automated instruments, copies or
p.(None): After verifying cerlified transcripts that are exact copies, microfiche. negatives
p.(None): photographic. magnetic or microfilm media, x-rays, subject files and records kept in
p.(None): the pharmacy in the laboratories and in the medical-technical departments involved in the study. clinical).
p.(None): 2.11. Amendment to the protocol. A written description of a formal change or clarification of a protocol.
p.(None): 2.12. Clinical trial. All research or experimental evaluation of a substance, medicine or
p.(None): device, through its application to human beings, oriented towards one of the following lines:
p.(None): and. Show its pharmacodynamic effects or collect data regarding its absorption,
p.(None): distribution, metabolism and excretion in the
p.(None): human organism.
p.(None): b. Establish its efficacy for a specific therapeutic, prophylactic or diagnostic indication.
p.(None): c. Know the profile of your adverse reactions and establish your safety.
p.(None): The administration of the drug or medication to a single patient in the setting of the clinic is not considered a clinical trial.
p.(None): habitual medical practice for the sole purpose of obtaining a benefit for it. Medical practice and
p.(None): professional freedom of prescription of the doctor will not protect, in any case, clinical trials not
p.(None): ar ›Iorized, or the use of secret or undeclared remedies to the sanitary authority.
p.(None): 2.J 3. Open-blind clinical trial. It is the one in which the subject lants as the researcher knows the group of
p.(None): tralamienlo to which he has been assigned.
p.(None): 2.14. Clinical trial with third-party evaluation. It is one in which the subject, researcher and
p.(None): palroclnador, ignore the treatment received. To evaluate the response, a third person is used who
p.(None): the treatment each subject is receiving is unknown.
p.(None): 2.1s. It is cynical with crossed groups. It is the one in which the experimental and control treatments are
p.(None): administered to each individual in successive periods that have been determined randomly, to which
p.(None): allow each subject to be their
p.(None): 2.16. Clinical trial with parallel groups. It is one in which one or several groups of subjects are
p.(None): assigned to receive the experimental treatment at the same time as the other group receives the control treatment.
p.(None): 2.17. Controlled clinical trial. It is the one that establishes a comparison with a control group or tesligo. The
p.(None): randomized controlled clinical trial including at least two groups of volunteers,
...
p.(None): NUMBER 2.S CENTER DIARY
p.(None): AMERICA Guotemolo, THURSDAY, February 22, 2007
p.(None): 2.43. Standard operating procedures (POEs). Written instructions to achieve uniformity in
p.(None): the execution of a specific function.
p.(None): 2.44. Produc to in In vestlgaclón. Pharmaceutical form of an active ingredient, placebo or device, which
p.(None): usanda is being tested as a reference in a clinical study, including a product with a
p.(None): marketing when used or packaged (formulated or packaged) in a manner unlike
p.(None): approve ‹›. when used for an unapproved indication or when used for
p.(None): 2.23. Phase IV clinical trial. They are those that are made with a medicine
p.(None): after its commercialization. These tests may be similar to those described
p.(None): Obtain more information about a previously approved use.
p.(None): ocolo. It is defined as the document where the reason for being is described
p.(None): in phases I, II and III if they study some aspect not yet evaluated or different conditions of use of the authors
p.(None): hoisted as it might be a new indication. These studies
p.(None): 2.45. Prot
p.(None): of the day, its objectives, design, methodology,
p.(None): statistical considerations and the
p.(None): to the original protocol, to its
p.(None): they will preferably be controlled and randomized.
p.(None): 2.24. Multicenter clinical trial. It is one conducted according to a single protocol but in more than one
p.(None): place and, therefore, carried out by more than one
p.(None): organization of a trial. The term protocol is highlighted
p.(None): successive versions and their modifications.
p.(None): 2.4s. Adverse drug reaction (ADR). This clinical experience before
p.(None): approval of a new medicinal product or its new uses, particularly
p.(None): investigator.
p.(None): when the therapeutic dose cannot be established.
p.(None): They should be considered
p.(None): 2.25. Uncontrolled clinical trial. It is the one that cannot be compared with a control or control group.
p.(None): 2.26. Clinical trial photo. It is the one that is carried out as a previous step to other broader studies with
p.(None): the purpose of knowing data that allows a more adequate design, establishing its viability, as well as
p.(None): determine the size of the sample for further studies.
p.(None): 2.27. Sequential clinical trial. It is the one in which testing a
p.(None): adverse medium reactions, all harmful and unintended responses to a medicinal product
p.(None): related to any dose. The phrase "responses to a medicinal product" means that a causal relationship
p.(None): between a medicinal product and an adverse event is at least a reasonable possibility, that is, that the relationship
p.(None): can be discarded. Regarding medicinal products on the market: a response to a medicine that
p.(None): is harmful and unintentional and occurs at doses normally used in man for prophylaxis,
p.(None): dlagnôsllco or treatment
p.(None): from diseases to for modification of the łisiołógica function.
p.(None): specific hypothesis, the number of subjects is not predetermined in advance, but
p.(None): 2.47. Unexpected drug adverse reaction:
p.(None): adverse reaction whose
p.(None): It depends on the results that are obtained throughout it.
p.(None): 2.28. Simple clinical trial clergy. It is the one in which the subjects do not know the allocation to the group of
p.(None): treatment, but not the investigator.
p.(None): 2.29. Unlcêntrlco cylindrical test. It is that carried out by a single Investigator to a research team in
p.(None): a central dream.
p.(None): z.ao. Observational study. Analytical epidemiological study in which the researcher does not determine
p.(None): the allocation of the subjects to each group, but is limited to recording (observing) what happens in the
p.(None): reality.
p.(None): 2.31. Experimental assessment. It is that study in which an unauthorized substance is used as a specialty
p.(None): pharmaceutical or a pharmaceutical specialty is used under conditions of use other than those
p.(None): authorized; also is that
p.(None): Nature to severity does not correspond to the reference information on the product.
p.(None): 2.48. Subscriber subinves. Any individual member I from the designated and supervised clinical study group
p.(None): by the researcher at a site where the study is carried out to carry out the critical procedures
p.(None): related to the study and / or makes important decisions related to that.
p.(None): 2.50. Vulnerable subjectsG. Individuals whose desire to participate in clinical study may be influenced
p.(None): by the explanation, justified or not, of the benefits associated with their participation, or a
p.(None): revenge on the part of the members
p.(None): study in which subjects are assigned to one or more therapeutic intervention groups in a
p.(None): random, or is conditioned, directly or indirectly. the
p.(None): superiors of a hierarchy in order to refuse to participate.
p.(None): members of a group with a hierarchical structure, such as
p.(None): students of
p.(None): usual medical prescription process.
p.(None): z.1z. Adverse event (EA). Any unfavorable medical event that occurs in a patient or subject of
p.(None): a clinical investigation to whom a pharmaceutical product was administered and who does not necessarily have a relationship
p.(None): causal with that treatment. Therefore, an adverse event can be any unfavorable sign and not
p.(None): disabled (inducing an abnormal laboratory finding). Sloma or temporally associated disease
p.(None): with the use of a medicinal (research) product, whether or not related to it.
p.(None): 2.13. Serious Adverse Event (EAS) or Serious Adverse Drug Reaction (Serious RAM). Any event
p.(None): adverse or adverse reaction that, at any dose, produces death, threatens the life of the subject, makes
p.(None): necessary hospitalization or prolongation, causes permanent or significant disability or incapacity, or
p.(None): give rise to an abnormality or congenital mallormaciõn.
p.(None): 2.16. Case report form (FRC). Printed, optical or electronic document designed to
p.(None): record all the information required in the protocol to be reported to the sponsor on each subject of the
p.(None): study.
p.(None): 2.57. Inspection. Official review by a regulatory authority of documents, facilities, record and
p.(None): any other resource that the authorities consider is related to the clinical study and that may be
p.(None): located at the site where the study is carried out, at the facilities of the sponsor and / or the
p.(None): Investigative organization by contract (OIC) or at other sites than regulatory authorities
p.(None): consider appropriate.
p.(None): 2.18. investigator. Person responsible for conducting a clinical study. If a study is conducted by
p.(None): a 9 group of individuals, the researcher is the leader responsible for the group and will be called the researcher
p.(None): principai.
p.(None): 2.40. Monitor. Professional trained with the necessary clinical competence, chosen by the sponsor, who will
p.(None): In charge of direct monitoring of the conduct of the trial. Serves as a link between the sponsor and
p.(None): the principal investigator, when they do not confer in the same person.
p.(None): 2.41. Investigation Organization by contract. Legal entity or organization (commercial, academic or other
...
p.(None): consent of the subject to his legal representative at the time of inclusion in the clinical trial.
p.(None): This fact will be reported to the Research Ethics Committee T at the sponsor of the researcher for its
p.(None): supervision, explaining the reasons that have given rise to it. This situation must be foreseen in
p.(None): the clinical trial protocol and informed consent approved by the corresponding Comitê de Élica in
p.(None): Research and will only proceed when it has a particular therapeutic interest for the patient. The
p.(None): Subject or his legal representative will be informed as soon as possible and will smell his condition for
p.(None): continue in the trial if applicable.
p.(None): to. The Iratamîenlo will receive and the possibility of allocation to each group of lralamienlo.
p.(None): s The necessary procedures, especially all those that are invasive. Those highlighted
p.(None): procedures to therapies that are experimental.
p.(None): c. Description of the product to be used and its profile of adverse effects. It is customary to add a
p.(None): general statement that "not all side effects of the product are known to date." When they are studies
p.(None): Comparatives, a description of the comparator and its side effects should be included.
p.(None): d. Responsibilities of the participating subject.
p.(None): and. The approximate number of subjects and sites that will participate in the study should be noted.
p.(None): The expected duration of the subject ‘participation in the study must also be specified.
p.(None): 25.5. Previous experience with the drug. The previous experimental experience should be indicated and
p.(None): clinic with the product, and the result of these experiments.
p.(None): z5.6. Annoyances and rieegoe. The inconveniences and risks that could be expected in the participants.
p.(None): It should be noted that side effects may occur from discomfort that is not yet known.
p.(None): 25.7. Alternative therapies. Alternative therapeutic procedures that extend with
p.(None): its potential risks and benefits.
p.(None): z5.8. Exclusions. Conditions that impede your participation in the study, such as pregnancy, lactation,
p.(None): allergies to certain products, and other circumstances.
p.(None): 25.9. Benefits. The benefits that the treatment could receive if it is effective. Must be
p.(None): note that you may not receive any therapeutic benefit from your participation.
p.(None): CHAPTER IV.
p.(None): OF THE ETHICS COMMITTEES IN INVESTIGATION
p.(None): Article 26. Accreditation of the Research Ethics Committees. They will be established based on t
p.(None): recognition of the Department of Regulation and Control of Pharmaceutical and Related Products. which
p.(None): The accreditation for the operation of the Research Ethics Committee that review and
p.(None): clinical trials approved. THE COMMISSION will be in charge of the coordination and establishment
p.(None): common criteria for the accreditation of the Committees. The accreditation of the Committee will be renewed
p.(None): periodically according to the procedures and deadlines that it determines. which should not exceed a
p.(None): two year period.
p.(None): Article 27. Minimum requirements for accreditation of a Research Ethics Committee for review and
...
p.(None): violation of yourself. The researcher, the sponsor and LA CÇMISIÓŞ must be notified in writing of the
p.(None): Committee's decision indicating the reasons for the suspension.
p.(None): 33.10. The Committee's opinions must be standardized in order to
p.(None): support communication between the Committee and researchers from the AN rma:
p.(None): evue \ to with racomenăaciones da oambios).
p.(None): c. Recite d:.
p.(None): 33.11. The Committee must keep all relevant records for a period of three years after its conclusion.
p.(None): the study and make them available at the request of the authority.
p.(None): CHAPTER V
p.(None): OF THE REQUIREMENTS OF CLINICAL TRIALS
p.(None): Article 34. Requirements for conducting clinical trials. Pursuant to Articles 93 and 94 of the Agreement
p.(None): Government 712-99, Regulation for the Sanitary Control of Medicines and Related Products, tests
p.(None): Clinicians must submit to the authorization of the LA regulatory authority and evaluation.
p.(None): COMMISSION. After the evaluation, yes. the regulatory authority shall grant the respective authorization.
p.(None): Clinical trial procedures must have the review and approval of an Ethics Committee in
p.(None): Research accredited by the Ministry of Health, through the respective agency.
p.(None): Article 35. Application for authorization of a clinical trial. You must have the following documentation:
p.(None): 35.1. Request made by the researcher or sponsor, addressed to THE COMMISSION, indicating:
p.(None): to. Protocol title and number.
p.(None): b. Name and address of the principal investigator. c Research site.
p.(None): d. Study drug (international code name, pharmaceutical form, concentration,
p.(None): presentation).
p.(None): and. Research phase.
p.(None): 1. Research Ethics Committee.
p.(None): g. Sponsor.
p.(None): h. Sub-investigators, when applicable.
p.(None): ‹Receipt of payment of the corresponding duty, according to the specific year.
p.(None): 35.2. Test protocol. clinical. Every protocol for the clinical trial shall be written in Spanish,
p.(None): including the following basic sections:
p.(None): to. Summary.
p.(None): b. indice.
p.(None): c. General information.
p.(None): d. Justification and objectives.
p.(None): and. Type of clinical test and its design.
p.(None): F. Selection of subjects.
p.(None): g. Description of thiaiamlento.
p.(None): h. Development of the trial and evaluation of the response.
p.(None): i. Adverse effects.
p.(None): j. Informed consent and other applicable ethical aspects.
p.(None): *. Practical considerations.
p.(None): 1. Statistical analysis.
p.(None): 35.a. Investigator's brochure, which may be in the original language with a summary in Spanish.
p.(None): 35.4. Procedure and model of the document to obtain consent
p.(None): as.s. Investigator's commitment to comply with good Clinical and Informal Practices
p.(None): periodically at the Research Ethics Committee from the beginning to the end of the research.
p.(None): CENTER JOURNAL 25
p.(None): AMERICA
p.(None): Guatemala, THURSDAY, February 22, 2007
p.(None): 35.6. Written information to be provided to test subjects.
...
Searching for indicator influence:
(return to top)
p.(None): professional freedom of prescription of the doctor will not protect, in any case, clinical trials not
p.(None): ar ›Iorized, or the use of secret or undeclared remedies to the sanitary authority.
p.(None): 2.J 3. Open-blind clinical trial. It is the one in which the subject lants as the researcher knows the group of
p.(None): tralamienlo to which he has been assigned.
p.(None): 2.14. Clinical trial with third-party evaluation. It is one in which the subject, researcher and
p.(None): palroclnador, ignore the treatment received. To evaluate the response, a third person is used who
p.(None): the treatment each subject is receiving is unknown.
p.(None): 2.1s. It is cynical with crossed groups. It is the one in which the experimental and control treatments are
p.(None): administered to each individual in successive periods that have been determined randomly, to which
p.(None): allow each subject to be their
p.(None): 2.16. Clinical trial with parallel groups. It is one in which one or several groups of subjects are
p.(None): assigned to receive the experimental treatment at the same time as the other group receives the control treatment.
p.(None): 2.17. Controlled clinical trial. It is the one that establishes a comparison with a control group or tesligo. The
p.(None): randomized controlled clinical trial including at least two groups of volunteers,
p.(None): 2.1s. patient or healthy. whose assignment to an experimental or control treatment is carried out at random so that
p.(None): Neither the subject nor the doctor responsible for their selection or treatment can influence their assignment. So the
p.(None): Selection of subjects as the periods of treatment and follow-up should take place simultaneously in all
p.(None): groups. In the vast majority of cases it is the only scientifically valid way to assess efficacy and safety
p.(None): of a lerapêutica intervention.
p.(None): 2.19. Double-blind clinical trial. It is one in which both the subject and the researcher are unaware of the
p.(None): assignment to Nos treatment groups.
p.(None): 2.2o. Phase 1 clinical trial. They are the first step in the investigation of a substance or
p.(None): new medicine in humans, they are also studies of pharmacokinetics and pharmacodynamics] that will provide
p.(None): Preliminary information on the effect and safety of the product on healthy subjects or in some cases-
p.(None): in patients, and will guide the most appropriate administration regimen for subsequent trials.
p.(None): 2.Z1. Phase II clinical trial. They represent the second stage in the evaluation of a new substance or
p.(None): medicine in humans. These will be carried out in healthy subjects or in some houses in patients, their end
p.(None): is to provide preliminary information on the effectiveness of the product, establish the relationship between the responses
p.(None): of the same. to know the variables used to measure efficacy and extend the safety data obtained in the
p.(None): lass 1. In general, these clinical trials will be controlled and randomized to the treatments.
p.(None): NUMBER 2.S CENTER DIARY
p.(None): AMERICA Guotemolo, THURSDAY, February 22, 2007
p.(None): 2.43. Standard operating procedures (POEs). Written instructions to achieve uniformity in
p.(None): the execution of a specific function.
...
Searching for indicator substance:
(return to top)
p.(None): carefully informed and documented about its nature. imporlancia. implications, risks,
p.(None): alternative treatments available, the confidentiality of the information,
p.(None): the rights of persons and responsibilities in accordance with the Declaration of Helsinki. At
p.(None): supposing that the subject has an impediment to write, the consent may be smelled at home
p.(None): exceptional orally in the presence of at least one whip.
p.(None): When the subject of the trial is not a person capable of giving his consent, the decision must be made by
p.(None): your legal representative after having been informed about all relevant aspects of it
p.(None): to take the "decision to participate. Informed sentiment is documented through a form of
p.(None): written, signed and dated informed consent.
p.(None): 2.10. Source documents. Original documents, data and records (for example, hospital records, sheets
p.(None): clinical, lab notes, memoranda, subject journals, or evaluation checklists,
p.(None): pharmacy delivery records, recorded data from automated instruments, copies or
p.(None): After verifying cerlified transcripts that are exact copies, microfiche. negatives
p.(None): photographic. magnetic or microfilm media, x-rays, subject files and records kept in
p.(None): the pharmacy in the laboratories and in the medical-technical departments involved in the study. clinical).
p.(None): 2.11. Amendment to the protocol. A written description of a formal change or clarification of a protocol.
p.(None): 2.12. Clinical trial. All research or experimental evaluation of a substance, medicine or
p.(None): device, through its application to human beings, oriented towards one of the following lines:
p.(None): and. Show its pharmacodynamic effects or collect data regarding its absorption,
p.(None): distribution, metabolism and excretion in the
p.(None): human organism.
p.(None): b. Establish its efficacy for a specific therapeutic, prophylactic or diagnostic indication.
p.(None): c. Know the profile of your adverse reactions and establish your safety.
p.(None): The administration of the drug or medication to a single patient in the setting of the clinic is not considered a clinical trial.
p.(None): habitual medical practice for the sole purpose of obtaining a benefit for it. Medical practice and
p.(None): professional freedom of prescription of the doctor will not protect, in any case, clinical trials not
p.(None): ar ›Iorized, or the use of secret or undeclared remedies to the sanitary authority.
p.(None): 2.J 3. Open-blind clinical trial. It is the one in which the subject lants as the researcher knows the group of
p.(None): tralamienlo to which he has been assigned.
p.(None): 2.14. Clinical trial with third-party evaluation. It is one in which the subject, researcher and
p.(None): palroclnador, ignore the treatment received. To evaluate the response, a third person is used who
p.(None): the treatment each subject is receiving is unknown.
p.(None): 2.1s. It is cynical with crossed groups. It is the one in which the experimental and control treatments are
p.(None): administered to each individual in successive periods that have been determined randomly, to which
p.(None): allow each subject to be their
p.(None): 2.16. Clinical trial with parallel groups. It is one in which one or several groups of subjects are
p.(None): assigned to receive the experimental treatment at the same time as the other group receives the control treatment.
p.(None): 2.17. Controlled clinical trial. It is the one that establishes a comparison with a control group or tesligo. The
p.(None): randomized controlled clinical trial including at least two groups of volunteers,
p.(None): 2.1s. patient or healthy. whose assignment to an experimental or control treatment is carried out at random so that
p.(None): Neither the subject nor the doctor responsible for their selection or treatment can influence their assignment. So the
p.(None): Selection of subjects as the periods of treatment and follow-up should take place simultaneously in all
p.(None): groups. In the vast majority of cases it is the only scientifically valid way to assess efficacy and safety
p.(None): of a lerapêutica intervention.
p.(None): 2.19. Double-blind clinical trial. It is one in which both the subject and the researcher are unaware of the
p.(None): assignment to Nos treatment groups.
p.(None): 2.2o. Phase 1 clinical trial. They are the first step in the investigation of a substance or
p.(None): new medicine in humans, they are also studies of pharmacokinetics and pharmacodynamics] that will provide
p.(None): Preliminary information on the effect and safety of the product on healthy subjects or in some cases-
p.(None): in patients, and will guide the most appropriate administration regimen for subsequent trials.
p.(None): 2.Z1. Phase II clinical trial. They represent the second stage in the evaluation of a new substance or
p.(None): medicine in humans. These will be carried out in healthy subjects or in some houses in patients, their end
p.(None): is to provide preliminary information on the effectiveness of the product, establish the relationship between the responses
p.(None): of the same. to know the variables used to measure efficacy and extend the safety data obtained in the
p.(None): lass 1. In general, these clinical trials will be controlled and randomized to the treatments.
p.(None): NUMBER 2.S CENTER DIARY
p.(None): AMERICA Guotemolo, THURSDAY, February 22, 2007
p.(None): 2.43. Standard operating procedures (POEs). Written instructions to achieve uniformity in
p.(None): the execution of a specific function.
p.(None): 2.44. Produc to in In vestlgaclón. Pharmaceutical form of an active ingredient, placebo or device, which
p.(None): usanda is being tested as a reference in a clinical study, including a product with a
p.(None): marketing when used or packaged (formulated or packaged) in a manner unlike
p.(None): approve ‹›. when used for an unapproved indication or when used for
p.(None): 2.23. Phase IV clinical trial. They are those that are made with a medicine
p.(None): after its commercialization. These tests may be similar to those described
p.(None): Obtain more information about a previously approved use.
p.(None): ocolo. It is defined as the document where the reason for being is described
p.(None): in phases I, II and III if they study some aspect not yet evaluated or different conditions of use of the authors
p.(None): hoisted as it might be a new indication. These studies
p.(None): 2.45. Prot
p.(None): of the day, its objectives, design, methodology,
p.(None): statistical considerations and the
p.(None): to the original protocol, to its
p.(None): they will preferably be controlled and randomized.
...
p.(None): determine the size of the sample for further studies.
p.(None): 2.27. Sequential clinical trial. It is the one in which testing a
p.(None): adverse medium reactions, all harmful and unintended responses to a medicinal product
p.(None): related to any dose. The phrase "responses to a medicinal product" means that a causal relationship
p.(None): between a medicinal product and an adverse event is at least a reasonable possibility, that is, that the relationship
p.(None): can be discarded. Regarding medicinal products on the market: a response to a medicine that
p.(None): is harmful and unintentional and occurs at doses normally used in man for prophylaxis,
p.(None): dlagnôsllco or treatment
p.(None): from diseases to for modification of the łisiołógica function.
p.(None): specific hypothesis, the number of subjects is not predetermined in advance, but
p.(None): 2.47. Unexpected drug adverse reaction:
p.(None): adverse reaction whose
p.(None): It depends on the results that are obtained throughout it.
p.(None): 2.28. Simple clinical trial clergy. It is the one in which the subjects do not know the allocation to the group of
p.(None): treatment, but not the investigator.
p.(None): 2.29. Unlcêntrlco cylindrical test. It is that carried out by a single Investigator to a research team in
p.(None): a central dream.
p.(None): z.ao. Observational study. Analytical epidemiological study in which the researcher does not determine
p.(None): the allocation of the subjects to each group, but is limited to recording (observing) what happens in the
p.(None): reality.
p.(None): 2.31. Experimental assessment. It is that study in which an unauthorized substance is used as a specialty
p.(None): pharmaceutical or a pharmaceutical specialty is used under conditions of use other than those
p.(None): authorized; also is that
p.(None): Nature to severity does not correspond to the reference information on the product.
p.(None): 2.48. Subscriber subinves. Any individual member I from the designated and supervised clinical study group
p.(None): by the researcher at a site where the study is carried out to carry out the critical procedures
p.(None): related to the study and / or makes important decisions related to that.
p.(None): 2.50. Vulnerable subjectsG. Individuals whose desire to participate in clinical study may be influenced
p.(None): by the explanation, justified or not, of the benefits associated with their participation, or a
p.(None): revenge on the part of the members
p.(None): study in which subjects are assigned to one or more therapeutic intervention groups in a
p.(None): random, or is conditioned, directly or indirectly. the
p.(None): superiors of a hierarchy in order to refuse to participate.
p.(None): members of a group with a hierarchical structure, such as
p.(None): students of
p.(None): usual medical prescription process.
p.(None): z.1z. Adverse event (EA). Any unfavorable medical event that occurs in a patient or subject of
p.(None): a clinical investigation to whom a pharmaceutical product was administered and who does not necessarily have a relationship
p.(None): causal with that treatment. Therefore, an adverse event can be any unfavorable sign and not
p.(None): disabled (inducing an abnormal laboratory finding). Sloma or temporally associated disease
p.(None): with the use of a medicinal (research) product, whether or not related to it.
...
p.(None): and. Type of clinical test and its design.
p.(None): F. Selection of subjects.
p.(None): g. Description of thiaiamlento.
p.(None): h. Development of the trial and evaluation of the response.
p.(None): i. Adverse effects.
p.(None): j. Informed consent and other applicable ethical aspects.
p.(None): *. Practical considerations.
p.(None): 1. Statistical analysis.
p.(None): 35.a. Investigator's brochure, which may be in the original language with a summary in Spanish.
p.(None): 35.4. Procedure and model of the document to obtain consent
p.(None): as.s. Investigator's commitment to comply with good Clinical and Informal Practices
p.(None): periodically at the Research Ethics Committee from the beginning to the end of the research.
p.(None): CENTER JOURNAL 25
p.(None): AMERICA
p.(None): Guatemala, THURSDAY, February 22, 2007
p.(None): 35.6. Written information to be provided to test subjects.
p.(None): 35.7. Approval report and follow-up of the trial by the Ethics Committee8 on Research duly
p.(None): accredited as appropriate.
p.(None): 35.8. When appropriate, declaration of conformity of the relevant authorities of the center where
p.(None): It will complete the test.
p.(None): Article 36. Procedure. THE COMMISSION will communicate in writing to the Researcher, sponsor and Ethics Committee8
p.(None): In Research, receipt of the application and complete documentation, as well as its subsequent authorization
p.(None): express.
p.(None): The following shall be subject to authorization: All clinical tests with a substance classified as a product in the
p.(None): clinical research; search for new therapeutic indications of an already registered substance.
p.(None): Article 37. Terms of authorization. During the first year of validity of this Agreement from
p.(None): of its publication in the Diario de Centro America, THE COMMISSION will rule on a clinical study in a
p.(None): no later than forty-five days after receipt of the request and complete documentation.
p.(None): During the second year of validity and subject to the raising of private funds from THE COMMISSION,
p.(None): This will have a term of thirty days. Within the aforementioned period, THE COMMISSION may request the information
p.(None): pertinent, make objections, checks and corresponding observations.
p.(None): In cases where additional information or clarifications are requested, once the new
p.(None): information that the interested party has presented in his case, the final resolution will be found within a plaza of
p.(None): 15 days from the receipt of the required information. This resolution will be notified to the
p.(None): Research Ethics, the researcher, the sponsor and any other party
p.(None): Article 46. Evaluation criteria for the use of the dispute. The Êtlca Committee on Research
p.(None): corresponding to evaluate the protocol, the investigator's brochure and the rest of the documentation that
p.(None): Accompany the application and it will issue its opinion taking into consideration the following questions:
p.(None): 46.1. Relevance of the clinical trial. taking into account the available knowledge.
p.(None): 46.2. Relevance of your design to obtain informed conclusions with the appropriate number of
p.(None): subjects in relation to the objective of the study.
...
Health / Healthy People
Searching for indicator volunteers:
(return to top)
p.(None): habitual medical practice for the sole purpose of obtaining a benefit for it. Medical practice and
p.(None): professional freedom of prescription of the doctor will not protect, in any case, clinical trials not
p.(None): ar ›Iorized, or the use of secret or undeclared remedies to the sanitary authority.
p.(None): 2.J 3. Open-blind clinical trial. It is the one in which the subject lants as the researcher knows the group of
p.(None): tralamienlo to which he has been assigned.
p.(None): 2.14. Clinical trial with third-party evaluation. It is one in which the subject, researcher and
p.(None): palroclnador, ignore the treatment received. To evaluate the response, a third person is used who
p.(None): the treatment each subject is receiving is unknown.
p.(None): 2.1s. It is cynical with crossed groups. It is the one in which the experimental and control treatments are
p.(None): administered to each individual in successive periods that have been determined randomly, to which
p.(None): allow each subject to be their
p.(None): 2.16. Clinical trial with parallel groups. It is one in which one or several groups of subjects are
p.(None): assigned to receive the experimental treatment at the same time as the other group receives the control treatment.
p.(None): 2.17. Controlled clinical trial. It is the one that establishes a comparison with a control group or tesligo. The
p.(None): randomized controlled clinical trial including at least two groups of volunteers,
p.(None): 2.1s. patient or healthy. whose assignment to an experimental or control treatment is carried out at random so that
p.(None): Neither the subject nor the doctor responsible for their selection or treatment can influence their assignment. So the
p.(None): Selection of subjects as the periods of treatment and follow-up should take place simultaneously in all
p.(None): groups. In the vast majority of cases it is the only scientifically valid way to assess efficacy and safety
p.(None): of a lerapêutica intervention.
p.(None): 2.19. Double-blind clinical trial. It is one in which both the subject and the researcher are unaware of the
p.(None): assignment to Nos treatment groups.
p.(None): 2.2o. Phase 1 clinical trial. They are the first step in the investigation of a substance or
p.(None): new medicine in humans, they are also studies of pharmacokinetics and pharmacodynamics] that will provide
p.(None): Preliminary information on the effect and safety of the product on healthy subjects or in some cases-
p.(None): in patients, and will guide the most appropriate administration regimen for subsequent trials.
p.(None): 2.Z1. Phase II clinical trial. They represent the second stage in the evaluation of a new substance or
p.(None): medicine in humans. These will be carried out in healthy subjects or in some houses in patients, their end
p.(None): is to provide preliminary information on the effectiveness of the product, establish the relationship between the responses
p.(None): of the same. to know the variables used to measure efficacy and extend the safety data obtained in the
p.(None): lass 1. In general, these clinical trials will be controlled and randomized to the treatments.
p.(None): NUMBER 2.S CENTER DIARY
...
Health / Mentally Disabled
Searching for indicator disabled:
(return to top)
p.(None): the allocation of the subjects to each group, but is limited to recording (observing) what happens in the
p.(None): reality.
p.(None): 2.31. Experimental assessment. It is that study in which an unauthorized substance is used as a specialty
p.(None): pharmaceutical or a pharmaceutical specialty is used under conditions of use other than those
p.(None): authorized; also is that
p.(None): Nature to severity does not correspond to the reference information on the product.
p.(None): 2.48. Subscriber subinves. Any individual member I from the designated and supervised clinical study group
p.(None): by the researcher at a site where the study is carried out to carry out the critical procedures
p.(None): related to the study and / or makes important decisions related to that.
p.(None): 2.50. Vulnerable subjectsG. Individuals whose desire to participate in clinical study may be influenced
p.(None): by the explanation, justified or not, of the benefits associated with their participation, or a
p.(None): revenge on the part of the members
p.(None): study in which subjects are assigned to one or more therapeutic intervention groups in a
p.(None): random, or is conditioned, directly or indirectly. the
p.(None): superiors of a hierarchy in order to refuse to participate.
p.(None): members of a group with a hierarchical structure, such as
p.(None): students of
p.(None): usual medical prescription process.
p.(None): z.1z. Adverse event (EA). Any unfavorable medical event that occurs in a patient or subject of
p.(None): a clinical investigation to whom a pharmaceutical product was administered and who does not necessarily have a relationship
p.(None): causal with that treatment. Therefore, an adverse event can be any unfavorable sign and not
p.(None): disabled (inducing an abnormal laboratory finding). Sloma or temporally associated disease
p.(None): with the use of a medicinal (research) product, whether or not related to it.
p.(None): 2.13. Serious Adverse Event (EAS) or Serious Adverse Drug Reaction (Serious RAM). Any event
p.(None): adverse or adverse reaction that, at any dose, produces death, threatens the life of the subject, makes
p.(None): necessary hospitalization or prolongation, causes permanent or significant disability or incapacity, or
p.(None): give rise to an abnormality or congenital mallormaciõn.
p.(None): 2.16. Case report form (FRC). Printed, optical or electronic document designed to
p.(None): record all the information required in the protocol to be reported to the sponsor on each subject of the
p.(None): study.
p.(None): 2.57. Inspection. Official review by a regulatory authority of documents, facilities, record and
p.(None): any other resource that the authorities consider is related to the clinical study and that may be
p.(None): located at the site where the study is carried out, at the facilities of the sponsor and / or the
p.(None): Investigative organization by contract (OIC) or at other sites than regulatory authorities
p.(None): consider appropriate.
p.(None): 2.18. investigator. Person responsible for conducting a clinical study. If a study is conducted by
p.(None): a 9 group of individuals, the researcher is the leader responsible for the group and will be called the researcher
p.(None): principai.
p.(None): 2.40. Monitor. Professional trained with the necessary clinical competence, chosen by the sponsor, who will
...
p.(None): Comilé of Ethics in Research
p.(None): accredited, or a member of the Comilê designated for that purpose, in accordance with its regulations, in each
p.(None): one of its leaves and this one is the one that is presented to the subject.
p.(None): at 1z. 3. Eslar written by Korma clear, without technicalities so that the subject
p.(None): participant can understand it easily.
p.(None): 17.4. Have all its leaves foliated.
p.(None): 17.5. Indicate version number and date.
p.(None): 17.6. The paniclpanic subject in the investigation must give his consent before entering the study.
p.(None): 17.7. The subject must give their consent, free of coercion, with knowledge of all other
p.(None): therapeutic options available.
p.(None): 17.s. The subject must know his right to change his mind and leave the study at any time
p.(None): want.
p.(None): 17.s. Participant must receive a signed copy of the informed consent for their files
p.(None): personal.
p.(None): Article 18. Special regulations. Some situations, due to their characteristics, require an approach
p.(None): In particular, for this, a special opinion given by "THE COMMITTEE Ô is required
p.(None): 18.1. Minors: In the case of minors, the person who
p.(None): For example, its legal representation will be responsible for giving the contract and signing the document.
p.(None): In extraordinary cases d = investigations without therapeutic purposes in minors, persons
p.(None): disabled or with diminished competition or autonomy, the necessary measures will be taken to
p.(None): avoid the possible exploitation of these dreams and the damage to their health. Minors who have the
p.(None): adequate maturity or age, you must give your consent to participate in the study.
p.(None): 18.2. Subjects with mental disabilities. In the case of the incapable or in
p.(None): status of a legal representative, must give consent and sign the report
p.(None): on behalf of the participant, to whom the scope of the investigation must be explained, according to their
p.(None): understanding capacity.
p.(None): ISSUE 25
p.(None): 19.3.
p.(None): jg g 1g.5.
p.(None): CENTRAL AMERICA JOURNAL
p.(None): If from the essay relevant knowledge about the
p.(None): disease or cause of invasion. gives vital imoortancia to understand it. palliate it to cure it.
p.(None): If these knowledge cannot be obtained in any other way.
p.(None): If there are guarantees on the correct obtaining of informed consent, in accordance with the provisions of
p.(None): this regulation.
p.(None): Guatemolo, THURSDAY, February 22, 2007
p.(None): 25.10. Remuneration. It should be noted the expenses that patients received for expenses
p.(None): transportation, allmenlación, and others, where appropriate. Likewise, in studies that do not
p.(None): Therapeutic impact, amounts and how your participation will be rewarded.
p.(None): 25.11. Lions compensation. It must be clearly specified that the investigator will give medical care
p.(None): the participant who suffers some
p.(None): Article 20. Qualified emergencies: The following situations are considered:
p.(None): The immediate use of the product under study is essential to preserve the life of a patient.
p.(None): 20.2. There is an inability to communicate with the patient, due to confusion, lethargy, coma, among olros.
p.(None): 20.3. There is no sufficient time to obtain the consent of an authorized legal representative.
p.(None): A qualified physician, who has no participation in the study, should review and evaluate the
p.(None): silutation. The Report completes the case, including the independent physician's report. it must be presented to
p.(None): Research Ethics Committee for immediate review. It is imperative that the subject or his representative
p.(None): be notified, \ an p £ o ¢ łlo as possible. to give the consent of
p.(None): that the lralamîento be continued.
p.(None): Article 21. Subjects who cannot read or write. Participation is essential in these houses
p.(None): from an impartial witness during the study discussion. The consent of the subject can be expressed through the
p.(None): printing of the fingerprint on the original document, after ensuring that the subject has understood
p.(None): the content of the informed consent. It must also be accompanied by the fingerprint signature of the witness
p.(None): impartial.
p.(None): Article 22. Minors or disabled subjects, whose legal representative does not know how to read or
p.(None): scrlblr. In these situations, the participation of a witness also applies, both during the
p.(None): explanation of consent as during its signing.
p.(None): Article 23. Prisoners. The deprivation of freedom can affect the ability of this group of individuals to take
p.(None): a truly voluntary decision without coercion. For this reason, they are usually not included in studies.
p.(None): clinicians and, when a subject participating in a study is incarcerated, they are excluded from the study if their condition
p.(None): is not affected by this decision.
p.(None): An exception to this general principle are some life and death situations, when the subject could
p.(None): Benefit only from the treatment or when it comes to products that will be applied in the treatment
p.(None): of prevailing conditions in prisoners.
p.(None): A Committee on Ethics in Investigation that evaluates clinical studies on prisoners should take into account
p.(None): Among its Members, at least one prisoner or a representative of them with experience and capacity to
p.(None): I fulfilled] this function.
p.(None): zs.1. Research Presentation. Indicating at least, title of the investigation, name of the
p.(None): Researcher, telephone number and address where it will take place.
p.(None): 2s.z. Introduction. Indicating that it is an experimental study.
...
p.(None): Article 46. Evaluation criteria for the use of the dispute. The Êtlca Committee on Research
p.(None): corresponding to evaluate the protocol, the investigator's brochure and the rest of the documentation that
p.(None): Accompany the application and it will issue its opinion taking into consideration the following questions:
p.(None): 46.1. Relevance of the clinical trial. taking into account the available knowledge.
p.(None): 46.2. Relevance of your design to obtain informed conclusions with the appropriate number of
p.(None): subjects in relation to the objective of the study.
p.(None): 46.3. Selection and withdrawal criteria for trial subjects, as well as the equitable selection of the
p.(None): show.
p.(None): 46.4 .. Justification of the foreseeable costs and inconveniences in relation to the expected benefits for
p.(None): the trial subjects, for other patients and for the community, taking into account the principle of
p.(None): protection of the test subjects developed in the elic postulates.
p.(None): 46.5. Justification of the control group either placebo to an active treatment.
p.(None): 46.6. Provisions for monitoring the trial.
p.(None): • s.7. Suitability of the researcher and his collaborators.
p.(None): 46.8. ldoneidad of the facilities.
p.(None): 46.9. Adequacy of written information for test subjects and the procedure for
p.(None): oblenciôn informed consent. and justification of research in disabled people
p.(None): to give your informed consent.
p.(None): 46.10. Financial guarantee insurance provided for the trial. 4s. 11. Remuneration forecasts, for the Subjects
p.(None): of the essay.
p.(None): 46.12. Plan planned for the recruitment of the subjects.
p.(None): interested. THE COMMISSION'S ACCLUTIONS MUST BE CONTAINED IN ADMINISTRATIVE RESOLUTIONS.
p.(None): "” ”“ ’) Uend
p.(None): be i et evaluated for each one be the Centers replicated n n s
p.(None): Article 38. Conditions of Authorization. The authorization of a clinical trial is carried out for one year
p.(None): and when necessary it must be renewed. For this, the researcher or sponsor must present a
p.(None): request for renewal accompanied by progress reports of the clinical trial sent to the Ethics Committee in
p.(None): Investigation for at least 30 days prior to the expiration of the current aulorization. THE COMMISSION respond
p.(None): within 15 days of receiving the
p.(None): Article 39. Modifications to the protocols of authorized clinical trials. C \ talquìe r modiflcation approved
p.(None): The Research Ethics Committee shall be known to THE COMMISSION, and must be accompanied by
p.(None): a summary of the proposed and approved modifications.
p.(None): Any relevant modification that implies an increased risk for the participating subjects, must
p.(None): be approved by the Research Ethics Committee and gUÎO ¢ i ¥ ãdâ ROI t_A COMMISSION.
p.(None): Article 40. Expansion of the number of sites. Expanding the number of research sites initially
...
Searching for indicator disability:
(return to top)
p.(None): by the researcher at a site where the study is carried out to carry out the critical procedures
p.(None): related to the study and / or makes important decisions related to that.
p.(None): 2.50. Vulnerable subjectsG. Individuals whose desire to participate in clinical study may be influenced
p.(None): by the explanation, justified or not, of the benefits associated with their participation, or a
p.(None): revenge on the part of the members
p.(None): study in which subjects are assigned to one or more therapeutic intervention groups in a
p.(None): random, or is conditioned, directly or indirectly. the
p.(None): superiors of a hierarchy in order to refuse to participate.
p.(None): members of a group with a hierarchical structure, such as
p.(None): students of
p.(None): usual medical prescription process.
p.(None): z.1z. Adverse event (EA). Any unfavorable medical event that occurs in a patient or subject of
p.(None): a clinical investigation to whom a pharmaceutical product was administered and who does not necessarily have a relationship
p.(None): causal with that treatment. Therefore, an adverse event can be any unfavorable sign and not
p.(None): disabled (inducing an abnormal laboratory finding). Sloma or temporally associated disease
p.(None): with the use of a medicinal (research) product, whether or not related to it.
p.(None): 2.13. Serious Adverse Event (EAS) or Serious Adverse Drug Reaction (Serious RAM). Any event
p.(None): adverse or adverse reaction that, at any dose, produces death, threatens the life of the subject, makes
p.(None): necessary hospitalization or prolongation, causes permanent or significant disability or incapacity, or
p.(None): give rise to an abnormality or congenital mallormaciõn.
p.(None): 2.16. Case report form (FRC). Printed, optical or electronic document designed to
p.(None): record all the information required in the protocol to be reported to the sponsor on each subject of the
p.(None): study.
p.(None): 2.57. Inspection. Official review by a regulatory authority of documents, facilities, record and
p.(None): any other resource that the authorities consider is related to the clinical study and that may be
p.(None): located at the site where the study is carried out, at the facilities of the sponsor and / or the
p.(None): Investigative organization by contract (OIC) or at other sites than regulatory authorities
p.(None): consider appropriate.
p.(None): 2.18. investigator. Person responsible for conducting a clinical study. If a study is conducted by
p.(None): a 9 group of individuals, the researcher is the leader responsible for the group and will be called the researcher
p.(None): principai.
p.(None): 2.40. Monitor. Professional trained with the necessary clinical competence, chosen by the sponsor, who will
p.(None): In charge of direct monitoring of the conduct of the trial. Serves as a link between the sponsor and
p.(None): the principal investigator, when they do not confer in the same person.
p.(None): 2.41. Investigation Organization by contract. Legal entity or organization (commercial, academic or other
p.(None): type) against by the employer to carry out one or more of the workings and functions of the related sponsor
p.(None): with the study.
p.(None): 2.42. Sponsor. Individual, company or ’entity, institution or organization
p.(None): responsible for the lniclb, completion, management and / or financing of a clinical trial.
...
Health / Mentally Incapacitated
Searching for indicator incapable:
(return to top)
p.(None): 17.7. The subject must give their consent, free of coercion, with knowledge of all other
p.(None): therapeutic options available.
p.(None): 17.s. The subject must know his right to change his mind and leave the study at any time
p.(None): want.
p.(None): 17.s. Participant must receive a signed copy of the informed consent for their files
p.(None): personal.
p.(None): Article 18. Special regulations. Some situations, due to their characteristics, require an approach
p.(None): In particular, for this, a special opinion given by "THE COMMITTEE Ô is required
p.(None): 18.1. Minors: In the case of minors, the person who
p.(None): For example, its legal representation will be responsible for giving the contract and signing the document.
p.(None): In extraordinary cases d = investigations without therapeutic purposes in minors, persons
p.(None): disabled or with diminished competition or autonomy, the necessary measures will be taken to
p.(None): avoid the possible exploitation of these dreams and the damage to their health. Minors who have the
p.(None): adequate maturity or age, you must give your consent to participate in the study.
p.(None): 18.2. Subjects with mental disabilities. In the case of the incapable or in
p.(None): status of a legal representative, must give consent and sign the report
p.(None): on behalf of the participant, to whom the scope of the investigation must be explained, according to their
p.(None): understanding capacity.
p.(None): ISSUE 25
p.(None): 19.3.
p.(None): jg g 1g.5.
p.(None): CENTRAL AMERICA JOURNAL
p.(None): If from the essay relevant knowledge about the
p.(None): disease or cause of invasion. gives vital imoortancia to understand it. palliate it to cure it.
p.(None): If these knowledge cannot be obtained in any other way.
p.(None): If there are guarantees on the correct obtaining of informed consent, in accordance with the provisions of
p.(None): this regulation.
p.(None): Guatemolo, THURSDAY, February 22, 2007
p.(None): 25.10. Remuneration. It should be noted the expenses that patients received for expenses
p.(None): transportation, allmenlación, and others, where appropriate. Likewise, in studies that do not
p.(None): Therapeutic impact, amounts and how your participation will be rewarded.
p.(None): 25.11. Lions compensation. It must be clearly specified that the investigator will give medical care
p.(None): the participant who suffers some
p.(None): Article 20. Qualified emergencies: The following situations are considered:
p.(None): The immediate use of the product under study is essential to preserve the life of a patient.
p.(None): 20.2. There is an inability to communicate with the patient, due to confusion, lethargy, coma, among olros.
p.(None): 20.3. There is no sufficient time to obtain the consent of an authorized legal representative.
...
Health / Motherhood/Family
Searching for indicator family:
(return to top)
p.(None): personnel involved in the study, who are present in the process of obtaining informed consent.
p.(None): z.sz. Compassionate use. Use of a medicine or product in isolated patients, regardless of
p.(None): a clinical trial. Specialties are included
p.(None): tarmacêuticas for indications or conditions of use different from those aulorizadas, under the responsibility
p.(None): exclusively for a doctor who considers essential his
p.(None): utilization.
p.(None): CHAPTER II
p.(None): PROTECTION OF CLINICAL TRIAL SUBJECTS
p.(None): Article 3. Respect for the ethical postulates. Only a clinical investigation may be initiated,
p.(None): when THE GOVERNMENT has annulled the research protocol, considering that the final project
p.(None): meets all the requisites within which is the review and approval of an Ethics Committee in lnv
p.(None): accredited research independent of the interests of the investigation. Based on the benefits
p.(None): expected for the test subject and society justify the risks; likewise, only
p.(None): continue st compliance with this criterion is permanently monitored.
p.(None): Article S. The participation of the subjects in the investigation is voluntary. The participating subject in -a
p.(None): Research or its representative, may revoke your consent at any time, without expression
p.(None): of causes, without this deriving for him any liability or damage.
p.(None): All parties involved in an investigation into human beings will keep the strictest
p.(None): confidentiality. in such a way that the personal and family intimacy of the participating subjects in
p.(None): there.
p.(None): Likewise, appropriate measures should be taken to prevent access by unauthorized persons to
p.(None): Investigation data. The COMMISSION, the Research Ethics Committee that approved the protocol,
p.(None): The sponsor and national and / or international health regulatory agencies will have access to documents and
p.(None): regintros related to investigations when requested.
p.(None): 1 2 Guatemala, JU5VčS February 22, 2007 CENTRAL AMERICA JOURNAL
p.(None): ISSUE 25
p.(None): Article 6. All people have the right to receive a fair and equitable kato.
p.(None): In the extraordinary houses of Investigations without therapeutic purposes in minors and in the selection of the subjects
p.(None): ponlclpantas an una lnvoellgäcîón u •• •• d • b •• incapaceg o people
p.(None): - In the case of autonomous competition, the distributions will be taken equally, so that there is no
p.(None): groups exposed to ransom measures necessary to prevent impairment in their
p.(None): health and the possible exploitation of the elderly. All research with human subjects must have an approach
p.(None): these subjects.
p.(None): Valid science and design in a well-developed protocol, which guarantees quality
p.(None): of the study, in addition, the protection of vulnerable subjects, compensation and treatment for injuries to
p.(None): participants.
...
Health / patients in emergency situations
Searching for indicator emergencies:
(return to top)
p.(None): avoid the possible exploitation of these dreams and the damage to their health. Minors who have the
p.(None): adequate maturity or age, you must give your consent to participate in the study.
p.(None): 18.2. Subjects with mental disabilities. In the case of the incapable or in
p.(None): status of a legal representative, must give consent and sign the report
p.(None): on behalf of the participant, to whom the scope of the investigation must be explained, according to their
p.(None): understanding capacity.
p.(None): ISSUE 25
p.(None): 19.3.
p.(None): jg g 1g.5.
p.(None): CENTRAL AMERICA JOURNAL
p.(None): If from the essay relevant knowledge about the
p.(None): disease or cause of invasion. gives vital imoortancia to understand it. palliate it to cure it.
p.(None): If these knowledge cannot be obtained in any other way.
p.(None): If there are guarantees on the correct obtaining of informed consent, in accordance with the provisions of
p.(None): this regulation.
p.(None): Guatemolo, THURSDAY, February 22, 2007
p.(None): 25.10. Remuneration. It should be noted the expenses that patients received for expenses
p.(None): transportation, allmenlación, and others, where appropriate. Likewise, in studies that do not
p.(None): Therapeutic impact, amounts and how your participation will be rewarded.
p.(None): 25.11. Lions compensation. It must be clearly specified that the investigator will give medical care
p.(None): the participant who suffers some
p.(None): Article 20. Qualified emergencies: The following situations are considered:
p.(None): The immediate use of the product under study is essential to preserve the life of a patient.
p.(None): 20.2. There is an inability to communicate with the patient, due to confusion, lethargy, coma, among olros.
p.(None): 20.3. There is no sufficient time to obtain the consent of an authorized legal representative.
p.(None): A qualified physician, who has no participation in the study, should review and evaluate the
p.(None): silutation. The Report completes the case, including the independent physician's report. it must be presented to
p.(None): Research Ethics Committee for immediate review. It is imperative that the subject or his representative
p.(None): be notified, \ an p £ o ¢ łlo as possible. to give the consent of
p.(None): that the lralamîento be continued.
p.(None): Article 21. Subjects who cannot read or write. Participation is essential in these houses
p.(None): from an impartial witness during the study discussion. The consent of the subject can be expressed through the
p.(None): printing of the fingerprint on the original document, after ensuring that the subject has understood
p.(None): the content of the informed consent. It must also be accompanied by the fingerprint signature of the witness
p.(None): impartial.
p.(None): Article 22. Minors or disabled subjects, whose legal representative does not know how to read or
p.(None): scrlblr. In these situations, the participation of a witness also applies, both during the
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.(None): z.sz. Compassionate use. Use of a medicine or product in isolated patients, regardless of
p.(None): a clinical trial. Specialties are included
p.(None): tarmacêuticas for indications or conditions of use different from those aulorizadas, under the responsibility
p.(None): exclusively for a doctor who considers essential his
p.(None): utilization.
p.(None): CHAPTER II
p.(None): PROTECTION OF CLINICAL TRIAL SUBJECTS
p.(None): Article 3. Respect for the ethical postulates. Only a clinical investigation may be initiated,
p.(None): when THE GOVERNMENT has annulled the research protocol, considering that the final project
p.(None): meets all the requisites within which is the review and approval of an Ethics Committee in lnv
p.(None): accredited research independent of the interests of the investigation. Based on the benefits
p.(None): expected for the test subject and society justify the risks; likewise, only
p.(None): continue st compliance with this criterion is permanently monitored.
p.(None): Article S. The participation of the subjects in the investigation is voluntary. The participating subject in -a
p.(None): Research or its representative, may revoke your consent at any time, without expression
p.(None): of causes, without this deriving for him any liability or damage.
p.(None): All parties involved in an investigation into human beings will keep the strictest
p.(None): confidentiality. in such a way that the personal and family intimacy of the participating subjects in
p.(None): there.
p.(None): Likewise, appropriate measures should be taken to prevent access by unauthorized persons to
p.(None): Investigation data. The COMMISSION, the Research Ethics Committee that approved the protocol,
p.(None): The sponsor and national and / or international health regulatory agencies will have access to documents and
p.(None): regintros related to investigations when requested.
p.(None): 1 2 Guatemala, JU5VčS February 22, 2007 CENTRAL AMERICA JOURNAL
p.(None): ISSUE 25
p.(None): Article 6. All people have the right to receive a fair and equitable kato.
p.(None): In the extraordinary houses of Investigations without therapeutic purposes in minors and in the selection of the subjects
p.(None): ponlclpantas an una lnvoellgäcîón u •• •• d • b •• incapaceg o people
p.(None): - In the case of autonomous competition, the distributions will be taken equally, so that there is no
p.(None): groups exposed to ransom measures necessary to prevent impairment in their
p.(None): health and the possible exploitation of the elderly. All research with human subjects must have an approach
p.(None): these subjects.
p.(None): Valid science and design in a well-developed protocol, which guarantees quality
p.(None): of the study, in addition, the protection of vulnerable subjects, compensation and treatment for injuries to
p.(None): participants.
p.(None): Article 7. In vulnerable populations, investigations may only be carried out when they are of the highest interest.
p.(None): for your particular Galud. Investigations with said subjects can only be carried out when the
p.(None): all the following requirements:
p.(None): 7.1. Have sufficient scientific data and, in particular, pharmacological and toxicological tests
p.(None): in animals, which guarantee that the risks involved in the person in which it is carried out are admissible.
p.(None): 7.z. That the study is based on the available knowledge, the information sought, presumably,
...
p.(None): modification or violation of the protocol or interruption of the trial, and the reasons for it.
p.(None): 48.6. SUPPLY GALLUALLY SUPPLY PRODUCTS IN INVEST'96 «ION, ENSURE THAT THE STANDARDS HAVE BEEN FULFILLED
p.(None): of a correct claim and that they are adequately packaged and labeled. Also responsible
p.(None): of the conservation of the product, its manufacturing and control protocols, registration of
p.(None): quantities delivered and make sure that in the center where the test is carried out there is a procedure
p.(None): correct handling, conservation and use of the same. Exceptionally, they can be agreed with the center
p.(None): other ways of supply.
p.(None): Article 45. Compassionate use of products. To use a product as compassionate use under
p.(None): conditions of the original clinical trial, a use protocol drawn up by the doctor will be required
p.(None): they request him; informed consent of the patient to his legal representative; clinical report in eJ that the doctor
p.(None): justify the need for such treatment; when applicable, the .conformity of the director of the
p.(None): the transfer is going to be administered; * ’and the aulorization of LA
p.(None): 4dL
p.(None): 48.8.
p.(None): 48.9.
p.(None): Designate the monitor that will monitor the progress of the trial, when applicable. Communicate to THE COMMISSION, researchers and
p.(None): Research Ethics Committees involved in the trial, suspected serious adverse reactions and
p.(None): unexpected in accordance with to established in this normative.
p.(None): Provide the staff of the clinical trial and Ethics Committee in
p.(None): Investigation, immediately, of any information of importance to which you have access during the trial.
p.(None): The responsible physician shall inform the COMMISSION of the results of the treatment, as well as the
p.(None): suspicions of adverse reactions that may be due to it.
p.(None): 48.10. Provide financial compensation to subjects in the event of a death injury subject to the trial,
p.(None): as long as the researcher adheres to the protocol and to the Good Clinical Practices in the conduct of the
p.(None): clinical trial.
p.(None): * Guatemala, THURSDAY, February 22, 2007
p.(None): CEFJTRO AMERICA JOURNAL
p.(None): ISSUE 25
p.(None): 48.11. Provide the investigator with legal and economic coverage in the event of one of the cases
p.(None): described above, except if the injury is a consequence of neggligence or bad practice of the Investigator.
p.(None): 48.1z. Agree with the researcher on the distribution of responsibilities regarding data management,
p.(None): preparation of reports and publication of results.
p.(None): 48.13. Ensure that the investigator provides subjects with more information about the trial.
p.(None): 48.14. Notify any change in the protocol, both to the Research Ethics Committee and to THE COMMISSION.
p.(None): Article 49. Organixaclön de Investigación por Conțrato (OIC). A sponsor may transfer any or all
p.(None): the tasks and functions related to studying an ICO, but the ultimate responsibility for quality and
p.(None): Completeness of study data always rests with the sponsor. The ICO must implement
p.(None): quality assurance and quality control. Any task and function related to the
p.(None): Study that is transferred and assigned by an ICO must be specified in writing, in accordance with the
p.(None): respective regulation.
p.(None): Article 50. Monitor. The monitor's responsibilities are:
p.(None): 50.1. Work in accordance with the Standard Operating Procedures (PEO’s) of the
...
Social / Age
Searching for indicator age:
(return to top)
p.(None): participant can understand it easily.
p.(None): 17.4. Have all its leaves foliated.
p.(None): 17.5. Indicate version number and date.
p.(None): 17.6. The paniclpanic subject in the investigation must give his consent before entering the study.
p.(None): 17.7. The subject must give their consent, free of coercion, with knowledge of all other
p.(None): therapeutic options available.
p.(None): 17.s. The subject must know his right to change his mind and leave the study at any time
p.(None): want.
p.(None): 17.s. Participant must receive a signed copy of the informed consent for their files
p.(None): personal.
p.(None): Article 18. Special regulations. Some situations, due to their characteristics, require an approach
p.(None): In particular, for this, a special opinion given by "THE COMMITTEE Ô is required
p.(None): 18.1. Minors: In the case of minors, the person who
p.(None): For example, its legal representation will be responsible for giving the contract and signing the document.
p.(None): In extraordinary cases d = investigations without therapeutic purposes in minors, persons
p.(None): disabled or with diminished competition or autonomy, the necessary measures will be taken to
p.(None): avoid the possible exploitation of these dreams and the damage to their health. Minors who have the
p.(None): adequate maturity or age, you must give your consent to participate in the study.
p.(None): 18.2. Subjects with mental disabilities. In the case of the incapable or in
p.(None): status of a legal representative, must give consent and sign the report
p.(None): on behalf of the participant, to whom the scope of the investigation must be explained, according to their
p.(None): understanding capacity.
p.(None): ISSUE 25
p.(None): 19.3.
p.(None): jg g 1g.5.
p.(None): CENTRAL AMERICA JOURNAL
p.(None): If from the essay relevant knowledge about the
p.(None): disease or cause of invasion. gives vital imoortancia to understand it. palliate it to cure it.
p.(None): If these knowledge cannot be obtained in any other way.
p.(None): If there are guarantees on the correct obtaining of informed consent, in accordance with the provisions of
p.(None): this regulation.
p.(None): Guatemolo, THURSDAY, February 22, 2007
p.(None): 25.10. Remuneration. It should be noted the expenses that patients received for expenses
p.(None): transportation, allmenlación, and others, where appropriate. Likewise, in studies that do not
p.(None): Therapeutic impact, amounts and how your participation will be rewarded.
p.(None): 25.11. Lions compensation. It must be clearly specified that the investigator will give medical care
p.(None): the participant who suffers some
p.(None): Article 20. Qualified emergencies: The following situations are considered:
p.(None): The immediate use of the product under study is essential to preserve the life of a patient.
...
Social / Elderly
Searching for indicator elderly:
(return to top)
p.(None): Article S. The participation of the subjects in the investigation is voluntary. The participating subject in -a
p.(None): Research or its representative, may revoke your consent at any time, without expression
p.(None): of causes, without this deriving for him any liability or damage.
p.(None): All parties involved in an investigation into human beings will keep the strictest
p.(None): confidentiality. in such a way that the personal and family intimacy of the participating subjects in
p.(None): there.
p.(None): Likewise, appropriate measures should be taken to prevent access by unauthorized persons to
p.(None): Investigation data. The COMMISSION, the Research Ethics Committee that approved the protocol,
p.(None): The sponsor and national and / or international health regulatory agencies will have access to documents and
p.(None): regintros related to investigations when requested.
p.(None): 1 2 Guatemala, JU5VčS February 22, 2007 CENTRAL AMERICA JOURNAL
p.(None): ISSUE 25
p.(None): Article 6. All people have the right to receive a fair and equitable kato.
p.(None): In the extraordinary houses of Investigations without therapeutic purposes in minors and in the selection of the subjects
p.(None): ponlclpantas an una lnvoellgäcîón u •• •• d • b •• incapaceg o people
p.(None): - In the case of autonomous competition, the distributions will be taken equally, so that there is no
p.(None): groups exposed to ransom measures necessary to prevent impairment in their
p.(None): health and the possible exploitation of the elderly. All research with human subjects must have an approach
p.(None): these subjects.
p.(None): Valid science and design in a well-developed protocol, which guarantees quality
p.(None): of the study, in addition, the protection of vulnerable subjects, compensation and treatment for injuries to
p.(None): participants.
p.(None): Article 7. In vulnerable populations, investigations may only be carried out when they are of the highest interest.
p.(None): for your particular Galud. Investigations with said subjects can only be carried out when the
p.(None): all the following requirements:
p.(None): 7.1. Have sufficient scientific data and, in particular, pharmacological and toxicological tests
p.(None): in animals, which guarantee that the risks involved in the person in which it is carried out are admissible.
p.(None): 7.z. That the study is based on the available knowledge, the information sought, presumably,
p.(None): an advance in scientific knowledge about humans or to improve their health and design
p.(None): mlnlmlce the risks for the subjects participating in êl-.
p.(None): 7.z, That the foreseeable risks and inconveniences for the trial subjects have been weighted and are
p.(None): lower than the foreseeable benefits for each trial subject and future patients.
p.(None): Unless proven otherwise, it is presumed that the damage that affects the health of the person being tested, during the
p.(None): performance of the same and that they persist after the study is completed, have occurred as a consequence of the trial.
p.(None): The damages that affect the subjects after the end of their participation in the clinical trial must be analyzed.
p.(None): by the researcher to determine the link between the damage produced and the clinical trial.
...
Social / Ethnicity
Searching for indicator ethnic:
(return to top)
p.(None): Investigative organization by contract (OIC) or at other sites than regulatory authorities
p.(None): consider appropriate.
p.(None): 2.18. investigator. Person responsible for conducting a clinical study. If a study is conducted by
p.(None): a 9 group of individuals, the researcher is the leader responsible for the group and will be called the researcher
p.(None): principai.
p.(None): 2.40. Monitor. Professional trained with the necessary clinical competence, chosen by the sponsor, who will
p.(None): In charge of direct monitoring of the conduct of the trial. Serves as a link between the sponsor and
p.(None): the principal investigator, when they do not confer in the same person.
p.(None): 2.41. Investigation Organization by contract. Legal entity or organization (commercial, academic or other
p.(None): type) against by the employer to carry out one or more of the workings and functions of the related sponsor
p.(None): with the study.
p.(None): 2.42. Sponsor. Individual, company or ’entity, institution or organization
p.(None): responsible for the lniclb, completion, management and / or financing of a clinical trial.
p.(None): medicine, dentistry, chemical-biological-biological and in fermeria, personal
p.(None): Sub-ordinate of hospital and laboratory, employees of the pharmaceutical industry, members of the forces
p.(None): armed and people who are detained / detained. Olrog vulnerable subjects include patients with disease
p.(None): incurable people
p.(None): in asylums, unemployed or indigent. patients in emergency situations. ethnic minority groups, people
p.(None): homeless, nomads, refugees, minors and those who cannot consent.
p.(None): z.st. Impartial Testłgo. Independent study person, who cannot be influenced in bad faith by the
p.(None): personnel involved in the study, who are present in the process of obtaining informed consent.
p.(None): z.sz. Compassionate use. Use of a medicine or product in isolated patients, regardless of
p.(None): a clinical trial. Specialties are included
p.(None): tarmacêuticas for indications or conditions of use different from those aulorizadas, under the responsibility
p.(None): exclusively for a doctor who considers essential his
p.(None): utilization.
p.(None): CHAPTER II
p.(None): PROTECTION OF CLINICAL TRIAL SUBJECTS
p.(None): Article 3. Respect for the ethical postulates. Only a clinical investigation may be initiated,
p.(None): when THE GOVERNMENT has annulled the research protocol, considering that the final project
p.(None): meets all the requisites within which is the review and approval of an Ethics Committee in lnv
p.(None): accredited research independent of the interests of the investigation. Based on the benefits
p.(None): expected for the test subject and society justify the risks; likewise, only
p.(None): continue st compliance with this criterion is permanently monitored.
p.(None): Article S. The participation of the subjects in the investigation is voluntary. The participating subject in -a
...
Social / Incarcerated
Searching for indicator incarcerated:
(return to top)
p.(None): silutation. The Report completes the case, including the independent physician's report. it must be presented to
p.(None): Research Ethics Committee for immediate review. It is imperative that the subject or his representative
p.(None): be notified, \ an p £ o ¢ łlo as possible. to give the consent of
p.(None): that the lralamîento be continued.
p.(None): Article 21. Subjects who cannot read or write. Participation is essential in these houses
p.(None): from an impartial witness during the study discussion. The consent of the subject can be expressed through the
p.(None): printing of the fingerprint on the original document, after ensuring that the subject has understood
p.(None): the content of the informed consent. It must also be accompanied by the fingerprint signature of the witness
p.(None): impartial.
p.(None): Article 22. Minors or disabled subjects, whose legal representative does not know how to read or
p.(None): scrlblr. In these situations, the participation of a witness also applies, both during the
p.(None): explanation of consent as during its signing.
p.(None): Article 23. Prisoners. The deprivation of freedom can affect the ability of this group of individuals to take
p.(None): a truly voluntary decision without coercion. For this reason, they are usually not included in studies.
p.(None): clinicians and, when a subject participating in a study is incarcerated, they are excluded from the study if their condition
p.(None): is not affected by this decision.
p.(None): An exception to this general principle are some life and death situations, when the subject could
p.(None): Benefit only from the treatment or when it comes to products that will be applied in the treatment
p.(None): of prevailing conditions in prisoners.
p.(None): A Committee on Ethics in Investigation that evaluates clinical studies on prisoners should take into account
p.(None): Among its Members, at least one prisoner or a representative of them with experience and capacity to
p.(None): I fulfilled] this function.
p.(None): zs.1. Research Presentation. Indicating at least, title of the investigation, name of the
p.(None): Researcher, telephone number and address where it will take place.
p.(None): 2s.z. Introduction. Indicating that it is an experimental study.
p.(None): 25.3. Purpose of the study. It must clearly indicate what will be the contributions that the study will reach
p.(None): Level lenlïfico and the objective (s) of the study.
p.(None): 25.4. Procedures to senum.
p.(None): study-related injury, without shifting that responsibility to health insurance or the
p.(None): state health services. The sponsor will cover the treatment ribs that the patient
p.(None): Anytime to recover from the injury, as long as the investigator adheres to protocol and Good Practice.
p.(None): Clinical practices in conducting the clinical trial.
p.(None): zs.1z. Confidentiality It must be specified that the confidentiality of the
p.(None): Pan-municipal subjects will be preserved and that no subject will be identified by name in the
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.(None): The damages that affect the subjects after the end of their participation in the clinical trial must be analyzed.
p.(None): by the researcher to determine the link between the damage produced and the clinical trial.
p.(None): Article 11. For the electors of the liability regime provided for in this article, it shall be considered
p.(None): object of compensation all the expenses derlvados of the impairment in the health of the subject submitted to
p.(None): trial, as well as the economic damages that directly undermine such damage, provided that this is
p.(None): consequence of submission to the clinical trial. It will not be subject to compensation under the
p.(None): liability provided for in this article, the damage suffered by the subject subject to the trial in their health when
p.(None): This is inhercnte to the pathology under study.
p.(None): CHAPTER III. INFORMED CONSENT
p.(None): Article 15. Informed consent process. The process for obtaining the informed consent of the
p.(None): Participating in a clinical trial is achieved with the following actions:
p.(None): 1s. 1. Elaboration of an informed consent document with all the elements and requirements
p.(None): established in the body of this provision.
p.(None): 1s. 2. Presentation of the content of the informed consent and procedure for its
p.(None): Obtained before the Comilê de Ética en Investigación, for approval.
p.(None): IN.3. Detailed explanation, in simple and understandable language for the subject or for Cu
p.(None): legal representative, what is the research, what are the risks and benefits and what are
p.(None): your rights to participate in the eCludio.
p.(None): 1g. 4. Discussion and answer to all the doubts and questions that the subject or his legal representative have.
p.(None): 1s. 5. . The participating subject or the legal representative, to give their consent to
p.(None): To participate in the study, you must sign and date the document, together with the person who conducted the
p.(None): information process ÿ explanation of the informed consent document.
p.(None): 1'i.6. If the subject to their legal representative cannot read or write, they must place their fingerprint. During
p.(None): the entire process must be attended by an impartial witness, who must also sign or place his fingerprint
p.(None): digital and date the document.
p.(None): IN.7. Delivery of a signed copy of the approved informed consent document to Subject or to your
p.(None): legal representative. •
p.(None): 15.8. File of the original of the informed consent document in the subject's clinical file.
p.(None): Art (ass 16. The written informed consent document and any other written information that is
p.(None): will provide subjects should be reviewed when new information emerges that may be relevant to
p.(None): the subject's consent. Any form of written informed consent and written information
...
p.(None): Clinical trial procedures must have the review and approval of an Ethics Committee in
p.(None): Research accredited by the Ministry of Health, through the respective agency.
p.(None): Article 35. Application for authorization of a clinical trial. You must have the following documentation:
p.(None): 35.1. Request made by the researcher or sponsor, addressed to THE COMMISSION, indicating:
p.(None): to. Protocol title and number.
p.(None): b. Name and address of the principal investigator. c Research site.
p.(None): d. Study drug (international code name, pharmaceutical form, concentration,
p.(None): presentation).
p.(None): and. Research phase.
p.(None): 1. Research Ethics Committee.
p.(None): g. Sponsor.
p.(None): h. Sub-investigators, when applicable.
p.(None): ‹Receipt of payment of the corresponding duty, according to the specific year.
p.(None): 35.2. Test protocol. clinical. Every protocol for the clinical trial shall be written in Spanish,
p.(None): including the following basic sections:
p.(None): to. Summary.
p.(None): b. indice.
p.(None): c. General information.
p.(None): d. Justification and objectives.
p.(None): and. Type of clinical test and its design.
p.(None): F. Selection of subjects.
p.(None): g. Description of thiaiamlento.
p.(None): h. Development of the trial and evaluation of the response.
p.(None): i. Adverse effects.
p.(None): j. Informed consent and other applicable ethical aspects.
p.(None): *. Practical considerations.
p.(None): 1. Statistical analysis.
p.(None): 35.a. Investigator's brochure, which may be in the original language with a summary in Spanish.
p.(None): 35.4. Procedure and model of the document to obtain consent
p.(None): as.s. Investigator's commitment to comply with good Clinical and Informal Practices
p.(None): periodically at the Research Ethics Committee from the beginning to the end of the research.
p.(None): CENTER JOURNAL 25
p.(None): AMERICA
p.(None): Guatemala, THURSDAY, February 22, 2007
p.(None): 35.6. Written information to be provided to test subjects.
p.(None): 35.7. Approval report and follow-up of the trial by the Ethics Committee8 on Research duly
p.(None): accredited as appropriate.
p.(None): 35.8. When appropriate, declaration of conformity of the relevant authorities of the center where
p.(None): It will complete the test.
p.(None): Article 36. Procedure. THE COMMISSION will communicate in writing to the Researcher, sponsor and Ethics Committee8
p.(None): In Research, receipt of the application and complete documentation, as well as its subsequent authorization
p.(None): express.
p.(None): The following shall be subject to authorization: All clinical tests with a substance classified as a product in the
p.(None): clinical research; search for new therapeutic indications of an already registered substance.
p.(None): Article 37. Terms of authorization. During the first year of validity of this Agreement from
p.(None): of its publication in the Diario de Centro America, THE COMMISSION will rule on a clinical study in a
p.(None): no later than forty-five days after receipt of the request and complete documentation.
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.(None): your legal representative after having been informed about all relevant aspects of it
p.(None): to take the "decision to participate. Informed sentiment is documented through a form of
p.(None): written, signed and dated informed consent.
p.(None): 2.10. Source documents. Original documents, data and records (for example, hospital records, sheets
p.(None): clinical, lab notes, memoranda, subject journals, or evaluation checklists,
p.(None): pharmacy delivery records, recorded data from automated instruments, copies or
p.(None): After verifying cerlified transcripts that are exact copies, microfiche. negatives
p.(None): photographic. magnetic or microfilm media, x-rays, subject files and records kept in
p.(None): the pharmacy in the laboratories and in the medical-technical departments involved in the study. clinical).
p.(None): 2.11. Amendment to the protocol. A written description of a formal change or clarification of a protocol.
p.(None): 2.12. Clinical trial. All research or experimental evaluation of a substance, medicine or
p.(None): device, through its application to human beings, oriented towards one of the following lines:
p.(None): and. Show its pharmacodynamic effects or collect data regarding its absorption,
p.(None): distribution, metabolism and excretion in the
p.(None): human organism.
p.(None): b. Establish its efficacy for a specific therapeutic, prophylactic or diagnostic indication.
p.(None): c. Know the profile of your adverse reactions and establish your safety.
p.(None): The administration of the drug or medication to a single patient in the setting of the clinic is not considered a clinical trial.
p.(None): habitual medical practice for the sole purpose of obtaining a benefit for it. Medical practice and
p.(None): professional freedom of prescription of the doctor will not protect, in any case, clinical trials not
p.(None): ar ›Iorized, or the use of secret or undeclared remedies to the sanitary authority.
p.(None): 2.J 3. Open-blind clinical trial. It is the one in which the subject lants as the researcher knows the group of
p.(None): tralamienlo to which he has been assigned.
p.(None): 2.14. Clinical trial with third-party evaluation. It is one in which the subject, researcher and
p.(None): palroclnador, ignore the treatment received. To evaluate the response, a third person is used who
p.(None): the treatment each subject is receiving is unknown.
p.(None): 2.1s. It is cynical with crossed groups. It is the one in which the experimental and control treatments are
p.(None): administered to each individual in successive periods that have been determined randomly, to which
p.(None): allow each subject to be their
p.(None): 2.16. Clinical trial with parallel groups. It is one in which one or several groups of subjects are
p.(None): assigned to receive the experimental treatment at the same time as the other group receives the control treatment.
p.(None): 2.17. Controlled clinical trial. It is the one that establishes a comparison with a control group or tesligo. The
p.(None): randomized controlled clinical trial including at least two groups of volunteers,
...
p.(None): is to provide preliminary information on the effectiveness of the product, establish the relationship between the responses
p.(None): of the same. to know the variables used to measure efficacy and extend the safety data obtained in the
p.(None): lass 1. In general, these clinical trials will be controlled and randomized to the treatments.
p.(None): NUMBER 2.S CENTER DIARY
p.(None): AMERICA Guotemolo, THURSDAY, February 22, 2007
p.(None): 2.43. Standard operating procedures (POEs). Written instructions to achieve uniformity in
p.(None): the execution of a specific function.
p.(None): 2.44. Produc to in In vestlgaclón. Pharmaceutical form of an active ingredient, placebo or device, which
p.(None): usanda is being tested as a reference in a clinical study, including a product with a
p.(None): marketing when used or packaged (formulated or packaged) in a manner unlike
p.(None): approve ‹›. when used for an unapproved indication or when used for
p.(None): 2.23. Phase IV clinical trial. They are those that are made with a medicine
p.(None): after its commercialization. These tests may be similar to those described
p.(None): Obtain more information about a previously approved use.
p.(None): ocolo. It is defined as the document where the reason for being is described
p.(None): in phases I, II and III if they study some aspect not yet evaluated or different conditions of use of the authors
p.(None): hoisted as it might be a new indication. These studies
p.(None): 2.45. Prot
p.(None): of the day, its objectives, design, methodology,
p.(None): statistical considerations and the
p.(None): to the original protocol, to its
p.(None): they will preferably be controlled and randomized.
p.(None): 2.24. Multicenter clinical trial. It is one conducted according to a single protocol but in more than one
p.(None): place and, therefore, carried out by more than one
p.(None): organization of a trial. The term protocol is highlighted
p.(None): successive versions and their modifications.
p.(None): 2.4s. Adverse drug reaction (ADR). This clinical experience before
p.(None): approval of a new medicinal product or its new uses, particularly
p.(None): investigator.
p.(None): when the therapeutic dose cannot be established.
p.(None): They should be considered
p.(None): 2.25. Uncontrolled clinical trial. It is the one that cannot be compared with a control or control group.
p.(None): 2.26. Clinical trial photo. It is the one that is carried out as a previous step to other broader studies with
p.(None): the purpose of knowing data that allows a more adequate design, establishing its viability, as well as
p.(None): determine the size of the sample for further studies.
p.(None): 2.27. Sequential clinical trial. It is the one in which testing a
p.(None): adverse medium reactions, all harmful and unintended responses to a medicinal product
p.(None): related to any dose. The phrase "responses to a medicinal product" means that a causal relationship
p.(None): between a medicinal product and an adverse event is at least a reasonable possibility, that is, that the relationship
p.(None): can be discarded. Regarding medicinal products on the market: a response to a medicine that
p.(None): is harmful and unintentional and occurs at doses normally used in man for prophylaxis,
p.(None): dlagnôsllco or treatment
p.(None): from diseases to for modification of the łisiołógica function.
p.(None): specific hypothesis, the number of subjects is not predetermined in advance, but
p.(None): 2.47. Unexpected drug adverse reaction:
p.(None): adverse reaction whose
p.(None): It depends on the results that are obtained throughout it.
p.(None): 2.28. Simple clinical trial clergy. It is the one in which the subjects do not know the allocation to the group of
p.(None): treatment, but not the investigator.
p.(None): 2.29. Unlcêntrlco cylindrical test. It is that carried out by a single Investigator to a research team in
p.(None): a central dream.
p.(None): z.ao. Observational study. Analytical epidemiological study in which the researcher does not determine
p.(None): the allocation of the subjects to each group, but is limited to recording (observing) what happens in the
p.(None): reality.
p.(None): 2.31. Experimental assessment. It is that study in which an unauthorized substance is used as a specialty
p.(None): pharmaceutical or a pharmaceutical specialty is used under conditions of use other than those
p.(None): authorized; also is that
p.(None): Nature to severity does not correspond to the reference information on the product.
p.(None): 2.48. Subscriber subinves. Any individual member I from the designated and supervised clinical study group
p.(None): by the researcher at a site where the study is carried out to carry out the critical procedures
p.(None): related to the study and / or makes important decisions related to that.
p.(None): 2.50. Vulnerable subjectsG. Individuals whose desire to participate in clinical study may be influenced
p.(None): by the explanation, justified or not, of the benefits associated with their participation, or a
p.(None): revenge on the part of the members
p.(None): study in which subjects are assigned to one or more therapeutic intervention groups in a
p.(None): random, or is conditioned, directly or indirectly. the
p.(None): superiors of a hierarchy in order to refuse to participate.
p.(None): members of a group with a hierarchical structure, such as
p.(None): students of
p.(None): usual medical prescription process.
p.(None): z.1z. Adverse event (EA). Any unfavorable medical event that occurs in a patient or subject of
...
Social / Property Ownership
Searching for indicator property:
(return to top)
p.(None): z.2. Quality assurance. All those planned and symbolic actions that
p.(None): established to guarantee that the study is being carried out and that the data is generated.
p.(None): Documented (registered) and reported in c. implemented with the 6 Good Clinical Practice (PCB) and the
p.(None): applicable regulatory requirements.
p.(None): 8. Random Assignment. Process of assigning study subjects to treatment groups
p.(None): or control using chance to determine allocations to reduce bias.
p.(None): 2.4. Audit. A systematic and independent examination of related activities and documents
p.(None): with the study to determine if the evaluated activities were carried out and the data were recorded,
p.(None): analyzed and reported accurately according to protocol, standard operating procedures
p.(None): Sponsor's (POEs), Good Practice Clinics (BPC) and apiicabies regulatory requirements.
p.(None): 2.5. Good clinical practices (PCB). Standard for design, conduction, realization, monitoring,
p.(None): audit, registration, analysis and reporting of clinical studies that provides a guarantee that the data and
p.(None): Reported results are credible and accurate and that the rights, integrity and confidentiality of
p.(None): study subjects.
p.(None): 2.6. Commission for the evaluation of clinical trials. Governing body in * the authorization to carry out
p.(None): a clinical trial protocol, and in the course of this legal body it will be called THE COMMISSION.
p.(None): 2.7. Investigative Ethics Committee (cEl). Independent organization, made up of professionals
p.(None): Physicians / Scientists and non-medical or non-scientific members, whose responsibility is to ensure protection
p.(None): of fas rights. the safety and property of the human beings involved in a study and
p.(None): provide a public guarantee of that protection. through, enter other houses. of the review and
p.(None): carefully informed and documented about its nature. imporlancia. implications, risks,
p.(None): alternative treatments available, the confidentiality of the information,
p.(None): the rights of persons and responsibilities in accordance with the Declaration of Helsinki. At
p.(None): supposing that the subject has an impediment to write, the consent may be smelled at home
p.(None): exceptional orally in the presence of at least one whip.
p.(None): When the subject of the trial is not a person capable of giving his consent, the decision must be made by
p.(None): your legal representative after having been informed about all relevant aspects of it
p.(None): to take the "decision to participate. Informed sentiment is documented through a form of
p.(None): written, signed and dated informed consent.
p.(None): 2.10. Source documents. Original documents, data and records (for example, hospital records, sheets
p.(None): clinical, lab notes, memoranda, subject journals, or evaluation checklists,
p.(None): pharmacy delivery records, recorded data from automated instruments, copies or
p.(None): After verifying cerlified transcripts that are exact copies, microfiche. negatives
p.(None): photographic. magnetic or microfilm media, x-rays, subject files and records kept in
p.(None): the pharmacy in the laboratories and in the medical-technical departments involved in the study. clinical).
p.(None): 2.11. Amendment to the protocol. A written description of a formal change or clarification of a protocol.
...
Social / Racial Minority
Searching for indicator minority:
(return to top)
p.(None): Investigative organization by contract (OIC) or at other sites than regulatory authorities
p.(None): consider appropriate.
p.(None): 2.18. investigator. Person responsible for conducting a clinical study. If a study is conducted by
p.(None): a 9 group of individuals, the researcher is the leader responsible for the group and will be called the researcher
p.(None): principai.
p.(None): 2.40. Monitor. Professional trained with the necessary clinical competence, chosen by the sponsor, who will
p.(None): In charge of direct monitoring of the conduct of the trial. Serves as a link between the sponsor and
p.(None): the principal investigator, when they do not confer in the same person.
p.(None): 2.41. Investigation Organization by contract. Legal entity or organization (commercial, academic or other
p.(None): type) against by the employer to carry out one or more of the workings and functions of the related sponsor
p.(None): with the study.
p.(None): 2.42. Sponsor. Individual, company or ’entity, institution or organization
p.(None): responsible for the lniclb, completion, management and / or financing of a clinical trial.
p.(None): medicine, dentistry, chemical-biological-biological and in fermeria, personal
p.(None): Sub-ordinate of hospital and laboratory, employees of the pharmaceutical industry, members of the forces
p.(None): armed and people who are detained / detained. Olrog vulnerable subjects include patients with disease
p.(None): incurable people
p.(None): in asylums, unemployed or indigent. patients in emergency situations. ethnic minority groups, people
p.(None): homeless, nomads, refugees, minors and those who cannot consent.
p.(None): z.st. Impartial Testłgo. Independent study person, who cannot be influenced in bad faith by the
p.(None): personnel involved in the study, who are present in the process of obtaining informed consent.
p.(None): z.sz. Compassionate use. Use of a medicine or product in isolated patients, regardless of
p.(None): a clinical trial. Specialties are included
p.(None): tarmacêuticas for indications or conditions of use different from those aulorizadas, under the responsibility
p.(None): exclusively for a doctor who considers essential his
p.(None): utilization.
p.(None): CHAPTER II
p.(None): PROTECTION OF CLINICAL TRIAL SUBJECTS
p.(None): Article 3. Respect for the ethical postulates. Only a clinical investigation may be initiated,
p.(None): when THE GOVERNMENT has annulled the research protocol, considering that the final project
p.(None): meets all the requisites within which is the review and approval of an Ethics Committee in lnv
p.(None): accredited research independent of the interests of the investigation. Based on the benefits
p.(None): expected for the test subject and society justify the risks; likewise, only
p.(None): continue st compliance with this criterion is permanently monitored.
p.(None): Article S. The participation of the subjects in the investigation is voluntary. The participating subject in -a
p.(None): Research or its representative, may revoke your consent at any time, without expression
...
Social / Religion
Searching for indicator faith:
(return to top)
p.(None): principai.
p.(None): 2.40. Monitor. Professional trained with the necessary clinical competence, chosen by the sponsor, who will
p.(None): In charge of direct monitoring of the conduct of the trial. Serves as a link between the sponsor and
p.(None): the principal investigator, when they do not confer in the same person.
p.(None): 2.41. Investigation Organization by contract. Legal entity or organization (commercial, academic or other
p.(None): type) against by the employer to carry out one or more of the workings and functions of the related sponsor
p.(None): with the study.
p.(None): 2.42. Sponsor. Individual, company or ’entity, institution or organization
p.(None): responsible for the lniclb, completion, management and / or financing of a clinical trial.
p.(None): medicine, dentistry, chemical-biological-biological and in fermeria, personal
p.(None): Sub-ordinate of hospital and laboratory, employees of the pharmaceutical industry, members of the forces
p.(None): armed and people who are detained / detained. Olrog vulnerable subjects include patients with disease
p.(None): incurable people
p.(None): in asylums, unemployed or indigent. patients in emergency situations. ethnic minority groups, people
p.(None): homeless, nomads, refugees, minors and those who cannot consent.
p.(None): z.st. Impartial Testłgo. Independent study person, who cannot be influenced in bad faith by the
p.(None): personnel involved in the study, who are present in the process of obtaining informed consent.
p.(None): z.sz. Compassionate use. Use of a medicine or product in isolated patients, regardless of
p.(None): a clinical trial. Specialties are included
p.(None): tarmacêuticas for indications or conditions of use different from those aulorizadas, under the responsibility
p.(None): exclusively for a doctor who considers essential his
p.(None): utilization.
p.(None): CHAPTER II
p.(None): PROTECTION OF CLINICAL TRIAL SUBJECTS
p.(None): Article 3. Respect for the ethical postulates. Only a clinical investigation may be initiated,
p.(None): when THE GOVERNMENT has annulled the research protocol, considering that the final project
p.(None): meets all the requisites within which is the review and approval of an Ethics Committee in lnv
p.(None): accredited research independent of the interests of the investigation. Based on the benefits
p.(None): expected for the test subject and society justify the risks; likewise, only
p.(None): continue st compliance with this criterion is permanently monitored.
p.(None): Article S. The participation of the subjects in the investigation is voluntary. The participating subject in -a
p.(None): Research or its representative, may revoke your consent at any time, without expression
p.(None): of causes, without this deriving for him any liability or damage.
p.(None): All parties involved in an investigation into human beings will keep the strictest
p.(None): confidentiality. in such a way that the personal and family intimacy of the participating subjects in
p.(None): there.
...
Social / Unemployment
Searching for indicator unemployed:
(return to top)
p.(None): any other resource that the authorities consider is related to the clinical study and that may be
p.(None): located at the site where the study is carried out, at the facilities of the sponsor and / or the
p.(None): Investigative organization by contract (OIC) or at other sites than regulatory authorities
p.(None): consider appropriate.
p.(None): 2.18. investigator. Person responsible for conducting a clinical study. If a study is conducted by
p.(None): a 9 group of individuals, the researcher is the leader responsible for the group and will be called the researcher
p.(None): principai.
p.(None): 2.40. Monitor. Professional trained with the necessary clinical competence, chosen by the sponsor, who will
p.(None): In charge of direct monitoring of the conduct of the trial. Serves as a link between the sponsor and
p.(None): the principal investigator, when they do not confer in the same person.
p.(None): 2.41. Investigation Organization by contract. Legal entity or organization (commercial, academic or other
p.(None): type) against by the employer to carry out one or more of the workings and functions of the related sponsor
p.(None): with the study.
p.(None): 2.42. Sponsor. Individual, company or ’entity, institution or organization
p.(None): responsible for the lniclb, completion, management and / or financing of a clinical trial.
p.(None): medicine, dentistry, chemical-biological-biological and in fermeria, personal
p.(None): Sub-ordinate of hospital and laboratory, employees of the pharmaceutical industry, members of the forces
p.(None): armed and people who are detained / detained. Olrog vulnerable subjects include patients with disease
p.(None): incurable people
p.(None): in asylums, unemployed or indigent. patients in emergency situations. ethnic minority groups, people
p.(None): homeless, nomads, refugees, minors and those who cannot consent.
p.(None): z.st. Impartial Testłgo. Independent study person, who cannot be influenced in bad faith by the
p.(None): personnel involved in the study, who are present in the process of obtaining informed consent.
p.(None): z.sz. Compassionate use. Use of a medicine or product in isolated patients, regardless of
p.(None): a clinical trial. Specialties are included
p.(None): tarmacêuticas for indications or conditions of use different from those aulorizadas, under the responsibility
p.(None): exclusively for a doctor who considers essential his
p.(None): utilization.
p.(None): CHAPTER II
p.(None): PROTECTION OF CLINICAL TRIAL SUBJECTS
p.(None): Article 3. Respect for the ethical postulates. Only a clinical investigation may be initiated,
p.(None): when THE GOVERNMENT has annulled the research protocol, considering that the final project
p.(None): meets all the requisites within which is the review and approval of an Ethics Committee in lnv
p.(None): accredited research independent of the interests of the investigation. Based on the benefits
p.(None): expected for the test subject and society justify the risks; likewise, only
p.(None): continue st compliance with this criterion is permanently monitored.
...
Social / employees
Searching for indicator employees:
(return to top)
p.(None): 2.16. Case report form (FRC). Printed, optical or electronic document designed to
p.(None): record all the information required in the protocol to be reported to the sponsor on each subject of the
p.(None): study.
p.(None): 2.57. Inspection. Official review by a regulatory authority of documents, facilities, record and
p.(None): any other resource that the authorities consider is related to the clinical study and that may be
p.(None): located at the site where the study is carried out, at the facilities of the sponsor and / or the
p.(None): Investigative organization by contract (OIC) or at other sites than regulatory authorities
p.(None): consider appropriate.
p.(None): 2.18. investigator. Person responsible for conducting a clinical study. If a study is conducted by
p.(None): a 9 group of individuals, the researcher is the leader responsible for the group and will be called the researcher
p.(None): principai.
p.(None): 2.40. Monitor. Professional trained with the necessary clinical competence, chosen by the sponsor, who will
p.(None): In charge of direct monitoring of the conduct of the trial. Serves as a link between the sponsor and
p.(None): the principal investigator, when they do not confer in the same person.
p.(None): 2.41. Investigation Organization by contract. Legal entity or organization (commercial, academic or other
p.(None): type) against by the employer to carry out one or more of the workings and functions of the related sponsor
p.(None): with the study.
p.(None): 2.42. Sponsor. Individual, company or ’entity, institution or organization
p.(None): responsible for the lniclb, completion, management and / or financing of a clinical trial.
p.(None): medicine, dentistry, chemical-biological-biological and in fermeria, personal
p.(None): Sub-ordinate of hospital and laboratory, employees of the pharmaceutical industry, members of the forces
p.(None): armed and people who are detained / detained. Olrog vulnerable subjects include patients with disease
p.(None): incurable people
p.(None): in asylums, unemployed or indigent. patients in emergency situations. ethnic minority groups, people
p.(None): homeless, nomads, refugees, minors and those who cannot consent.
p.(None): z.st. Impartial Testłgo. Independent study person, who cannot be influenced in bad faith by the
p.(None): personnel involved in the study, who are present in the process of obtaining informed consent.
p.(None): z.sz. Compassionate use. Use of a medicine or product in isolated patients, regardless of
p.(None): a clinical trial. Specialties are included
p.(None): tarmacêuticas for indications or conditions of use different from those aulorizadas, under the responsibility
p.(None): exclusively for a doctor who considers essential his
p.(None): utilization.
p.(None): CHAPTER II
p.(None): PROTECTION OF CLINICAL TRIAL SUBJECTS
p.(None): Article 3. Respect for the ethical postulates. Only a clinical investigation may be initiated,
p.(None): when THE GOVERNMENT has annulled the research protocol, considering that the final project
p.(None): meets all the requisites within which is the review and approval of an Ethics Committee in lnv
...
Social / gender
Searching for indicator gender:
(return to top)
p.(None): Have the approval of the Administration or the Direction of the same and explicit guarantee by the owner of the
p.(None): Center, which guarantees that the Committee has the necessary means to carry out its mission.
p.(None): The Committees established without being under the administrative authority of any ”institution. they should
p.(None): demonstrate that they have the necessary resources to carry out their task.
p.(None): Article 28. Integration of the Comlt ¢ de Étlca in Inx • estIgacIón. The Research Ethics Committee will be integrated
p.(None): for a minimum of seven members, of which:
p.(None): 28.1. At least five members must have experience in ethics and research design.
p.(None): 1 4 Guotemolo, THURSDAY, February 22, 2007 CENTER DIARY
p.(None): AMERICA
p.(None): NUMBER
p.(None): 24.2. For our own sake one must be oblivious to the health profession
p.(None): Article 33. General norms for the functioning of the Ethical Committees in
p.(None): scientific community.
p.(None): 2e.8. At least one, must not be part of the clinical, public or private institution, at which time the
p.(None): Committee.
p.(None): 28.4. In case of community trials, the Committee + must include an additional number of representatives of said
p.(None): community for the duration of the
p.(None): Investigation.
p.(None): 33.1. Its members will respect the principle of confidentiality. in regards to the documentation
p.(None): received for the evaluation of the protocol and the identity of the participants and the discussions that take place within
p.(None): of the Committee.
p.(None): test.
p.(None): 33.2. For decisions u
p.(None): oncrete are valid, it
p.(None): z8.5. There must be gender representation among Comll + members.
p.(None): 28.6. The members of the Comiłês cannot have director or other financial interests with the
p.(None): pharmaceutical industry or with entities contracted by it, which may affect the impartiality of
p.(None): its functions.
p.(None): 28.7. For the above purposes, the Committee must keep a record of
p.(None): permanent and updated interests based on a public declaration of interests, from each of the
p.(None): members.
p.(None): 28.8. Any member with a special or particular interest in a proposal, direct or
p.(None): hint; You should not take part in your evaluation if this interest could distort your judgment.
p.(None): 33.3. JJ4. 33.5.
p.(None): The participation of at least five members is required, of which at least. one will be alien to the profession
p.(None): sanitary.
p.(None): When it is timely, it will seek the advice of expert persons not belonging to the Committee, who
p.(None): respect the principle of confidentiality.
p.(None): The principal investigator or collaborators of a clinical trial did not
p.(None): They may participate neither in the evaluation nor in the opinion of their own protocol.
p.(None): Establish a system that guarantees that the protocol approved by the
p.(None): Research Ethics Committee, is identical to that sent to THE COMMISSION, and the same one that finally
p.(None): will take place.
p.(None): Article 29. Accreditation Procedure. The procedure consists of two stages:
p.(None): z9.1. Evaluation of the documentation presented.
p.(None): 33.G. Establish a communication system with the investigators, which will
p.(None): Let us know when a fatal to serious and unexpected adverse event has occurred.
p.(None): 33.7. ’Notify the periodicity of ordinary visits to the research site.
p.(None): 29.I. Local inspection.
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.(None): Guołemolo, THURSDAY, February 22, 2007
p.(None): MIEfIG '¥' ERIO DE GAkŁfDP ziB> zCA ASEG ‘¥’ AND ICEA GOC7A
p.(None): DIAI2IO of CENTRO AMÉAÌCA
p.(None): NUMBER 25
p.(None): approval / favorable opinion of the study protocol, the capacity of the researcher (s) and
p.(None): adequate supply of the facilities, methods and material to be used in obtaining and documenting the
p.(None): informed consent of the subjects of the state.
p.(None): 2.8. Comparator (product). Research or marketed product used as reference for a trial
p.(None): clinical.
p.(None): .NsAvosmLlmcosE N'eUm N s. '
p.(None): FOR THE REGULATION OF THE
p.(None): 2.s. Informed consent. Process through which a subject voluntarily confirms his decision to
p.(None): participate in a particular school, voluntarily adopted by a person capable of giving
p.(None): consent after being
p.(None): MINISTERIAL AGREEMENT SP-M-466-2007
p.(None): THE PUBLIC HEALTH MINISTER
p.(None): AND CONSIDERING SOCIAL ASSISTANCE. '
p.(None): Oue the Political Constitution of the Republic recognizes that the enjoyment of health is a fundamental right of being
p.(None): without discrimination, and obliges the State to ensure it, developing through
p.(None): its institutions preventive actions. recovery and rehabilitation, in order to provide the habit before
p.(None): the most complex physical, mental and social well-being, also recognizing that the health of the inhabitants of the
p.(None): nation is a public good.
p.(None): CONSIDERING:
p.(None): That it is the competence and responsibility of the State regarding manufacturing. marketing, surveillance
p.(None): and control of pharmaceutical and related products to contribute to the existence of products
...
p.(None): 17.1. The consent used in the investigation must have the formal approval of the Committee
p.(None): of Élica en Invesligation before presenlarlo to the panicipants.
p.(None): 1z.z. The approved informed consent must be signed and signed by the president or coordinator of the
p.(None): Comilé of Ethics in Research
p.(None): accredited, or a member of the Comilê designated for that purpose, in accordance with its regulations, in each
p.(None): one of its leaves and this one is the one that is presented to the subject.
p.(None): at 1z. 3. Eslar written by Korma clear, without technicalities so that the subject
p.(None): participant can understand it easily.
p.(None): 17.4. Have all its leaves foliated.
p.(None): 17.5. Indicate version number and date.
p.(None): 17.6. The paniclpanic subject in the investigation must give his consent before entering the study.
p.(None): 17.7. The subject must give their consent, free of coercion, with knowledge of all other
p.(None): therapeutic options available.
p.(None): 17.s. The subject must know his right to change his mind and leave the study at any time
p.(None): want.
p.(None): 17.s. Participant must receive a signed copy of the informed consent for their files
p.(None): personal.
p.(None): Article 18. Special regulations. Some situations, due to their characteristics, require an approach
p.(None): In particular, for this, a special opinion given by "THE COMMITTEE Ô is required
p.(None): 18.1. Minors: In the case of minors, the person who
p.(None): For example, its legal representation will be responsible for giving the contract and signing the document.
p.(None): In extraordinary cases d = investigations without therapeutic purposes in minors, persons
p.(None): disabled or with diminished competition or autonomy, the necessary measures will be taken to
p.(None): avoid the possible exploitation of these dreams and the damage to their health. Minors who have the
p.(None): adequate maturity or age, you must give your consent to participate in the study.
p.(None): 18.2. Subjects with mental disabilities. In the case of the incapable or in
p.(None): status of a legal representative, must give consent and sign the report
p.(None): on behalf of the participant, to whom the scope of the investigation must be explained, according to their
p.(None): understanding capacity.
p.(None): ISSUE 25
p.(None): 19.3.
p.(None): jg g 1g.5.
p.(None): CENTRAL AMERICA JOURNAL
p.(None): If from the essay relevant knowledge about the
p.(None): disease or cause of invasion. gives vital imoortancia to understand it. palliate it to cure it.
p.(None): If these knowledge cannot be obtained in any other way.
p.(None): If there are guarantees on the correct obtaining of informed consent, in accordance with the provisions of
p.(None): this regulation.
...
p.(None): Committee.
p.(None): 28.4. In case of community trials, the Committee + must include an additional number of representatives of said
p.(None): community for the duration of the
p.(None): Investigation.
p.(None): 33.1. Its members will respect the principle of confidentiality. in regards to the documentation
p.(None): received for the evaluation of the protocol and the identity of the participants and the discussions that take place within
p.(None): of the Committee.
p.(None): test.
p.(None): 33.2. For decisions u
p.(None): oncrete are valid, it
p.(None): z8.5. There must be gender representation among Comll + members.
p.(None): 28.6. The members of the Comiłês cannot have director or other financial interests with the
p.(None): pharmaceutical industry or with entities contracted by it, which may affect the impartiality of
p.(None): its functions.
p.(None): 28.7. For the above purposes, the Committee must keep a record of
p.(None): permanent and updated interests based on a public declaration of interests, from each of the
p.(None): members.
p.(None): 28.8. Any member with a special or particular interest in a proposal, direct or
p.(None): hint; You should not take part in your evaluation if this interest could distort your judgment.
p.(None): 33.3. JJ4. 33.5.
p.(None): The participation of at least five members is required, of which at least. one will be alien to the profession
p.(None): sanitary.
p.(None): When it is timely, it will seek the advice of expert persons not belonging to the Committee, who
p.(None): respect the principle of confidentiality.
p.(None): The principal investigator or collaborators of a clinical trial did not
p.(None): They may participate neither in the evaluation nor in the opinion of their own protocol.
p.(None): Establish a system that guarantees that the protocol approved by the
p.(None): Research Ethics Committee, is identical to that sent to THE COMMISSION, and the same one that finally
p.(None): will take place.
p.(None): Article 29. Accreditation Procedure. The procedure consists of two stages:
p.(None): z9.1. Evaluation of the documentation presented.
p.(None): 33.G. Establish a communication system with the investigators, which will
p.(None): Let us know when a fatal to serious and unexpected adverse event has occurred.
p.(None): 33.7. ’Notify the periodicity of ordinary visits to the research site.
p.(None): 29.I. Local inspection.
p.(None): The two stages will be evaluated by THE COMMISSION, who will issue and send its opinion to the Department of
p.(None): Regulation and Control of Pharmaceutical and Related Products, for the issuance of the authorization.
p.(None): If any non-compliance is detected, the recommendations will be delivered to the President or Coordinator of the Committee
p.(None): written, which, once made and at the request of the interested parties, will be the subject of a new
p.(None): evaluation for subsequent authorization, if applicable.
p.(None): Article 30. Evaluation of the documentation presented. The documentation detailed below must
p.(None): appear before THE COMMISSION:
p.(None): 33.8.
p.(None): 33.9.
p.(None): Prepare and follow for its operation the standard operating procedures, mark a periodicity of
p.(None): meeting and a maximum response time. These procedures must be public knowledge, upon request.
p.(None): Of the interested.
p.(None): Each meeting of the Committee will be included in the corresponding minutes. in which the members will be detailed
p.(None): Attendees, it will be noted that for each study evaluated, the aspects have been weighted with
p.(None): tempered in article 46 of this regulation, as well as information about the opinion and a summary of the
p.(None): substantive elements of the discussion, explicit opinions about the reasons for which it was approved
p.(None): whether or not a protocol is approved, which supports the decisions of the Committee.
p.(None): 30.1. Written request, signed and sealed by the Chairman of the Committee, addressed to THE COMMISSION.
p.(None): in which the name, address and telephone number of the Research Ethics Committee are recorded.
p.(None): 30.2. For each of the members who will make up the Committee, the following must be attached
p.(None): paper it:
p.(None): to. Photocopy of the identity card.
p.(None): b. Photocopy of the Curriculum Vİtae, specifying scientific activities performed and projection activities
p.(None): Social.
p.(None): c. Proof of active Collegiate in force when applicable.
p.(None): d. Training in the subject of Research ethics.
p.(None): and. Proof of participation in courses and other activities related to wind power in
p.(None): investigation.
p.(None): 30.3. The Research Ethics Committees established under the administrative authority give a
p.(None): Institution, whether public or public, must have proof of the address of the same.
p.(None): 30.4. Copy of the Regulations that will govern the operation of the Committee.
p.(None): 30.s. Minutes book or individual sheets, to be authorized and sealed by THE COMMISSION.
p.(None): Article 31. Local inspection. The locative inspection will be carried out by THE COMMISSION in order to verify that
p.(None): it has the necessary support infrastructure so that the Committee can function properly.
...
p.(None): express.
p.(None): The following shall be subject to authorization: All clinical tests with a substance classified as a product in the
p.(None): clinical research; search for new therapeutic indications of an already registered substance.
p.(None): Article 37. Terms of authorization. During the first year of validity of this Agreement from
p.(None): of its publication in the Diario de Centro America, THE COMMISSION will rule on a clinical study in a
p.(None): no later than forty-five days after receipt of the request and complete documentation.
p.(None): During the second year of validity and subject to the raising of private funds from THE COMMISSION,
p.(None): This will have a term of thirty days. Within the aforementioned period, THE COMMISSION may request the information
p.(None): pertinent, make objections, checks and corresponding observations.
p.(None): In cases where additional information or clarifications are requested, once the new
p.(None): information that the interested party has presented in his case, the final resolution will be found within a plaza of
p.(None): 15 days from the receipt of the required information. This resolution will be notified to the
p.(None): Research Ethics, the researcher, the sponsor and any other party
p.(None): Article 46. Evaluation criteria for the use of the dispute. The Êtlca Committee on Research
p.(None): corresponding to evaluate the protocol, the investigator's brochure and the rest of the documentation that
p.(None): Accompany the application and it will issue its opinion taking into consideration the following questions:
p.(None): 46.1. Relevance of the clinical trial. taking into account the available knowledge.
p.(None): 46.2. Relevance of your design to obtain informed conclusions with the appropriate number of
p.(None): subjects in relation to the objective of the study.
p.(None): 46.3. Selection and withdrawal criteria for trial subjects, as well as the equitable selection of the
p.(None): show.
p.(None): 46.4 .. Justification of the foreseeable costs and inconveniences in relation to the expected benefits for
p.(None): the trial subjects, for other patients and for the community, taking into account the principle of
p.(None): protection of the test subjects developed in the elic postulates.
p.(None): 46.5. Justification of the control group either placebo to an active treatment.
p.(None): 46.6. Provisions for monitoring the trial.
p.(None): • s.7. Suitability of the researcher and his collaborators.
p.(None): 46.8. ldoneidad of the facilities.
p.(None): 46.9. Adequacy of written information for test subjects and the procedure for
p.(None): oblenciôn informed consent. and justification of research in disabled people
p.(None): to give your informed consent.
p.(None): 46.10. Financial guarantee insurance provided for the trial. 4s. 11. Remuneration forecasts, for the Subjects
p.(None): of the essay.
p.(None): 46.12. Plan planned for the recruitment of the subjects.
p.(None): interested. THE COMMISSION'S ACCLUTIONS MUST BE CONTAINED IN ADMINISTRATIVE RESOLUTIONS.
p.(None): "” ”“ ’) Uend
...
p.(None): same. The sponsor must keep a record of imported products.
p.(None): Article 44. Continuation of treatment after the end of the trial. Once the trial is over
p.(None): clinical, the continuation of the administration of used products, should be governed by the rules
p.(None): established for the compassionate uro, contained in the following article, as long as
p.(None): authorized śu use for those conditions. This provision of medication for study subjects by a
p.(None): Time to be agreed, may be requested from the sponsor, at the request of the Ethics Committee in
p.(None): Research, the lnstilución where the study was carried out, THE COLLECTION and the researcher.
p.(None): Article 47. Rules of good practice cllnlca. All clinical trials conducted in the country must
p.(None): Carry out in accordance with internationally accepted standards of good clinical practice.
p.(None): The Standards of Good Clinical Practice indicate the standards to be followed in designing, implementing and
p.(None): communicate the results of the clinical tests, in order to ensure that the data is reliable and protected
p.(None): the rights and integrity of the subjects. including the confidentiality of your data; Likewise,
p.(None): The responsibilities of the different parties involved in each of the planning phases are indicated.
p.(None): and execution of a clinical trial. They require the existence of pre-established procedures for
p.(None): written, which must be applied systematically in the organization, direction, collection of
p.(None): data, documentation and verification of clinical trials (Operation Standard Procedures).
p.(None): It corresponds to the pairocinador established in the country, to sign the request for an opinion and authorization
p.(None): addressed to the Research Ethics Committee and THE COMMUNITY.
p.(None): In the event that the sponsor of the clinical study is not registered =. In the country. must present
p.(None): proof that you are registered in the country of origin, complying with the law. In the case, you must
p.(None): add to the documentation described in article 35 a copy of its most recent work report and the
p.(None): names of its directors or board of directors.
p.(None): The responsibilities of the sponsor or its representative are:
p.(None): 48.1. Establish and maintain a system of guarantees and quality control, with standardized procedures
p.(None): of written works, so that the tests are carried out and the data generated is documented and
p.(None): Communicated according to the protocol, the standards of good clinical practice and provided in this
p.(None): normative.
p.(None): 48.2. Sign, together with the corresponding researcher, the protocol and any of its modifications.
p.(None): 4s. 3. Select the researcher and other personnel participating in the clinical trial more
p.(None): appropriate according to their qualification and available means, and ensure that the latter will carry out the study as
p.(None): as specified in the protocol.
p.(None): 4s. 4. Provide the basic and clinical information available on the product under investigation and update it to
p.(None): throughout the trial.
p.(None): 48.5. Request the opinion of the Research Ethics Committee and the authorization of LA
p.(None): COMMISSION, as well as supplying them with the information and obtaining the appropriate authorizations, in case of
p.(None): modification or violation of the protocol or interruption of the trial, and the reasons for it.
p.(None): 48.6. SUPPLY GALLUALLY SUPPLY PRODUCTS IN INVEST'96 «ION, ENSURE THAT THE STANDARDS HAVE BEEN FULFILLED
p.(None): of a correct claim and that they are adequately packaged and labeled. Also responsible
p.(None): of the conservation of the product, its manufacturing and control protocols, registration of
p.(None): quantities delivered and make sure that in the center where the test is carried out there is a procedure
p.(None): correct handling, conservation and use of the same. Exceptionally, they can be agreed with the center
p.(None): other ways of supply.
p.(None): Article 45. Compassionate use of products. To use a product as compassionate use under
p.(None): conditions of the original clinical trial, a use protocol drawn up by the doctor will be required
p.(None): they request him; informed consent of the patient to his legal representative; clinical report in eJ that the doctor
p.(None): justify the need for such treatment; when applicable, the .conformity of the director of the
p.(None): the transfer is going to be administered; * ’and the aulorization of LA
p.(None): 4dL
p.(None): 48.8.
p.(None): 48.9.
p.(None): Designate the monitor that will monitor the progress of the trial, when applicable. Communicate to THE COMMISSION, researchers and
p.(None): Research Ethics Committees involved in the trial, suspected serious adverse reactions and
p.(None): unexpected in accordance with to established in this normative.
...
General/Other / Diminished Autonomy
Searching for indicator diminished:
(return to top)
p.(None): Comilé of Ethics in Research
p.(None): accredited, or a member of the Comilê designated for that purpose, in accordance with its regulations, in each
p.(None): one of its leaves and this one is the one that is presented to the subject.
p.(None): at 1z. 3. Eslar written by Korma clear, without technicalities so that the subject
p.(None): participant can understand it easily.
p.(None): 17.4. Have all its leaves foliated.
p.(None): 17.5. Indicate version number and date.
p.(None): 17.6. The paniclpanic subject in the investigation must give his consent before entering the study.
p.(None): 17.7. The subject must give their consent, free of coercion, with knowledge of all other
p.(None): therapeutic options available.
p.(None): 17.s. The subject must know his right to change his mind and leave the study at any time
p.(None): want.
p.(None): 17.s. Participant must receive a signed copy of the informed consent for their files
p.(None): personal.
p.(None): Article 18. Special regulations. Some situations, due to their characteristics, require an approach
p.(None): In particular, for this, a special opinion given by "THE COMMITTEE Ô is required
p.(None): 18.1. Minors: In the case of minors, the person who
p.(None): For example, its legal representation will be responsible for giving the contract and signing the document.
p.(None): In extraordinary cases d = investigations without therapeutic purposes in minors, persons
p.(None): disabled or with diminished competition or autonomy, the necessary measures will be taken to
p.(None): avoid the possible exploitation of these dreams and the damage to their health. Minors who have the
p.(None): adequate maturity or age, you must give your consent to participate in the study.
p.(None): 18.2. Subjects with mental disabilities. In the case of the incapable or in
p.(None): status of a legal representative, must give consent and sign the report
p.(None): on behalf of the participant, to whom the scope of the investigation must be explained, according to their
p.(None): understanding capacity.
p.(None): ISSUE 25
p.(None): 19.3.
p.(None): jg g 1g.5.
p.(None): CENTRAL AMERICA JOURNAL
p.(None): If from the essay relevant knowledge about the
p.(None): disease or cause of invasion. gives vital imoortancia to understand it. palliate it to cure it.
p.(None): If these knowledge cannot be obtained in any other way.
p.(None): If there are guarantees on the correct obtaining of informed consent, in accordance with the provisions of
p.(None): this regulation.
p.(None): Guatemolo, THURSDAY, February 22, 2007
p.(None): 25.10. Remuneration. It should be noted the expenses that patients received for expenses
p.(None): transportation, allmenlación, and others, where appropriate. Likewise, in studies that do not
p.(None): Therapeutic impact, amounts and how your participation will be rewarded.
p.(None): 25.11. Lions compensation. It must be clearly specified that the investigator will give medical care
p.(None): the participant who suffers some
...
General/Other / Impaired Autonomy
Searching for indicator autonomy:
(return to top)
p.(None): accredited, or a member of the Comilê designated for that purpose, in accordance with its regulations, in each
p.(None): one of its leaves and this one is the one that is presented to the subject.
p.(None): at 1z. 3. Eslar written by Korma clear, without technicalities so that the subject
p.(None): participant can understand it easily.
p.(None): 17.4. Have all its leaves foliated.
p.(None): 17.5. Indicate version number and date.
p.(None): 17.6. The paniclpanic subject in the investigation must give his consent before entering the study.
p.(None): 17.7. The subject must give their consent, free of coercion, with knowledge of all other
p.(None): therapeutic options available.
p.(None): 17.s. The subject must know his right to change his mind and leave the study at any time
p.(None): want.
p.(None): 17.s. Participant must receive a signed copy of the informed consent for their files
p.(None): personal.
p.(None): Article 18. Special regulations. Some situations, due to their characteristics, require an approach
p.(None): In particular, for this, a special opinion given by "THE COMMITTEE Ô is required
p.(None): 18.1. Minors: In the case of minors, the person who
p.(None): For example, its legal representation will be responsible for giving the contract and signing the document.
p.(None): In extraordinary cases d = investigations without therapeutic purposes in minors, persons
p.(None): disabled or with diminished competition or autonomy, the necessary measures will be taken to
p.(None): avoid the possible exploitation of these dreams and the damage to their health. Minors who have the
p.(None): adequate maturity or age, you must give your consent to participate in the study.
p.(None): 18.2. Subjects with mental disabilities. In the case of the incapable or in
p.(None): status of a legal representative, must give consent and sign the report
p.(None): on behalf of the participant, to whom the scope of the investigation must be explained, according to their
p.(None): understanding capacity.
p.(None): ISSUE 25
p.(None): 19.3.
p.(None): jg g 1g.5.
p.(None): CENTRAL AMERICA JOURNAL
p.(None): If from the essay relevant knowledge about the
p.(None): disease or cause of invasion. gives vital imoortancia to understand it. palliate it to cure it.
p.(None): If these knowledge cannot be obtained in any other way.
p.(None): If there are guarantees on the correct obtaining of informed consent, in accordance with the provisions of
p.(None): this regulation.
p.(None): Guatemolo, THURSDAY, February 22, 2007
p.(None): 25.10. Remuneration. It should be noted the expenses that patients received for expenses
p.(None): transportation, allmenlación, and others, where appropriate. Likewise, in studies that do not
p.(None): Therapeutic impact, amounts and how your participation will be rewarded.
p.(None): 25.11. Lions compensation. It must be clearly specified that the investigator will give medical care
p.(None): the participant who suffers some
...
General/Other / Incapacitated
Searching for indicator incapacity:
(return to top)
p.(None): related to the study and / or makes important decisions related to that.
p.(None): 2.50. Vulnerable subjectsG. Individuals whose desire to participate in clinical study may be influenced
p.(None): by the explanation, justified or not, of the benefits associated with their participation, or a
p.(None): revenge on the part of the members
p.(None): study in which subjects are assigned to one or more therapeutic intervention groups in a
p.(None): random, or is conditioned, directly or indirectly. the
p.(None): superiors of a hierarchy in order to refuse to participate.
p.(None): members of a group with a hierarchical structure, such as
p.(None): students of
p.(None): usual medical prescription process.
p.(None): z.1z. Adverse event (EA). Any unfavorable medical event that occurs in a patient or subject of
p.(None): a clinical investigation to whom a pharmaceutical product was administered and who does not necessarily have a relationship
p.(None): causal with that treatment. Therefore, an adverse event can be any unfavorable sign and not
p.(None): disabled (inducing an abnormal laboratory finding). Sloma or temporally associated disease
p.(None): with the use of a medicinal (research) product, whether or not related to it.
p.(None): 2.13. Serious Adverse Event (EAS) or Serious Adverse Drug Reaction (Serious RAM). Any event
p.(None): adverse or adverse reaction that, at any dose, produces death, threatens the life of the subject, makes
p.(None): necessary hospitalization or prolongation, causes permanent or significant disability or incapacity, or
p.(None): give rise to an abnormality or congenital mallormaciõn.
p.(None): 2.16. Case report form (FRC). Printed, optical or electronic document designed to
p.(None): record all the information required in the protocol to be reported to the sponsor on each subject of the
p.(None): study.
p.(None): 2.57. Inspection. Official review by a regulatory authority of documents, facilities, record and
p.(None): any other resource that the authorities consider is related to the clinical study and that may be
p.(None): located at the site where the study is carried out, at the facilities of the sponsor and / or the
p.(None): Investigative organization by contract (OIC) or at other sites than regulatory authorities
p.(None): consider appropriate.
p.(None): 2.18. investigator. Person responsible for conducting a clinical study. If a study is conducted by
p.(None): a 9 group of individuals, the researcher is the leader responsible for the group and will be called the researcher
p.(None): principai.
p.(None): 2.40. Monitor. Professional trained with the necessary clinical competence, chosen by the sponsor, who will
p.(None): In charge of direct monitoring of the conduct of the trial. Serves as a link between the sponsor and
p.(None): the principal investigator, when they do not confer in the same person.
p.(None): 2.41. Investigation Organization by contract. Legal entity or organization (commercial, academic or other
p.(None): type) against by the employer to carry out one or more of the workings and functions of the related sponsor
p.(None): with the study.
p.(None): 2.42. Sponsor. Individual, company or ’entity, institution or organization
p.(None): responsible for the lniclb, completion, management and / or financing of a clinical trial.
p.(None): medicine, dentistry, chemical-biological-biological and in fermeria, personal
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.(None): located at the site where the study is carried out, at the facilities of the sponsor and / or the
p.(None): Investigative organization by contract (OIC) or at other sites than regulatory authorities
p.(None): consider appropriate.
p.(None): 2.18. investigator. Person responsible for conducting a clinical study. If a study is conducted by
p.(None): a 9 group of individuals, the researcher is the leader responsible for the group and will be called the researcher
p.(None): principai.
p.(None): 2.40. Monitor. Professional trained with the necessary clinical competence, chosen by the sponsor, who will
p.(None): In charge of direct monitoring of the conduct of the trial. Serves as a link between the sponsor and
p.(None): the principal investigator, when they do not confer in the same person.
p.(None): 2.41. Investigation Organization by contract. Legal entity or organization (commercial, academic or other
p.(None): type) against by the employer to carry out one or more of the workings and functions of the related sponsor
p.(None): with the study.
p.(None): 2.42. Sponsor. Individual, company or ’entity, institution or organization
p.(None): responsible for the lniclb, completion, management and / or financing of a clinical trial.
p.(None): medicine, dentistry, chemical-biological-biological and in fermeria, personal
p.(None): Sub-ordinate of hospital and laboratory, employees of the pharmaceutical industry, members of the forces
p.(None): armed and people who are detained / detained. Olrog vulnerable subjects include patients with disease
p.(None): incurable people
p.(None): in asylums, unemployed or indigent. patients in emergency situations. ethnic minority groups, people
p.(None): homeless, nomads, refugees, minors and those who cannot consent.
p.(None): z.st. Impartial Testłgo. Independent study person, who cannot be influenced in bad faith by the
p.(None): personnel involved in the study, who are present in the process of obtaining informed consent.
p.(None): z.sz. Compassionate use. Use of a medicine or product in isolated patients, regardless of
p.(None): a clinical trial. Specialties are included
p.(None): tarmacêuticas for indications or conditions of use different from those aulorizadas, under the responsibility
p.(None): exclusively for a doctor who considers essential his
p.(None): utilization.
p.(None): CHAPTER II
p.(None): PROTECTION OF CLINICAL TRIAL SUBJECTS
p.(None): Article 3. Respect for the ethical postulates. Only a clinical investigation may be initiated,
p.(None): when THE GOVERNMENT has annulled the research protocol, considering that the final project
p.(None): meets all the requisites within which is the review and approval of an Ethics Committee in lnv
p.(None): accredited research independent of the interests of the investigation. Based on the benefits
p.(None): expected for the test subject and society justify the risks; likewise, only
p.(None): continue st compliance with this criterion is permanently monitored.
p.(None): Article S. The participation of the subjects in the investigation is voluntary. The participating subject in -a
...
p.(None): Level lenlïfico and the objective (s) of the study.
p.(None): 25.4. Procedures to senum.
p.(None): study-related injury, without shifting that responsibility to health insurance or the
p.(None): state health services. The sponsor will cover the treatment ribs that the patient
p.(None): Anytime to recover from the injury, as long as the investigator adheres to protocol and Good Practice.
p.(None): Clinical practices in conducting the clinical trial.
p.(None): zs.1z. Confidentiality It must be specified that the confidentiality of the
p.(None): Pan-municipal subjects will be preserved and that no subject will be identified by name in the
p.(None): publication of the results of the study. Which regulatory authorities should be indicated. nationals remain
p.(None): Aulorized to review their clinical record in order to see the results of the study. This same
p.(None): Aulorization will apply to studio monitors, sponsor auditors and agency inspectors.
p.(None): regulators and representatives of the Research Ethics Committee in charge of the study.
p.(None): zs.13. Notification of new findings. The subject to their legal representative will be informed in due course of
p.(None): any new discoveries that occurred during the study that could alert your decision to
p.(None): I continue to participate in it.
p.(None): 25.IJ. Contacts. The name and telephone number of the entity (ies) must be indicated (including the
p.(None): Research Ethics that approved the protocol) and person (s) to whom to turn to obtain
p.(None): additional information about the study; and, in the eventual presentation of any injury attributable to t
p.(None): Also, specify the name and telephone number of the main investigator to whom you will contact in case of emergency.
p.(None): 25.15. Voluntary participation: The absolutely voluntary nature of participation should be highlighted
p.(None): of the subject, the option to withdraw at any time from the study without suffering any type of retaliation or
p.(None): penalization for that act and the option of receiving alternative treatment, if you so desire.
p.(None): zs.1ț. Completion of the study: The conditions or circumstances that could give must be specified
p.(None): leading to premature termination of
p.(None): study, such as the need for additional medication, violation of the study protocol,
p.(None): the appearance of any study-related injury, the researcher said that, for
p.(None): the good of the patient, is convenient, his retirement or for administrative reasons.
p.(None): 25.17. C onsentiment: A final paragraph should highlight that the participant has read and understood the document of the
p.(None): consent. that your doubts have been clarified and all your questions answered to your satisfaction and that you accept
p.(None): Voluntary participation in the study.
p.(None): 25.18. Names and signatures: The document is concluded with the names of the participating subject, the person who
p.(None): explained consent and witness to witnesses; their signature, including their documents
p.(None): personal identification, and the date the document was signed.
p.(None): 25.19. Exceptional houses: In case that due to the urgency of applying the treatment it was not possible to have the
p.(None): consent of the subject to his legal representative at the time of inclusion in the clinical trial.
p.(None): This fact will be reported to the Research Ethics Committee T at the sponsor of the researcher for its
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.(None): its institutions preventive actions. recovery and rehabilitation, in order to provide the habit before
p.(None): the most complex physical, mental and social well-being, also recognizing that the health of the inhabitants of the
p.(None): nation is a public good.
p.(None): CONSIDERING:
p.(None): That it is the competence and responsibility of the State regarding manufacturing. marketing, surveillance
p.(None): and control of pharmaceutical and related products to contribute to the existence of products
p.(None): safe, effective, quality, correctly identified and with appropriate information; understanding each other
p.(None): within this activity the authorization of clinical tests, which in order to be carried out
p.(None): must be evaluated by the Commission for the Evaluation of Clinical Trials, informed according to a Ministerial Agreement
p.(None): SP-M-2264-2004, in accordance with Article ninety four of the Regulations for Health Control
p.(None): of Medicines and Related Products; therefore, in compliance with the established, it is intended to make a
p.(None): technical proposal for the evaluation and approval of clinical trial protocols with drugs and all
p.(None): related to your development.
p.(None): SO:
p.(None): In exercise of the functions conferred on him by Articles 194 literal a) and g) of the Political Constitution of
p.(None): the Republic of Guatemala; and 27 literal m) of the Law of the Executive Organism, Decree number 114-97 of the
p.(None): Congress of the republic.
p.(None): AGREES:
p.(None): Issue the regulatory presenle:
p.(None): FOR THE REGULATION OF CLINICAL TRIALS IN HUMANS
p.(None): CHAPTER I
p.(None): GENERAL DISPOSITION
p.(None): 2.1. Accreditation. Declaration by means of the issuance of a certificate, in which the competent authority,
p.(None): auloriza the execution of activities of a Comilé de Élica in research, after having verified that
p.(None): he himself complies with all the requirements set out in the current regulations. ”
p.(None): z.2. Quality assurance. All those planned and symbolic actions that
p.(None): established to guarantee that the study is being carried out and that the data is generated.
p.(None): Documented (registered) and reported in c. implemented with the 6 Good Clinical Practice (PCB) and the
p.(None): applicable regulatory requirements.
p.(None): 8. Random Assignment. Process of assigning study subjects to treatment groups
p.(None): or control using chance to determine allocations to reduce bias.
p.(None): 2.4. Audit. A systematic and independent examination of related activities and documents
p.(None): with the study to determine if the evaluated activities were carried out and the data were recorded,
p.(None): analyzed and reported accurately according to protocol, standard operating procedures
p.(None): Sponsor's (POEs), Good Practice Clinics (BPC) and apiicabies regulatory requirements.
p.(None): 2.5. Good clinical practices (PCB). Standard for design, conduction, realization, monitoring,
p.(None): audit, registration, analysis and reporting of clinical studies that provides a guarantee that the data and
p.(None): Reported results are credible and accurate and that the rights, integrity and confidentiality of
p.(None): study subjects.
p.(None): 2.6. Commission for the evaluation of clinical trials. Governing body in * the authorization to carry out
p.(None): a clinical trial protocol, and in the course of this legal body it will be called THE COMMISSION.
p.(None): 2.7. Investigative Ethics Committee (cEl). Independent organization, made up of professionals
...
p.(None): clinical, lab notes, memoranda, subject journals, or evaluation checklists,
p.(None): pharmacy delivery records, recorded data from automated instruments, copies or
p.(None): After verifying cerlified transcripts that are exact copies, microfiche. negatives
p.(None): photographic. magnetic or microfilm media, x-rays, subject files and records kept in
p.(None): the pharmacy in the laboratories and in the medical-technical departments involved in the study. clinical).
p.(None): 2.11. Amendment to the protocol. A written description of a formal change or clarification of a protocol.
p.(None): 2.12. Clinical trial. All research or experimental evaluation of a substance, medicine or
p.(None): device, through its application to human beings, oriented towards one of the following lines:
p.(None): and. Show its pharmacodynamic effects or collect data regarding its absorption,
p.(None): distribution, metabolism and excretion in the
p.(None): human organism.
p.(None): b. Establish its efficacy for a specific therapeutic, prophylactic or diagnostic indication.
p.(None): c. Know the profile of your adverse reactions and establish your safety.
p.(None): The administration of the drug or medication to a single patient in the setting of the clinic is not considered a clinical trial.
p.(None): habitual medical practice for the sole purpose of obtaining a benefit for it. Medical practice and
p.(None): professional freedom of prescription of the doctor will not protect, in any case, clinical trials not
p.(None): ar ›Iorized, or the use of secret or undeclared remedies to the sanitary authority.
p.(None): 2.J 3. Open-blind clinical trial. It is the one in which the subject lants as the researcher knows the group of
p.(None): tralamienlo to which he has been assigned.
p.(None): 2.14. Clinical trial with third-party evaluation. It is one in which the subject, researcher and
p.(None): palroclnador, ignore the treatment received. To evaluate the response, a third person is used who
p.(None): the treatment each subject is receiving is unknown.
p.(None): 2.1s. It is cynical with crossed groups. It is the one in which the experimental and control treatments are
p.(None): administered to each individual in successive periods that have been determined randomly, to which
p.(None): allow each subject to be their
p.(None): 2.16. Clinical trial with parallel groups. It is one in which one or several groups of subjects are
p.(None): assigned to receive the experimental treatment at the same time as the other group receives the control treatment.
p.(None): 2.17. Controlled clinical trial. It is the one that establishes a comparison with a control group or tesligo. The
p.(None): randomized controlled clinical trial including at least two groups of volunteers,
p.(None): 2.1s. patient or healthy. whose assignment to an experimental or control treatment is carried out at random so that
p.(None): Neither the subject nor the doctor responsible for their selection or treatment can influence their assignment. So the
p.(None): Selection of subjects as the periods of treatment and follow-up should take place simultaneously in all
p.(None): groups. In the vast majority of cases it is the only scientifically valid way to assess efficacy and safety
p.(None): of a lerapêutica intervention.
...
p.(None): revenge on the part of the members
p.(None): study in which subjects are assigned to one or more therapeutic intervention groups in a
p.(None): random, or is conditioned, directly or indirectly. the
p.(None): superiors of a hierarchy in order to refuse to participate.
p.(None): members of a group with a hierarchical structure, such as
p.(None): students of
p.(None): usual medical prescription process.
p.(None): z.1z. Adverse event (EA). Any unfavorable medical event that occurs in a patient or subject of
p.(None): a clinical investigation to whom a pharmaceutical product was administered and who does not necessarily have a relationship
p.(None): causal with that treatment. Therefore, an adverse event can be any unfavorable sign and not
p.(None): disabled (inducing an abnormal laboratory finding). Sloma or temporally associated disease
p.(None): with the use of a medicinal (research) product, whether or not related to it.
p.(None): 2.13. Serious Adverse Event (EAS) or Serious Adverse Drug Reaction (Serious RAM). Any event
p.(None): adverse or adverse reaction that, at any dose, produces death, threatens the life of the subject, makes
p.(None): necessary hospitalization or prolongation, causes permanent or significant disability or incapacity, or
p.(None): give rise to an abnormality or congenital mallormaciõn.
p.(None): 2.16. Case report form (FRC). Printed, optical or electronic document designed to
p.(None): record all the information required in the protocol to be reported to the sponsor on each subject of the
p.(None): study.
p.(None): 2.57. Inspection. Official review by a regulatory authority of documents, facilities, record and
p.(None): any other resource that the authorities consider is related to the clinical study and that may be
p.(None): located at the site where the study is carried out, at the facilities of the sponsor and / or the
p.(None): Investigative organization by contract (OIC) or at other sites than regulatory authorities
p.(None): consider appropriate.
p.(None): 2.18. investigator. Person responsible for conducting a clinical study. If a study is conducted by
p.(None): a 9 group of individuals, the researcher is the leader responsible for the group and will be called the researcher
p.(None): principai.
p.(None): 2.40. Monitor. Professional trained with the necessary clinical competence, chosen by the sponsor, who will
p.(None): In charge of direct monitoring of the conduct of the trial. Serves as a link between the sponsor and
p.(None): the principal investigator, when they do not confer in the same person.
p.(None): 2.41. Investigation Organization by contract. Legal entity or organization (commercial, academic or other
p.(None): type) against by the employer to carry out one or more of the workings and functions of the related sponsor
p.(None): with the study.
p.(None): 2.42. Sponsor. Individual, company or ’entity, institution or organization
p.(None): responsible for the lniclb, completion, management and / or financing of a clinical trial.
p.(None): medicine, dentistry, chemical-biological-biological and in fermeria, personal
p.(None): Sub-ordinate of hospital and laboratory, employees of the pharmaceutical industry, members of the forces
p.(None): armed and people who are detained / detained. Olrog vulnerable subjects include patients with disease
p.(None): incurable people
...
p.(None): z5.8. Exclusions. Conditions that impede your participation in the study, such as pregnancy, lactation,
p.(None): allergies to certain products, and other circumstances.
p.(None): 25.9. Benefits. The benefits that the treatment could receive if it is effective. Must be
p.(None): note that you may not receive any therapeutic benefit from your participation.
p.(None): CHAPTER IV.
p.(None): OF THE ETHICS COMMITTEES IN INVESTIGATION
p.(None): Article 26. Accreditation of the Research Ethics Committees. They will be established based on t
p.(None): recognition of the Department of Regulation and Control of Pharmaceutical and Related Products. which
p.(None): The accreditation for the operation of the Research Ethics Committee that review and
p.(None): clinical trials approved. THE COMMISSION will be in charge of the coordination and establishment
p.(None): common criteria for the accreditation of the Committees. The accreditation of the Committee will be renewed
p.(None): periodically according to the procedures and deadlines that it determines. which should not exceed a
p.(None): two year period.
p.(None): Article 27. Minimum requirements for accreditation of a Research Ethics Committee for review and
p.(None): approval of clinical trial protocols. Be made up of a reasonable number of people who collectively
p.(None): have the ability and experience to review and evaluate the science, medical aspects, and ethics of a CllniCo trial.
p.(None): The Research Ethics Committees established under the administrative authority of an institution must
p.(None): Have the approval of the Administration or the Direction of the same and explicit guarantee by the owner of the
p.(None): Center, which guarantees that the Committee has the necessary means to carry out its mission.
p.(None): The Committees established without being under the administrative authority of any ”institution. they should
p.(None): demonstrate that they have the necessary resources to carry out their task.
p.(None): Article 28. Integration of the Comlt ¢ de Étlca in Inx • estIgacIón. The Research Ethics Committee will be integrated
p.(None): for a minimum of seven members, of which:
p.(None): 28.1. At least five members must have experience in ethics and research design.
p.(None): 1 4 Guotemolo, THURSDAY, February 22, 2007 CENTER DIARY
p.(None): AMERICA
p.(None): NUMBER
p.(None): 24.2. For our own sake one must be oblivious to the health profession
p.(None): Article 33. General norms for the functioning of the Ethical Committees in
p.(None): scientific community.
p.(None): 2e.8. At least one, must not be part of the clinical, public or private institution, at which time the
p.(None): Committee.
p.(None): 28.4. In case of community trials, the Committee + must include an additional number of representatives of said
p.(None): community for the duration of the
p.(None): Investigation.
p.(None): 33.1. Its members will respect the principle of confidentiality. in regards to the documentation
p.(None): received for the evaluation of the protocol and the identity of the participants and the discussions that take place within
p.(None): of the Committee.
p.(None): test.
p.(None): 33.2. For decisions u
p.(None): oncrete are valid, it
p.(None): z8.5. There must be gender representation among Comll + members.
p.(None): 28.6. The members of the Comiłês cannot have director or other financial interests with the
p.(None): pharmaceutical industry or with entities contracted by it, which may affect the impartiality of
p.(None): its functions.
p.(None): 28.7. For the above purposes, the Committee must keep a record of
...
p.(None): 33.9.
p.(None): Prepare and follow for its operation the standard operating procedures, mark a periodicity of
p.(None): meeting and a maximum response time. These procedures must be public knowledge, upon request.
p.(None): Of the interested.
p.(None): Each meeting of the Committee will be included in the corresponding minutes. in which the members will be detailed
p.(None): Attendees, it will be noted that for each study evaluated, the aspects have been weighted with
p.(None): tempered in article 46 of this regulation, as well as information about the opinion and a summary of the
p.(None): substantive elements of the discussion, explicit opinions about the reasons for which it was approved
p.(None): whether or not a protocol is approved, which supports the decisions of the Committee.
p.(None): 30.1. Written request, signed and sealed by the Chairman of the Committee, addressed to THE COMMISSION.
p.(None): in which the name, address and telephone number of the Research Ethics Committee are recorded.
p.(None): 30.2. For each of the members who will make up the Committee, the following must be attached
p.(None): paper it:
p.(None): to. Photocopy of the identity card.
p.(None): b. Photocopy of the Curriculum Vİtae, specifying scientific activities performed and projection activities
p.(None): Social.
p.(None): c. Proof of active Collegiate in force when applicable.
p.(None): d. Training in the subject of Research ethics.
p.(None): and. Proof of participation in courses and other activities related to wind power in
p.(None): investigation.
p.(None): 30.3. The Research Ethics Committees established under the administrative authority give a
p.(None): Institution, whether public or public, must have proof of the address of the same.
p.(None): 30.4. Copy of the Regulations that will govern the operation of the Committee.
p.(None): 30.s. Minutes book or individual sheets, to be authorized and sealed by THE COMMISSION.
p.(None): Article 31. Local inspection. The locative inspection will be carried out by THE COMMISSION in order to verify that
p.(None): it has the necessary support infrastructure so that the Committee can function properly.
p.(None): Article 32. Functions of the Research Ethics Committees. The responsibility of a Committee
p.(None): at evaluating biomedical research, it is to contribute to safeguarding the dignity, rights, security and well-being
p.(None): of all current and potential participants of the research; for this you must perform the
p.(None): following functions:
p.(None): 32.1. Evaluate the adequacy of the protocol in relation to the objectives of the study. its efficiency
p.(None): scientific, the possibility of reaching valid conclusions with the least possible exposlción of subjects and the
p.(None): justification of the foreseeable risks and inconveniences, weighted according to the expected benefits
p.(None): for subjects and society.
p.(None): 32.2. Assess the suitability of the research team for the proposed trial. It will take into account your experience and
p.(None): investigative capacity to carry out the study, depending on their healthcare obligations and the
p.(None): previously acquired commitments with other research protocols.
p.(None): Evaluate the written information on the characteristics of the essay that
p.(None): will give the possible subjects of the investigation, or failing that, their legal representative, the way
p.(None): that said information will be provided and the type of informed consent that will
p.(None): be obtained.
p.(None): 3t.4. Check the 'forecast of compensation and treatment to be offered to subjects
p.(None): participants in case of injury or death attributable to the clinical trial, and compensation for
p.(None): cover responsibilities.
p.(None): 32.5. They know and evaluate the scope of the compensations that will be offered to the subjects of the investigation for their
p.(None): participation.
p.(None): 32.8. To approve the performance of the clinical trial before it is presented to THE COMMISSION.
p.(None): 32.7. Approve changes or amendments to the protocol to informed consent, before being
p.(None): implemented.
p.(None): 32.8. Follow up on the clinical trial, from its start to receipt of the final report
p.(None): of the researcher, through ordinary and extraordinary9 visits in accordance with the nature of the protocol and as
p.(None): to define in its regulations. one'
p.(None): 32.9. Suspend general or permanently execute a protocol if serious abnormalities are detected.
p.(None): violation of yourself. The researcher, the sponsor and LA CÇMISIÓŞ must be notified in writing of the
p.(None): Committee's decision indicating the reasons for the suspension.
p.(None): 33.10. The Committee's opinions must be standardized in order to
p.(None): support communication between the Committee and researchers from the AN rma:
p.(None): evue \ to with racomenăaciones da oambios).
p.(None): c. Recite d:.
p.(None): 33.11. The Committee must keep all relevant records for a period of three years after its conclusion.
p.(None): the study and make them available at the request of the authority.
p.(None): CHAPTER V
p.(None): OF THE REQUIREMENTS OF CLINICAL TRIALS
p.(None): Article 34. Requirements for conducting clinical trials. Pursuant to Articles 93 and 94 of the Agreement
p.(None): Government 712-99, Regulation for the Sanitary Control of Medicines and Related Products, tests
p.(None): Clinicians must submit to the authorization of the LA regulatory authority and evaluation.
p.(None): COMMISSION. After the evaluation, yes. the regulatory authority shall grant the respective authorization.
p.(None): Clinical trial procedures must have the review and approval of an Ethics Committee in
p.(None): Research accredited by the Ministry of Health, through the respective agency.
p.(None): Article 35. Application for authorization of a clinical trial. You must have the following documentation:
p.(None): 35.1. Request made by the researcher or sponsor, addressed to THE COMMISSION, indicating:
p.(None): to. Protocol title and number.
p.(None): b. Name and address of the principal investigator. c Research site.
p.(None): d. Study drug (international code name, pharmaceutical form, concentration,
p.(None): presentation).
p.(None): and. Research phase.
p.(None): 1. Research Ethics Committee.
p.(None): g. Sponsor.
p.(None): h. Sub-investigators, when applicable.
p.(None): ‹Receipt of payment of the corresponding duty, according to the specific year.
p.(None): 35.2. Test protocol. clinical. Every protocol for the clinical trial shall be written in Spanish,
p.(None): including the following basic sections:
p.(None): to. Summary.
p.(None): b. indice.
p.(None): c. General information.
p.(None): d. Justification and objectives.
p.(None): and. Type of clinical test and its design.
p.(None): F. Selection of subjects.
p.(None): g. Description of thiaiamlento.
p.(None): h. Development of the trial and evaluation of the response.
p.(None): i. Adverse effects.
p.(None): j. Informed consent and other applicable ethical aspects.
p.(None): *. Practical considerations.
p.(None): 1. Statistical analysis.
...
General/Other / participants in a control group
Searching for indicator control group:
(return to top)
p.(None): c. Know the profile of your adverse reactions and establish your safety.
p.(None): The administration of the drug or medication to a single patient in the setting of the clinic is not considered a clinical trial.
p.(None): habitual medical practice for the sole purpose of obtaining a benefit for it. Medical practice and
p.(None): professional freedom of prescription of the doctor will not protect, in any case, clinical trials not
p.(None): ar ›Iorized, or the use of secret or undeclared remedies to the sanitary authority.
p.(None): 2.J 3. Open-blind clinical trial. It is the one in which the subject lants as the researcher knows the group of
p.(None): tralamienlo to which he has been assigned.
p.(None): 2.14. Clinical trial with third-party evaluation. It is one in which the subject, researcher and
p.(None): palroclnador, ignore the treatment received. To evaluate the response, a third person is used who
p.(None): the treatment each subject is receiving is unknown.
p.(None): 2.1s. It is cynical with crossed groups. It is the one in which the experimental and control treatments are
p.(None): administered to each individual in successive periods that have been determined randomly, to which
p.(None): allow each subject to be their
p.(None): 2.16. Clinical trial with parallel groups. It is one in which one or several groups of subjects are
p.(None): assigned to receive the experimental treatment at the same time as the other group receives the control treatment.
p.(None): 2.17. Controlled clinical trial. It is the one that establishes a comparison with a control group or tesligo. The
p.(None): randomized controlled clinical trial including at least two groups of volunteers,
p.(None): 2.1s. patient or healthy. whose assignment to an experimental or control treatment is carried out at random so that
p.(None): Neither the subject nor the doctor responsible for their selection or treatment can influence their assignment. So the
p.(None): Selection of subjects as the periods of treatment and follow-up should take place simultaneously in all
p.(None): groups. In the vast majority of cases it is the only scientifically valid way to assess efficacy and safety
p.(None): of a lerapêutica intervention.
p.(None): 2.19. Double-blind clinical trial. It is one in which both the subject and the researcher are unaware of the
p.(None): assignment to Nos treatment groups.
p.(None): 2.2o. Phase 1 clinical trial. They are the first step in the investigation of a substance or
p.(None): new medicine in humans, they are also studies of pharmacokinetics and pharmacodynamics] that will provide
p.(None): Preliminary information on the effect and safety of the product on healthy subjects or in some cases-
p.(None): in patients, and will guide the most appropriate administration regimen for subsequent trials.
p.(None): 2.Z1. Phase II clinical trial. They represent the second stage in the evaluation of a new substance or
p.(None): medicine in humans. These will be carried out in healthy subjects or in some houses in patients, their end
p.(None): is to provide preliminary information on the effectiveness of the product, establish the relationship between the responses
p.(None): of the same. to know the variables used to measure efficacy and extend the safety data obtained in the
...
p.(None): usanda is being tested as a reference in a clinical study, including a product with a
p.(None): marketing when used or packaged (formulated or packaged) in a manner unlike
p.(None): approve ‹›. when used for an unapproved indication or when used for
p.(None): 2.23. Phase IV clinical trial. They are those that are made with a medicine
p.(None): after its commercialization. These tests may be similar to those described
p.(None): Obtain more information about a previously approved use.
p.(None): ocolo. It is defined as the document where the reason for being is described
p.(None): in phases I, II and III if they study some aspect not yet evaluated or different conditions of use of the authors
p.(None): hoisted as it might be a new indication. These studies
p.(None): 2.45. Prot
p.(None): of the day, its objectives, design, methodology,
p.(None): statistical considerations and the
p.(None): to the original protocol, to its
p.(None): they will preferably be controlled and randomized.
p.(None): 2.24. Multicenter clinical trial. It is one conducted according to a single protocol but in more than one
p.(None): place and, therefore, carried out by more than one
p.(None): organization of a trial. The term protocol is highlighted
p.(None): successive versions and their modifications.
p.(None): 2.4s. Adverse drug reaction (ADR). This clinical experience before
p.(None): approval of a new medicinal product or its new uses, particularly
p.(None): investigator.
p.(None): when the therapeutic dose cannot be established.
p.(None): They should be considered
p.(None): 2.25. Uncontrolled clinical trial. It is the one that cannot be compared with a control or control group.
p.(None): 2.26. Clinical trial photo. It is the one that is carried out as a previous step to other broader studies with
p.(None): the purpose of knowing data that allows a more adequate design, establishing its viability, as well as
p.(None): determine the size of the sample for further studies.
p.(None): 2.27. Sequential clinical trial. It is the one in which testing a
p.(None): adverse medium reactions, all harmful and unintended responses to a medicinal product
p.(None): related to any dose. The phrase "responses to a medicinal product" means that a causal relationship
p.(None): between a medicinal product and an adverse event is at least a reasonable possibility, that is, that the relationship
p.(None): can be discarded. Regarding medicinal products on the market: a response to a medicine that
p.(None): is harmful and unintentional and occurs at doses normally used in man for prophylaxis,
p.(None): dlagnôsllco or treatment
p.(None): from diseases to for modification of the łisiołógica function.
p.(None): specific hypothesis, the number of subjects is not predetermined in advance, but
p.(None): 2.47. Unexpected drug adverse reaction:
p.(None): adverse reaction whose
p.(None): It depends on the results that are obtained throughout it.
p.(None): 2.28. Simple clinical trial clergy. It is the one in which the subjects do not know the allocation to the group of
p.(None): treatment, but not the investigator.
p.(None): 2.29. Unlcêntrlco cylindrical test. It is that carried out by a single Investigator to a research team in
p.(None): a central dream.
p.(None): z.ao. Observational study. Analytical epidemiological study in which the researcher does not determine
p.(None): the allocation of the subjects to each group, but is limited to recording (observing) what happens in the
p.(None): reality.
...
p.(None): pertinent, make objections, checks and corresponding observations.
p.(None): In cases where additional information or clarifications are requested, once the new
p.(None): information that the interested party has presented in his case, the final resolution will be found within a plaza of
p.(None): 15 days from the receipt of the required information. This resolution will be notified to the
p.(None): Research Ethics, the researcher, the sponsor and any other party
p.(None): Article 46. Evaluation criteria for the use of the dispute. The Êtlca Committee on Research
p.(None): corresponding to evaluate the protocol, the investigator's brochure and the rest of the documentation that
p.(None): Accompany the application and it will issue its opinion taking into consideration the following questions:
p.(None): 46.1. Relevance of the clinical trial. taking into account the available knowledge.
p.(None): 46.2. Relevance of your design to obtain informed conclusions with the appropriate number of
p.(None): subjects in relation to the objective of the study.
p.(None): 46.3. Selection and withdrawal criteria for trial subjects, as well as the equitable selection of the
p.(None): show.
p.(None): 46.4 .. Justification of the foreseeable costs and inconveniences in relation to the expected benefits for
p.(None): the trial subjects, for other patients and for the community, taking into account the principle of
p.(None): protection of the test subjects developed in the elic postulates.
p.(None): 46.5. Justification of the control group either placebo to an active treatment.
p.(None): 46.6. Provisions for monitoring the trial.
p.(None): • s.7. Suitability of the researcher and his collaborators.
p.(None): 46.8. ldoneidad of the facilities.
p.(None): 46.9. Adequacy of written information for test subjects and the procedure for
p.(None): oblenciôn informed consent. and justification of research in disabled people
p.(None): to give your informed consent.
p.(None): 46.10. Financial guarantee insurance provided for the trial. 4s. 11. Remuneration forecasts, for the Subjects
p.(None): of the essay.
p.(None): 46.12. Plan planned for the recruitment of the subjects.
p.(None): interested. THE COMMISSION'S ACCLUTIONS MUST BE CONTAINED IN ADMINISTRATIVE RESOLUTIONS.
p.(None): "” ”“ ’) Uend
p.(None): be i et evaluated for each one be the Centers replicated n n s
p.(None): Article 38. Conditions of Authorization. The authorization of a clinical trial is carried out for one year
p.(None): and when necessary it must be renewed. For this, the researcher or sponsor must present a
p.(None): request for renewal accompanied by progress reports of the clinical trial sent to the Ethics Committee in
p.(None): Investigation for at least 30 days prior to the expiration of the current aulorization. THE COMMISSION respond
p.(None): within 15 days of receiving the
p.(None): Article 39. Modifications to the protocols of authorized clinical trials. C \ talquìe r modiflcation approved
p.(None): The Research Ethics Committee shall be known to THE COMMISSION, and must be accompanied by
...
Searching for indicator placebo:
(return to top)
p.(None): groups. In the vast majority of cases it is the only scientifically valid way to assess efficacy and safety
p.(None): of a lerapêutica intervention.
p.(None): 2.19. Double-blind clinical trial. It is one in which both the subject and the researcher are unaware of the
p.(None): assignment to Nos treatment groups.
p.(None): 2.2o. Phase 1 clinical trial. They are the first step in the investigation of a substance or
p.(None): new medicine in humans, they are also studies of pharmacokinetics and pharmacodynamics] that will provide
p.(None): Preliminary information on the effect and safety of the product on healthy subjects or in some cases-
p.(None): in patients, and will guide the most appropriate administration regimen for subsequent trials.
p.(None): 2.Z1. Phase II clinical trial. They represent the second stage in the evaluation of a new substance or
p.(None): medicine in humans. These will be carried out in healthy subjects or in some houses in patients, their end
p.(None): is to provide preliminary information on the effectiveness of the product, establish the relationship between the responses
p.(None): of the same. to know the variables used to measure efficacy and extend the safety data obtained in the
p.(None): lass 1. In general, these clinical trials will be controlled and randomized to the treatments.
p.(None): NUMBER 2.S CENTER DIARY
p.(None): AMERICA Guotemolo, THURSDAY, February 22, 2007
p.(None): 2.43. Standard operating procedures (POEs). Written instructions to achieve uniformity in
p.(None): the execution of a specific function.
p.(None): 2.44. Produc to in In vestlgaclón. Pharmaceutical form of an active ingredient, placebo or device, which
p.(None): usanda is being tested as a reference in a clinical study, including a product with a
p.(None): marketing when used or packaged (formulated or packaged) in a manner unlike
p.(None): approve ‹›. when used for an unapproved indication or when used for
p.(None): 2.23. Phase IV clinical trial. They are those that are made with a medicine
p.(None): after its commercialization. These tests may be similar to those described
p.(None): Obtain more information about a previously approved use.
p.(None): ocolo. It is defined as the document where the reason for being is described
p.(None): in phases I, II and III if they study some aspect not yet evaluated or different conditions of use of the authors
p.(None): hoisted as it might be a new indication. These studies
p.(None): 2.45. Prot
p.(None): of the day, its objectives, design, methodology,
p.(None): statistical considerations and the
p.(None): to the original protocol, to its
p.(None): they will preferably be controlled and randomized.
p.(None): 2.24. Multicenter clinical trial. It is one conducted according to a single protocol but in more than one
p.(None): place and, therefore, carried out by more than one
p.(None): organization of a trial. The term protocol is highlighted
p.(None): successive versions and their modifications.
p.(None): 2.4s. Adverse drug reaction (ADR). This clinical experience before
p.(None): approval of a new medicinal product or its new uses, particularly
p.(None): investigator.
p.(None): when the therapeutic dose cannot be established.
p.(None): They should be considered
p.(None): 2.25. Uncontrolled clinical trial. It is the one that cannot be compared with a control or control group.
...
p.(None): In cases where additional information or clarifications are requested, once the new
p.(None): information that the interested party has presented in his case, the final resolution will be found within a plaza of
p.(None): 15 days from the receipt of the required information. This resolution will be notified to the
p.(None): Research Ethics, the researcher, the sponsor and any other party
p.(None): Article 46. Evaluation criteria for the use of the dispute. The Êtlca Committee on Research
p.(None): corresponding to evaluate the protocol, the investigator's brochure and the rest of the documentation that
p.(None): Accompany the application and it will issue its opinion taking into consideration the following questions:
p.(None): 46.1. Relevance of the clinical trial. taking into account the available knowledge.
p.(None): 46.2. Relevance of your design to obtain informed conclusions with the appropriate number of
p.(None): subjects in relation to the objective of the study.
p.(None): 46.3. Selection and withdrawal criteria for trial subjects, as well as the equitable selection of the
p.(None): show.
p.(None): 46.4 .. Justification of the foreseeable costs and inconveniences in relation to the expected benefits for
p.(None): the trial subjects, for other patients and for the community, taking into account the principle of
p.(None): protection of the test subjects developed in the elic postulates.
p.(None): 46.5. Justification of the control group either placebo to an active treatment.
p.(None): 46.6. Provisions for monitoring the trial.
p.(None): • s.7. Suitability of the researcher and his collaborators.
p.(None): 46.8. ldoneidad of the facilities.
p.(None): 46.9. Adequacy of written information for test subjects and the procedure for
p.(None): oblenciôn informed consent. and justification of research in disabled people
p.(None): to give your informed consent.
p.(None): 46.10. Financial guarantee insurance provided for the trial. 4s. 11. Remuneration forecasts, for the Subjects
p.(None): of the essay.
p.(None): 46.12. Plan planned for the recruitment of the subjects.
p.(None): interested. THE COMMISSION'S ACCLUTIONS MUST BE CONTAINED IN ADMINISTRATIVE RESOLUTIONS.
p.(None): "” ”“ ’) Uend
p.(None): be i et evaluated for each one be the Centers replicated n n s
p.(None): Article 38. Conditions of Authorization. The authorization of a clinical trial is carried out for one year
p.(None): and when necessary it must be renewed. For this, the researcher or sponsor must present a
p.(None): request for renewal accompanied by progress reports of the clinical trial sent to the Ethics Committee in
p.(None): Investigation for at least 30 days prior to the expiration of the current aulorization. THE COMMISSION respond
p.(None): within 15 days of receiving the
p.(None): Article 39. Modifications to the protocols of authorized clinical trials. C \ talquìe r modiflcation approved
p.(None): The Research Ethics Committee shall be known to THE COMMISSION, and must be accompanied by
p.(None): a summary of the proposed and approved modifications.
...
Orphaned Trigger Words
p.(None): To participate in the study, you must sign and date the document, together with the person who conducted the
p.(None): information process ÿ explanation of the informed consent document.
p.(None): 1'i.6. If the subject to their legal representative cannot read or write, they must place their fingerprint. During
p.(None): the entire process must be attended by an impartial witness, who must also sign or place his fingerprint
p.(None): digital and date the document.
p.(None): IN.7. Delivery of a signed copy of the approved informed consent document to Subject or to your
p.(None): legal representative. •
p.(None): 15.8. File of the original of the informed consent document in the subject's clinical file.
p.(None): Art (ass 16. The written informed consent document and any other written information that is
p.(None): will provide subjects should be reviewed when new information emerges that may be relevant to
p.(None): the subject's consent. Any form of written informed consent and written information
p.(None): reviewed shall have the favorable approval of the Research Ethics Committee before
p.(None): use. The subject or his legal representative must be informed in a timely manner if any
p.(None): New information that may be relevant to your desire to continue participating in the study. The
p.(None): Communication of the Information must be documented in the same way as the informed consent.
p.(None): Article 17. Obtaining informed consent. The following requirements must be met:
p.(None): 17.1. The consent used in the investigation must have the formal approval of the Committee
p.(None): of Élica en Invesligation before presenlarlo to the panicipants.
p.(None): 1z.z. The approved informed consent must be signed and signed by the president or coordinator of the
p.(None): Comilé of Ethics in Research
p.(None): accredited, or a member of the Comilê designated for that purpose, in accordance with its regulations, in each
p.(None): one of its leaves and this one is the one that is presented to the subject.
p.(None): at 1z. 3. Eslar written by Korma clear, without technicalities so that the subject
p.(None): participant can understand it easily.
p.(None): 17.4. Have all its leaves foliated.
p.(None): 17.5. Indicate version number and date.
p.(None): 17.6. The paniclpanic subject in the investigation must give his consent before entering the study.
p.(None): 17.7. The subject must give their consent, free of coercion, with knowledge of all other
p.(None): therapeutic options available.
p.(None): 17.s. The subject must know his right to change his mind and leave the study at any time
p.(None): want.
p.(None): 17.s. Participant must receive a signed copy of the informed consent for their files
p.(None): personal.
p.(None): Article 18. Special regulations. Some situations, due to their characteristics, require an approach
...
p.(None): interested. THE COMMISSION'S ACCLUTIONS MUST BE CONTAINED IN ADMINISTRATIVE RESOLUTIONS.
p.(None): "” ”“ ’) Uend
p.(None): be i et evaluated for each one be the Centers replicated n n s
p.(None): Article 38. Conditions of Authorization. The authorization of a clinical trial is carried out for one year
p.(None): and when necessary it must be renewed. For this, the researcher or sponsor must present a
p.(None): request for renewal accompanied by progress reports of the clinical trial sent to the Ethics Committee in
p.(None): Investigation for at least 30 days prior to the expiration of the current aulorization. THE COMMISSION respond
p.(None): within 15 days of receiving the
p.(None): Article 39. Modifications to the protocols of authorized clinical trials. C \ talquìe r modiflcation approved
p.(None): The Research Ethics Committee shall be known to THE COMMISSION, and must be accompanied by
p.(None): a summary of the proposed and approved modifications.
p.(None): Any relevant modification that implies an increased risk for the participating subjects, must
p.(None): be approved by the Research Ethics Committee and gUÎO ¢ i ¥ ãdâ ROI t_A COMMISSION.
p.(None): Article 40. Expansion of the number of sites. Expanding the number of research sites initially
p.(None): provided for in Guatemala must be approved by the Research Ethics Committee, which will not qualify LA
p.(None): COMMISSION.
p.(None): Article 41. Suspension of an authorized clinical trial. The performance of a clinical trial was
p.(None): will suspend by justified petition of the investigator. from the sponsor, from the Ethics Committee8
p.(None): Investigation or by decision of THE COMMISSION in the following cases:
p.(None): 41.1. For violation of these regulations.
p.(None): 41.z. Alteration of the conditions of your authorization.
p.(None): 41.3. Failure to comply with the ethical principles set forth in the regulations, to protect the subjects of the trial.
p.(None): 41.4. In defense of public health.
p.(None): Article 42. Final report of the Investigator. Upon completion of the trial, the investigator or
p.(None): The sponsor will send the final report to THE COMMISSION, taking responsibility with his signature for the veracity of the
p.(None): data. In the event that the investigation does not come to an end, the researcher or sponsor will send
p.(None): TO THE COMMISSION the Suspension Report and its reasons. Likewise, it will nolify the completion of the at trial
p.(None): Research Ethics Committee.
p.(None): Article 43. Importation of products for clinical trials. The authorization for the importation of
p.(None): products to be used in clinical trials shall conform to the legal regulations applicable in each case and may be
p.(None): granted in unit of act with the authorization of the clinical trial and its validity will be the
p.(None): same. The sponsor must keep a record of imported products.
p.(None): Article 44. Continuation of treatment after the end of the trial. Once the trial is over
p.(None): clinical, the continuation of the administration of used products, should be governed by the rules
p.(None): established for the compassionate uro, contained in the following article, as long as
p.(None): authorized śu use for those conditions. This provision of medication for study subjects by a
p.(None): Time to be agreed, may be requested from the sponsor, at the request of the Ethics Committee in
p.(None): Research, the lnstilución where the study was carried out, THE COLLECTION and the researcher.
p.(None): Article 47. Rules of good practice cllnlca. All clinical trials conducted in the country must
p.(None): Carry out in accordance with internationally accepted standards of good clinical practice.
p.(None): The Standards of Good Clinical Practice indicate the standards to be followed in designing, implementing and
p.(None): communicate the results of the clinical tests, in order to ensure that the data is reliable and protected
p.(None): the rights and integrity of the subjects. including the confidentiality of your data; Likewise,
p.(None): The responsibilities of the different parties involved in each of the planning phases are indicated.
p.(None): and execution of a clinical trial. They require the existence of pre-established procedures for
...
p.(None): sponsor, visit the researcher before, during and after the trial to check the
p.(None): protocol compliance. ensure that the data is recorded correctly and completes it in the bulletin
p.(None): data collection. In this way, make sure that the informed behavior of all subjects has been reduced.
p.(None): before inclusion in the trial.
p.(None): Sü.2. Make sure that the researchers and the center where the research will be carried out are adequate
p.(None): for this purpose during the test period.
p.(None): so.a. Make sure that both the principal investigator and his collaborators have been adequately informed and
p.(None): guarantee at all at least one
p.(None): ¢ Quick communication between invigator and sponsor.
p.(None): 5ü.4. , Verify that the investigator complies with the protocol and all its approved amendments.
p.(None): so.5. Verify with respect to the products under investigation that the times and conditions of
p.(None): They are acceptable and that supplies are sufficient during the study.
p.(None): 50.6. Verify that research products are supplied only to subjects who
p.(None): they are eligible to receive it and at the doses specified in the protocol.
p.(None): so.7. Verify that subjects are provided with the necessary instructions on the
p.(None): proper use, handling, storage and return of research products.
p.(None): 50.8. Verify that the receipt, use and return of the products under investigation in the
p.(None): The facilities where the study is carried out are procedures properly controlled and documented.
p.(None): 5ü.I. Verify that unused research products are destroyed or returned ă where applicable.
p.(None): s0.10. Determine if all adverse events are reported appropriately within
p.(None): the periods of time required by Good Clinical Practice. the protocol, the Committee of
p.(None): Research Ethics and these regulations.
p.(None): 50.11. Submit to the sponsor reports of the monitoring visits and all IOș Contactor
p.(None): relevant to the researcher, including their perception of the veracity of the information and the quality
p.(None): of the work carried out by the researcher and his team.
p.(None): Article 51. Investigator. The investigator directs and is responsible for the practical realization of the clinical trial
p.(None): at a center, and sign the application together with the sponsor, sponsoring him. He can only act
p.(None): as a researcher a doctor to a person who exercises a recognized profession in the country to carry out
p.(None): the
p.(None): . research based on his scientific training and his experience in health education
p.(None): required.
p.(None): In case said prolesional is not a doctor. A collegiate doctor in the country should be included as a sub-researcher.
p.(None): The investigator's responsibilities are:
p.(None): SI.1. Agree and sign the trial protocol with the sponsor.
p.(None): The results or conclusions of the clinical tests will be reported prøțgrønlęmente in
p.(None): scientific publications before being disclosed to non-health public. They will not be disclosed so
p.(None): Premature or sensationalist traumatization of efficacy not yet determined, nor will it be exaggerated.
p.(None): The advertising of investigational drugs is strictly prohibited, as established in the
p.(None): regulation that regulates the advertising of medicines.
p.(None): Article 53. Archive of the clinical trial documentation. The pat ^ oCiFìgłdOF 0 owner of the data of the
p.(None): rehearsal is responsible for the archiving of the rehearsal documentation and shall retain all documentation relating to the
p.(None): test, in accordance with its internal regulations. These documents will include:
p.(None): sB.1. The protocol, including its justification, objectives, statistical design and
p.(None): melodology of the test, with the conditions in which it is carried out and
p.(None): manage, as well as the details of the research products used.
p.(None): sa.z. Standard work procedures.
p.(None): s8.3. All written reports on protocol and procedures. s3.4. Investigator's brochure,
p.(None): s3.s. Data collection notebook for each subject.
p.(None): s3.6. Final report.
p.(None): 53.7. -Audit certificate, when applicable.
p.(None): Any change that occurs in the possession of your data will be documented. All data and documents are
p.(None): will make available to the competent authorities in. cheers if they request it. In any case, it
p.(None): ensure the confidentiality of the data and documents contained in the file.
p.(None): Article 55. Inspections. THE COMMISSION will verify4 the application of the norm corresponding to the
p.(None): monitoring compliance with the standards of good clinical practice, by means of inspections.
p.(None): Inspections will be carried out in Cabo by duly qualified and appointed inspectors.
p.(None): effect in places related to the conduct of clinical trials and, among others, in the center or
p.(None): centers where the test is carried out, the place of manufacture of the medicine in
p.(None): research, any analytical laboratory used in the clinical test and / or in the facilities
p.(None): from the sponsor. After inspection, a report will be prepared and made available to the inspected,
p.(None): of the Research Ethics Committee involved and the competent authorities in the country.
p.(None): Article 56. Monitoring compliance with the rules of good clinical practice. THE COMMISSION may
p.(None): carry out periodic inspections of any of the parties involved in the con ¢ iuction of a
p.(None): clinical study, with the purpose of verifying compliance with Good Clinical Practice and
p.(None): the corresponding Yes regŁilacio.
p.(None): CHAPTER VI
p.(None): OF THE SECURITY SURVEILLANCE OF MEDICINES IN INVESTIGATION
p.(None): Article 57. Obligations of Investigators in the registry and communication of adverse events. The
p.(None): The researcher will communicate within the first twenty-four hours, from the no recfication requested by
p.(None): the sponsor, at Research Ethics Committee and THE COMMISSION, all serious adverse events, except
p.(None): when dealing with those indicated in the protocol or in the investigator's brochure as events that do not require
p.(None): Inmedlala communication. The initial communication will be followed by detailed written co-communications.
p.(None): In the 'initial communications and in the follow-up communications, the subjects will be identified
p.(None): 51.2.
p.(None): yes4
p.(None): 51.g.
p.(None): 51.7.
p.(None): Request and obtain authorization for the clinical trial.
p.(None): In-depth knowledge of the properties of the product under investigation, its protocol and procedures.
p.(None): Ensure that informed consent is followed in accordance with the provisions of this regulation.
p.(None): Collect, register and nolify IOS data for correct ›and guarantee its veracity.
p.(None): Immediately report serious or unexpected enemas to the sponsor and to the Ethics Committee in
p.(None): Investigation.
p.(None): Ensuring that all the people involved respected the validity of any information
p.(None): around the subjects of the trial, as well as the protection of their personal data.
p.(None): of the clinical trial using a specific code number for each of them.
p.(None): Adverse events and / or the results of abnormal work in the protocol qualified as
p.(None): Determiners for safety evaluations will be communicated to the sponsor in accordance with the requirements of
p.(None): communication and within the periods specified in the protocol.
p.(None): In the event that a report has been reported from a subject participating in a clinical trial, the investigator
p.(None): provide the sponsor and the Research Ethics Committees involved with all the relevant information
p.(None): laria que sołicilen.
p.(None): Article 58. Obligations of the person responsible for the clinical trial in the registry, evaluation and communication of
p.(None): adverse enemas. The palrocinadqr manlendrã
p.(None): 51.0. Regularly informal at the March Research Ethics Committee
p.(None): of the essay.
p.(None): 509. A ¢ Chiva £ and keep all documentation related to the study for a minimum of 2 years after
p.(None): the approval of a commercialization request in the country and has passed at least 2
p.(None): aO ^ iO5 de5from the formal suspension of the clinical development of the product under investigation.
p.(None): Af‘ticuIA 52. Publish actions. Sponsor is obliged to disclose and publish the results
p.(None): from clinical trials in scientific journals, both positive and negative.
p.(None): ..z
p.(None): I '
p.(None): When esududlos y lrabajos are released öe research on medicines, aimed at the community
p.(None): scientific, the funds obtained by the author by a will be corrected for its realization and the source of
p.(None): financing. The nonimatitude of the subjects participating in the trial will be maintained at all times.
p.(None): Detailed records of all adverse events reported to you by the investigators. Is the
p.(None): Registrations will be submitted to THE COMMISSION when requested to do so.
p.(None): The sponsor has an obligation to continually evaluate the safety of medications in
p.(None): research using all the information at your fingertips. Likewise, you must communicate without
p.(None): delay to THE COMlSlÓhi, the competent bodies and the Ethics Committees in
p.(None): Research involving any important information that affects the safety of the medicine in
p.(None): investigation.
p.(None): Said communication will be made according to the criteria specified in the following articles and
p.(None): in accordance with the procedures established in the instructions for carrying out clinical tests
p.(None): in the country.
p.(None): The communication of the sponsor's security information to the investigators will be specified in the
p.(None): standards of good clinical practice.
p.(None): MINIG3’ERIO DE kA DEFENGA NACIONAc
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| age | Age |
| authority | Relationship to Authority |
| autonomy | Impaired Autonomy |
| coma | Comatose |
| control group | participants in a control group |
| diminished | Diminished Autonomy |
| disability | Mentally Disabled |
| disabled | Mentally Disabled |
| drug | Drug Usage |
| elderly | Elderly |
| emergencies | patients in emergency situations |
| emergency | Public Emergency |
| employees | employees |
| ethnic | Ethnicity |
| faith | Religion |
| family | Motherhood/Family |
| gender | gender |
| impairment | Cognitive Impairment |
| incapable | Mentally Incapacitated |
| incapacity | Incapacitated |
| incarcerated | Incarcerated |
| influence | Drug Usage |
| language | Linguistic Proficiency |
| minority | Racial Minority |
| nomads | nomad |
| opinion | philosophical differences/differences of opinion |
| party | political affiliation |
| placebo | participants in a control group |
| political | political affiliation |
| prisoners | Criminal Convictions |
| property | Property Ownership |
| single | Marital Status |
| substance | Drug Usage |
| unemployed | Unemployment |
| volunteers | Healthy People |
| vulnerable | vulnerable |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| control group | ['placebo'] |
| disability | ['disabled'] |
| disabled | ['disability'] |
| drug | ['influence', 'substance'] |
| influence | ['drug', 'substance'] |
| party | ['political'] |
| placebo | ['controlXgroup'] |
| political | ['party'] |
| substance | ['drug', 'influence'] |
Trigger Words
capacity
coercion
consent
developing
ethics
protect
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input