0A4F4F9BD490A749D5437F821CF06DF1
Supreme Decree No. 021-2017- SA. Regulation of Clinical Trials (2017)
https://busquedas.elperuano.pe/download/url/aprueban-reglamento-de-ensayos-clinicos-decreto-supremo-n-021-2017-sa-1538902-2
http://leaux.net/URLS/ConvertAPI Text Files/44FF6453C6D30DAC7FE3F9F65E0CAC06.en.txt
Examining the file media/Synopses/44FF6453C6D30DAC7FE3F9F65E0CAC06.html:
This file was generated: 2020-07-15 06:09:54
| 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 / Illegal Activity
Searching for indicator crime:
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p.(None): clinical.
p.(None): d) Cancellation of the registration of the research center
p.(None): e) Cancellation of the clinical trial
p.(None): f) Restricting the investigator to carry out future trials for a period to be determined by the INS OGITT
p.(None): according to the level of seriousness of the infraction.
p.(None): The scale of fines for each type of infraction is determined by Supreme Decree. The fine must be paid within
p.(None): of the maximum term of fifteen (15) business days, counted from the day after the sanction is notified.
p.(None): In case of non-compliance, the authority that imposed the fine will order its coercive collection according to
p.(None): law procedure.
p.(None): Article 133. Criteria for the imposition of sanctions
p.(None): The sanctions will be imposed by the INS OGITT by means of a Directorial Resolution applying the criteria indicated in the
p.(None): Article 135 of the General Health Law.
p.(None): Article 134. Clinical trials without authorization
p.(None): In the event that the INS OGITT detects the conduct of a clinical trial without the corresponding authorization, it will have
p.(None): the cancellation of the clinical trial and / or invalidation of the data obtained in it, without prejudice to the actions
p.(None): civil and / or criminal offenses and / or communication to the Public Ministry, the ANM and / or the schools
p.(None): corresponding professionals.
p.(None): Article 135. Clinical trials in which there is falsification or manufacture of the required information or of
p.(None): the data.
p.(None): In the event that the INS OGITT detects the falsification or fabrication of the information required by this
p.(None): Regulations or data related to the study, as well as any other offense or crime related to
p.(None): the clinical trial in accordance with these Regulations, will provide for the cancellation and / or invalidation of said trial
p.(None): clinical, in accordance with the provisions of article 132 of these Regulations, without prejudice to actions
p.(None): civil and / or criminal offenses and / or communication to the Public Ministry, the ANM and the schools
p.(None): corresponding professionals.
p.(None): Article 136. Infringement by foreign sponsors
p.(None): If the sponsor (s) participating in the cases established in articles 134 and
p.(None): 135 of these Regulations, if they were foreigners, the INS will inform the authorities of their respective country (ies)
p.(None): so that they have the corresponding legal actions.
p.(None): Article 137. Notification and publication of sanctions
p.(None): 137.1 The INS OGITT will notify the security measure and / or the sanction imposed on people and
p.(None): entities participating in the execution of the trial
p.(None): El Peruano / Friday, June 30, 2017
p.(None): LEGAL STANDARDS 59
p.(None): clinical, without prejudice to the civil and / or criminal actions that may take place and / or the communication to the
p.(None): Public Ministry, the National Level Health Authority, the ANM and the professional associations
p.(None): corresponding.
p.(None): 137.2 Once the resolution that determines the imposition of a sanction is final or the route has been exhausted
p.(None): Administrative, the INS OGITT will publish, on the INS institutional website, the name of the person or
p.(None): institution that has been subject to the sanction. Said publication will be kept for one year, unless the sanction is for
...
Political / Indigenous
Searching for indicator indigenous:
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p.(None): biological, obtained from microorganisms, blood or other tissues, whose manufacturing methods
p.(None): may include one or more of the following elements: growth of strains of microorganisms in different types
p.(None): of substrates; eukaryotic cell jobs; extraction of substances from biological tissues, including
p.(None): humans, animals and plants; products obtained by recombinant DNA or hybridomas and; the spread of
p.(None): microorganisms in embryos or animals, among others.
p.(None): 36. Product under investigation.- It is a pharmaceutical product or medical device that is investigated or
p.(None): used as a comparator in a clinical trial, including products with health registration when
p.(None): used or combined, in the formulation or in the packaging, in a different way from that authorized, or when
p.(None): used to treat an unauthorized indication, or to obtain more information about its authorized use. For the purposes of
p.(None): This Regulation, the terms "pharmaceutical product" and "medical device" refer to what is stated in the
p.(None): Law No. 29459, Law on Pharmaceutical Products, Medical Devices and Health Products.
p.(None): 37. Complementary product.- It is a pharmaceutical product or medical device used for
p.(None): needs of a clinical trial as described in the study protocol, but not as a product in
p.(None): investigation.
p.(None): 38. Investigation protocol.- Document that establishes the background, rationale and objectives of the
p.(None): clinical trial and accurately describes its design,
p.(None): methodology and organization, including statistical considerations and the conditions under which
p.(None): will execute. The protocol must be dated and signed by the investigator and the sponsor.
p.(None): 39. Indigenous or Native Peoples: Are those with direct descent from the populations
p.(None): originating from the national territory, with lifestyles and spiritual and historical links with the
p.(None): territory that they traditionally use or occupy, with their own social institutions and customs, with patrons
p.(None): cultural and way of life different from those of other sectors of the national population and that
p.(None): at the same time they have an indigenous or original identity. Peasant or Andean communities and
p.(None): Native communities or Amazonian peoples may be considered as indigenous or native peoples, under the
p.(None): same criteria as above.
p.(None): 40. Adverse reaction.- It is any adverse event in which there is a clearly defined causal relationship with a
p.(None): product of investigation or there is at least a reasonable possibility of a causal relationship, which arises
p.(None): regardless of the administered dose.
p.(None): 41. Serious adverse reaction.- It is any adverse reaction that results in death, is life-threatening,
p.(None): requires hospitalization or prolonged hospitalization, produces disability or incapacity
p.(None): permanent or important, cause a congenital anomaly or malformation. For the purposes of your notification,
p.(None): They will also treat as serious those events that from the medical point of view, can endanger the
p.(None): research subject or require an intervention to prevent one of the results initially noted in this
p.(None): definition.
p.(None): 42. Unexpected adverse reaction.- It is an adverse reaction whose nature or severity is not consistent with the
p.(None): information of the product under investigation, that is, it is not described in the researcher's manual and / or file
p.(None): technique.
p.(None): 43. Suspected serious and unexpected adverse reaction.- It is any serious adverse event in the
p.(None): that there is at least a reasonable possibility of a causal relationship with the product under investigation and whose
p.(None): nature or severity is not described in the researcher's manual and / or technical sheet.
p.(None): 44. Controversial situations.- That situation in which it is identified during the evaluation process of the
p.(None): clinical trial, that the benefit / risk balance is debatable.
...
p.(None): safety for the fetus and the pregnant woman.
p.(None): c) Investigations with deaths, natimes, macerated fetal matter, cells, tissues, placenta, cord
p.(None): umbilical, embryonic remains and organs removed from them, will be made observing due respect
p.(None): the pregnant woman or the product of pregnancy in a situation of death or corpse and the applicable provisions
p.(None): in the Regulations of the Cemeteries and Funeral Services Law, as appropriate.
p.(None): Article 24. Of clinical trials in subordinate groups
p.(None): The performance of clinical trials in subordinate groups can only be carried out when they are completed, in addition
p.(None): of the provisions of Title II of these Regulations, the following conditions:
p.(None): a) When research is carried out in subordinate groups, one or more members must participate in the CIEI
p.(None): of the study population, or another person in society capable of protecting the conditions and rights
p.(None): humans that correspond to the group in question.
p.(None): b) Participation, rejection or withdrawal of their consent during the study of the subjects
p.(None): under investigation, do not affect your academic, work, military or judicial situation
p.(None): to which they were subject and the conditions of compliance with the judgment, if applicable; and that
p.(None): research results are not used to their detriment.
p.(None): Article 25. Clinical trials in indigenous or native peoples
p.(None): The carrying out of clinical trials in indigenous or native peoples may only be carried out when
p.(None): In addition to the provisions of Title II of these Regulations, they comply with the following conditions:
p.(None): a) When the product or knowledge generated by the research is available or applied for benefit
p.(None): potential of these communities.
p.(None): b) When the principal investigator has the approval of the regional authority of
p.(None): corresponding health and the authorities belonging to the community to study. These approvals
p.(None): they must be obtained prior to the informed consent of the research subjects included in the
p.(None): clinical trial.
p.(None): c) Sponsors and researchers should develop culturally appropriate ways and means with
p.(None): anthropologists, sociologists, translators and interpreters to communicate the necessary information and complete the process
p.(None): of informed consent. In addition, the research protocol must describe and justify
p.(None): the procedure they plan to use to communicate the information to the research subjects.
p.(None): d) It will not be appropriate to include them as research subjects when the individuals that make up a
p.(None): community do not have the capacity to understand the implications of participating in an investigation, despite the
p.(None): employment of a translator or interpreter.
p.(None): e) In the case of including the storage of biological samples, additionally,
p.(None): You must have the authorization of the corresponding regional and local government, and the authorities
...
Searching for indicator native:
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p.(None): Health has provided that the Ministry of Health is competent in health research and technologies;
p.(None): That article 4 of the aforementioned Law establishes that the Health Sector is made up of the Ministry of
p.(None): Health, as the governing body, the entities attached to it and those public and private institutions
p.(None): at the national, regional and local level, and natural persons who carry out activities related to
p.(None): competencies established in said Law, and that have direct or indirect impact on health, individual or collective;
p.(None): That, literals a) and b) of article 5 of Legislative Decree No. 1161 provide as governing functions
p.(None): of the Ministry of Health formulating, planning, directing, coordinating, executing, supervising and evaluating the policy
p.(None): and national sector of Health Promotion, Disease Prevention, Recovery and
p.(None): Rehabilitation in Health, under its jurisdiction, applicable to all levels of government, as well as issuing regulations
p.(None): and technical guidelines for the proper execution and supervision of national and sectoral policies;
p.(None): That, literal a) of article 32 of Law No. 27657 establishes that the National Institute of Health (INS) is a
p.(None): Public Body attached to the Ministry of Health;
p.(None): That, by Supreme Decree No. 017-2006-SA, the Regulation of Clinical Trials in Peru was approved, which was modified
p.(None): by Supreme Decree No. 006-2007-SA;
p.(None): That, also, with Supreme Decree No. 020-2015-SA, temporary preventive measures were established,
p.(None): control and supervision of the clinical trials that are being developed in the country, in protection of the
p.(None): rights of minors and native communities participating in clinical trials, further providing that the
p.(None): National Institute of Health propose to the Ministry of Health the draft of the new Clinical Trials Regulation;
p.(None): That, through Ministerial Resolution No. 437-2015 / MINSA, the prepublication of the draft
p.(None): Clinical Trials Regulation, in order to receive suggestions and contributions from public entities or
p.(None): private and citizens in general, during the period of fifteen (15) calendar days, a period that was extended by
p.(None): fifteen (15) additional business days pursuant to
p.(None): El Peruano / Friday, June 30, 2017
p.(None): LEGAL STANDARDS 39
p.(None): the provisions of Ministerial Resolution No. 457-2015 / MINSA;
p.(None): That, due to scientific and technological advances in the development of new research products
p.(None): It is necessary to establish provisions that allow the qualification of research projects to
p.(None): national level, in order to protect the rights, safety, dignity and well-being of
p.(None): the research subjects, as well as ensuring that the data obtained in a clinical trial are reliable and
p.(None): solids;
p.(None): In accordance with the provisions of number 8 of article 118 of the Political Constitution of Peru, the
p.(None): Law No. 26842, General Health Law, Legislative Decree No. 1161, Organization and Functions Law of the Ministry of
p.(None): Health and Law No. 29158, Organic Law of the Executive Power;
p.(None): DECREES:
p.(None): Article 1.- Approval
p.(None): Approve the Clinical Trials Regulation, which consists of twelve (12) titles, one hundred thirty-seven (137)
p.(None): articles, eight (8) final complementary provisions, two transitory complementary provisions and five (5)
p.(None): annexes, which is an integral part of this Supreme Decree.
...
p.(None): may include one or more of the following elements: growth of strains of microorganisms in different types
p.(None): of substrates; eukaryotic cell jobs; extraction of substances from biological tissues, including
p.(None): humans, animals and plants; products obtained by recombinant DNA or hybridomas and; the spread of
p.(None): microorganisms in embryos or animals, among others.
p.(None): 36. Product under investigation.- It is a pharmaceutical product or medical device that is investigated or
p.(None): used as a comparator in a clinical trial, including products with health registration when
p.(None): used or combined, in the formulation or in the packaging, in a different way from that authorized, or when
p.(None): used to treat an unauthorized indication, or to obtain more information about its authorized use. For the purposes of
p.(None): This Regulation, the terms "pharmaceutical product" and "medical device" refer to what is stated in the
p.(None): Law No. 29459, Law on Pharmaceutical Products, Medical Devices and Health Products.
p.(None): 37. Complementary product.- It is a pharmaceutical product or medical device used for
p.(None): needs of a clinical trial as described in the study protocol, but not as a product in
p.(None): investigation.
p.(None): 38. Investigation protocol.- Document that establishes the background, rationale and objectives of the
p.(None): clinical trial and accurately describes its design,
p.(None): methodology and organization, including statistical considerations and the conditions under which
p.(None): will execute. The protocol must be dated and signed by the investigator and the sponsor.
p.(None): 39. Indigenous or Native Peoples: Are those with direct descent from the populations
p.(None): originating from the national territory, with lifestyles and spiritual and historical links with the
p.(None): territory that they traditionally use or occupy, with their own social institutions and customs, with patrons
p.(None): cultural and way of life different from those of other sectors of the national population and that
p.(None): at the same time they have an indigenous or original identity. Peasant or Andean communities and
p.(None): Native communities or Amazonian peoples may be considered as indigenous or native peoples, under the
p.(None): same criteria as above.
p.(None): 40. Adverse reaction.- It is any adverse event in which there is a clearly defined causal relationship with a
p.(None): product of investigation or there is at least a reasonable possibility of a causal relationship, which arises
p.(None): regardless of the administered dose.
p.(None): 41. Serious adverse reaction.- It is any adverse reaction that results in death, is life-threatening,
p.(None): requires hospitalization or prolonged hospitalization, produces disability or incapacity
p.(None): permanent or important, cause a congenital anomaly or malformation. For the purposes of your notification,
p.(None): They will also treat as serious those events that from the medical point of view, can endanger the
p.(None): research subject or require an intervention to prevent one of the results initially noted in this
p.(None): definition.
p.(None): 42. Unexpected adverse reaction.- It is an adverse reaction whose nature or severity is not consistent with the
p.(None): information of the product under investigation, that is, it is not described in the researcher's manual and / or file
p.(None): technique.
p.(None): 43. Suspected serious and unexpected adverse reaction.- It is any serious adverse event in the
p.(None): that there is at least a reasonable possibility of a causal relationship with the product under investigation and whose
p.(None): nature or severity is not described in the researcher's manual and / or technical sheet.
p.(None): 44. Controversial situations.- That situation in which it is identified during the evaluation process of the
p.(None): clinical trial, that the benefit / risk balance is debatable.
p.(None): 45. Suspension of the clinical trial.- It is the temporary interruption of enrollment and / or
...
p.(None): safety for the fetus and the pregnant woman.
p.(None): c) Investigations with deaths, natimes, macerated fetal matter, cells, tissues, placenta, cord
p.(None): umbilical, embryonic remains and organs removed from them, will be made observing due respect
p.(None): the pregnant woman or the product of pregnancy in a situation of death or corpse and the applicable provisions
p.(None): in the Regulations of the Cemeteries and Funeral Services Law, as appropriate.
p.(None): Article 24. Of clinical trials in subordinate groups
p.(None): The performance of clinical trials in subordinate groups can only be carried out when they are completed, in addition
p.(None): of the provisions of Title II of these Regulations, the following conditions:
p.(None): a) When research is carried out in subordinate groups, one or more members must participate in the CIEI
p.(None): of the study population, or another person in society capable of protecting the conditions and rights
p.(None): humans that correspond to the group in question.
p.(None): b) Participation, rejection or withdrawal of their consent during the study of the subjects
p.(None): under investigation, do not affect your academic, work, military or judicial situation
p.(None): to which they were subject and the conditions of compliance with the judgment, if applicable; and that
p.(None): research results are not used to their detriment.
p.(None): Article 25. Clinical trials in indigenous or native peoples
p.(None): The carrying out of clinical trials in indigenous or native peoples may only be carried out when
p.(None): In addition to the provisions of Title II of these Regulations, they comply with the following conditions:
p.(None): a) When the product or knowledge generated by the research is available or applied for benefit
p.(None): potential of these communities.
p.(None): b) When the principal investigator has the approval of the regional authority of
p.(None): corresponding health and the authorities belonging to the community to study. These approvals
p.(None): they must be obtained prior to the informed consent of the research subjects included in the
p.(None): clinical trial.
p.(None): c) Sponsors and researchers should develop culturally appropriate ways and means with
p.(None): anthropologists, sociologists, translators and interpreters to communicate the necessary information and complete the process
p.(None): of informed consent. In addition, the research protocol must describe and justify
p.(None): the procedure they plan to use to communicate the information to the research subjects.
p.(None): d) It will not be appropriate to include them as research subjects when the individuals that make up a
p.(None): community do not have the capacity to understand the implications of participating in an investigation, despite the
p.(None): employment of a translator or interpreter.
p.(None): e) In the case of including the storage of biological samples, additionally,
p.(None): You must have the authorization of the corresponding regional and local government, and the authorities
p.(None): respective communities, who must consider the interest of the community involved.
...
Political / criminal
Searching for indicator criminal:
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p.(None): Article 132. Sanctions
p.(None): Without prejudice to consider compliance with the principle called non bis in idem as mandatory, except
p.(None): the concurrence of a case of continuation of infractions, those who incur in typified infractions in the
p.(None): article 131 of these Regulations; will be liable to one of the following administrative sanctions:
p.(None): a) Warning.
p.(None): b) Fine comprised between half (0.5) and one hundred (100) Tax Units.
p.(None): c) Closure of a research center for a trial
p.(None): clinical.
p.(None): d) Cancellation of the registration of the research center
p.(None): e) Cancellation of the clinical trial
p.(None): f) Restricting the investigator to carry out future trials for a period to be determined by the INS OGITT
p.(None): according to the level of seriousness of the infraction.
p.(None): The scale of fines for each type of infraction is determined by Supreme Decree. The fine must be paid within
p.(None): of the maximum term of fifteen (15) business days, counted from the day after the sanction is notified.
p.(None): In case of non-compliance, the authority that imposed the fine will order its coercive collection according to
p.(None): law procedure.
p.(None): Article 133. Criteria for the imposition of sanctions
p.(None): The sanctions will be imposed by the INS OGITT by means of a Directorial Resolution applying the criteria indicated in the
p.(None): Article 135 of the General Health Law.
p.(None): Article 134. Clinical trials without authorization
p.(None): In the event that the INS OGITT detects the conduct of a clinical trial without the corresponding authorization, it will have
p.(None): the cancellation of the clinical trial and / or invalidation of the data obtained in it, without prejudice to the actions
p.(None): civil and / or criminal offenses and / or communication to the Public Ministry, the ANM and / or the schools
p.(None): corresponding professionals.
p.(None): Article 135. Clinical trials in which there is falsification or manufacture of the required information or of
p.(None): the data.
p.(None): In the event that the INS OGITT detects the falsification or fabrication of the information required by this
p.(None): Regulations or data related to the study, as well as any other offense or crime related to
p.(None): the clinical trial in accordance with these Regulations, will provide for the cancellation and / or invalidation of said trial
p.(None): clinical, in accordance with the provisions of article 132 of these Regulations, without prejudice to actions
p.(None): civil and / or criminal offenses and / or communication to the Public Ministry, the ANM and the schools
p.(None): corresponding professionals.
p.(None): Article 136. Infringement by foreign sponsors
p.(None): If the sponsor (s) participating in the cases established in articles 134 and
p.(None): 135 of these Regulations, if they were foreigners, the INS will inform the authorities of their respective country (ies)
p.(None): so that they have the corresponding legal actions.
p.(None): Article 137. Notification and publication of sanctions
p.(None): 137.1 The INS OGITT will notify the security measure and / or the sanction imposed on people and
p.(None): entities participating in the execution of the trial
p.(None): El Peruano / Friday, June 30, 2017
p.(None): LEGAL STANDARDS 59
p.(None): clinical, without prejudice to the civil and / or criminal actions that may take place and / or the communication to the
p.(None): Public Ministry, the National Level Health Authority, the ANM and the professional associations
p.(None): corresponding.
p.(None): 137.2 Once the resolution that determines the imposition of a sanction is final or the route has been exhausted
p.(None): Administrative, the INS OGITT will publish, on the INS institutional website, the name of the person or
p.(None): institution that has been subject to the sanction. Said publication will be kept for one year, unless the sanction is for
p.(None): a longer period, being withdrawn automatically or at the request of a party at the end of said period.
p.(None): FINAL SUPPLEMENTARY PROVISIONS
p.(None): First.- Aspects not provided for in these Regulations
p.(None): The aspects not foreseen in these Regulations will be resolved by the INS OGITT within the framework of the regulations
p.(None): of Good Clinical Practices of the International Conference on Harmonization of Technical Requirements for the
p.(None): Registration of Pharmaceutical Products for Human Use, as well as national regulations and
p.(None): international that are in force and are applicable to it.
p.(None): Second.- From the Manual of Clinical Trial Procedures
p.(None): Within a maximum period of ninety (90) calendar days from the effective date of these Regulations, the INS OGITT
p.(None): will elaborate the Manual of Procedures of Clinical Trials, which will be approved by Resolution of the INS.
p.(None): Third.- Term for the constitution of Dispensing Units
p.(None): A maximum period of one year from the validity of this Regulation will be granted so that
p.(None): the research institutions comply with the conformation of the Dispensing Units to which
p.(None): refers to article 92 of this Regulation.
...
Political / political affiliation
Searching for indicator party:
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p.(None): treatment of
p.(None): 46 LEGAL STANDARDS Friday, June 30, 2017 /
p.(None): A Peruvian man
p.(None): research subject; about your rights as a research subject or contact in case of injury,
p.(None): for which the name, address and telephone number of the principal investigator and those of the president of the
p.(None): CIEI as appropriate.
p.(None): - The freedom to withdraw your consent at any time and stop participating in the study without it
p.(None): damages are created to continue their care and treatment.
p.(None): - The security that the research subject will not be identified and that the confidentiality of the
p.(None): information related to your privacy.
p.(None): - That the representatives of the sponsor, the CIEI and the OGITT of the INS will have access to the clinical history of the
p.(None): Research subject for verification of the clinical trial procedures and / or data, without violating their
p.(None): confidentiality, and that, by signing the informed consent form, the research subject or his
p.(None): legal representative are authorizing access to this data.
p.(None): - The commitment to provide you with updated information about the product or the procedure in
p.(None): research or when the research subject requests it, although it may affect the will of the
p.(None): research subject to continue participating.
p.(None): - The circumstances and / or anticipated reasons why the clinical trial could end or
p.(None): the participation of the research subject in it.
p.(None): - The availability of medical treatment and the compensation to which you would legally be entitled, for
p.(None): party responsible for the clinical trial, in the case of damages that directly affect it, caused by
p.(None): the investigation, pointing out the existence of the insurance contracted by the sponsor.
p.(None): - The detail of the financial compensation for additional expenses, such as transportation, accommodation, communication, and
p.(None): food if they exist; which will be covered by the budget of the clinical trial.
p.(None): - In the event that the woman or the man are in reproductive capacity, the
p.(None): potential risks in the event of her or his partner's pregnancy, and that a
p.(None): effective contraceptive method chosen by the participant and their partner.
p.(None): - That in the event of a pregnancy of the research subject or his partner, he must report the fact to the
p.(None): investigator. In addition, the format must establish whether such condition is considered grounds for exclusion from the
p.(None): clinical trial. Likewise, it will indicate the application of the procedures for the monitoring and control of the
p.(None): gestation and newborn to at least six
p.(None): (6) months of age in order to identify any effect related to the research product. The
p.(None): expenses that such monitoring demands will be financed by the sponsor. The sponsor will be
p.(None): responsible for the respective compensation for damages produced during the pregnancy or that had been
p.(None): caused to the newborn as a consequence of the clinical trial.
p.(None): - Specify the time, means and responsible for which the research subject will be provided
p.(None): the final results of the clinical trial, which must be in a language understandable to him.
...
p.(None): available as required; and, the quality of the research product based on the information related to
p.(None): the quality of the product under investigation according to Annex 5 of this Regulation, issuing a binding opinion
p.(None): through a technical report within a maximum period of thirty (30) business days. In case the product in
p.(None): Research is not included in what corresponds to the ANM, it must be evaluated by the competent body.
p.(None): In clinical trials with biological research products, the maximum period for issuing the report
p.(None): Technician will be forty-five (45) business days.
p.(None): In the case of bioequivalence studies to demonstrate interchangeability as part of the requirement
p.(None): for sanitary registration in the country, the ANM will also issue a binding opinion on the research protocol
p.(None): through a technical report, within the same period in which the opinion of the safety and quality profile is issued
p.(None): of the product under investigation.
p.(None): Article 70. Authorization of the clinical trial
p.(None): The INS OGITT will issue the clinical trial authorization resolution after evaluating the protocol
p.(None): of investigation, technical report containing the binding opinion issued by the ANM and other requirements
p.(None): established in article 67 of these regulations, within a maximum period of forty (40) days
p.(None): business days, which include the 30 days of the evaluation of the safety profile and the quality of the product in
p.(None): investigation by the ANM. If additional information is required to be submitted by the interested party, it will be suspended
p.(None): the calculation of the evaluation period until the requested information is received.
p.(None): 52 LEGAL STANDARDS Friday, June 30, 2017 /
p.(None): A Peruvian man
p.(None): In clinical trials with biological research products and those controversial situations that
p.(None): involve the call of technical commissions, the maximum term for the authorization of the clinical trial will be
p.(None): sixty (60) business days, which include 45 days of the evaluation of the safety profile and the quality of the
p.(None): product under investigation by the ANM.
p.(None): The Directorates General in charge of strategic interventions for prevention, control and
p.(None): reduction of risks and damages in tuberculosis or HIV / AIDS infection the approval of clinical trials whose
p.(None): research product is intended for the prevention, diagnosis or treatment of conditions
p.(None): mentioned doctors.
p.(None): Article 71. Validity of the test authorization
p.(None): clinical
p.(None): The authorization of the clinical trial is granted for the total period of time scheduled for its execution, the
p.(None): which was registered in the authorization request, which is the Registration Form according to REPEC.
p.(None): Article 72. Call for technical commissions
p.(None): The INS may call technical committees made up of health professionals with a recognized track record
p.(None): in the field of research and independent from the pharmaceutical industry, when situations arise
p.(None): controversial in the authorization process for conducting clinical trials.
p.(None): Article 73. Filing of appeals for reconsideration and appeal
p.(None): In the event that the clinical trial is not authorized, the sponsor or OIC may optionally file the
...
p.(None): clinical, in accordance with the provisions of article 132 of these Regulations, without prejudice to actions
p.(None): civil and / or criminal offenses and / or communication to the Public Ministry, the ANM and the schools
p.(None): corresponding professionals.
p.(None): Article 136. Infringement by foreign sponsors
p.(None): If the sponsor (s) participating in the cases established in articles 134 and
p.(None): 135 of these Regulations, if they were foreigners, the INS will inform the authorities of their respective country (ies)
p.(None): so that they have the corresponding legal actions.
p.(None): Article 137. Notification and publication of sanctions
p.(None): 137.1 The INS OGITT will notify the security measure and / or the sanction imposed on people and
p.(None): entities participating in the execution of the trial
p.(None): El Peruano / Friday, June 30, 2017
p.(None): LEGAL STANDARDS 59
p.(None): clinical, without prejudice to the civil and / or criminal actions that may take place and / or the communication to the
p.(None): Public Ministry, the National Level Health Authority, the ANM and the professional associations
p.(None): corresponding.
p.(None): 137.2 Once the resolution that determines the imposition of a sanction is final or the route has been exhausted
p.(None): Administrative, the INS OGITT will publish, on the INS institutional website, the name of the person or
p.(None): institution that has been subject to the sanction. Said publication will be kept for one year, unless the sanction is for
p.(None): a longer period, being withdrawn automatically or at the request of a party at the end of said period.
p.(None): FINAL SUPPLEMENTARY PROVISIONS
p.(None): First.- Aspects not provided for in these Regulations
p.(None): The aspects not foreseen in these Regulations will be resolved by the INS OGITT within the framework of the regulations
p.(None): of Good Clinical Practices of the International Conference on Harmonization of Technical Requirements for the
p.(None): Registration of Pharmaceutical Products for Human Use, as well as national regulations and
p.(None): international that are in force and are applicable to it.
p.(None): Second.- From the Manual of Clinical Trial Procedures
p.(None): Within a maximum period of ninety (90) calendar days from the effective date of these Regulations, the INS OGITT
p.(None): will elaborate the Manual of Procedures of Clinical Trials, which will be approved by Resolution of the INS.
p.(None): Third.- Term for the constitution of Dispensing Units
p.(None): A maximum period of one year from the validity of this Regulation will be granted so that
p.(None): the research institutions comply with the conformation of the Dispensing Units to which
p.(None): refers to article 92 of this Regulation.
p.(None): Fourth.- Temporary application of these Regulations for research products that
p.(None): correspond to herbal medicines, dietary products and sweeteners, galenic products and
p.(None): medical devices.
p.(None): Specific aspects for the execution of clinical trials with herbal medicines, products
p.(None): dietetics and sweeteners, galenic products and medical devices will be determined by
p.(None): Supreme decret. Said standard proposal will be prepared by the INS OGITT within a maximum period of one hundred and eighty
p.(None): (180) calendar days counted from the validity of this Regulation. As long as the standard is approved
p.(None): pertinent, clinical trials with these research products are governed by the standards indicated
...
Searching for indicator political:
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p.(None): That, by Supreme Decree No. 017-2006-SA, the Regulation of Clinical Trials in Peru was approved, which was modified
p.(None): by Supreme Decree No. 006-2007-SA;
p.(None): That, also, with Supreme Decree No. 020-2015-SA, temporary preventive measures were established,
p.(None): control and supervision of the clinical trials that are being developed in the country, in protection of the
p.(None): rights of minors and native communities participating in clinical trials, further providing that the
p.(None): National Institute of Health propose to the Ministry of Health the draft of the new Clinical Trials Regulation;
p.(None): That, through Ministerial Resolution No. 437-2015 / MINSA, the prepublication of the draft
p.(None): Clinical Trials Regulation, in order to receive suggestions and contributions from public entities or
p.(None): private and citizens in general, during the period of fifteen (15) calendar days, a period that was extended by
p.(None): fifteen (15) additional business days pursuant to
p.(None): El Peruano / Friday, June 30, 2017
p.(None): LEGAL STANDARDS 39
p.(None): the provisions of Ministerial Resolution No. 457-2015 / MINSA;
p.(None): That, due to scientific and technological advances in the development of new research products
p.(None): It is necessary to establish provisions that allow the qualification of research projects to
p.(None): national level, in order to protect the rights, safety, dignity and well-being of
p.(None): the research subjects, as well as ensuring that the data obtained in a clinical trial are reliable and
p.(None): solids;
p.(None): In accordance with the provisions of number 8 of article 118 of the Political Constitution of Peru, the
p.(None): Law No. 26842, General Health Law, Legislative Decree No. 1161, Organization and Functions Law of the Ministry of
p.(None): Health and Law No. 29158, Organic Law of the Executive Power;
p.(None): DECREES:
p.(None): Article 1.- Approval
p.(None): Approve the Clinical Trials Regulation, which consists of twelve (12) titles, one hundred thirty-seven (137)
p.(None): articles, eight (8) final complementary provisions, two transitory complementary provisions and five (5)
p.(None): annexes, which is an integral part of this Supreme Decree.
p.(None): Article 2.- Endorsement
p.(None): This Supreme Decree is endorsed by the Minister of Health.
p.(None): SUPPLEMENTARY DEROGATORY PROVISION
p.(None): Sole.- Repeal
p.(None): Repeal Supreme Decree No. 017-2006-SA, which approved the Regulation of Clinical Trials in Peru and its
p.(None): amending, as well as Supreme Decree No. 020-2015-SA, which dictates temporary preventive measures, inspection
p.(None): and supervision of clinical trials.
p.(None): Given at the Government House, in Lima, on the twenty-eighth day of the month of June of the year two thousand seventeen.
p.(None): PEDRO PABLO KUCZYNSKI GODARD
p.(None): Republic President
p.(None): PATRICIA J. GARCIA FUNEGRA
p.(None): Minister of Health
p.(None): TITLE I CLINICAL TRIALS REGULATION
p.(None): GENERAL DISPOSITION
p.(None): Article 1. Purpose
p.(None): The purpose of this Regulation is to establish the procedure for authorization, execution and actions
p.(None): after the execution of clinical trials in the country.
p.(None): Article 2. Operational definitions and abbreviations
p.(None): For the purposes of these Regulations, the
p.(None): following operational definitions and abbreviations
p.(None): 2.1 Operational definitions
p.(None): 1. Assent.- It is the process by which the authorization or permission granted in the form
...
p.(None): The Institutional Committee for Research Ethics (CIEI) is the non-profit instance of a
p.(None): research institution, public research institute or Peruvian university, constituted by
p.(None): professionals from various disciplines and members of the community willing to participate, in charge
p.(None): from ensuring the protection of the rights, safety and well-being of research subjects to
p.(None): Through, among other things, review and approval / favorable opinion of the study protocol, the
p.(None): competence of researchers and the adequacy of the facilities, methods and material that
p.(None): they will use when obtaining and documenting the informed consent of the research subjects.
p.(None): Article 59. Institutional Research Ethics Committees and Research Institutions
p.(None): Each research institution may establish a CIEI and register it with the INS. Those institutions
p.(None): Research that do not have a CIEI may make use, at their choice, of another CIEI accredited by the
p.(None): INS, preferably located in the same region.
p.(None): Institutions must provide all necessary resources, such as human resources,
p.(None): infrastructure, logistics and financial for the CIEI to fulfill its mandate. To fulfill his mandate
p.(None): Furthermore, it is imperative that the institutions guarantee that the committees enjoy autonomy and independence.
p.(None): institutional, professional, union, political, commercial and economic.
p.(None): Conflict procedures should be established and described in CIEI regulations
p.(None): of interest, independence and transparency. Regarding independence, all kinds of influence should be prohibited.
p.(None): undue to obtain particular results, decisions or actions of the committee, its members or staff.
p.(None): Regarding transparency, independent internal and external evaluations of the CIEI should be considered.
p.(None): 50 LEGAL STANDARDS Friday, June 30, 2017 /
p.(None): A Peruvian man
p.(None): carried out periodically by professionals without
p.(None): biases and with specific knowledge in the area.
p.(None): Article 60. Functions of Institutional Research Ethics Committees
p.(None): CIEIs have the following functions:
p.(None): a) Evaluate the methodological, ethical and legal aspects
p.(None): of the research protocols that are sent to it.
p.(None): b) Evaluate the amendments to the protocols of
p.(None): authorized research.
p.(None): c) Evaluate the suitability of the principal investigator and his team considering, among other things, the
p.(None): availability of time of the principal investigator and an adequate delegation of responsibilities within the
p.(None): equipment.
p.(None): d) Evaluate the suitability of the facilities of the
p.(None): research centers.
p.(None): e) Conduct supervision, including active supervision at research sites, of trials
p.(None): INS authorized clinicians, from inception to receipt of final report, at appropriate intervals
p.(None): according to the degree of risk for the research subjects, at least one (1) time a year. For
...
Political / stateless persons
Searching for indicator nation:
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p.(None): Diplomat of the Republic Gustavo Enrique Bonelli Vásquez, in accordance with the provisions of article 18,
p.(None): subsection e) of Law No. 28091, as of July 1, 2017;
p.(None): Scale Report (OAP) No. 113/2017, of the Office of Personnel Administration, of the Office
p.(None): General of Human Resources, of June 26, 2017;
p.(None): CONSIDERING:
p.(None): That article 18 of Law No. 28091, Law of the Diplomatic Service of the Republic, provides that the situation
p.(None): Retirement is one in which the member of the Diplomatic Service is definitively separated from
p.(None): the activity situation, among other reasons, at your request in written form;
p.(None): That, the move to the retirement situation, at your request in writing, will be made effective by
p.(None): Supreme Resolution;
p.(None): That, the Counselor at the Diplomatic Service of the Republic Gustavo Enrique Bonelli Vásquez, is not
p.(None): incurso in the established by the article 49 of the Regulation of the Law of the Diplomatic Service of the
p.(None): Republic, approved by Supreme Decree No. 130-2003-RE;
p.(None): In accordance with Law No. 28091, Law of the Diplomatic Service of the Republic and amendments; its
p.(None): Regulations approved by Supreme Decree No. 130-2003-RE and amendments; and, the Organization Regulations and
p.(None): Functions of the Ministry of Foreign Relations, approved by Supreme Decree No. 135-2010-RE;
p.(None): RESOLVES:
p.(None): Article 1.- Go to the retirement situation, at your request in written form, to the Counselor in the Diplomatic Service
p.(None): of the Republic Gustavo Enrique Bonelli Vásquez, as of July 1, 2017.
p.(None): Article 2.- Thank the Counselor at the Diplomatic Service of the Republic Gustavo Enrique Bonelli
p.(None): Vásquez, for the services rendered to the Nation.
p.(None): Article 3.- This Supreme Resolution will be countersigned by the Minister of Foreign Relations.
p.(None): Register, communicate and publish. PEDRO PABLO KUCZYNSKI GODARD
p.(None): Republic President
p.(None): RICARDO LUNA MENDOZA
p.(None): Minister of Foreign Affairs
p.(None): 1538901-3
p.(None): HEALTH
p.(None): Clinical Trials Regulations Approved
p.(None): SUPREME DECREE N ° 021-2017-SA
p.(None): THE PRESIDENT OF THE REPUBLIC CONSIDERING:
p.(None): That, numerals I and XV of the Preliminary Title of Law No. 26842, General Health Law establish that the
p.(None): protection of health is in the public interest and therefore it is the responsibility of the State to regulate, monitor and
p.(None): promote it and that the State promotes scientific and technological research in the field of health;
p.(None): That article 28 of the aforementioned Law establishes that experimental research with people must adhere to the
p.(None): special legislation on the matter and ethical postulates contained in the Declaration of Helsinki and subsequent
p.(None): statements that update the aforementioned postulates;
p.(None): That, number 9 of article 3 of Legislative Decree No. 1161, Law of Organization and Functions of the Ministry of
p.(None): Health has provided that the Ministry of Health is competent in health research and technologies;
p.(None): That article 4 of the aforementioned Law establishes that the Health Sector is made up of the Ministry of
p.(None): Health, as the governing body, the entities attached to it and those public and private institutions
p.(None): at the national, regional and local level, and natural persons who carry out activities related to
p.(None): competencies established in said Law, and that have direct or indirect impact on health, individual or collective;
...
Political / vulnerable
Searching for indicator vulnerable:
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p.(None): at the research center, at the facilities of the sponsor or the Research Organization by
p.(None): Contract (OIC), CIEI or any other involving the clinical trial.
p.(None): 28. Researcher.- Professional in charge of conducting the clinical trial in a center
p.(None): research based on his scientific background and professional experience.
p.(None): 29. Principal investigator.- Investigator responsible for a team of investigators who carry out a
p.(None): clinical trial in a clinical trial center.
p.(None): 30. Investigator's Manual.- Confidential document that describes in detail and in a manner
p.(None): updated physical-chemical and pharmaceutical data, pre-
p.(None): El Peruano / Friday, June 30, 2017
p.(None): LEGAL STANDARDS 41
p.(None): and clinical features of the investigational product that are relevant to the study in humans.
p.(None): Its aim is to provide researchers and other authorized persons participating in the
p.(None): clinical trial, information that facilitates your understanding and compliance with the protocol.
p.(None): 31. Countries with high health surveillance.- Germany, Australia, Belgium, are considered as such.
p.(None): Canada, Republic of Korea, Denmark, Spain, United States of America, France, Holland, Italy,
p.(None): Japan, Norway, Portugal, United Kingdom, Sweden and Switzerland, according to the Regulation for Registration, Control
p.(None): and Health Surveillance of Pharmaceutical Products, Medical Devices and Health Products.
p.(None): 32. Placebo.- Product with pharmaceutical form, without active principle and therefore devoid of action
p.(None): specific pharmacological, which can be used as a control in the clinical trial or for the purpose of maintaining the
p.(None): blinding.
p.(None): 33. Vulnerable population.- They are people who relatively or totally cannot protect their
p.(None): own interests. Specifically they may have insufficient power, education, resources, strength or
p.(None): other attributes necessary to protect your interests. They can also be considered vulnerable to
p.(None): people whose consent to volunteer in a research study
p.(None): may be excessively influenced by expectations, justified or not, of benefits associated with
p.(None): participation, or by a retaliatory response by senior members of a hierarchy if
p.(None): refuse to participate.
p.(None): 34. Insurance policy.- Contract between the insured and an insurance company in which the rights are established,
p.(None): obligations of both parties and coverage, which includes the risks assumed by the insurer and which
p.(None): described in the policy, in relation to the contracted insurance. Among other information, it must contain the
p.(None): necessary to identify the insured, insurer, date of issue, period of validity, description of the
p.(None): insurance, the risks covered and the amounts insured, the specification of the premium to be paid, the
p.(None): grounds for termination of the contract, the procedure to claim compensation if it occurs
p.(None): the claim, clauses that clarify or modify part of the content of the policy contract, as well as the
p.(None): definition of the most important terms used in the policy and the other clauses that must appear in the
p.(None): policy, policy annexes, policy endorsements, in accordance with current legal provisions.
p.(None): 35. Biological product.- They are defined as pharmaceutical products that contain a substance.
p.(None): biological, obtained from microorganisms, blood or other tissues, whose manufacturing methods
p.(None): may include one or more of the following elements: growth of strains of microorganisms in different types
p.(None): of substrates; eukaryotic cell jobs; extraction of substances from biological tissues, including
...
p.(None): The research subject can leave the clinical trial at any time without any justification and without
p.(None): suffer any prejudice for it, withdrawing himself or his legally designated representative, the
p.(None): informed consent. Withdrawal of informed consent will not affect activities that are already
p.(None): have made and used the data obtained based on informed consent before
p.(None): his retirement.
p.(None): Article 12. Clinical trials for promotional purposes
p.(None): In order to guarantee optimal protection of the health and rights of research subjects, they may not be
p.(None): carry out trials aimed at promoting an investigational product.
p.(None): Article 13. Design
p.(None): In designing the clinical trial, consideration shall be given to minimizing pain, discomfort, fear
p.(None): caused by the study procedures and any other possible risk related to the disease, age or
p.(None): degree of development of the research subject. The research subject is always above any
p.(None): objective or methodological design of a clinical trial.
p.(None): Article 14. Information to the research subject
p.(None): The research subjects will have as their reference instance the main researcher, the CIEI that authorized the
p.(None): clinical trial and the INS OGITT where they can obtain more information about the clinical trial and its
p.(None): rights, which will also appear in the informed consent document.
p.(None): Article 15. Clinical trials in vulnerable populations
p.(None): Clinical trials in vulnerable populations should be of specific interest to them, that is,
p.(None): respond to the health needs or priorities of this group.
p.(None): Likewise, it must be justified that the investigation cannot be carried out in a non-vulnerable population.
p.(None): TITLE III
p.(None): OF THE SUBJECTS OF INVESTIGATION CHAPTER I
p.(None): OF THE PROTECTION OF SUBJECTS OF INVESTIGATION
p.(None): Article 16. Subject of investigation
p.(None): The research subject is the individual who participates
p.(None): in a clinical trial and can be:
p.(None): El Peruano / Friday, June 30, 2017
p.(None): LEGAL STANDARDS 43
p.(None): a) A healthy person.
p.(None): b) A person (usually a patient) whose condition is relevant to the use of the product in
p.(None): investigation.
p.(None): Article 17. Protection of the research subject
p.(None): The performance of clinical trials in research subjects is carried out in accordance with the provisions of the
p.(None): this Chapter, without prejudice to the application of the general provisions established in Title II of the
p.(None): these Regulations.
p.(None): Article 18. Clinical trials in minors
p.(None): Clinical trials may be carried out on minors in accordance with the provisions of Title II of this
p.(None): Regulation and when:
p.(None): a) The protocol has been approved by a CIEI that has a pediatric specialist or has received
p.(None): advice on clinical, ethical and psychosocial aspects in the field of pediatrics if required.
p.(None): b) Obtaining informed consent is adjusted
p.(None): to what is specified in Chapter II of this Title.
p.(None): c) The minor who reaches the age of majority during the clinical trial, must provide their
p.(None): express informed consent before said research subject can continue participating in the
p.(None): clinical trial.
...
p.(None): Conflict procedures should be established and described in CIEI regulations
p.(None): of interest, independence and transparency. Regarding independence, all kinds of influence should be prohibited.
p.(None): undue to obtain particular results, decisions or actions of the committee, its members or staff.
p.(None): Regarding transparency, independent internal and external evaluations of the CIEI should be considered.
p.(None): 50 LEGAL STANDARDS Friday, June 30, 2017 /
p.(None): A Peruvian man
p.(None): carried out periodically by professionals without
p.(None): biases and with specific knowledge in the area.
p.(None): Article 60. Functions of Institutional Research Ethics Committees
p.(None): CIEIs have the following functions:
p.(None): a) Evaluate the methodological, ethical and legal aspects
p.(None): of the research protocols that are sent to it.
p.(None): b) Evaluate the amendments to the protocols of
p.(None): authorized research.
p.(None): c) Evaluate the suitability of the principal investigator and his team considering, among other things, the
p.(None): availability of time of the principal investigator and an adequate delegation of responsibilities within the
p.(None): equipment.
p.(None): d) Evaluate the suitability of the facilities of the
p.(None): research centers.
p.(None): e) Conduct supervision, including active supervision at research sites, of trials
p.(None): INS authorized clinicians, from inception to receipt of final report, at appropriate intervals
p.(None): according to the degree of risk for the research subjects, at least one (1) time a year. For
p.(None): in the case of supervisions in pediatric populations and other vulnerable populations, there will be
p.(None): participation of specialists in aspects related to these types of populations.
p.(None): f) Submit to the INS OGITT the reports of the supervisions carried out.
p.(None): g) Evaluate reports of serious adverse events and international safety reports submitted by the
p.(None): Principal Investigator, Sponsor, or ICO.
p.(None): h) Suspend or cancel a clinical trial, when they have evidence that the research subjects are
p.(None): exposed to an uncontrolled risk that threatens your life, health, safety or other reasons
p.(None): defined in the CIEI regulations, informing the research institution, sponsor or ICO and
p.(None): to the INS OGITT of the suspension or cancellation.
p.(None): Article 61. Constitution of Institutional Research Ethics Committees
p.(None): The research institution will select the members of the CIEI upon call. The CIEI
p.(None): It is constituted taking into account the following:
p.(None): a) The CIEI must be multidisciplinary, with the participation of civil society and be made up of
p.(None): minus five (5) full members, who must ensure independence in their decisions.
p.(None): b) Members must include people with scientific expertise in the field of health, including
p.(None): also people with expertise in behavioral or social sciences, members with expertise in ethical issues,
p.(None): members with expertise in legal matters; and, representatives of the community, whose primary function is to share their
p.(None): appreciations about the communities from which the research subjects probably come. The
p.(None): CIEI may consider the assistance of expert consultants on different topics.
p.(None): c) The list of all CIEI members, both internal and external, must be publicly accessible.
...
p.(None): research center, at the place of manufacture of the product under investigation and / or in the
p.(None): facilities of the sponsor, the ICO, the CIEI and the principal investigator.
p.(None): The INS will publish the results of the inspections according to the procedures established in the
p.(None): Inspections.
p.(None): Article 122. Powers of inspectors
p.(None): a) Review the documentation of the clinical trial to verify compliance with the protocol and its amendments.
p.(None): b) Review the informed consent of the research subjects to verify that security,
p.(None): welfare and the rights of patients are protected.
p.(None): c) Review the record of data reported and analyzed according to the protocol, to verify the quality and
p.(None): data integrity.
p.(None): d) Request a copy of the documentation object of the inspection.
p.(None): e) Take samples of the product under investigation.
p.(None): f) Interview the research subjects according to what is stated in the Inspection Guide. Must be
p.(None): consider an adequate justification according to each case, the information collected must be done with methods
p.(None): adequate and the confidentiality of research subjects must be preserved.
p.(None): Article 123. Confidentiality.
p.(None): Inspectors are obliged, under responsibility, to maintain the confidentiality of the information to which
p.(None): they agree on the occasion of the inspection.
p.(None): Article 124. Scheduling of ordinary inspections
p.(None): The ordinary inspections programmed by the INS OGITT, will be carried out based on the following
p.(None): criteria:
p.(None): a) By research protocol:
p.(None): i. Vulnerable population.
p.(None): ii. Investigation phase.
p.(None): iii. Impact of the study on public health.
p.(None): iv. Safety criteria of the product under investigation.
p.(None): b) By research center:
p.(None): i. High recruitment.
p.(None): ii. Investigator Background.
p.(None): iii. High number of clinical trials.
p.(None): iv. Relevant information received in security reports and / or progress reports at the discretion of the
p.(None): INS.
p.(None): When a research center is notified by a High Drug Regulatory Agency
p.(None): Sanitary Surveillance to carry out an inspection visit in our country, the sponsor or OIC,
p.(None): You must notify the INS OGITT of the date and time of this inspection visit within five (5) days.
p.(None): working days of having received the notification from the Regulatory Agency for High Surveillance Medicines
p.(None): Sanitary. The OGITT will coordinate, with the Regulatory Agencies of Medicines of High Sanitary Surveillance, their
p.(None): participation in the inspection visit as an observer.
p.(None): Article 125. Extraordinary inspections
p.(None): Extraordinary inspections are carried out at any time with the purpose of anticipating or
p.(None): correct any circumstance that endangers the health of the research subject and in the event of a complaint.
p.(None): Article 126. Notification for carrying out inspections
p.(None): In order to carry out ordinary inspections, prior and by
p.(None): writing, to the establishment or service object of the inspection, as well as to the sponsor or OIC, of
p.(None): correspond, the date and time in which it will take place. The notification will be made with a
p.(None): not less than two (2) business days in advance.
p.(None): Extraordinary inspections will be carried out without the
p.(None): prior notification requirement.
p.(None): Article 127. Participation of the ANM
...
Health / Drug Dependence
Searching for indicator dependency:
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p.(None): of investigation must communicate it to the sponsor of the clinical trial, who in turn must
p.(None): request authorization from the ANM.
p.(None): Article 117. Requirements for post-study access to the research product in case of
p.(None): require authorization by the ANM
p.(None): ANM authorization is granted for each specific case. This request will be made by the sponsor who
p.(None): conducted the clinical trial. The requirements for this authorization are:
p.(None): a) Request for authorization addressed to the ANM
p.(None): b) Written informed consent of the research subject or his legal representative (signed by the subject
p.(None): research and principal investigator)
p.(None): c) Clinical report in which the principal investigator justifies the need for said treatment.
p.(None): d) Official medical prescription duly completed.
p.(None): e) Compliance of the person in charge of the institution or establishment where the treatment will be applied, according
p.(None): it corresponds.
p.(None): f) Updated researcher manual, according to
p.(None): it corresponds.
p.(None): g) Copy of the directorial resolution authorizing the
p.(None): clinical trial from which the specific case is derived.
p.(None): Article 118. Communication of results
p.(None): The sponsor will communicate to the ANM the results of the treatment within the established period, as well as suspicions of
p.(None): adverse drug reactions that may be due to it, without prejudice to the communication of
p.(None): adverse reactions to the decentralized health dependency at the corresponding territorial level.
p.(None): TITLE XI
p.(None): OF THE SUPERVISION OF CLINICAL TRIALS
p.(None): Article 119. Authority in charge of supervision In order to ensure the quality and integrity of the data or
p.(None): other elements related to a clinical trial and protect the rights and well-being of the subjects
p.(None): of research, the OGITT of the INS will supervise the execution of the clinical trials that are carried out in the
p.(None): country.
p.(None): Article 120. Supervision
p.(None): It is understood by supervision to the technical administrative diligence ordered by the INS OGITT, with the
p.(None): object of verifying that the clinical trial performance complies with the provisions of these Regulations.
p.(None): Article 121. Inspections
p.(None): Supervision is carried out through ordinary and extraordinary inspections and with qualified personnel
p.(None): multi-disciplinary.
p.(None): The inspections will be carried out based on the Inspection Guide approved by INS resolution.
p.(None): Inspections may be carried out at the beginning, during the execution and at the end of the clinical trial in the respective
p.(None): research center, at the place of manufacture of the product under investigation and / or in the
p.(None): facilities of the sponsor, the ICO, the CIEI and the principal investigator.
p.(None): The INS will publish the results of the inspections according to the procedures established in the
p.(None): Inspections.
p.(None): Article 122. Powers of inspectors
p.(None): a) Review the documentation of the clinical trial to verify compliance with the protocol and its amendments.
p.(None): b) Review the informed consent of the research subjects to verify that security,
...
Health / Drug Usage
Searching for indicator drug:
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p.(None): El Peruano / Friday, June 30, 2017
p.(None): LEGAL STANDARDS 57
p.(None): principal investigator and its use will continue as
p.(None): there would be benefit.
p.(None): The principal investigator considering post-study access to the research product for the subject
p.(None): of investigation must communicate it to the sponsor of the clinical trial, who in turn must
p.(None): request authorization from the ANM.
p.(None): Article 117. Requirements for post-study access to the research product in case of
p.(None): require authorization by the ANM
p.(None): ANM authorization is granted for each specific case. This request will be made by the sponsor who
p.(None): conducted the clinical trial. The requirements for this authorization are:
p.(None): a) Request for authorization addressed to the ANM
p.(None): b) Written informed consent of the research subject or his legal representative (signed by the subject
p.(None): research and principal investigator)
p.(None): c) Clinical report in which the principal investigator justifies the need for said treatment.
p.(None): d) Official medical prescription duly completed.
p.(None): e) Compliance of the person in charge of the institution or establishment where the treatment will be applied, according
p.(None): it corresponds.
p.(None): f) Updated researcher manual, according to
p.(None): it corresponds.
p.(None): g) Copy of the directorial resolution authorizing the
p.(None): clinical trial from which the specific case is derived.
p.(None): Article 118. Communication of results
p.(None): The sponsor will communicate to the ANM the results of the treatment within the established period, as well as suspicions of
p.(None): adverse drug reactions that may be due to it, without prejudice to the communication of
p.(None): adverse reactions to the decentralized health dependency at the corresponding territorial level.
p.(None): TITLE XI
p.(None): OF THE SUPERVISION OF CLINICAL TRIALS
p.(None): Article 119. Authority in charge of supervision In order to ensure the quality and integrity of the data or
p.(None): other elements related to a clinical trial and protect the rights and well-being of the subjects
p.(None): of research, the OGITT of the INS will supervise the execution of the clinical trials that are carried out in the
p.(None): country.
p.(None): Article 120. Supervision
p.(None): It is understood by supervision to the technical administrative diligence ordered by the INS OGITT, with the
p.(None): object of verifying that the clinical trial performance complies with the provisions of these Regulations.
p.(None): Article 121. Inspections
p.(None): Supervision is carried out through ordinary and extraordinary inspections and with qualified personnel
p.(None): multi-disciplinary.
p.(None): The inspections will be carried out based on the Inspection Guide approved by INS resolution.
p.(None): Inspections may be carried out at the beginning, during the execution and at the end of the clinical trial in the respective
p.(None): research center, at the place of manufacture of the product under investigation and / or in the
p.(None): facilities of the sponsor, the ICO, the CIEI and the principal investigator.
p.(None): The INS will publish the results of the inspections according to the procedures established in the
p.(None): Inspections.
p.(None): Article 122. Powers of inspectors
p.(None): a) Review the documentation of the clinical trial to verify compliance with the protocol and its amendments.
p.(None): b) Review the informed consent of the research subjects to verify that security,
p.(None): welfare and the rights of patients are protected.
p.(None): c) Review the record of data reported and analyzed according to the protocol, to verify the quality and
p.(None): data integrity.
p.(None): d) Request a copy of the documentation object of the inspection.
p.(None): e) Take samples of the product under investigation.
p.(None): f) Interview the research subjects according to what is stated in the Inspection Guide. Must be
p.(None): consider an adequate justification according to each case, the information collected must be done with methods
p.(None): adequate and the confidentiality of research subjects must be preserved.
p.(None): Article 123. Confidentiality.
p.(None): Inspectors are obliged, under responsibility, to maintain the confidentiality of the information to which
p.(None): they agree on the occasion of the inspection.
p.(None): Article 124. Scheduling of ordinary inspections
p.(None): The ordinary inspections programmed by the INS OGITT, will be carried out based on the following
p.(None): criteria:
p.(None): a) By research protocol:
p.(None): i. Vulnerable population.
p.(None): ii. Investigation phase.
p.(None): iii. Impact of the study on public health.
p.(None): iv. Safety criteria of the product under investigation.
p.(None): b) By research center:
p.(None): i. High recruitment.
p.(None): ii. Investigator Background.
p.(None): iii. High number of clinical trials.
p.(None): iv. Relevant information received in security reports and / or progress reports at the discretion of the
p.(None): INS.
p.(None): When a research center is notified by a High Drug Regulatory Agency
p.(None): Sanitary Surveillance to carry out an inspection visit in our country, the sponsor or OIC,
p.(None): You must notify the INS OGITT of the date and time of this inspection visit within five (5) days.
p.(None): working days of having received the notification from the Regulatory Agency for High Surveillance Medicines
p.(None): Sanitary. The OGITT will coordinate, with the Regulatory Agencies of Medicines of High Sanitary Surveillance, their
p.(None): participation in the inspection visit as an observer.
p.(None): Article 125. Extraordinary inspections
p.(None): Extraordinary inspections are carried out at any time with the purpose of anticipating or
p.(None): correct any circumstance that endangers the health of the research subject and in the event of a complaint.
p.(None): Article 126. Notification for carrying out inspections
p.(None): In order to carry out ordinary inspections, prior and by
p.(None): writing, to the establishment or service object of the inspection, as well as to the sponsor or OIC, of
p.(None): correspond, the date and time in which it will take place. The notification will be made with a
p.(None): not less than two (2) business days in advance.
p.(None): Extraordinary inspections will be carried out without the
p.(None): prior notification requirement.
p.(None): Article 127. Participation of the ANM
p.(None): To verify compliance with Good Manufacturing Practices standards, Good Manufacturing Practices
p.(None): Storage and other related regulations, the INS OGITT will coordinate with the ANM the participation of personnel from that area
p.(None): in the inspection team.
p.(None): Article 128. Inspection certificate
p.(None): Once the inspection is completed, the inspector will draw up the corresponding report in duplicate, indicating
p.(None): 58 LEGAL STANDARDS Friday, June 30, 2017 /
p.(None): A Peruvian man
...
p.(None): directly related to the primary objective of the trial. The primary endpoint should be the
p.(None): variable used in sample size calculations, or the main result used to
p.(None): determine the effect of the intervention. Secondary endpoints correspond to other
p.(None): variables used to measure the effect or influence of the studied intervention. A result
p.(None): Secondary may involve the same event, variable, or experience as the primary outcome, but measured
p.(None): at different time points than the primary result.
p.(None): 5. DESIGN OF THE TEST
p.(None): to. Type of test (eg parallel group, crossover group, factorial, single group), ratio of
p.(None): assignment and framework (eg superiority, equivalence, non-inferiority, exploratory)
p.(None): including a schematic diagram of the design, procedures and periods.
p.(None): b. The expected duration of participation of the research subjects and a description of the sequence and
p.(None): duration of all trial periods.
p.(None): c. Description of measures taken to minimize or avoid bias, such as randomization, which includes the
p.(None): method to generate the allocation sequence and mechanisms for its concealment, and blinding, that
p.(None): includes who will be blinded, how the blinding will be implemented and maintained, the circumstances under which
p.(None): which the blind opening is allowed according to the present regulation and the way to proceed in those cases.
p.(None): d. Description of the dose, the dosage regimen, the route and method of administration and the duration of the
p.(None): treatment.
p.(None): and. Pre-inclusion or washing periods; waiting time for drug purification, if applicable.
p.(None): F. Description of the criteria for termination or interruption of the clinical trial.
p.(None): 6. SELECTION OF THE INVESTIGATION SUBJECTS
p.(None): to. Description of the inclusion and exclusion criteria of the subjects.
p.(None): b. Criteria for withdrawal of individual research subjects from treatment or clinical trial, including
p.(None): the procedures for collecting data on the retired research subjects, the
p.(None): procedures for subject substitution and follow-up of subjects who have been withdrawn from the
p.(None): treatment or clinical trial.
p.(None): 7. DESCRIPTION OF THE TREATMENT
p.(None): to. Description of treatments or interventions for each group with sufficient details to allow
p.(None): reproduce them.
p.(None): b. Generic name, manufacturer, constituents, pharmaceutical form, route of administration,
p.(None): dosage scheme. The description of the non-pharmacological study interventions require
p.(None): information related to: any material that will be used in the intervention, each of the procedures,
p.(None): activities and / or processes used, who will provide the intervention and, if applicable, their experience, how
p.(None): distribution (for example, face-to-face or by some other mechanism, and if it will be provided
p.(None): individual or group), the number of times the intervention will be delivered and during what period of
p.(None): time including the number of sessions, schedule and its duration, intensity or dose (for example 8
p.(None): one-hour sessions, once / week for 8 weeks, then once / month for 4 months) and the location in the
p.(None): that the intervention occurs, for example, hospital, the residence of the research subject, etc.
p.(None): c. Declaration of compliance with the provisions of these regulations regarding the packaging and labeling of the
p.(None): product under investigation.
...
p.(None): participation. Make it clear that participation is voluntary and include the measures that will be taken to avoid
p.(None): coercion of research subjects:
p.(None): - Ask all the questions you consider.
p.(None): - Take the time to decide whether or not you want to participate.
p.(None): - Take an unsigned copy to read again, if necessary.
p.(None): - Talk about the study with their relatives,
p.(None): friends and / or your GP, if you wish.
p.(None): - That you can choose to participate or not in the study, without
p.(None): none of your rights are affected.
p.(None): - That you can withdraw your participation at any time without giving explanations and without sanction or loss of the
p.(None): benefits to which you would be entitled.
p.(None): 5) Justification, Objectives and purpose of the Research:
p.(None): Explain in local and simplified terms Why is this study being carried out? and what are the
p.(None): objectives?
p.(None): 6) Number of people to enroll (worldwide and in Peru)
p.(None): 7) Expected duration of participation of the research subject
p.(None): Including number and duration of visits to the research center and total time involved).
p.(None): 8) The circumstances and / or anticipated reasons under which the study or the
p.(None): subject participation in the study.
p.(None): 9) Trial treatments or interventions
p.(None): clinical.
p.(None): a) Description of the product under investigation
p.(None): experimental. It should include:
p.(None): - Name of the research product
p.(None): - Explanation of the reasons for its development
p.(None): - Previous experience with the product
p.(None): - If it is approved or not in Peru and in other countries.
p.(None): b) Comparator description
p.(None): c) Explanation in case of use of inactive drug or placebo and the reasons for its use: It is important
p.(None): make sure the participant understands what a placebo is or what it means to use an inactive drug
p.(None): as well as the reasons for its use.
p.(None): 10) Randomization and blinding.
p.(None): It should include:
p.(None): a) Explanation of randomization and how likely they are to receive one drug or another
p.(None): in terms understandable to the research subject.
p.(None): b) Explanation of blinding, reasons for its use as well as the possibility of obtaining information from the
p.(None): assigned treatment in emergencies.
p.(None): 11) Study procedures:
p.(None): a) Explanation of the study procedures to be followed (interviews,
p.(None): questionnaires, auxiliary exams, diet to follow): Describe or explain the procedures
p.(None): will perform and all medications given (including premedication, rescue medication, or other
p.(None): medication necessary for any study procedure, such as local anesthesia in case of biopsies)
p.(None): being able to include a simplified scheme and / or calendar of visits and procedures.
p.(None): b) Biological samples to be collected: type, quantity and number of times to be extracted. It is necessary
p.(None): explain how many times and how much is needed, in measures that the subject understands.
p.(None): c) Final destination of remaining biological samples. Explicitly mention that biological samples
p.(None): obtained will be used only for ongoing research and will be destroyed when the clinical trial is
p.(None): have completed, unless your storage is contemplated for future use.
p.(None): d) Storage of biological samples or their remnants for future studies: If you plan to store samples
p.(None): remnants beyond the end of the clinical trial and / or biological samples will be removed for
p.(None): storage and future studies, should be incorporated into a specific informed consent form for
p.(None): such an end.
p.(None): e) Information on the results of the tests carried out. It should include:
p.(None): - Your results will be explained to you
p.(None): - Who will inform you
p.(None): - At what time will you be informed
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p.(None): research subjects and that staff are knowledgeable about the clinical trial and procedures
p.(None): to be followed in any situation.
p.(None): d) Obtain authorization from the research institution where the clinical trial will be carried out,
p.(None): prior to its start.
p.(None): e) Obtain approval of the clinical trial by the CIEI of the research institution where it will be carried out
p.(None): the clinical trial, before its start.
p.(None): f) Start the clinical trial only after obtaining the approval by the CIEI and the authorization of the INS for the
p.(None): execution of the clinical trial in the research center.
p.(None): g) Properly inform the potential research subject, giving them enough time to
p.(None): He will discuss his participation, if he wishes, with relatives or the treating doctor, so that the recruitment is carried out
p.(None): conducted according to the research protocol.
p.(None): h) Obtain and document the informed consent of the research subject.
p.(None): i) Ensure the follow-up of the established guidelines
p.(None): in the protocol and facilitate the supervision of the CIEI.
p.(None): El Peruano / Friday, June 30, 2017
p.(None): LEGAL STANDARDS 49
p.(None): j) Ensure that the product under investigation is stored, dispensed, used and collected as established
p.(None): in the approved research protocol. It is also responsible for the accounting of the product
p.(None): of research in the research center.
p.(None): k) Facilitate the inspection visits that the personnel designated by the INS OGITT carry out at the beginning,
p.(None): during the execution of a clinical trial or after its completion.
p.(None): l) Guarantee the safety of research subjects and decisions that influence
p.(None): in their treatment.
p.(None): m) Ensure that all persons participating in the execution of the clinical trial respect the
p.(None): confidentiality of the research subjects and the information obtained in carrying out the trial
p.(None): clinical.
p.(None): n) Present progress and final reports to the research institution and the referring CIEI.
p.(None): o) Monitor the safety of the product under investigation, as established in Article 110 of this
p.(None): Regulation.
p.(None): CHAPTER V
p.(None): OF THE RESEARCH CENTERS
p.(None): Article 53. About research centers
p.(None): Understand as a research center the physical unit of the research institution where
p.(None): conducts one or more clinical trials and that meets the minimum requirements established in the Annex
p.(None): 3 of these Regulations and others that are appropriate to the nature of the study.
p.(None): Article 54. Registration of research centers
p.(None): The research centers of the public and private sector will be registered in the REPEC led by the OGITT of the
p.(None): INS, at the request of the research institution, for conducting clinical trials.
p.(None): The registration will be valid for three (3) years. The requirements for registration or renewal are:
p.(None): a) Registration request issued by the legal representative of the research institution.
p.(None): b) Form prepared according to Annex 3 of these Regulations, duly completed.
p.(None): c) National Registry of Institutions that Provide Health Services - RENIPRESS in force from the
p.(None): research institution where the research center and its categorization will operate.
p.(None): d) Proof of payment for registration as a center
p.(None): research.
p.(None): Registration will be granted based on the evaluation of the documentation presented and verification at the center of the
p.(None): characteristics required by these Regulations.
...
p.(None): professionals from various disciplines and members of the community willing to participate, in charge
p.(None): from ensuring the protection of the rights, safety and well-being of research subjects to
p.(None): Through, among other things, review and approval / favorable opinion of the study protocol, the
p.(None): competence of researchers and the adequacy of the facilities, methods and material that
p.(None): they will use when obtaining and documenting the informed consent of the research subjects.
p.(None): Article 59. Institutional Research Ethics Committees and Research Institutions
p.(None): Each research institution may establish a CIEI and register it with the INS. Those institutions
p.(None): Research that do not have a CIEI may make use, at their choice, of another CIEI accredited by the
p.(None): INS, preferably located in the same region.
p.(None): Institutions must provide all necessary resources, such as human resources,
p.(None): infrastructure, logistics and financial for the CIEI to fulfill its mandate. To fulfill his mandate
p.(None): Furthermore, it is imperative that the institutions guarantee that the committees enjoy autonomy and independence.
p.(None): institutional, professional, union, political, commercial and economic.
p.(None): Conflict procedures should be established and described in CIEI regulations
p.(None): of interest, independence and transparency. Regarding independence, all kinds of influence should be prohibited.
p.(None): undue to obtain particular results, decisions or actions of the committee, its members or staff.
p.(None): Regarding transparency, independent internal and external evaluations of the CIEI should be considered.
p.(None): 50 LEGAL STANDARDS Friday, June 30, 2017 /
p.(None): A Peruvian man
p.(None): carried out periodically by professionals without
p.(None): biases and with specific knowledge in the area.
p.(None): Article 60. Functions of Institutional Research Ethics Committees
p.(None): CIEIs have the following functions:
p.(None): a) Evaluate the methodological, ethical and legal aspects
p.(None): of the research protocols that are sent to it.
p.(None): b) Evaluate the amendments to the protocols of
p.(None): authorized research.
p.(None): c) Evaluate the suitability of the principal investigator and his team considering, among other things, the
p.(None): availability of time of the principal investigator and an adequate delegation of responsibilities within the
p.(None): equipment.
p.(None): d) Evaluate the suitability of the facilities of the
p.(None): research centers.
p.(None): e) Conduct supervision, including active supervision at research sites, of trials
p.(None): INS authorized clinicians, from inception to receipt of final report, at appropriate intervals
p.(None): according to the degree of risk for the research subjects, at least one (1) time a year. For
p.(None): in the case of supervisions in pediatric populations and other vulnerable populations, there will be
p.(None): participation of specialists in aspects related to these types of populations.
p.(None): f) Submit to the INS OGITT the reports of the supervisions carried out.
...
p.(None): published.
p.(None): c. Justification of the dose, the dosage regimen, the route and method of administration and the duration of the
p.(None): treatment.
p.(None): d. Justification for comparator selection
p.(None): and. Justification for the selection of the population of
p.(None): study
p.(None): F. Justification of the design and the evaluation criteria considered.
p.(None): 4. OBJECTIVES, VALUATION CRITERIA OR
p.(None): SPECIFIC RESULTS AND HYPOTHESES.
p.(None): to. Objectives: Based on the justification developed and the study design, specify the
p.(None): objectives of the trial, differentiating it where appropriate, the general from the specific or the primary from the
p.(None): secondary. For multi-arm trials, objectives should clarify how they will be compared.
p.(None): all treatment groups (for example: A versus B; A versus C).
p.(None): b. Hypothesis: If the proposition is feasible in the problem statement.
p.(None): c. Primary and secondary assessment criteria, and other assessments of evolution or outcome, including
p.(None): the specific measurement variable (for example, systolic blood pressure), the analysis metric (for
p.(None): example, change from baseline or baseline value, end value, or time to event), the method of
p.(None): aggregation (for example, median, proportion) and the moment of measurement of each variable. The critery
p.(None): primary endpoint is the variable capable of providing the most clinically relevant and convincing evidence
p.(None): directly related to the primary objective of the trial. The primary endpoint should be the
p.(None): variable used in sample size calculations, or the main result used to
p.(None): determine the effect of the intervention. Secondary endpoints correspond to other
p.(None): variables used to measure the effect or influence of the studied intervention. A result
p.(None): Secondary may involve the same event, variable, or experience as the primary outcome, but measured
p.(None): at different time points than the primary result.
p.(None): 5. DESIGN OF THE TEST
p.(None): to. Type of test (eg parallel group, crossover group, factorial, single group), ratio of
p.(None): assignment and framework (eg superiority, equivalence, non-inferiority, exploratory)
p.(None): including a schematic diagram of the design, procedures and periods.
p.(None): b. The expected duration of participation of the research subjects and a description of the sequence and
p.(None): duration of all trial periods.
p.(None): c. Description of measures taken to minimize or avoid bias, such as randomization, which includes the
p.(None): method to generate the allocation sequence and mechanisms for its concealment, and blinding, that
p.(None): includes who will be blinded, how the blinding will be implemented and maintained, the circumstances under which
p.(None): which the blind opening is allowed according to the present regulation and the way to proceed in those cases.
p.(None): d. Description of the dose, the dosage regimen, the route and method of administration and the duration of the
p.(None): treatment.
p.(None): and. Pre-inclusion or washing periods; waiting time for drug purification, if applicable.
p.(None): F. Description of the criteria for termination or interruption of the clinical trial.
p.(None): 6. SELECTION OF THE INVESTIGATION SUBJECTS
p.(None): to. Description of the inclusion and exclusion criteria of the subjects.
p.(None): b. Criteria for withdrawal of individual research subjects from treatment or clinical trial, including
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p.(None): own interests. Specifically they may have insufficient power, education, resources, strength or
p.(None): other attributes necessary to protect your interests. They can also be considered vulnerable to
p.(None): people whose consent to volunteer in a research study
p.(None): may be excessively influenced by expectations, justified or not, of benefits associated with
p.(None): participation, or by a retaliatory response by senior members of a hierarchy if
p.(None): refuse to participate.
p.(None): 34. Insurance policy.- Contract between the insured and an insurance company in which the rights are established,
p.(None): obligations of both parties and coverage, which includes the risks assumed by the insurer and which
p.(None): described in the policy, in relation to the contracted insurance. Among other information, it must contain the
p.(None): necessary to identify the insured, insurer, date of issue, period of validity, description of the
p.(None): insurance, the risks covered and the amounts insured, the specification of the premium to be paid, the
p.(None): grounds for termination of the contract, the procedure to claim compensation if it occurs
p.(None): the claim, clauses that clarify or modify part of the content of the policy contract, as well as the
p.(None): definition of the most important terms used in the policy and the other clauses that must appear in the
p.(None): policy, policy annexes, policy endorsements, in accordance with current legal provisions.
p.(None): 35. Biological product.- They are defined as pharmaceutical products that contain a substance.
p.(None): biological, obtained from microorganisms, blood or other tissues, whose manufacturing methods
p.(None): may include one or more of the following elements: growth of strains of microorganisms in different types
p.(None): of substrates; eukaryotic cell jobs; extraction of substances from biological tissues, including
p.(None): humans, animals and plants; products obtained by recombinant DNA or hybridomas and; the spread of
p.(None): microorganisms in embryos or animals, among others.
p.(None): 36. Product under investigation.- It is a pharmaceutical product or medical device that is investigated or
p.(None): used as a comparator in a clinical trial, including products with health registration when
p.(None): used or combined, in the formulation or in the packaging, in a different way from that authorized, or when
p.(None): used to treat an unauthorized indication, or to obtain more information about its authorized use. For the purposes of
p.(None): This Regulation, the terms "pharmaceutical product" and "medical device" refer to what is stated in the
p.(None): Law No. 29459, Law on Pharmaceutical Products, Medical Devices and Health Products.
p.(None): 37. Complementary product.- It is a pharmaceutical product or medical device used for
p.(None): needs of a clinical trial as described in the study protocol, but not as a product in
p.(None): investigation.
p.(None): 38. Investigation protocol.- Document that establishes the background, rationale and objectives of the
p.(None): clinical trial and accurately describes its design,
p.(None): methodology and organization, including statistical considerations and the conditions under which
p.(None): will execute. The protocol must be dated and signed by the investigator and the sponsor.
...
p.(None): Original if it is different from Spanish (printed and electronic media).
p.(None): f) Document approving the amendment to the research protocol and / or informed consent by
p.(None): an INS accredited CIEI.
p.(None): g) Have a valid insurance policy
p.(None): h) Proof of payment of the right to process.
p.(None): TITLE VI
p.(None): OF THE PRODUCT UNDER INVESTIGATION
p.(None): Article 89. Financing of research products
p.(None): Research products for use in clinical trials will be funded by the sponsor and
p.(None): provided free of charge to the research subject.
p.(None): Article 90. Manufacture in the country of the products under investigation
p.(None): The manufacture in the country of research products for use in the field of a clinical trial
p.(None): It will be authorized by the ANM, and will be subject to Good Manufacturing Practices and other regulations issued by MINSA.
p.(None): Article 91. Labeling of the products under investigation
p.(None): The mediate labeling of the products under investigation and of complementary products that do not have
p.(None): Marketing authorization in Peru must be printed in indelible ink and in Spanish or
p.(None): English indicating at a minimum: Data identifying the sponsor, the clinical trial and the product, indicating: Date
p.(None): expiration or re-analysis, manufacturing lot number, dosage form, route of administration,
p.(None): special storage and conservation conditions, and record the phrases: “For use only in
p.(None): investigation ”and“ Prohibited sale ”or similar consideration.
p.(None): The immediate labeling of the products under investigation must contain as information: Product name,
p.(None): concentration of the active substance, route of administration, manufacturer's name or logo, batch number and date of
p.(None): expiration.
p.(None): In double blind tests, the lot number and the manufacturer's name will not be included on the labeling,
p.(None): but in the document that contains the identification of the treatment, the codes of
p.(None): Product identification.
p.(None): When the expiration dates of the products in comparison differ, or when their conditions of
p.(None): storage are particular and different, must indicate on the labeling of both the most
p.(None): restrictive of either product.
p.(None): Article 92. The Dispensing Unit for Clinical Trials
p.(None): The dispensing of the products under investigation will be carried out compulsorily through a Unit of
p.(None): Dispensation for Clinical Trials dependent on the Service or Department of Pharmacy of the institution of
p.(None): research where the clinical trial is conducted. To maintain the quality of the product under investigation
p.(None): Good Storage Practices and Good Dispensing Practices approved by MINSA and the
p.(None): study sponsor specifications.
p.(None): Article 93. Responsibility of the Dispensing Unit for Clinical Trials.
p.(None): The Dispensing Unit for Clinical Trials dependent on the Service or Department of Pharmacy is
p.(None): responsible of:
p.(None): a) Keep a record of entry and exit dates, quantities of the product under investigation.
p.(None): b) Make the inventory of the products in
p.(None): investigation.
p.(None): c) Control leftover research products, used and unused, for final disposal according to the
p.(None): established in the protocol.
p.(None): Article 94. Of the authorization to import the product under investigation and products
p.(None): complementary
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p.(None): on PCB standards or insert / or technical sheet or
p.(None): 62 LEGAL STANDARDS Friday, June 30, 2017 /
p.(None): A Peruvian man
p.(None): equivalent document). It will conform in its structure and content to the ICH guide to good practice standards
p.(None): clinic (Topic E6 step 5 Note of Guidance on Good Clinical Practice CPMP / ICH / 135/95) consisting of:
p.(None): FIRST PAGE:
p.(None): It must contain, name of the sponsor, product under investigation, research number, chemical name, generic
p.(None): (if any), Therapeutic Group (ATC classification) (if any), edition number, publication date,
p.(None): replaces the previous edition number, date.
p.(None): CONTENT
p.(None): Confidentiality statement (optional)
p.(None): SUMMARY INDEX
p.(None): A brief summary should be provided highlighting the relevant physical, pharmaceutical, chemical information.
p.(None): pharmacological, toxicological, pharmacokinetic, metabolic and clinical available that is relevant to the
p.(None): clinical development stage of the research product.
p.(None): INTRODUCTION
p.(None): A short introductory paragraph should be provided that includes the chemical name (and generic and name
p.(None): commercial when approved) of the investigational product, all active ingredients, the
p.(None): pharmacological class of the research product and its expected position within this class (for example,
p.(None): advantages), the basis for conducting an investigation with the product under investigation and the indication
p.(None): prophylactic, therapeutic or diagnostic in advance. Finally, the introductory paragraph should provide the
p.(None): proposal and general approach to be followed when evaluating the product under investigation.
p.(None): PHYSICAL, CHEMICAL, PHARMACEUTICAL PROPERTIES AND FORMULATION
p.(None): A description of the substance of the product under investigation (including the chemical formula and / or
p.(None): structural) as well as a brief summary of the relevant physical, chemical and pharmaceutical properties. With
p.(None): In order for appropriate security measures to be taken in the course of the study, it should be provided
p.(None): a description of the formulation to be used, including excipients and justified if it were
p.(None): clinically relevant.
p.(None): Instructions for storage and handling of the dosage form should also be provided. It should
p.(None): mention any structural similarity with other known compounds.
p.(None): PRECLINICAL STUDIES
p.(None): Introduction:
p.(None): Summary results of all relevant non-clinical studies should be provided; pharmacological,
p.(None): Toxicological, pharmacokinetic and metabolism of the investigational product.
p.(None): This summary should mention the methodology used, the results and a discussion of the relevance of
p.(None): findings for investigated therapeutic effects and for possible unexpected adverse effects in humans
p.(None): humans.
p.(None): Information provided, if known / available, as appropriate, may include the following:
p.(None): - Proven species.
p.(None): - Number and sex of animals in each group.
p.(None): - Unit dose (for example, milligram / kilogram (mg
p.(None): / kg)).
p.(None): - Dose interval.
p.(None): - Administration route.
p.(None): - Duration of the dose.
p.(None): - Information on systemic distribution.
p.(None): - Duration of follow-up after exposure.
p.(None): - Results, including the following aspects:
p.(None): • Nature and frequency of pharmacological effects
p.(None): or toxic.
p.(None): • Severity or intensity of pharmacological or toxic effects.
p.(None): • Time for the appearance / occurrence of effects.
p.(None): • Reversibility of the effects.
p.(None): • Duration of the effects.
...
p.(None): following:
p.(None): i. Document issued by the manufacturer or sponsor indicating the modification
p.(None): made in the pharmaceutical form, the name (s), address (es) and responsibilities of the manufacturers
p.(None): involved in the modification; the name of the marketing authorization holder and the number
p.(None): of the marketing authorization, indicating the regulatory authority of the country from which it comes.
p.(None): ii. Modified comparator batch analysis certificate or document issued by the manufacturer or
p.(None): sponsor that includes the tests and acceptance criteria, depending on the degree of modification of the
p.(None): authorized product and according to the corresponding pharmaceutical form, signed by the Technical Director or person
p.(None): qualified responsible for the quality of the product, that the corresponding modification was made in compliance
p.(None): with GMP and scientific support that the stability and bioavailability of the
p.(None): product.
p.(None): iii. Documentation from the competent authorities certifying that the person in charge of the modification is
p.(None): Authorized to manufacture investigational or comparator medicinal products (Manufacturing License).
p.(None): If the comparator is a marketed product and does not come from countries with high health surveillance and / or
p.(None): countries with mutual recognition, all the quality documentation indicated for the products must be provided in
p.(None): non-comparators research.
p.(None): If the comparator is a placebo, you must present an official document issued by the manufacturer in which
p.(None): indicate the name of the substance used and its corresponding certificate of analysis.
p.(None): If the comparator is a product with a current sanitary registration in Peru, only a declaration will be necessary
p.(None): sworn issued by the sponsor indicating the name and address of the manufacturer, the name of the owner
p.(None): of the sanitary registry and the sanitary registry number. If necessary, the sponsor or executor of the
p.(None): Authorized clinical trial will be able to locally acquire medicines with sanitary registration in the country used as
p.(None): comparators, for use in clinical research.
p.(None): 3. In the case of complementary products. Complementary products that do not have sanitary registration
p.(None): in Peru or in countries with high health surveillance and / or countries with mutual recognition must
p.(None): present the requirements indicated in the numeral
p.(None): 1. If the product has a current health registry in Peru or in countries with high health surveillance and / or
p.(None): from countries with mutual recognition, only an affidavit issued by the sponsor will be necessary
p.(None): indicating the name and address of the manufacturer, the name of the holder of the sanitary registration or of the
p.(None): marketing authorization and the number of the health registration or marketing authorization,
p.(None): indicating the regulatory authority of the country from which it comes.
p.(None): El Peruano / Friday, June 30, 2017
p.(None): LEGAL STANDARDS 67
p.(None): In the case of biological products and medical devices, the ANM will establish the certificates or other
p.(None): documents that for sanitary necessity are required.
p.(None): 1538902-2
p.(None): TRANSPORTATION AND COMMUNICATIONS
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p.(None): c) Notify the sponsor or the ICO of the non-serious adverse events classified in the protocol
p.(None): of research as determinants for safety evaluations, within the periods specified in the
p.(None): mentioned protocol.
p.(None): d) Provide the sponsor or the OIC, the INS OGITT and the CIEI all the additional information that
p.(None): request.
p.(None): CHAPTER II
p.(None): NOTIFICATION OF ADVERSE EVENTS AND ADVERSE REACTIONS
p.(None): Article 110. Of the notification of serious adverse events, serious adverse reactions and suspected reactions
p.(None): serious and unexpected adverse events.
p.(None): The sponsor or ICO will notify the INS OGITT of serious adverse events, serious adverse reactions and suspicions
p.(None): serious and unexpected adverse reactions as follows:
p.(None): a) All serious adverse events, serious adverse reactions and suspected serious adverse reactions
p.(None): and unexpected occurred in the country within a maximum period of seven (7) calendar days, after the
p.(None): fact or as soon as it becomes aware of the fact, through the Virtual Event Reporting System
p.(None): Serious Adverse (REAS-NET).
p.(None): b) Complete, if necessary, the information from the initial report, within eight (8) days
p.(None): following calendars, otherwise you must submit monitoring reports. When the
p.(None): Follow-up will send its final report and after the opening of the blind, if applicable, according to the format established in the
p.(None): REAS-NET.
p.(None): c) Submit quarterly or semi-annually, under responsibility, the CIOMS reports of the reactions
p.(None): serious adverse events and suspicions of serious and unexpected adverse reactions occurring internationally, whether they have
p.(None): occurred in the authorized clinical trial, in other clinical trials with the same investigational product or in a
p.(None): different usage context. These reports must be sent electronically.
p.(None): The sponsor or ICO and the principal investigator should take the urgent measures necessary to
p.(None): protect research subjects. These measures must be communicated to the INS OGITT and to the CIEI in a
p.(None): maximum period of seven (7) calendar days, from the occurrence of the event or as soon as it becomes aware of the fact.
p.(None): Article 111. Of the notification to the ANM
p.(None): The INS OGITT will notify the ANM of serious adverse reactions and suspected serious adverse reactions and
p.(None): unexpected to the product under investigation, occurred in a clinical trial authorized in the country, within the
p.(None): maximum of fifteen (15) business days after receiving the notification.
p.(None): CHAPTER III
p.(None): OF THE BLIND OPENING
p.(None): Article 112. Contingency plan
p.(None): Every clinical trial that uses blind mode, in any of its forms, must have a plan of
p.(None): contingency that will be included in the research protocol, in order to open the
p.(None): blind in the shortest possible time to any condition that threatens the safety of the research subject.
p.(None): Article 113. Opening of the blind
p.(None): It is the responsibility of the principal investigator to open the blind if required for the safety of the
p.(None): research subject.
p.(None): The INS OGITT, after evaluating the case, may order the opening of the blind when it is
p.(None): the safety of the research subject compromised.
p.(None): Article 114. Preservation of blindness
p.(None): The blind nature of the clinical trial will be maintained for the researcher, and for the people in charge of the
p.(None): analysis and interpretation of the results and elaboration of the conclusions of the study, whenever possible.
p.(None): TITLE X
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Health / HIV/AIDS
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p.(None): through a technical report, within the same period in which the opinion of the safety and quality profile is issued
p.(None): of the product under investigation.
p.(None): Article 70. Authorization of the clinical trial
p.(None): The INS OGITT will issue the clinical trial authorization resolution after evaluating the protocol
p.(None): of investigation, technical report containing the binding opinion issued by the ANM and other requirements
p.(None): established in article 67 of these regulations, within a maximum period of forty (40) days
p.(None): business days, which include the 30 days of the evaluation of the safety profile and the quality of the product in
p.(None): investigation by the ANM. If additional information is required to be submitted by the interested party, it will be suspended
p.(None): the calculation of the evaluation period until the requested information is received.
p.(None): 52 LEGAL STANDARDS Friday, June 30, 2017 /
p.(None): A Peruvian man
p.(None): In clinical trials with biological research products and those controversial situations that
p.(None): involve the call of technical commissions, the maximum term for the authorization of the clinical trial will be
p.(None): sixty (60) business days, which include 45 days of the evaluation of the safety profile and the quality of the
p.(None): product under investigation by the ANM.
p.(None): The Directorates General in charge of strategic interventions for prevention, control and
p.(None): reduction of risks and damages in tuberculosis or HIV / AIDS infection the approval of clinical trials whose
p.(None): research product is intended for the prevention, diagnosis or treatment of conditions
p.(None): mentioned doctors.
p.(None): Article 71. Validity of the test authorization
p.(None): clinical
p.(None): The authorization of the clinical trial is granted for the total period of time scheduled for its execution, the
p.(None): which was registered in the authorization request, which is the Registration Form according to REPEC.
p.(None): Article 72. Call for technical commissions
p.(None): The INS may call technical committees made up of health professionals with a recognized track record
p.(None): in the field of research and independent from the pharmaceutical industry, when situations arise
p.(None): controversial in the authorization process for conducting clinical trials.
p.(None): Article 73. Filing of appeals for reconsideration and appeal
p.(None): In the event that the clinical trial is not authorized, the sponsor or OIC may optionally file the
p.(None): appeal for reconsideration against the resolution denying the authorization of the clinical trial, before the OGITT of the
p.(None): INS must be supported by new evidence.
p.(None): The appeal will be filed when the challenge is based on a different interpretation of
p.(None): the evidence produced or in the case of questions of pure law, should contact the OGITT to raise the
p.(None): acted to the hierarchical superior.
p.(None): Article 74. Public information on clinical trials
p.(None): Once the authorization process is completed, the INS will put the following through its institutional web portal
p.(None): Information Regarding Authorized and Unauthorized Clinical Trials: Study Title, Sponsor
p.(None): and researchers, product under investigation, condition studied, study design, number of subjects to
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Health / Healthy People
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p.(None): research and its objective is to obtain long-term safety or tolerability data.
p.(None): 15. Adverse event.- Any event or situation detrimental to the subject's health
p.(None): research, who is being administered a research product, and who does not necessarily
p.(None): it has a causal relationship with its administration. Therefore, an adverse event (EA) can be
p.(None): any unfavorable and unintended signs; including an abnormal laboratory finding, symptom, or
p.(None): disease temporarily associated with the use of an investigational product; whether or not related to it.
p.(None): 16. Serious adverse event.- Any adverse event that produces death, threatens the life of the subject of
p.(None): investigation, requires hospitalization or its prolongation, produces disability or
p.(None): permanent or significant disability, or a congenital anomaly or malformation. For the purposes of his
p.(None): Notification will be treated as serious those events that from the medical point of view, can put
p.(None): endangered the research subject or require an intervention to prevent one of the indicated results
p.(None): initially in this definition.
p.(None): 17. Extension of the time to carry out the clinical trial.- Administrative procedure by which it is authorized
p.(None): extend the total time initially scheduled for the execution of a clinical trial.
p.(None): 18. Phases of Clinical Trials.- Trials
p.(None): Clinicians have the following phases:
p.(None): Phase I: First human trials of an investigational product. They comprise essays of
p.(None): pharmacokinetics and pharmacodynamics to provide preliminary information on effect and safety
p.(None): of the product generally carried out in healthy volunteers or in some cases in patients, who guide the
p.(None): most appropriate administration regimen for further testing.
p.(None): Phase II: Second stage in the evaluation of a product under investigation. Has as
p.(None): objective to provide preliminary information on the effectiveness of the product, establish the relationship
p.(None): dose-response thereof, know the variables used to measure efficacy and expand the data of
p.(None): safety obtained in phase I, in patients affected by a certain disease or pathological condition
p.(None): or in healthy volunteers for prevention studies.
p.(None): Phase III: Trials aimed at evaluating the efficacy and safety of the experimental treatment,
p.(None): trying to reproduce the usual conditions of use and considering the alternatives
p.(None): Therapeutics available in the indication studied. They are performed on a larger sample of patients
p.(None): that in the previous phase and that is representative of the general population to which the
p.(None): product in research or in healthy volunteers for prevention studies.
p.(None): Phase IV: Tests that are carried out once the product under investigation has a sanitary registration for its
p.(None): marketing and according to the conditions established in it. Provide additional information on effectiveness
p.(None): and
p.(None): safety profile (benefit - risk) after use in large populations for a prolonged period of
p.(None): weather.
p.(None): 19. Re-analysis date.-. Date assigned by the manufacturer to carry out a new analysis on the product
p.(None): under investigation, before the expiration date, to verify that the product under investigation retains its
p.(None): physical-chemical and pharmaceutical properties, and is still appropriate for exclusive use in clinical trials.
p.(None): 20. Expiration date.- Date provided by the manufacturer in an uncoded way that is based
p.(None): in the stability studies of the investigational product and after which the product in
p.(None): Research should not be used. This date is set for each batch by adding a life span.
p.(None): useful at the manufacturing date.
p.(None): 21. Subordinate groups.- Includes students, health facility workers, sector employees
p.(None): public or private, members of the armed forces and the Peruvian National Police, inmates in prisons or centers
p.(None): of social rehabilitation and other special groups of the population, in which their participation can be
p.(None): influenced by some authority or hierarchical structure.
p.(None): 22. Reliable impossibility: Situation in which it is not materially possible for one of the parents to grant the
...
p.(None): a) When the product or knowledge generated by the research is available or applied for benefit
p.(None): potential of these communities.
p.(None): b) When the principal investigator has the approval of the regional authority of
p.(None): corresponding health and the authorities belonging to the community to study. These approvals
p.(None): they must be obtained prior to the informed consent of the research subjects included in the
p.(None): clinical trial.
p.(None): c) Sponsors and researchers should develop culturally appropriate ways and means with
p.(None): anthropologists, sociologists, translators and interpreters to communicate the necessary information and complete the process
p.(None): of informed consent. In addition, the research protocol must describe and justify
p.(None): the procedure they plan to use to communicate the information to the research subjects.
p.(None): d) It will not be appropriate to include them as research subjects when the individuals that make up a
p.(None): community do not have the capacity to understand the implications of participating in an investigation, despite the
p.(None): employment of a translator or interpreter.
p.(None): e) In the case of including the storage of biological samples, additionally,
p.(None): You must have the authorization of the corresponding regional and local government, and the authorities
p.(None): respective communities, who must consider the interest of the community involved.
p.(None): Article 26. Clinical trials without direct benefit to the health of the research subjects or
p.(None): healthy volunteers
p.(None): Carrying out clinical trials in healthy volunteers can only be carried out when the
p.(None): following conditions:
p.(None): a) When the risk they assume is justified by reason of an expected benefit for the community.
p.(None): b) When the interventions to which the research subjects are going to be subjected are comparable to
p.(None): those that correspond to the usual medical practice depending on your medical, psychological or social situation and are taken
p.(None): adequate security protection measures.
p.(None): c) When relevant knowledge about the disease or situation under investigation can be obtained, it is vital
p.(None): importance to understand, alleviate or cure it and that they cannot be obtained in any other way.
p.(None): Article 27. On care and compensation for the research subject
p.(None): Principal Investigator and Sponsor are responsible for providing medical care and treatment
p.(None): Free of charge for the research subject in case of any damage as a consequence of the clinical trial.
p.(None): Sponsor is obligated to award compensation for damage that a research subject
p.(None): may suffer as a result of using the product under investigation or by a procedure or
p.(None): intervention performed for the purpose of research, such as non-therapeutic procedures.
p.(None): Article 28. Of the insurance policy and the financial fund for the immediate and timely attention of the subject of
p.(None): investigation
p.(None): For the purposes of the liability regime provided for in article 27, the sponsor must contract a policy of
p.(None): insurance that covers damages to the research subject, as a result of their participation in the
p.(None): clinical trial. As long as the policy is activated, the sponsor must have a financial fund
p.(None): that immediately and timely guarantees free medical attention and treatment of the subject of
...
p.(None): (dose / response), safety, efficacy and other pharmacological activities. Whenever possible,
p.(None): provide a summary of each specific clinical study. Information must also be provided
p.(None): Regarding the results of any use of the product in research other than that of the studies
p.(None): clinical, such as experience during marketing.
p.(None): (a) Pharmacokinetics and Product Metabolism in Humans
p.(None): El Peruano / Friday, June 30, 2017
p.(None): LEGAL STANDARDS 63
p.(None): A summary of the information on the pharmacokinetics of the investigational product must be presented,
p.(None): including the following, if available:
p.(None): - Pharmacokinetics (including metabolism, as appropriate, and absorption, binding of plasma proteins,
p.(None): distribution and disposal).
p.(None): - Bioavailability of the product under investigation
p.(None): ANNEX 3
p.(None): MINIMUM REQUIREMENTS OF A RESEARCH CENTER
p.(None): CONDITIONING OBSERVATIONS
p.(None): Hospitalization area
p.(None): It is an independent environment
p.(None): (absolute, where possible and / or relative) using a reference dosage form. Subgroups
p.(None): population (for example, sex, age and altered organic function).
p.(None): - Interactions (for example, interactions between the investigational product and other medicinal products and the effects of
p.(None): the food).
p.(None): - Other pharmacokinetic data (for example, results of population studies conducted within
p.(None): Clinical studies).
p.(None): (b) Safety and Efficacy
p.(None): A summary of information on safety, pharmacodynamics, efficacy, and dose response should be provided.
p.(None): (dose / response) of the investigational product (including metabolites, when applicable) that has been
p.(None): obtained in previous studies in humans (healthy volunteers and / or patients). The
p.(None): implications of this information. In these cases in which several clinical studies have been
p.(None): completed, using safety and efficacy summaries across multiple indication studies
p.(None): in subgroups it can provide a clear presentation of the data. They could be useful
p.(None): tabular summaries of adverse reactions of all indications studied). Should be discussed
p.(None): significant differences in patterns / incidence of adverse reactions through indications or
p.(None): subgroups.
p.(None): The Investigator's Manual should provide a description of the possible risks and reactions
p.(None): adverse events that are anticipated, based on previous experiences with the product under investigation and with
p.(None): related products. A description of the precautions or special monitoring that must be
p.(None): will be carried out as part of the use of the research product.
p.(None): EXPERIENCE AFTER ITS MARKETING
p.(None): The Investigator's Manual should identify the countries where it has been commercialized or approved
p.(None): the product under investigation.
p.(None): Any significant information arising from the commercialized use should be summarized, for example,
p.(None): formulations, doses, routes of administration and adverse reactions of the product under investigation). The Manual of the
p.(None): Researcher must also identify all countries where the research product did not receive approval /
p.(None): registration to be marketed or withdrawn from the market or whose registration was suspended.
p.(None): When appropriate, published reports on related products should be discussed.
p.(None): This could help the investigator to anticipate adverse reactions or other problems in clinical studies.
p.(None): The overall objective of this section is to provide the researcher with a clear understanding of the possible
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p.(None): Research subjects are previously assigned to the research product and the assignment is
p.(None): determined by the research protocol.
p.(None): 12. Multicenter clinical trial.- Clinical trial conducted according to a single protocol but in more
p.(None): of a center and, therefore, carried out by more than one researcher and a coordinator who is in charge of
p.(None): processing of all data and analysis of results.
p.(None): 13. Research team.- Group made up of professionals with skills and knowledge in the
p.(None): execution of a clinical trial and that fulfill a direct and significant role in said execution, includes
p.(None): doctors, nurses, pharmaceutical chemists, among other professionals led by a principal investigator.
p.(None): 14. Extension study.- Clinical trial by which the treatment or monitoring of the
p.(None): research subjects who give their informed consent to do so. It is performed based on a protocol of
p.(None): research and its objective is to obtain long-term safety or tolerability data.
p.(None): 15. Adverse event.- Any event or situation detrimental to the subject's health
p.(None): research, who is being administered a research product, and who does not necessarily
p.(None): it has a causal relationship with its administration. Therefore, an adverse event (EA) can be
p.(None): any unfavorable and unintended signs; including an abnormal laboratory finding, symptom, or
p.(None): disease temporarily associated with the use of an investigational product; whether or not related to it.
p.(None): 16. Serious adverse event.- Any adverse event that produces death, threatens the life of the subject of
p.(None): investigation, requires hospitalization or its prolongation, produces disability or
p.(None): permanent or significant disability, or a congenital anomaly or malformation. For the purposes of his
p.(None): Notification will be treated as serious those events that from the medical point of view, can put
p.(None): endangered the research subject or require an intervention to prevent one of the indicated results
p.(None): initially in this definition.
p.(None): 17. Extension of the time to carry out the clinical trial.- Administrative procedure by which it is authorized
p.(None): extend the total time initially scheduled for the execution of a clinical trial.
p.(None): 18. Phases of Clinical Trials.- Trials
p.(None): Clinicians have the following phases:
p.(None): Phase I: First human trials of an investigational product. They comprise essays of
p.(None): pharmacokinetics and pharmacodynamics to provide preliminary information on effect and safety
p.(None): of the product generally carried out in healthy volunteers or in some cases in patients, who guide the
p.(None): most appropriate administration regimen for further testing.
p.(None): Phase II: Second stage in the evaluation of a product under investigation. Has as
p.(None): objective to provide preliminary information on the effectiveness of the product, establish the relationship
p.(None): dose-response thereof, know the variables used to measure efficacy and expand the data of
p.(None): safety obtained in phase I, in patients affected by a certain disease or pathological condition
p.(None): or in healthy volunteers for prevention studies.
p.(None): Phase III: Trials aimed at evaluating the efficacy and safety of the experimental treatment,
p.(None): trying to reproduce the usual conditions of use and considering the alternatives
p.(None): Therapeutics available in the indication studied. They are performed on a larger sample of patients
...
p.(None): 38. Investigation protocol.- Document that establishes the background, rationale and objectives of the
p.(None): clinical trial and accurately describes its design,
p.(None): methodology and organization, including statistical considerations and the conditions under which
p.(None): will execute. The protocol must be dated and signed by the investigator and the sponsor.
p.(None): 39. Indigenous or Native Peoples: Are those with direct descent from the populations
p.(None): originating from the national territory, with lifestyles and spiritual and historical links with the
p.(None): territory that they traditionally use or occupy, with their own social institutions and customs, with patrons
p.(None): cultural and way of life different from those of other sectors of the national population and that
p.(None): at the same time they have an indigenous or original identity. Peasant or Andean communities and
p.(None): Native communities or Amazonian peoples may be considered as indigenous or native peoples, under the
p.(None): same criteria as above.
p.(None): 40. Adverse reaction.- It is any adverse event in which there is a clearly defined causal relationship with a
p.(None): product of investigation or there is at least a reasonable possibility of a causal relationship, which arises
p.(None): regardless of the administered dose.
p.(None): 41. Serious adverse reaction.- It is any adverse reaction that results in death, is life-threatening,
p.(None): requires hospitalization or prolonged hospitalization, produces disability or incapacity
p.(None): permanent or important, cause a congenital anomaly or malformation. For the purposes of your notification,
p.(None): They will also treat as serious those events that from the medical point of view, can endanger the
p.(None): research subject or require an intervention to prevent one of the results initially noted in this
p.(None): definition.
p.(None): 42. Unexpected adverse reaction.- It is an adverse reaction whose nature or severity is not consistent with the
p.(None): information of the product under investigation, that is, it is not described in the researcher's manual and / or file
p.(None): technique.
p.(None): 43. Suspected serious and unexpected adverse reaction.- It is any serious adverse event in the
p.(None): that there is at least a reasonable possibility of a causal relationship with the product under investigation and whose
p.(None): nature or severity is not described in the researcher's manual and / or technical sheet.
p.(None): 44. Controversial situations.- That situation in which it is identified during the evaluation process of the
p.(None): clinical trial, that the benefit / risk balance is debatable.
p.(None): 45. Suspension of the clinical trial.- It is the temporary interruption of enrollment and / or
p.(None): administration of the investigational product, or of all clinical trial activities in all
p.(None): research centers. This procedure is given for just cause, at the request of the sponsor or
p.(None): as a security measure applied by OGITT.
p.(None): 46. Suspension of the registration of a Research center.- Procedure under which the
p.(None): temporary deactivation of the registration of the research center in REPEC, implying the disqualification
p.(None): research center to run new clinical trials or ongoing clinical trials.
...
p.(None): El Peruano / Friday, June 30, 2017
p.(None): LEGAL STANDARDS 43
p.(None): a) A healthy person.
p.(None): b) A person (usually a patient) whose condition is relevant to the use of the product in
p.(None): investigation.
p.(None): Article 17. Protection of the research subject
p.(None): The performance of clinical trials in research subjects is carried out in accordance with the provisions of the
p.(None): this Chapter, without prejudice to the application of the general provisions established in Title II of the
p.(None): these Regulations.
p.(None): Article 18. Clinical trials in minors
p.(None): Clinical trials may be carried out on minors in accordance with the provisions of Title II of this
p.(None): Regulation and when:
p.(None): a) The protocol has been approved by a CIEI that has a pediatric specialist or has received
p.(None): advice on clinical, ethical and psychosocial aspects in the field of pediatrics if required.
p.(None): b) Obtaining informed consent is adjusted
p.(None): to what is specified in Chapter II of this Title.
p.(None): c) The minor who reaches the age of majority during the clinical trial, must provide their
p.(None): express informed consent before said research subject can continue participating in the
p.(None): clinical trial.
p.(None): Article 19. Clinical trials in people with disabilities
p.(None): Carrying out clinical trials in those who are not in a position to give their informed consent and who
p.(None): have not given it prior to the start of their disability, requires in addition to the provisions of the Title
p.(None): II of these Regulations:
p.(None): a) That informed consent is in accordance with
p.(None): specified in Chapter II of this Title.
p.(None): b) That the protocol be approved by a CIEI that has experts in the disease under study or has
p.(None): collected advice on clinical, ethical and psycho-social aspects in the field of disease and
p.(None): group of affected patients.
p.(None): Article 20. Clinical trials in women and men with reproductive capacity
p.(None): Carrying out clinical trials in women and men with reproductive capacity, except those
p.(None): clinical trials in which the objective of the study is to evaluate the product under investigation in population
p.(None): pregnant or planning to leave, can only be done when they are met in addition to what
p.(None): provided in Title II of these Regulations, the following conditions:
p.(None): a) For research in women with reproductive capacity, the principal investigator will perform a test of
p.(None): pregnancy to rule out pregnancy prior to study start and both investigator and sponsor
p.(None): assure counseling on the importance of avoiding pregnancy for the duration of your study participation and
p.(None): accessibility to an effective contraceptive method at no cost to the research subject, chosen by
p.(None): this and that it is not incompatible with the clinical trial. The researcher will ensure their commitment
...
p.(None): This information must be presented in a clear, accurate, complete, truthful and understandable language and language for
p.(None): he, during a previous interview. During the informed consent process, new
p.(None): Evidence-based tools and strategies that improve the understanding of research subjects. I know
p.(None): You must verify that the latter has understood the information received.
p.(None): c) The research subject, or failing that to his legal representative, will be provided with the time
p.(None): enough for you to reflect on your decision to participate in the clinical trial, have the
p.(None): opportunity to ask questions and answer your questions to your satisfaction and to discuss your
p.(None): Participation, if you wish, with relatives or a treating doctor.
p.(None): d) Informed consent must be obtained before proceeding with the evaluation of the criteria
p.(None): of eligibility or any other specific study procedure.
p.(None): e) Informed consent is given in writing
p.(None): through the respective format. This format must be
p.(None): signed, dated and with the time indicated by the research subject or his legal representative and by the researcher
p.(None): who drove the process. A copy must be given to the research subject.
p.(None): f) If the research subject cannot read and write, they will print their fingerprint as a sign of compliance.
p.(None): In the event that the research subject has a disability that prevents him from signing or printing his
p.(None): fingerprint, another means that evidences your consent may be accepted. In both cases, additionally,
p.(None): Another person he designates and who does not belong to the investigation team must sign as a witness.
p.(None): g) The process of obtaining informed consent must be part of the medical history
p.(None): of the research subject, including start date and time, which was provided to the research subject
p.(None): enough time to reflect and ask questions, the understanding of the information was verified, two were signed
p.(None): copies of the informed consent form and one of them was given to the research subject or his representative
p.(None): legal.
p.(None): The informed consent of minors must meet the same consent requirements
p.(None): informed as appropriate and should be done using language that takes into account the evolution of
p.(None): faculties according to their age and maturity to allow their understanding, having to register their name and / or signature in
p.(None): sign of your authorization.
p.(None): Article 34. Requirements for the informed consent format
p.(None): The informed consent form of the subject of
p.(None): Research is subject to the following requirements:
p.(None): a) Be prepared by the main researcher, sponsor or both, with the information indicated in
...
p.(None): Research subjects may receive reasonable compensation from the sponsor for expenses
p.(None): extraordinary causes and loss of productivity arising from your participation, which will be specified
p.(None): in the informed consent. The CIEI will evaluate said compensation according to each case; and, will evaluate that no
p.(None): unduly influences the consent of the research subject.
p.(None): Article 36. Subject of minor investigation
p.(None): When the research subject is a minor
p.(None): is required:
p.(None): a) Obtain the informed consent of both parents or the minor's guardian, which may
p.(None): withdraw at any time without prejudice to them. The consent of one of the parents can only
p.(None): dispense in the event of death, loss of rights in accordance with current regulations or
p.(None): duly documented irrefutable impossibility.
p.(None): b) In the event that one of the parents is a minor, the consent of the immediate family member is additionally required
p.(None): ascendant in a straight line unless the father is a minor of 16 years or more and his relative disability has
p.(None): terminated by marriage or by obtaining an official title authorizing you to exercise a profession or trade,
p.(None): in accordance with the provisions of the Civil Code.
p.(None): c) Obtain the consent of the minor, from
p.(None): 8 years old, to participate as a research subject.
p.(None): d) Give the minor information appropriate to their ability to understand the clinical trial, the risks, the
p.(None): discomforts and benefits.
p.(None): e) Accept the withdrawal of informed consent or assent at the request of a parent / guardian
p.(None): or the minor at any time, without prejudice to them, as long as it does not affect or put
p.(None): your health at risk.
p.(None): f) Opt for the exclusion of the minor from considering a conflict of opinion between the parent (s) and
p.(None): the minor on participation in the clinical trial.
p.(None): Informed parental consent is not required if the research subject is a minor
p.(None): age of 16 years or more and whose relative disability has ceased by marriage or by obtaining an official title that
p.(None): authorize you to exercise a profession or trade, in accordance with the provisions of the Civil Code.
p.(None): Article 37. Research subject with mental or intellectual disability
p.(None): When the research subject is a person with a mental or intellectual disability, it must be taken into account
p.(None): the next:
p.(None): a) Obtain the informed written consent of the research subject to participate in the clinical trial,
p.(None): after having received all the relevant information adapted to your level of understanding. Consent must
p.(None): employ tools and strategies to ensure understanding of research subjects. The
p.(None): Informed consent may be withdrawn at any time, without prejudice to it, as long as it is not
p.(None): affect or jeopardize your health.
p.(None): b) In the case of research subjects whose mental disability prevents them from expressing their free will,
p.(None): based on a full understanding of informed consent, it will be granted through your representative
p.(None): legal, after being informed about the possible risks, discomforts and benefits of the trial
p.(None): clinical. The consent may be withdrawn at any time, through its legal representative, without prejudice
p.(None): for the person. Safeguards must be guaranteed by the different actors in the investigation.
p.(None): Article 38. Research subject with physical or sensory disability
p.(None): When the research subject is a person with a physical or sensory disability that prevents him from signing, but
p.(None): with other preserved capacities, you can grant
p.(None): El Peruano / Friday, June 30, 2017
p.(None): LEGAL STANDARDS 47
p.(None): your written consent by printing your fingerprint, in the presence of at least one
p.(None): witness, designated by the subject of investigation and not belonging to the investigation team,
p.(None): who in turn will sign the informed consent form. In case you do not have upper limbs or
p.(None): Below, you can accept another means, other than the fingerprint, that shows your consent.
p.(None): The consent must use tools and strategies to facilitate the understanding of the subjects of
p.(None): investigation and may be withdrawn at any time without prejudice to the person.
p.(None): TITLE IV
p.(None): OF THE PEOPLE AND ENTITIES THAT PARTICIPATE IN THE EXECUTION OF THE CLINICAL TRIALS
p.(None): CHAPTER I
p.(None): OF THE SPONSOR
p.(None): Article 39. The sponsor
p.(None): Sponsor is the individual person, group of people, company, institution or organization,
p.(None): including academic ones, with legal representation in the country duly registered in public records
p.(None): corresponding, which assumes responsibility for the initiation, maintenance, conclusion and
p.(None): financing a clinical trial. The sponsor must be registered in the REPEC conducted by the
p.(None): INS prior to requesting authorization of a clinical trial.
p.(None): When an independent investigator initiates and takes full responsibility for a clinical trial, he / she assumes the
p.(None): sponsor role.
p.(None): Article 40. Responsibilities of the sponsor
p.(None): The sponsor is responsible for:
...
p.(None): immediately to the investigator, suspension of treatment, withdrawal of the study, monitoring of pregnancy and
p.(None): newborn for 6 months, compensation in case of damage as a result of the clinical trial.
p.(None): 13) Commitments assumed by the research subject if he agrees to participate in the study.
p.(None): 14) Available alternatives.
p.(None): Specify if there are therapeutic, prevention or diagnostic alternatives currently available in the
p.(None): country.
p.(None): El Peruano / Friday, June 30, 2017
p.(None): LEGAL STANDARDS 65
p.(None): 15) Benefits derived from the study
p.(None): In general, it cannot be guaranteed that the product under investigation will directly benefit the subject, since
p.(None): this is what you want to try, so it is more appropriate to use the phrase: "you may or may not benefit from the
p.(None): study medication ”or“ your medical condition may improve, stay the same, and even worsen with
p.(None): study medication ”.
p.(None): The benefits can be divided into benefits for the individual and benefits for their community or for the
p.(None): entire society if an answer to the research question is found.
p.(None): 16) Compensation and treatment in case of damage or injury for your participation in the trial.
p.(None): a) Free medical attention and treatment in case of injury or any adverse event as a result of the
p.(None): administration of the investigational product (experimental and comparator) or any of the procedures or
p.(None): interventions performed under the clinical trial.
p.(None): b) Insurance policy: coverage and validity
p.(None): c) Compensation for the research subject, his family or relatives he is in charge of in case of
p.(None): disability or death resulting from such investigation
p.(None): Not include any text that restricts or contradicts the provisions of articles 27, 28 and 29 of the
p.(None): present regulation.
p.(None): 17) Commitment to provide you with updated information about the product or the procedure in
p.(None): research, although this could affect the will of the research subject to continue
p.(None): participating.
p.(None): 18) Costs and payments
p.(None): a) Free treatment and procedures
p.(None): as part of the clinical trial
p.(None): b) Financial compensation for additional expenses (transportation, accommodation, communication, and food).
p.(None): Indicate amount.
p.(None): 19) Privacy and confidentiality
p.(None): In order to indicate that the confidentiality of the information related to
p.(None): your privacy and security that the research subject will not be identified. The content of this section
p.(None): It must be within what is allowed by Law No. 29733, the Personal Data Protection Law and its regulations.
p.(None): You must incorporate the following:
p.(None): a) What data of the subject will have access? and that
p.(None): information will be collected?
p.(None): b) Use that will be given to the data of the subject of
p.(None): investigation.
p.(None): c) How will the data of the research subject be stored and protected? And who will have access?
p.(None): d) Access to your data by the representatives
p.(None): from the sponsor, CIEI and INS.
p.(None): e) Management of your data and biological samples in case
p.(None): withdrawal of informed consent.
...
Health / Motherhood/Family
Searching for indicator family:
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p.(None): It must be explained in an additional informed consent format as indicated in the Manual of
p.(None): Clinical trial procedures.
p.(None): Article 35. Compensation to research subjects
p.(None): Research subjects may receive reasonable compensation from the sponsor for expenses
p.(None): extraordinary causes and loss of productivity arising from your participation, which will be specified
p.(None): in the informed consent. The CIEI will evaluate said compensation according to each case; and, will evaluate that no
p.(None): unduly influences the consent of the research subject.
p.(None): Article 36. Subject of minor investigation
p.(None): When the research subject is a minor
p.(None): is required:
p.(None): a) Obtain the informed consent of both parents or the minor's guardian, which may
p.(None): withdraw at any time without prejudice to them. The consent of one of the parents can only
p.(None): dispense in the event of death, loss of rights in accordance with current regulations or
p.(None): duly documented irrefutable impossibility.
p.(None): b) In the event that one of the parents is a minor, the consent of the immediate family member is additionally required
p.(None): ascendant in a straight line unless the father is a minor of 16 years or more and his relative disability has
p.(None): terminated by marriage or by obtaining an official title authorizing you to exercise a profession or trade,
p.(None): in accordance with the provisions of the Civil Code.
p.(None): c) Obtain the consent of the minor, from
p.(None): 8 years old, to participate as a research subject.
p.(None): d) Give the minor information appropriate to their ability to understand the clinical trial, the risks, the
p.(None): discomforts and benefits.
p.(None): e) Accept the withdrawal of informed consent or assent at the request of a parent / guardian
p.(None): or the minor at any time, without prejudice to them, as long as it does not affect or put
p.(None): your health at risk.
p.(None): f) Opt for the exclusion of the minor from considering a conflict of opinion between the parent (s) and
p.(None): the minor on participation in the clinical trial.
p.(None): Informed parental consent is not required if the research subject is a minor
...
p.(None): that they are suitable for the test, as well as the time that their use is necessary.
p.(None): - Procedure to follow in case of pregnancy of the research subject or his partner: communication
p.(None): immediately to the investigator, suspension of treatment, withdrawal of the study, monitoring of pregnancy and
p.(None): newborn for 6 months, compensation in case of damage as a result of the clinical trial.
p.(None): 13) Commitments assumed by the research subject if he agrees to participate in the study.
p.(None): 14) Available alternatives.
p.(None): Specify if there are therapeutic, prevention or diagnostic alternatives currently available in the
p.(None): country.
p.(None): El Peruano / Friday, June 30, 2017
p.(None): LEGAL STANDARDS 65
p.(None): 15) Benefits derived from the study
p.(None): In general, it cannot be guaranteed that the product under investigation will directly benefit the subject, since
p.(None): this is what you want to try, so it is more appropriate to use the phrase: "you may or may not benefit from the
p.(None): study medication ”or“ your medical condition may improve, stay the same, and even worsen with
p.(None): study medication ”.
p.(None): The benefits can be divided into benefits for the individual and benefits for their community or for the
p.(None): entire society if an answer to the research question is found.
p.(None): 16) Compensation and treatment in case of damage or injury for your participation in the trial.
p.(None): a) Free medical attention and treatment in case of injury or any adverse event as a result of the
p.(None): administration of the investigational product (experimental and comparator) or any of the procedures or
p.(None): interventions performed under the clinical trial.
p.(None): b) Insurance policy: coverage and validity
p.(None): c) Compensation for the research subject, his family or relatives he is in charge of in case of
p.(None): disability or death resulting from such investigation
p.(None): Not include any text that restricts or contradicts the provisions of articles 27, 28 and 29 of the
p.(None): present regulation.
p.(None): 17) Commitment to provide you with updated information about the product or the procedure in
p.(None): research, although this could affect the will of the research subject to continue
p.(None): participating.
p.(None): 18) Costs and payments
p.(None): a) Free treatment and procedures
p.(None): as part of the clinical trial
p.(None): b) Financial compensation for additional expenses (transportation, accommodation, communication, and food).
p.(None): Indicate amount.
p.(None): 19) Privacy and confidentiality
p.(None): In order to indicate that the confidentiality of the information related to
p.(None): your privacy and security that the research subject will not be identified. The content of this section
p.(None): It must be within what is allowed by Law No. 29733, the Personal Data Protection Law and its regulations.
p.(None): You must incorporate the following:
p.(None): a) What data of the subject will have access? and that
p.(None): information will be collected?
p.(None): b) Use that will be given to the data of the subject of
p.(None): investigation.
p.(None): c) How will the data of the research subject be stored and protected? And who will have access?
p.(None): d) Access to your data by the representatives
p.(None): from the sponsor, CIEI and INS.
p.(None): e) Management of your data and biological samples in case
...
Health / Pregnant
Searching for indicator pregnant:
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p.(None): to what is specified in Chapter II of this Title.
p.(None): c) The minor who reaches the age of majority during the clinical trial, must provide their
p.(None): express informed consent before said research subject can continue participating in the
p.(None): clinical trial.
p.(None): Article 19. Clinical trials in people with disabilities
p.(None): Carrying out clinical trials in those who are not in a position to give their informed consent and who
p.(None): have not given it prior to the start of their disability, requires in addition to the provisions of the Title
p.(None): II of these Regulations:
p.(None): a) That informed consent is in accordance with
p.(None): specified in Chapter II of this Title.
p.(None): b) That the protocol be approved by a CIEI that has experts in the disease under study or has
p.(None): collected advice on clinical, ethical and psycho-social aspects in the field of disease and
p.(None): group of affected patients.
p.(None): Article 20. Clinical trials in women and men with reproductive capacity
p.(None): Carrying out clinical trials in women and men with reproductive capacity, except those
p.(None): clinical trials in which the objective of the study is to evaluate the product under investigation in population
p.(None): pregnant or planning to leave, can only be done when they are met in addition to what
p.(None): provided in Title II of these Regulations, the following conditions:
p.(None): a) For research in women with reproductive capacity, the principal investigator will perform a test of
p.(None): pregnancy to rule out pregnancy prior to study start and both investigator and sponsor
p.(None): assure counseling on the importance of avoiding pregnancy for the duration of your study participation and
p.(None): accessibility to an effective contraceptive method at no cost to the research subject, chosen by
p.(None): this and that it is not incompatible with the clinical trial. The researcher will ensure their commitment
p.(None): to use the chosen method. This must be specified in the research protocol and in the consent
p.(None): informed.
p.(None): If a pregnancy occurs during the study, the research protocol should establish:
p.(None): 1) The exclusion of the pregnant woman and 2) The application of the procedures for monitoring and
p.(None): control of the pregnancy, as well as of the newborn up to at least six (6) months of age, with the aim of
p.(None): identify any effect related to the product under investigation.
p.(None): Only in exceptional cases and after evaluation, the pregnant woman may continue participating in
p.(None): the clinical trial, as long as the conditions established in article 21 hereof are complied with
p.(None): Regulation.
p.(None): b) For research in males with reproductive capacity, and according to pharmacology, studies of
p.(None): genotoxicity, reproductive and developmental toxicity and available clinical information on intrauterine exposure to
p.(None): research product, researcher and sponsor will ensure accessibility to a method
p.(None): effective contraception at no cost to the research subject, chosen by him and other than
p.(None): incompatible with the clinical trial, which must be specified in the research protocol and in the
p.(None): informed consent. The researcher will ensure their commitment to prevent the conception of
p.(None): the couple during the development of the study, using the chosen contraceptive method.
p.(None): In case the partner of the research subject becomes pregnant, the monitoring and control of the
p.(None): gestation, as well as the newborn up to at least six (6) months of age, with the aim of
p.(None): identify any effect related to the product under investigation.
p.(None): Article 21. Clinical trials in pregnant women
p.(None): Carrying out clinical trials in pregnant women can only be carried out when they are completed, in addition to
p.(None): provided in Title II of these Regulations, the following conditions:
p.(None): a) The informed consent of the pregnant woman and the father of the intended child will be required, with prior information from the
p.(None): possible risks for the embryo, fetus or newborn, as the case may be.
p.(None): b) The informed consent of the father of the child conceived in the case set forth in the preceding paragraph
p.(None): may only be excepted in case of death, irrefutable impossibility, loss of rights
p.(None): in accordance with current regulations or, when there is an imminent risk to the health or life of the
p.(None): woman or conceived.
p.(None): c) Informed consent may be withdrawn at the request of the pregnant woman or the father of the child conceived in
p.(None): any time, without prejudice to them, as long as it does not affect or put into
p.(None): risk to the conceived or the mother.
p.(None): d) In the case of pregnant adolescents, the procedure established in article 18 hereof shall be followed.
p.(None): Regulation.
p.(None): e) Research in pregnant women must be preceded by trials carried out on women not
p.(None): pregnant women who demonstrate their safety, with the exception of specific tests that require this condition.
p.(None): f) When they are intended to improve the health of pregnant women and represent only a minimal risk to
p.(None): designed or intended to increase the viability of the product of pregnancy, with minimal risk
p.(None): for the pregnant woman.
p.(None): g) During the execution of investigations in pregnant women, the investigators will not have authority to
p.(None): decide on the time, method or procedure used to end the pregnancy, nor will they participate in
p.(None): decisions on the viability of the conceived.
p.(None): Article 22. Clinical trials during labor, postpartum and lactation
p.(None): Carrying out clinical trials in women during labor, the puerperium and lactation can only be done
p.(None): carry out when, in addition to the provisions of Title II of these Regulations, the
p.(None): following conditions:
p.(None): a) Informed consent for research during labor must be obtained according to the
p.(None): stipulated in Chapter II of this Title, before labor begins.
p.(None): b) The clinical trial has the potential to generate direct benefits greater than the risks for women
p.(None): breastfeeding or child after birth.
p.(None): c) The risk to the infant is minimal.
p.(None): d) In the case of adolescents, proceed according to
p.(None): the provisions of article 18 of these Regulations.
p.(None): e) Informed consent may be withdrawn at the request of the woman or the father of the person conceived in any
p.(None): moment, without prejudice to them, as long as
p.(None): 44 LEGAL STANDARDS Friday, June 30, 2017 /
p.(None): A Peruvian man
p.(None): when it does not affect or put at risk the conceived or the
p.(None): mother.
p.(None): Article 23. Clinical Trials in fetuses and deaths
p.(None): Carrying out clinical trials on fetuses and deaths can only be carried out, in addition to the provisions of Title II
p.(None): of this Regulation according to the following criteria:
p.(None): a) Investigations into embryos are found
p.(None): prohibited.
p.(None): b) Research on fetuses can only be carried out if the techniques and means used provide the maximum
p.(None): safety for the fetus and the pregnant woman.
p.(None): c) Investigations with deaths, natimes, macerated fetal matter, cells, tissues, placenta, cord
p.(None): umbilical, embryonic remains and organs removed from them, will be made observing due respect
p.(None): the pregnant woman or the product of pregnancy in a situation of death or corpse and the applicable provisions
p.(None): in the Regulations of the Cemeteries and Funeral Services Law, as appropriate.
p.(None): Article 24. Of clinical trials in subordinate groups
p.(None): The performance of clinical trials in subordinate groups can only be carried out when they are completed, in addition
p.(None): of the provisions of Title II of these Regulations, the following conditions:
p.(None): a) When research is carried out in subordinate groups, one or more members must participate in the CIEI
p.(None): of the study population, or another person in society capable of protecting the conditions and rights
p.(None): humans that correspond to the group in question.
p.(None): b) Participation, rejection or withdrawal of their consent during the study of the subjects
p.(None): under investigation, do not affect your academic, work, military or judicial situation
p.(None): to which they were subject and the conditions of compliance with the judgment, if applicable; and that
p.(None): research results are not used to their detriment.
p.(None): Article 25. Clinical trials in indigenous or native peoples
p.(None): The carrying out of clinical trials in indigenous or native peoples may only be carried out when
p.(None): In addition to the provisions of Title II of these Regulations, they comply with the following conditions:
p.(None): a) When the product or knowledge generated by the research is available or applied for benefit
p.(None): potential of these communities.
...
Health / patients in emergency situations
Searching for indicator emergencies:
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p.(None): adverse events that are anticipated, based on previous experiences with the product under investigation and with
p.(None): related products. A description of the precautions or special monitoring that must be
p.(None): will be carried out as part of the use of the research product.
p.(None): EXPERIENCE AFTER ITS MARKETING
p.(None): The Investigator's Manual should identify the countries where it has been commercialized or approved
p.(None): the product under investigation.
p.(None): Any significant information arising from the commercialized use should be summarized, for example,
p.(None): formulations, doses, routes of administration and adverse reactions of the product under investigation). The Manual of the
p.(None): Researcher must also identify all countries where the research product did not receive approval /
p.(None): registration to be marketed or withdrawn from the market or whose registration was suspended.
p.(None): When appropriate, published reports on related products should be discussed.
p.(None): This could help the investigator to anticipate adverse reactions or other problems in clinical studies.
p.(None): The overall objective of this section is to provide the researcher with a clear understanding of the possible
p.(None): risks and adverse reactions as well as the specific tests, observations and precautions that could
p.(None): needed in a clinical trial. This understanding
p.(None): Office area
p.(None): Nursing area Waiting room
p.(None): Hygienic services for research team Hygienic services for research subjects
p.(None): Administration and management area of the research center.
p.(None): Storage area of the
p.(None): product under investigation
p.(None): Research product dispensing unit
p.(None): Sampling area Clinical laboratory area Processing area and
p.(None): sample storage
p.(None): Area for emergencies and medical emergencies
p.(None): Access for emergencies and medical emergencies
p.(None): EQUIPMENT
p.(None): Calibrated equipment
p.(None): Emergency medical team
p.(None): Computer equipment
p.(None): HUMAN RESOURCES
p.(None): Principal Investigator of the Clinical Trial
p.(None): Research team
p.(None): Administrative staff of the research center
p.(None): of care settings.
p.(None): It is an environment independent of the care environments. Must have spaces for file
p.(None): Documentary and electronic physicist in adequate conditions for the security of the trial information. Should
p.(None): Include spaces for discussion and meeting of the research team.
p.(None): You must comply with the conditions authorized in the protocol for storage.
p.(None): You must comply with the authorized conditions in the dispensing of medications and other pharmaceutical products.
p.(None): Must have operational mechanisms for the transfer and transportation of patients
p.(None): Computer (s), laptop, printers, server or others that are required, according to the characteristics of the
p.(None): clinical trials it manages.
p.(None): You must have the necessary time to fulfill your responsibilities AND you must ensure a
p.(None): good delegation of responsibilities in the team. They must ensure that they have the availability of
p.(None): time necessary to fulfill all your responsibilities within the clinical trial.
p.(None): They must comply with the responsibilities assigned within the protocol and in the procedures, as well as
p.(None): have enough time to ensure a good execution of the clinical trial
p.(None): must be based on physical, chemical, pharmaceutical, pharmacological, toxicological and
p.(None): Clinic available on the research product. You should also be given guidelines for the
p.(None): recognition and treatment of possible overdose and adverse reactions based on previous experience in
p.(None): and in the pharmacology of the research product.
...
p.(None): Explain in local and simplified terms Why is this study being carried out? and what are the
p.(None): objectives?
p.(None): 6) Number of people to enroll (worldwide and in Peru)
p.(None): 7) Expected duration of participation of the research subject
p.(None): Including number and duration of visits to the research center and total time involved).
p.(None): 8) The circumstances and / or anticipated reasons under which the study or the
p.(None): subject participation in the study.
p.(None): 9) Trial treatments or interventions
p.(None): clinical.
p.(None): a) Description of the product under investigation
p.(None): experimental. It should include:
p.(None): - Name of the research product
p.(None): - Explanation of the reasons for its development
p.(None): - Previous experience with the product
p.(None): - If it is approved or not in Peru and in other countries.
p.(None): b) Comparator description
p.(None): c) Explanation in case of use of inactive drug or placebo and the reasons for its use: It is important
p.(None): make sure the participant understands what a placebo is or what it means to use an inactive drug
p.(None): as well as the reasons for its use.
p.(None): 10) Randomization and blinding.
p.(None): It should include:
p.(None): a) Explanation of randomization and how likely they are to receive one drug or another
p.(None): in terms understandable to the research subject.
p.(None): b) Explanation of blinding, reasons for its use as well as the possibility of obtaining information from the
p.(None): assigned treatment in emergencies.
p.(None): 11) Study procedures:
p.(None): a) Explanation of the study procedures to be followed (interviews,
p.(None): questionnaires, auxiliary exams, diet to follow): Describe or explain the procedures
p.(None): will perform and all medications given (including premedication, rescue medication, or other
p.(None): medication necessary for any study procedure, such as local anesthesia in case of biopsies)
p.(None): being able to include a simplified scheme and / or calendar of visits and procedures.
p.(None): b) Biological samples to be collected: type, quantity and number of times to be extracted. It is necessary
p.(None): explain how many times and how much is needed, in measures that the subject understands.
p.(None): c) Final destination of remaining biological samples. Explicitly mention that biological samples
p.(None): obtained will be used only for ongoing research and will be destroyed when the clinical trial is
p.(None): have completed, unless your storage is contemplated for future use.
p.(None): d) Storage of biological samples or their remnants for future studies: If you plan to store samples
p.(None): remnants beyond the end of the clinical trial and / or biological samples will be removed for
p.(None): storage and future studies, should be incorporated into a specific informed consent form for
p.(None): such an end.
p.(None): e) Information on the results of the tests carried out. It should include:
p.(None): - Your results will be explained to you
p.(None): - Who will inform you
p.(None): - At what time will you be informed
p.(None): - Justification in case of not revealing data temporarily or permanently.
p.(None): 12) Risks and inconveniences derived from the trial
p.(None): clinical
p.(None): a) Risks of the experimental research product, the comparator and any other medication
...
Social / Access to Social Goods
Searching for indicator access:
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p.(None): Whoever takes his place, under the conditions and under the requirements established in these Regulations.
p.(None): Any modification of the conditions in which the authorization was granted and the amendments indicated in the
p.(None): Article 85 of these Regulations must also be previously authorized.
p.(None): Article 7. Regulatory authority in clinical trials
p.(None): The INS is the authority charged at the national level to ensure compliance with these Regulations and
p.(None): the related norms that govern the authorization and execution of clinical trials, as well as dictate the
p.(None): complementary provisions that are required for its application.
p.(None): Article 8. Responsibilities of the National Authority of Pharmaceutical Products, Medical Devices and
p.(None): Sanitary Products (ANM)
p.(None): Corresponds to the National Authority of Pharmaceutical Products, Medical Devices and Health Products
p.(None): (ANM) issue binding technical opinion on the safety and quality of the product under investigation that corresponds
p.(None): within the scope of its competence, on the research protocol of bioequivalence studies
p.(None): to demonstrate interchangeability, as part of the requirement for sanitary registration in the country, as well
p.(None): how to authorize, for exclusive research purposes, the import or manufacture of products in
p.(None): research and complementary products; and authorize the use of a research product under the
p.(None): post-study access conditions.
p.(None): TITLE II
p.(None): RESPECT FOR ETHICAL POSTULATES
p.(None): Article 9. Conditions to the clinical trial
p.(None): All clinical trials must be carried out under conditions of respect for dignity, protection of
p.(None): rights and welfare of research subjects; their physical and mental integrity must be safeguarded, as well as their
p.(None): privacy and protection of your data; and, be carried out with scientific integrity.
p.(None): Article 10. Initiation of the clinical trial
p.(None): A clinical trial can only be started when you have authorization to carry it out according to the
p.(None): indicated in article 6 of these Regulations. This authorization will be granted after the CIEI that
p.(None): corresponds and the INS consider that the benefit / risk balance is favorable for the research subject or for
p.(None): the society; Likewise, it can only continue if compliance with this criterion is permanently maintained.
p.(None): Article 11. Informed consent
p.(None): The written informed consent freely expressed by each of the parties will be obtained and documented.
p.(None): the research subjects, before their inclusion in the clinical trial, in the terms provided in Chapter II
p.(None): of Title III of these Regulations.
p.(None): The research subject can leave the clinical trial at any time without any justification and without
p.(None): suffer any prejudice for it, withdrawing himself or his legally designated representative, the
...
p.(None): inform the research subject of the results of the examinations carried out or the justification for not doing so.
p.(None): - Approximate number of research subjects to
p.(None): include worldwide and in Peru.
p.(None): - The expected duration of the subject's participation
p.(None): research.
p.(None): - The inconvenience, the expected risks or the risks
p.(None): unpredictable.
p.(None): - Free treatment and procedures
p.(None): used as part of the clinical trial design.
p.(None): - The expected benefits that can be obtained.
p.(None): - If there are alternative procedures that could be advantageous to the research subject.
p.(None): - The commitments assumed by the subject of
p.(None): research if you agree to participate in the study.
p.(None): - The guarantee of receiving answers to any questions and clarification of any doubts about
p.(None): the procedures, risks, benefits and other matters related to the clinical trial and the
p.(None): treatment of
p.(None): 46 LEGAL STANDARDS Friday, June 30, 2017 /
p.(None): A Peruvian man
p.(None): research subject; about your rights as a research subject or contact in case of injury,
p.(None): for which the name, address and telephone number of the principal investigator and those of the president of the
p.(None): CIEI as appropriate.
p.(None): - The freedom to withdraw your consent at any time and stop participating in the study without it
p.(None): damages are created to continue their care and treatment.
p.(None): - The security that the research subject will not be identified and that the confidentiality of the
p.(None): information related to your privacy.
p.(None): - That the representatives of the sponsor, the CIEI and the OGITT of the INS will have access to the clinical history of the
p.(None): Research subject for verification of the clinical trial procedures and / or data, without violating their
p.(None): confidentiality, and that, by signing the informed consent form, the research subject or his
p.(None): legal representative are authorizing access to this data.
p.(None): - The commitment to provide you with updated information about the product or the procedure in
p.(None): research or when the research subject requests it, although it may affect the will of the
p.(None): research subject to continue participating.
p.(None): - The circumstances and / or anticipated reasons why the clinical trial could end or
p.(None): the participation of the research subject in it.
p.(None): - The availability of medical treatment and the compensation to which you would legally be entitled, for
p.(None): party responsible for the clinical trial, in the case of damages that directly affect it, caused by
p.(None): the investigation, pointing out the existence of the insurance contracted by the sponsor.
p.(None): - The detail of the financial compensation for additional expenses, such as transportation, accommodation, communication, and
p.(None): food if they exist; which will be covered by the budget of the clinical trial.
p.(None): - In the event that the woman or the man are in reproductive capacity, the
p.(None): potential risks in the event of her or his partner's pregnancy, and that a
p.(None): effective contraceptive method chosen by the participant and their partner.
p.(None): - That in the event of a pregnancy of the research subject or his partner, he must report the fact to the
p.(None): investigator. In addition, the format must establish whether such condition is considered grounds for exclusion from the
p.(None): clinical trial. Likewise, it will indicate the application of the procedures for the monitoring and control of the
p.(None): gestation and newborn to at least six
p.(None): (6) months of age in order to identify any effect related to the research product. The
p.(None): expenses that such monitoring demands will be financed by the sponsor. The sponsor will be
p.(None): responsible for the respective compensation for damages produced during the pregnancy or that had been
p.(None): caused to the newborn as a consequence of the clinical trial.
p.(None): - Specify the time, means and responsible for which the research subject will be provided
p.(None): the final results of the clinical trial, which must be in a language understandable to him.
p.(None): - Inform the research subject about post-study access and according to the considerations
p.(None): indicated in Title X of these Regulations.
p.(None): - The existence of a description of the clinical trial available in the Peruvian Registry of Clinical Trials and accessible
p.(None): through the INS institutional web portal
p.(None): - The contact information of the OGITT of the INS, according to what is indicated in number 21 of Annex 4 of the
p.(None): these Regulations.
p.(None): The informed consent form for minors must meet the same requirements as the
p.(None): informed consent where appropriate.
p.(None): If the clinical trial contemplates the collection and storage of biological samples for future use,
p.(None): It must be explained in an additional informed consent format as indicated in the Manual of
p.(None): Clinical trial procedures.
p.(None): Article 35. Compensation to research subjects
p.(None): Research subjects may receive reasonable compensation from the sponsor for expenses
p.(None): extraordinary causes and loss of productivity arising from your participation, which will be specified
p.(None): in the informed consent. The CIEI will evaluate said compensation according to each case; and, will evaluate that no
p.(None): unduly influences the consent of the research subject.
p.(None): Article 36. Subject of minor investigation
p.(None): When the research subject is a minor
p.(None): is required:
...
p.(None): e) Keep the principal investigator, CIEI and the INS OGITT informed about new information regarding the
p.(None): investigational product of the ongoing clinical trial.
p.(None): f) Select the investigator (s) of the clinical trial, ensure for themselves that they are competent,
p.(None): who has sufficient time and agrees to comply with Good Clinical Practices and regulations
p.(None): ethical.
p.(None): g) Have a documented record of the monitoring that is being carried out in clinical trials, including the
p.(None): provision of specially selected and specialized personnel (monitors).
p.(None): h) Inform the INS OGITT when the first research subject in Peru is enrolled, as well as the
p.(None): end date of enrollment in the country.
p.(None): i) Present progress and final reports to the INS OGITT.
p.(None): j) Present to the INS OGITT a copy of the publication of authorized clinical trials.
p.(None): k) Guarantee that the manufacture of the product under investigation is carried out in accordance with Good Practices
p.(None): Manufacturing or Manufacturing, as well as proper packaging and labeling.
p.(None): l) Keep samples of the product under investigation, its manufacturing and control protocols, as well as the
p.(None): records of the products under investigation.
p.(None): m) Guarantee and supervise the notification of adverse events to the INS OGITT.
p.(None): n) Report critical or very serious and major or serious deviations to the clinical trial protocol within a period
p.(None): maximum of fifteen (15) calendar days from the time the sponsor or OIC becomes aware of them.
p.(None): o) To archive in the country all the documentation and data obtained for at least ten (10) years after concluding the
p.(None): study. After two (2) years, it may be filed electronically, prior communication to the INS.
p.(None): p) Ensure access of research subjects, after the completion of the clinical trial to the product of
p.(None): investigation according to the considerations indicated in Title X of these Regulations. This must be
p.(None): specified in the informed consent.
p.(None): q) Count and keep the insurance policy in force.
p.(None): r) Have a financial fund that guarantees immediate and timely care and treatment
p.(None): free of charge for the research subject, in the event of an adverse event as a consequence of the clinical trial, in
p.(None): both the activation of the insurance policy occurs, and a declaration must be signed for this purpose.
p.(None): s) Ensure free access to the research product, complementary products
p.(None): and procedures used as part of a clinical trial to research subjects during their participation in
p.(None): the study.
p.(None): t) Grant compensation to the subject of investigation, as indicated in article 27
p.(None): of these Regulations.
p.(None): In the event that the sponsor ceases to sponsor the clinical trial and the
p.(None): product under investigation, whoever replaces it will assume it.
p.(None): CHAPTER II
p.(None): OF THE CONTRACT INVESTIGATION ORGANIZATION
p.(None): Article 41. The Research Organization for
p.(None): Contract
p.(None): The OIC is the public or private organization, national or foreign, to which the sponsor transfers
p.(None): some of their tasks and obligations by signing a contract.
p.(None): The ICOs must have legal status recognized in Peru, which develop
p.(None): its activities in the field of health. Universities may assume the responsibilities of a sponsor or
p.(None): an ICO.
p.(None): Article 42. Final responsibility in the execution of the clinical trial
p.(None): The sponsor may legally transfer any or all of their tasks and functions related to the trial
p.(None): clinician to an ICO, with final responsibility for executing the protocol remaining with the sponsor
p.(None): research and clinical trial results.
p.(None): Article 43. Foreign Contract Research Organizations
p.(None): Foreign ICOs must have a branch in Peru, established according to the laws
p.(None): in force and will assume all the responsibilities of the sponsor established in the contract.
p.(None): Article 44. Obligations of Contract Research Organizations
p.(None): The ICO's obligations are:
p.(None): a) Send the INS OGITT an annual report of the total number of clinical trials that are being carried out in the country, as well as
p.(None): the specific responsibilities that have been assumed by the sponsor in each clinical trial.
...
p.(None): b) Copy of the authorization of the clinical trial granted by the OGITT of the INS.
p.(None): c) List of products under investigation, complementary products and supplies to be used in the trial
p.(None): clinical.
p.(None): d) Proof of payment of processing fees to ANM.
p.(None): Article 95. Manufacture or import of special products
p.(None): The manufacture or import of pharmaceutical products, narcotic drugs,
p.(None): psychotropics, precursors for medical use and other substances subject to health control, as well as blood products,
p.(None): they are governed by the specific regulations approved by MINSA.
p.(None): Article 96. Final destination of unused and / or returned research products
p.(None): a) The sponsor or OIC is responsible for the destruction of the unused research product
p.(None): and / or returned. Therefore, the product under investigation should not be destroyed without prior authorization by
p.(None): brief from the sponsor or the ICO.
p.(None): b) The products under investigation will only be destroyed once any discrepancy in the final accounting
p.(None): of these have been investigated, explained and resolved.
p.(None): c) All procedures for the destruction of the product under investigation must be documented. Records must
p.(None): detail the quantities destroyed and allow the traceability of the product under investigation.
p.(None): d) The destruction of the products under investigation will be carried out in the presence of a notary public, with
p.(None): knowledge of the ANM and the OGITT of the INS.
p.(None): Article 97. Exception to the destruction of an unused and / or returned product under investigation
p.(None): This procedure will be excepted in the following circumstances:
p.(None): a) Its use is considered for post-study access to the product under investigation according to article 116 of the
p.(None): these Regulations.
p.(None): b) For the purpose of returning the product under investigation to the country of origin for
p.(None): accounting and final destruction, as stated in the clinical trial protocol or in the procedures of the
p.(None): sponsor, and must be accredited to the ANM.
p.(None): c) It is considered as a donation through an agreement with the research institution, as long as the
p.(None): research product has a sanitary registry in Peru, is used under the conditions of use
p.(None): approved, the labeling of the product under investigation is changed and its sale is prohibited.
p.(None): Article 98. Final destination of complementary products not used and / or returned
p.(None): Complementary products not used and / or returned may be destroyed, returned to the country of
p.(None): origin or donated, and must be credited to the ANM.
p.(None): El Peruano / Friday, June 30, 2017
p.(None): LEGAL STANDARDS 55
p.(None): TITLE VII
p.(None): OF THE ADMINISTRATIVE RECORD AND THE PERUVIAN REGISTRY OF CLINICAL TRIALS
p.(None): CHAPTER I
p.(None): OF THE ADMINISTRATIVE TECHNICAL FILE
p.(None): Article 99. Access to information related to the clinical trial
p.(None): The authorized staff of the INS OGITT, will have access to all the information related to trials
p.(None): clinicians. ANM authorized personnel will have access to information related to the safety and quality of the
p.(None): investigational product of clinical trial.
p.(None): Said personnel are under the obligation, under responsibility, to maintain the confidentiality of
p.(None): the information you access, following the information security procedures that include signing a
p.(None): confidentiality agreement.
p.(None): Article 100. Conservation of clinical trial records
p.(None): The OGITT of the INS keeps the file of clinical trial files and will keep them for ten (10)
p.(None): years after the end of the clinical trial. After which they can go to the Central Archive of the INS. From
p.(None): the two (2) years, may be filed in electronic version. In case controversies arise about the security of the
p.(None): Product under investigation will be kept for an additional period of ten (10) years.
p.(None): Article 101. Final destination of the remaining printed materials
p.(None): The printed materials left over from the execution of the clinical trial must be incinerated at the end of the trial with
p.(None): knowledge and authorization of the OGITT of the INS.
p.(None): CHAPTER II
p.(None): OF THE PERUVIAN REGISTRY OF CLINICAL TRIALS
p.(None): Article 102. Of the Peruvian Registry of Clinical Trials
p.(None): The INS OGITT is responsible for REPEC and its update, which is accessed through the portal
p.(None): institutional of the INS.
p.(None): Article 103. Information contained in the Peruvian Registry of Clinical Trials- REPEC
p.(None): The REPEC contains information on: Study title, sponsor and researchers, product in
p.(None): research, condition studied, study design, number of subjects to include and others who have
p.(None): have been considered within the dataset of the World Health Organization trial registry.
p.(None): TITLE VIII
p.(None): OF REPORTS AND PUBLICATION OF CLINICAL TRIALS
p.(None): CHAPTER I
p.(None): OF PROGRESS AND FINAL REPORTS
p.(None): Article 104. The progress reports
p.(None): The progress report of each of the research centers, in which the clinical trial is executed, will be
...
p.(None): The sponsor or ICO and the principal investigator should take the urgent measures necessary to
p.(None): protect research subjects. These measures must be communicated to the INS OGITT and to the CIEI in a
p.(None): maximum period of seven (7) calendar days, from the occurrence of the event or as soon as it becomes aware of the fact.
p.(None): Article 111. Of the notification to the ANM
p.(None): The INS OGITT will notify the ANM of serious adverse reactions and suspected serious adverse reactions and
p.(None): unexpected to the product under investigation, occurred in a clinical trial authorized in the country, within the
p.(None): maximum of fifteen (15) business days after receiving the notification.
p.(None): CHAPTER III
p.(None): OF THE BLIND OPENING
p.(None): Article 112. Contingency plan
p.(None): Every clinical trial that uses blind mode, in any of its forms, must have a plan of
p.(None): contingency that will be included in the research protocol, in order to open the
p.(None): blind in the shortest possible time to any condition that threatens the safety of the research subject.
p.(None): Article 113. Opening of the blind
p.(None): It is the responsibility of the principal investigator to open the blind if required for the safety of the
p.(None): research subject.
p.(None): The INS OGITT, after evaluating the case, may order the opening of the blind when it is
p.(None): the safety of the research subject compromised.
p.(None): Article 114. Preservation of blindness
p.(None): The blind nature of the clinical trial will be maintained for the researcher, and for the people in charge of the
p.(None): analysis and interpretation of the results and elaboration of the conclusions of the study, whenever possible.
p.(None): TITLE X
p.(None): POST-STUDY ACCESS
p.(None): Article 115. Post-study access to the product under investigation
p.(None): Post-study access is understood to be the free availability, for the research subject, of the product in
p.(None): Research that was studied in a clinical trial - even when it has a record
p.(None): health in the country- after the completion of the study or when their participation in the
p.(None): same. Before the start of the study, post-study access should be foreseen and this information must be provided
p.(None): in the informed consent process.
p.(None): For your requirement, the severity of the medical condition in question and the expected effect will be considered.
p.(None): to withdraw or modify your treatment (if interruption of treatment can negatively affect your
p.(None): health or well-being), the absence of satisfactory therapeutic alternatives in the country for the condition
p.(None): of the research subject, there is sufficient information on efficacy and safety and the balance
p.(None): benefit-risk of the intervention is positive.
p.(None): To use a research product under post-study access conditions, it must have
p.(None): shown to be beneficial to the research subject, at the discretion of the principal investigator, and its use will be maintained
p.(None): as soon as there is benefit.
p.(None): If pathology is part of the management of some MINSA General Directorates, or those that take their place, the
p.(None): Sponsor must ensure the accessibility of the research product until it is accessible through
p.(None): those addresses.
p.(None): Article 116. Authorization of post-study access to the research product:
p.(None): Post-study access authorization may be
p.(None): granted through the following mechanisms:
p.(None): - Authorization of a clinical trial corresponding to an extension study, which will be granted by the
p.(None): OGITT in accordance with the provisions of article 67 of these Regulations.
p.(None): - ANM authorization for a research product, which must have been proven to be
p.(None): beneficial to the research subject, at the discretion of the
p.(None): El Peruano / Friday, June 30, 2017
p.(None): LEGAL STANDARDS 57
p.(None): principal investigator and its use will continue as
p.(None): there would be benefit.
p.(None): The principal investigator considering post-study access to the research product for the subject
p.(None): of investigation must communicate it to the sponsor of the clinical trial, who in turn must
p.(None): request authorization from the ANM.
p.(None): Article 117. Requirements for post-study access to the research product in case of
p.(None): require authorization by the ANM
p.(None): ANM authorization is granted for each specific case. This request will be made by the sponsor who
p.(None): conducted the clinical trial. The requirements for this authorization are:
p.(None): a) Request for authorization addressed to the ANM
p.(None): b) Written informed consent of the research subject or his legal representative (signed by the subject
p.(None): research and principal investigator)
p.(None): c) Clinical report in which the principal investigator justifies the need for said treatment.
p.(None): d) Official medical prescription duly completed.
p.(None): e) Compliance of the person in charge of the institution or establishment where the treatment will be applied, according
p.(None): it corresponds.
p.(None): f) Updated researcher manual, according to
p.(None): it corresponds.
p.(None): g) Copy of the directorial resolution authorizing the
p.(None): clinical trial from which the specific case is derived.
p.(None): Article 118. Communication of results
p.(None): The sponsor will communicate to the ANM the results of the treatment within the established period, as well as suspicions of
p.(None): adverse drug reactions that may be due to it, without prejudice to the communication of
p.(None): adverse reactions to the decentralized health dependency at the corresponding territorial level.
p.(None): TITLE XI
p.(None): OF THE SUPERVISION OF CLINICAL TRIALS
p.(None): Article 119. Authority in charge of supervision In order to ensure the quality and integrity of the data or
...
p.(None): temporal, detection method, treatment administered, if applicable, alternative causes or predisposing factors,
p.(None): type and duration of follow-up).
p.(None): b. Indicate the causality criteria to be used.
p.(None): c. Indicate the procedures for the immediate notification of serious or unexpected adverse events
p.(None): in accordance with the provisions of these regulations.
p.(None): El Peruano / Friday, June 30, 2017
p.(None): LEGAL STANDARDS 61
p.(None): 10. STATISTICAL CONSIDERATIONS
p.(None): to. Sample size: Estimated number of participants needed to achieve the objectives
p.(None): of the study and explanation of how this number was determined, including the clinical and statistical premises that
p.(None): support the sample size calculation.
p.(None): b. Approximate duration of the recruitment period based on the number of patients available and
p.(None): Strategies for Proper Recruitment to Achieve Target Sample Size: Where They Will Be
p.(None): recruited subjects, form (media, patient registry), expected recruitment rates.
p.(None): c. Specify the statistical tests expected to be used in the analysis of the primary endpoints and
p.(None): secondary. Specify where the details of the statistical analysis plan that are not included in the
p.(None): protocol.
p.(None): d. Methods for any other additional analyzes (eg subgroup analyzes or fitted analyzes).
p.(None): and. Definition of the analysis population (s) (it is not enough just to mention that the analysis will be carried out
p.(None): by intention to treat or by protocol, the protocol must indicate the considered definition) and of any method
p.(None): Statistical to deal with missing data (for example, multiple imputation).
p.(None): F. Indicate if any intermediate analysis and interruption rules are planned,
p.(None): including who will have access to the intermediate results and who will make the final decision to end the trial.
p.(None): 11. DATA COLLECTION AND MONITORING OF THE CLINICAL TRIAL
p.(None): to. Data collection methods: Plans to evaluate and collect the initial variables, of evolution
p.(None): and other study data, including any processes to improve the quality of the data (for example,
p.(None): duplicate measurements, training of evaluators) and description of the instruments used
p.(None): in the study (eg, questionnaires, laboratory tests) along with their reliability and validity, if known.
p.(None): Indicate where the data collection forms can be found, if they are not in the protocol.
p.(None): b. Plans to promote participant retention and follow-up
p.(None): full, including a list of data to be collected from participants who drop out of the trial or stray
p.(None): of the.
p.(None): c. Composition of the data monitoring committee, summary of its function and notification procedure,
p.(None): statement about your independence from the sponsor and about your conflicts of interest.
p.(None): Specify where other details about their statutes can be found that have not been included in the protocol.
p.(None): Alternatively, explain why this committee is not needed.
p.(None): d. Description of the provisions for monitoring or auditing the conduct of the clinical trial.
p.(None): and. Sponsor's statement guaranteeing that researchers are going to allow monitoring,
p.(None): audits, CIEI supervisions, and clinical trial inspections by INS OGITT, including
p.(None): direct access to the documentation of the clinical trial.
p.(None): 12. DATA MANAGEMENT AND RECORD KEEPING
p.(None): to. Plans to enter, encrypt, protect and save data, including any process to improve your
p.(None): quality (for example, duplicate entry or range revision), with respect to the privacy of the
p.(None): information and in accordance with the regulations on personal data protection.
p.(None): b. Specify where the details of the data management procedure can be found that are not included in the
p.(None): protocol.
p.(None): 13. ETHICAL ASPECTS
p.(None): to. General considerations: Acceptance of national and international regulations in this regard.
p.(None): b. Information that will be provided to the subjects and provisions for obtaining consent
p.(None): informed.
p.(None): c. Plans by the investigator, sponsor, or ICO to notify and obtain approval of the amendments to the
p.(None): research protocol of the CIEI and the OGITT of the INS, before its implementation.
p.(None): d. Specify who will have access to the data of the research subjects in order to guarantee
p.(None): its confidentiality according to national regulations and international recommendations.
p.(None): and. Guarantee of the existence of an insurance policy, compensation and compensation in accordance with the
p.(None): provided in these regulations.
p.(None): F. Forecasts for post-study access to the product under investigation.
p.(None): 14. PUBLICATION OF THE RESULTS
p.(None): Investigator and sponsor plans to communicate trial results to subjects in
p.(None): research, health professionals, the public, and other relevant groups (for example, in a publication,
p.(None): presentation of information in results databases or other arrangements for dissemination
p.(None): data), including any publication restrictions.
p.(None): 15. BIBLIOGRAPHIC REFERENCES
p.(None): Elaborated according to the standard of publications.
p.(None): 16. ANNEXES
p.(None): APPENDIX 2
p.(None): RESEARCHER'S MANUAL
p.(None): Contains the clinical and non-clinical data that are relevant to the use of the product in research
p.(None): in the clinical trial. Its objective is to provide researchers and others involved in the trial,
p.(None): information to understand the key aspects of the intended use of the research product in the
p.(None): essay, such as; dosages and intervals and forms of administration and procedures for monitoring
p.(None): safety.
p.(None): The information must be presented in a concise, simple, objective, balanced and not
p.(None): promotional, understandable to potential researchers and that allows an evaluation not
p.(None): biased risks and benefits and relevance of the proposed clinical trial. It should be noted that
p.(None): This document will serve as a reference for evaluating the expected or not character of the reactions.
p.(None): serious adverse events that may occur during the conduct of the trial.
p.(None): The investigator's manual must be validated and updated regularly by the sponsor,
p.(None): at least once a year whenever the nature of the product under investigation allows it, if it occurs
p.(None): The latter is under the responsibility of the sponsor, who submits the updated product information in
p.(None): research not yet included in the manual. Document updates should maintain the
...
p.(None): will be carried out as part of the use of the research product.
p.(None): EXPERIENCE AFTER ITS MARKETING
p.(None): The Investigator's Manual should identify the countries where it has been commercialized or approved
p.(None): the product under investigation.
p.(None): Any significant information arising from the commercialized use should be summarized, for example,
p.(None): formulations, doses, routes of administration and adverse reactions of the product under investigation). The Manual of the
p.(None): Researcher must also identify all countries where the research product did not receive approval /
p.(None): registration to be marketed or withdrawn from the market or whose registration was suspended.
p.(None): When appropriate, published reports on related products should be discussed.
p.(None): This could help the investigator to anticipate adverse reactions or other problems in clinical studies.
p.(None): The overall objective of this section is to provide the researcher with a clear understanding of the possible
p.(None): risks and adverse reactions as well as the specific tests, observations and precautions that could
p.(None): needed in a clinical trial. This understanding
p.(None): Office area
p.(None): Nursing area Waiting room
p.(None): Hygienic services for research team Hygienic services for research subjects
p.(None): Administration and management area of the research center.
p.(None): Storage area of the
p.(None): product under investigation
p.(None): Research product dispensing unit
p.(None): Sampling area Clinical laboratory area Processing area and
p.(None): sample storage
p.(None): Area for emergencies and medical emergencies
p.(None): Access for emergencies and medical emergencies
p.(None): EQUIPMENT
p.(None): Calibrated equipment
p.(None): Emergency medical team
p.(None): Computer equipment
p.(None): HUMAN RESOURCES
p.(None): Principal Investigator of the Clinical Trial
p.(None): Research team
p.(None): Administrative staff of the research center
p.(None): of care settings.
p.(None): It is an environment independent of the care environments. Must have spaces for file
p.(None): Documentary and electronic physicist in adequate conditions for the security of the trial information. Should
p.(None): Include spaces for discussion and meeting of the research team.
p.(None): You must comply with the conditions authorized in the protocol for storage.
p.(None): You must comply with the authorized conditions in the dispensing of medications and other pharmaceutical products.
p.(None): Must have operational mechanisms for the transfer and transportation of patients
p.(None): Computer (s), laptop, printers, server or others that are required, according to the characteristics of the
p.(None): clinical trials it manages.
p.(None): You must have the necessary time to fulfill your responsibilities AND you must ensure a
p.(None): good delegation of responsibilities in the team. They must ensure that they have the availability of
p.(None): time necessary to fulfill all your responsibilities within the clinical trial.
p.(None): They must comply with the responsibilities assigned within the protocol and in the procedures, as well as
p.(None): have enough time to ensure a good execution of the clinical trial
p.(None): must be based on physical, chemical, pharmaceutical, pharmacological, toxicological and
p.(None): Clinic available on the research product. You should also be given guidelines for the
...
p.(None): remnants beyond the end of the clinical trial and / or biological samples will be removed for
p.(None): storage and future studies, should be incorporated into a specific informed consent form for
p.(None): such an end.
p.(None): e) Information on the results of the tests carried out. It should include:
p.(None): - Your results will be explained to you
p.(None): - Who will inform you
p.(None): - At what time will you be informed
p.(None): - Justification in case of not revealing data temporarily or permanently.
p.(None): 12) Risks and inconveniences derived from the trial
p.(None): clinical
p.(None): a) Risks of the experimental research product, the comparator and any other medication
p.(None): used for clinical trial purposes. Clearly indicate, in a language and language that the subject understands, the
p.(None): reasonably expected risks or discomforts (according to the Investigator's Manual or technical sheet) as well as the possibility
p.(None): of serious events or other unexpected events, or the non-relief or worsening of the symptoms of the pathology of
p.(None): study.
p.(None): b) Risks and inconveniences of the procedures of the
p.(None): clinical trial.
p.(None): c) Risks and measures of prevention and protection against pregnancy of the research subject or his partner. Should
p.(None): include:
p.(None): - Potential risks in case of pregnancy for the
p.(None): fetus or lactating embryo.
p.(None): - Pregnancy tests: initial and additional
p.(None): - Free access and list of contraceptive methods to be chosen by the research subject and his partner,
p.(None): that they are suitable for the test, as well as the time that their use is necessary.
p.(None): - Procedure to follow in case of pregnancy of the research subject or his partner: communication
p.(None): immediately to the investigator, suspension of treatment, withdrawal of the study, monitoring of pregnancy and
p.(None): newborn for 6 months, compensation in case of damage as a result of the clinical trial.
p.(None): 13) Commitments assumed by the research subject if he agrees to participate in the study.
p.(None): 14) Available alternatives.
p.(None): Specify if there are therapeutic, prevention or diagnostic alternatives currently available in the
p.(None): country.
p.(None): El Peruano / Friday, June 30, 2017
p.(None): LEGAL STANDARDS 65
p.(None): 15) Benefits derived from the study
p.(None): In general, it cannot be guaranteed that the product under investigation will directly benefit the subject, since
p.(None): this is what you want to try, so it is more appropriate to use the phrase: "you may or may not benefit from the
p.(None): study medication ”or“ your medical condition may improve, stay the same, and even worsen with
p.(None): study medication ”.
p.(None): The benefits can be divided into benefits for the individual and benefits for their community or for the
p.(None): entire society if an answer to the research question is found.
p.(None): 16) Compensation and treatment in case of damage or injury for your participation in the trial.
p.(None): a) Free medical attention and treatment in case of injury or any adverse event as a result of the
p.(None): administration of the investigational product (experimental and comparator) or any of the procedures or
p.(None): interventions performed under the clinical trial.
p.(None): b) Insurance policy: coverage and validity
p.(None): c) Compensation for the research subject, his family or relatives he is in charge of in case of
p.(None): disability or death resulting from such investigation
p.(None): Not include any text that restricts or contradicts the provisions of articles 27, 28 and 29 of the
p.(None): present regulation.
p.(None): 17) Commitment to provide you with updated information about the product or the procedure in
p.(None): research, although this could affect the will of the research subject to continue
p.(None): participating.
p.(None): 18) Costs and payments
p.(None): a) Free treatment and procedures
p.(None): as part of the clinical trial
p.(None): b) Financial compensation for additional expenses (transportation, accommodation, communication, and food).
p.(None): Indicate amount.
p.(None): 19) Privacy and confidentiality
p.(None): In order to indicate that the confidentiality of the information related to
p.(None): your privacy and security that the research subject will not be identified. The content of this section
p.(None): It must be within what is allowed by Law No. 29733, the Personal Data Protection Law and its regulations.
p.(None): You must incorporate the following:
p.(None): a) What data of the subject will have access? and that
p.(None): information will be collected?
p.(None): b) Use that will be given to the data of the subject of
p.(None): investigation.
p.(None): c) How will the data of the research subject be stored and protected? And who will have access?
p.(None): d) Access to your data by the representatives
p.(None): from the sponsor, CIEI and INS.
p.(None): e) Management of your data and biological samples in case
p.(None): withdrawal of informed consent.
p.(None): f) Non-identification of the subject in case of publications or scientific presentations of the clinical trial.
p.(None): 20) Situation after completion of the clinical trial, post-study access to the product under investigation.
p.(None): If the product under investigation will be available to the research subjects in which it has been shown to be
p.(None): beneficial, after you have completed your participation in the clinical trial, when and how you will be
p.(None): available.
p.(None): 21) Clinical trial information
p.(None): a) Availability of publicly available clinical trial information available at REPEC,
p.(None): should point to the address of their website: http://www.ensayosclinicos-repec.ins.gob.pe
p.(None): b) Information on the final results of the clinical trial. Specify the time, means and responsible for the
p.(None): which will provide the research subject with the final results of the clinical trial.
p.(None): 22) Contact details
p.(None): a) Contacts to answer any questions or doubts and in case of injuries
p.(None): - Principal investigator (s): Address, email and telephone numbers.
p.(None): - CIEI President: Address, email and telephone.
p.(None): b) Contact details of the Regulatory Authority
p.(None): (INS). Include the following text:
p.(None): "When you consider that your rights are violated or before any complaint, you can
p.(None): contact the INS (General Office for Research and Technology Transfer, OGITT), the regulatory body for
p.(None): clinical trials, through the following telephone number: 7481111 annex 2191 or by written communication through the
p.(None): following email: consultaensayos@ins.gob. eg, or through a formal document presented through
p.(None): table of parties of the institution or go in person to the OGITT at the following address: Cápac Yupanqui 1400, Jesús
p.(None): María, Lima 11 ”.
p.(None): Section to be completed by the research subject:
p.(None): - I ...................... (Name and surname) ....................
p.(None): .........................
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p.(None): detail the quantities destroyed and allow the traceability of the product under investigation.
p.(None): d) The destruction of the products under investigation will be carried out in the presence of a notary public, with
p.(None): knowledge of the ANM and the OGITT of the INS.
p.(None): Article 97. Exception to the destruction of an unused and / or returned product under investigation
p.(None): This procedure will be excepted in the following circumstances:
p.(None): a) Its use is considered for post-study access to the product under investigation according to article 116 of the
p.(None): these Regulations.
p.(None): b) For the purpose of returning the product under investigation to the country of origin for
p.(None): accounting and final destruction, as stated in the clinical trial protocol or in the procedures of the
p.(None): sponsor, and must be accredited to the ANM.
p.(None): c) It is considered as a donation through an agreement with the research institution, as long as the
p.(None): research product has a sanitary registry in Peru, is used under the conditions of use
p.(None): approved, the labeling of the product under investigation is changed and its sale is prohibited.
p.(None): Article 98. Final destination of complementary products not used and / or returned
p.(None): Complementary products not used and / or returned may be destroyed, returned to the country of
p.(None): origin or donated, and must be credited to the ANM.
p.(None): El Peruano / Friday, June 30, 2017
p.(None): LEGAL STANDARDS 55
p.(None): TITLE VII
p.(None): OF THE ADMINISTRATIVE RECORD AND THE PERUVIAN REGISTRY OF CLINICAL TRIALS
p.(None): CHAPTER I
p.(None): OF THE ADMINISTRATIVE TECHNICAL FILE
p.(None): Article 99. Access to information related to the clinical trial
p.(None): The authorized staff of the INS OGITT, will have access to all the information related to trials
p.(None): clinicians. ANM authorized personnel will have access to information related to the safety and quality of the
p.(None): investigational product of clinical trial.
p.(None): Said personnel are under the obligation, under responsibility, to maintain the confidentiality of
p.(None): the information you access, following the information security procedures that include signing a
p.(None): confidentiality agreement.
p.(None): Article 100. Conservation of clinical trial records
p.(None): The OGITT of the INS keeps the file of clinical trial files and will keep them for ten (10)
p.(None): years after the end of the clinical trial. After which they can go to the Central Archive of the INS. From
p.(None): the two (2) years, may be filed in electronic version. In case controversies arise about the security of the
p.(None): Product under investigation will be kept for an additional period of ten (10) years.
p.(None): Article 101. Final destination of the remaining printed materials
p.(None): The printed materials left over from the execution of the clinical trial must be incinerated at the end of the trial with
p.(None): knowledge and authorization of the OGITT of the INS.
p.(None): CHAPTER II
p.(None): OF THE PERUVIAN REGISTRY OF CLINICAL TRIALS
p.(None): Article 102. Of the Peruvian Registry of Clinical Trials
p.(None): The INS OGITT is responsible for REPEC and its update, which is accessed through the portal
p.(None): institutional of the INS.
p.(None): Article 103. Information contained in the Peruvian Registry of Clinical Trials- REPEC
p.(None): The REPEC contains information on: Study title, sponsor and researchers, product in
p.(None): research, condition studied, study design, number of subjects to include and others who have
p.(None): have been considered within the dataset of the World Health Organization trial registry.
p.(None): TITLE VIII
p.(None): OF REPORTS AND PUBLICATION OF CLINICAL TRIALS
p.(None): CHAPTER I
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p.(None): annexes, which is an integral part of this Supreme Decree.
p.(None): Article 2.- Endorsement
p.(None): This Supreme Decree is endorsed by the Minister of Health.
p.(None): SUPPLEMENTARY DEROGATORY PROVISION
p.(None): Sole.- Repeal
p.(None): Repeal Supreme Decree No. 017-2006-SA, which approved the Regulation of Clinical Trials in Peru and its
p.(None): amending, as well as Supreme Decree No. 020-2015-SA, which dictates temporary preventive measures, inspection
p.(None): and supervision of clinical trials.
p.(None): Given at the Government House, in Lima, on the twenty-eighth day of the month of June of the year two thousand seventeen.
p.(None): PEDRO PABLO KUCZYNSKI GODARD
p.(None): Republic President
p.(None): PATRICIA J. GARCIA FUNEGRA
p.(None): Minister of Health
p.(None): TITLE I CLINICAL TRIALS REGULATION
p.(None): GENERAL DISPOSITION
p.(None): Article 1. Purpose
p.(None): The purpose of this Regulation is to establish the procedure for authorization, execution and actions
p.(None): after the execution of clinical trials in the country.
p.(None): Article 2. Operational definitions and abbreviations
p.(None): For the purposes of these Regulations, the
p.(None): following operational definitions and abbreviations
p.(None): 2.1 Operational definitions
p.(None): 1. Assent.- It is the process by which the authorization or permission granted in the form
p.(None): Documented the child or adolescent under 18 years, subject of research, to participate in the research. I know
p.(None): requests the assent of children who can understand the explanations. Generally considered
p.(None): that children from 8 years to adolescents under 18 years of age can give their assent.
p.(None): 2. Good Clinical Practices.- It is a standard for the design, conduction, realization, monitoring, audit,
p.(None): registration, analysis and reporting of clinical trials that provides assurance that data and
p.(None): results
p.(None): reported are credible and accurate, and that rights, integrity and confidentiality are protected
p.(None): of the subjects under investigation, as provided by the International Conference on Harmonization of Requirements
p.(None): Technicians for the Registration of Pharmaceutical Products for Human Use.
p.(None): 3. Cancellation of the clinical trial.- It is the definitive interruption of all the activities of
p.(None): a clinical trial in all research centers, for justified reasons. This procedure is given upon request
p.(None): of the sponsor or as a sanction applied by the INS OGITT.
p.(None): 4. Cancellation of the registration of a Research Center.- Procedure under which the
p.(None): permanent deactivation of the registration of the research center in the Peruvian Registry of Clinical Trials
p.(None): (REPEC) implying the disqualification of the research center to execute clinical trials. The
p.(None): Registration of a research center will be canceled at the request of the legal representative of the institution of
p.(None): investigation or as a sanction imposed by the INS OGITT.
p.(None): 5. Blinding.- Procedure in which one or more parts of the study do not know the assignments to the
p.(None): treatment. Generally, simple blinding refers to the fact that the research subjects are unaware of the
p.(None): assignment; double blinding refers to the fact that research subjects and researchers are unaware of the
p.(None): allocation to treatment; and, triple blinding refers to the research subjects, researchers and
p.(None): the one who analyzes the results does not know the treatment allocation.
...
p.(None): research subject or require an intervention to prevent one of the results initially noted in this
p.(None): definition.
p.(None): 42. Unexpected adverse reaction.- It is an adverse reaction whose nature or severity is not consistent with the
p.(None): information of the product under investigation, that is, it is not described in the researcher's manual and / or file
p.(None): technique.
p.(None): 43. Suspected serious and unexpected adverse reaction.- It is any serious adverse event in the
p.(None): that there is at least a reasonable possibility of a causal relationship with the product under investigation and whose
p.(None): nature or severity is not described in the researcher's manual and / or technical sheet.
p.(None): 44. Controversial situations.- That situation in which it is identified during the evaluation process of the
p.(None): clinical trial, that the benefit / risk balance is debatable.
p.(None): 45. Suspension of the clinical trial.- It is the temporary interruption of enrollment and / or
p.(None): administration of the investigational product, or of all clinical trial activities in all
p.(None): research centers. This procedure is given for just cause, at the request of the sponsor or
p.(None): as a security measure applied by OGITT.
p.(None): 46. Suspension of the registration of a Research center.- Procedure under which the
p.(None): temporary deactivation of the registration of the research center in REPEC, implying the disqualification
p.(None): research center to run new clinical trials or ongoing clinical trials.
p.(None): The registration of a research center will be suspended as a security measure imposed by the INS OGITT.
p.(None): 47. Witness.- Person of legal age, independent of the investigation team, who participates in the
p.(None): process of obtaining informed consent as a guarantee that it respects the rights and interests of a
p.(None): potential research subject.
p.(None): 2.2 Abbreviations
p.(None): 1. ANM: National Authority for Pharmaceutical Products, Medical Devices and Products
p.(None): Sanitary.
p.(None): 2. PCB: Good Clinical Practice.
p.(None): 3. BPM: Good Manufacturing Practices.
p.(None): 4. CIEI: Institutional Research Ethics Committee.
p.(None): 5. CIOMS: Council of International Organizations of Medical Sciences in Collaboration with WHO.
p.(None): 6. FCI: Informed consent form.
p.(None): 42 LEGAL STANDARDS Friday, June 30, 2017 /
p.(None): A Peruvian man
p.(None): 7. ICH: International Conference on Harmonization of Technical Requirements for Product Registration
p.(None): Pharmaceuticals for Human Use.
p.(None): 8. INS: National Institute of Health.
p.(None): 9. MINSA: Ministry of Health.
p.(None): 10. OGITT: General Office for Research and Technology Transfer.
p.(None): 11. OIC: Contract Research Organization.
p.(None): 12. REAS-NET: Virtual Reporting System of Serious Adverse Events.
p.(None): 13. RENIPRESS: National Registry of Institutions that Provide Health Services.
p.(None): 14. REPEC: Peruvian Registry of Clinical Trials.
p.(None): Article 3. Scope
p.(None): Natural or legal, public or natural persons are subject to the provisions of these regulations.
p.(None): private, national or foreign that carry out or are linked to clinical trials in human beings
p.(None): humans in the national territory
p.(None): Article 4. Purpose
...
p.(None): the society; Likewise, it can only continue if compliance with this criterion is permanently maintained.
p.(None): Article 11. Informed consent
p.(None): The written informed consent freely expressed by each of the parties will be obtained and documented.
p.(None): the research subjects, before their inclusion in the clinical trial, in the terms provided in Chapter II
p.(None): of Title III of these Regulations.
p.(None): The research subject can leave the clinical trial at any time without any justification and without
p.(None): suffer any prejudice for it, withdrawing himself or his legally designated representative, the
p.(None): informed consent. Withdrawal of informed consent will not affect activities that are already
p.(None): have made and used the data obtained based on informed consent before
p.(None): his retirement.
p.(None): Article 12. Clinical trials for promotional purposes
p.(None): In order to guarantee optimal protection of the health and rights of research subjects, they may not be
p.(None): carry out trials aimed at promoting an investigational product.
p.(None): Article 13. Design
p.(None): In designing the clinical trial, consideration shall be given to minimizing pain, discomfort, fear
p.(None): caused by the study procedures and any other possible risk related to the disease, age or
p.(None): degree of development of the research subject. The research subject is always above any
p.(None): objective or methodological design of a clinical trial.
p.(None): Article 14. Information to the research subject
p.(None): The research subjects will have as their reference instance the main researcher, the CIEI that authorized the
p.(None): clinical trial and the INS OGITT where they can obtain more information about the clinical trial and its
p.(None): rights, which will also appear in the informed consent document.
p.(None): Article 15. Clinical trials in vulnerable populations
p.(None): Clinical trials in vulnerable populations should be of specific interest to them, that is,
p.(None): respond to the health needs or priorities of this group.
p.(None): Likewise, it must be justified that the investigation cannot be carried out in a non-vulnerable population.
p.(None): TITLE III
p.(None): OF THE SUBJECTS OF INVESTIGATION CHAPTER I
p.(None): OF THE PROTECTION OF SUBJECTS OF INVESTIGATION
p.(None): Article 16. Subject of investigation
p.(None): The research subject is the individual who participates
p.(None): in a clinical trial and can be:
p.(None): El Peruano / Friday, June 30, 2017
p.(None): LEGAL STANDARDS 43
p.(None): a) A healthy person.
p.(None): b) A person (usually a patient) whose condition is relevant to the use of the product in
p.(None): investigation.
p.(None): Article 17. Protection of the research subject
p.(None): The performance of clinical trials in research subjects is carried out in accordance with the provisions of the
p.(None): this Chapter, without prejudice to the application of the general provisions established in Title II of the
p.(None): these Regulations.
p.(None): Article 18. Clinical trials in minors
p.(None): Clinical trials may be carried out on minors in accordance with the provisions of Title II of this
p.(None): Regulation and when:
p.(None): a) The protocol has been approved by a CIEI that has a pediatric specialist or has received
p.(None): advice on clinical, ethical and psychosocial aspects in the field of pediatrics if required.
p.(None): b) Obtaining informed consent is adjusted
p.(None): to what is specified in Chapter II of this Title.
p.(None): c) The minor who reaches the age of majority during the clinical trial, must provide their
p.(None): express informed consent before said research subject can continue participating in the
p.(None): clinical trial.
p.(None): Article 19. Clinical trials in people with disabilities
p.(None): Carrying out clinical trials in those who are not in a position to give their informed consent and who
p.(None): have not given it prior to the start of their disability, requires in addition to the provisions of the Title
p.(None): II of these Regulations:
p.(None): a) That informed consent is in accordance with
p.(None): specified in Chapter II of this Title.
p.(None): b) That the protocol be approved by a CIEI that has experts in the disease under study or has
p.(None): collected advice on clinical, ethical and psycho-social aspects in the field of disease and
p.(None): group of affected patients.
p.(None): Article 20. Clinical trials in women and men with reproductive capacity
p.(None): Carrying out clinical trials in women and men with reproductive capacity, except those
p.(None): clinical trials in which the objective of the study is to evaluate the product under investigation in population
p.(None): pregnant or planning to leave, can only be done when they are met in addition to what
p.(None): provided in Title II of these Regulations, the following conditions:
p.(None): a) For research in women with reproductive capacity, the principal investigator will perform a test of
p.(None): pregnancy to rule out pregnancy prior to study start and both investigator and sponsor
p.(None): assure counseling on the importance of avoiding pregnancy for the duration of your study participation and
p.(None): accessibility to an effective contraceptive method at no cost to the research subject, chosen by
p.(None): this and that it is not incompatible with the clinical trial. The researcher will ensure their commitment
p.(None): to use the chosen method. This must be specified in the research protocol and in the consent
p.(None): informed.
p.(None): If a pregnancy occurs during the study, the research protocol should establish:
p.(None): 1) The exclusion of the pregnant woman and 2) The application of the procedures for monitoring and
p.(None): control of the pregnancy, as well as of the newborn up to at least six (6) months of age, with the aim of
p.(None): identify any effect related to the product under investigation.
p.(None): Only in exceptional cases and after evaluation, the pregnant woman may continue participating in
p.(None): the clinical trial, as long as the conditions established in article 21 hereof are complied with
p.(None): Regulation.
p.(None): b) For research in males with reproductive capacity, and according to pharmacology, studies of
p.(None): genotoxicity, reproductive and developmental toxicity and available clinical information on intrauterine exposure to
p.(None): research product, researcher and sponsor will ensure accessibility to a method
p.(None): effective contraception at no cost to the research subject, chosen by him and other than
p.(None): incompatible with the clinical trial, which must be specified in the research protocol and in the
p.(None): informed consent. The researcher will ensure their commitment to prevent the conception of
p.(None): the couple during the development of the study, using the chosen contraceptive method.
p.(None): In case the partner of the research subject becomes pregnant, the monitoring and control of the
p.(None): gestation, as well as the newborn up to at least six (6) months of age, with the aim of
p.(None): identify any effect related to the product under investigation.
p.(None): Article 21. Clinical trials in pregnant women
p.(None): Carrying out clinical trials in pregnant women can only be carried out when they are completed, in addition to
p.(None): provided in Title II of these Regulations, the following conditions:
p.(None): a) The informed consent of the pregnant woman and the father of the intended child will be required, with prior information from the
p.(None): possible risks for the embryo, fetus or newborn, as the case may be.
p.(None): b) The informed consent of the father of the child conceived in the case set forth in the preceding paragraph
p.(None): may only be excepted in case of death, irrefutable impossibility, loss of rights
p.(None): in accordance with current regulations or, when there is an imminent risk to the health or life of the
p.(None): woman or conceived.
p.(None): c) Informed consent may be withdrawn at the request of the pregnant woman or the father of the child conceived in
...
p.(None): through the respective format. This format must be
p.(None): signed, dated and with the time indicated by the research subject or his legal representative and by the researcher
p.(None): who drove the process. A copy must be given to the research subject.
p.(None): f) If the research subject cannot read and write, they will print their fingerprint as a sign of compliance.
p.(None): In the event that the research subject has a disability that prevents him from signing or printing his
p.(None): fingerprint, another means that evidences your consent may be accepted. In both cases, additionally,
p.(None): Another person he designates and who does not belong to the investigation team must sign as a witness.
p.(None): g) The process of obtaining informed consent must be part of the medical history
p.(None): of the research subject, including start date and time, which was provided to the research subject
p.(None): enough time to reflect and ask questions, the understanding of the information was verified, two were signed
p.(None): copies of the informed consent form and one of them was given to the research subject or his representative
p.(None): legal.
p.(None): The informed consent of minors must meet the same consent requirements
p.(None): informed as appropriate and should be done using language that takes into account the evolution of
p.(None): faculties according to their age and maturity to allow their understanding, having to register their name and / or signature in
p.(None): sign of your authorization.
p.(None): Article 34. Requirements for the informed consent format
p.(None): The informed consent form of the subject of
p.(None): Research is subject to the following requirements:
p.(None): a) Be prepared by the main researcher, sponsor or both, with the information indicated in
p.(None): literal d) of this article and according to the model of the Informed Consent Form established in
p.(None): Annex 4 of these Regulations.
p.(None): b) Be reviewed and approved by a CIEI of the institution where the clinical trial will be conducted, accredited by
p.(None): the INS, in accordance with the provisions of Chapter VII of Title IV of these Regulations.
p.(None): c) The consent must be written in Spanish and in the language that the research subject identifies as
p.(None): own; the wording must be understandable to him.
p.(None): d) You must enter, among others, the following information:
p.(None): - The title of the clinical trial.
p.(None): - The explicit invitation to participate in an experimental research study and the
p.(None): voluntary nature of participation.
p.(None): - The justification, objectives and purpose of the clinical trial.
p.(None): - Trial treatments or interventions: investigational product, active comparator and do
p.(None): reference to placebo and blinding if applicable, as well as the probability of allocation for
p.(None): each intervention.
...
p.(None): - The commitment to provide you with updated information about the product or the procedure in
p.(None): research or when the research subject requests it, although it may affect the will of the
p.(None): research subject to continue participating.
p.(None): - The circumstances and / or anticipated reasons why the clinical trial could end or
p.(None): the participation of the research subject in it.
p.(None): - The availability of medical treatment and the compensation to which you would legally be entitled, for
p.(None): party responsible for the clinical trial, in the case of damages that directly affect it, caused by
p.(None): the investigation, pointing out the existence of the insurance contracted by the sponsor.
p.(None): - The detail of the financial compensation for additional expenses, such as transportation, accommodation, communication, and
p.(None): food if they exist; which will be covered by the budget of the clinical trial.
p.(None): - In the event that the woman or the man are in reproductive capacity, the
p.(None): potential risks in the event of her or his partner's pregnancy, and that a
p.(None): effective contraceptive method chosen by the participant and their partner.
p.(None): - That in the event of a pregnancy of the research subject or his partner, he must report the fact to the
p.(None): investigator. In addition, the format must establish whether such condition is considered grounds for exclusion from the
p.(None): clinical trial. Likewise, it will indicate the application of the procedures for the monitoring and control of the
p.(None): gestation and newborn to at least six
p.(None): (6) months of age in order to identify any effect related to the research product. The
p.(None): expenses that such monitoring demands will be financed by the sponsor. The sponsor will be
p.(None): responsible for the respective compensation for damages produced during the pregnancy or that had been
p.(None): caused to the newborn as a consequence of the clinical trial.
p.(None): - Specify the time, means and responsible for which the research subject will be provided
p.(None): the final results of the clinical trial, which must be in a language understandable to him.
p.(None): - Inform the research subject about post-study access and according to the considerations
p.(None): indicated in Title X of these Regulations.
p.(None): - The existence of a description of the clinical trial available in the Peruvian Registry of Clinical Trials and accessible
p.(None): through the INS institutional web portal
p.(None): - The contact information of the OGITT of the INS, according to what is indicated in number 21 of Annex 4 of the
p.(None): these Regulations.
p.(None): The informed consent form for minors must meet the same requirements as the
p.(None): informed consent where appropriate.
p.(None): If the clinical trial contemplates the collection and storage of biological samples for future use,
p.(None): It must be explained in an additional informed consent format as indicated in the Manual of
p.(None): Clinical trial procedures.
p.(None): Article 35. Compensation to research subjects
p.(None): Research subjects may receive reasonable compensation from the sponsor for expenses
...
p.(None): terminated by marriage or by obtaining an official title authorizing you to exercise a profession or trade,
p.(None): in accordance with the provisions of the Civil Code.
p.(None): c) Obtain the consent of the minor, from
p.(None): 8 years old, to participate as a research subject.
p.(None): d) Give the minor information appropriate to their ability to understand the clinical trial, the risks, the
p.(None): discomforts and benefits.
p.(None): e) Accept the withdrawal of informed consent or assent at the request of a parent / guardian
p.(None): or the minor at any time, without prejudice to them, as long as it does not affect or put
p.(None): your health at risk.
p.(None): f) Opt for the exclusion of the minor from considering a conflict of opinion between the parent (s) and
p.(None): the minor on participation in the clinical trial.
p.(None): Informed parental consent is not required if the research subject is a minor
p.(None): age of 16 years or more and whose relative disability has ceased by marriage or by obtaining an official title that
p.(None): authorize you to exercise a profession or trade, in accordance with the provisions of the Civil Code.
p.(None): Article 37. Research subject with mental or intellectual disability
p.(None): When the research subject is a person with a mental or intellectual disability, it must be taken into account
p.(None): the next:
p.(None): a) Obtain the informed written consent of the research subject to participate in the clinical trial,
p.(None): after having received all the relevant information adapted to your level of understanding. Consent must
p.(None): employ tools and strategies to ensure understanding of research subjects. The
p.(None): Informed consent may be withdrawn at any time, without prejudice to it, as long as it is not
p.(None): affect or jeopardize your health.
p.(None): b) In the case of research subjects whose mental disability prevents them from expressing their free will,
p.(None): based on a full understanding of informed consent, it will be granted through your representative
p.(None): legal, after being informed about the possible risks, discomforts and benefits of the trial
p.(None): clinical. The consent may be withdrawn at any time, through its legal representative, without prejudice
p.(None): for the person. Safeguards must be guaranteed by the different actors in the investigation.
...
p.(None): l) Have a valid insurance policy
p.(None): m) List of additional supplies necessary for the execution of the clinical trial (if required),
p.(None): according to the format established in the Manual of Clinical Trial Procedures.
p.(None): n) Proof of payment of processing fees for each additional research center.
p.(None): Article 77. Modification by extension or modification of the list of supplies to import.
p.(None): To request the modification by extension or modification of the list of supplies to import,
p.(None): the sponsor or the ICO must present the following documents, duly foliated:
p.(None): a) Request for expansion or modification of the supply list.
p.(None): b) Report justifying the reasons for the expansion or modification of the supply list.
p.(None): c) Additional or modified detailed list of supplies necessary for the execution of the test
p.(None): clinical, according to the model established in the Clinical Trials Procedure Manual.
p.(None): Article 78. Change of sponsor or Contract Research Organization
p.(None): To communicate the change of the sponsor or ICO, the current sponsor or ICO must present the
p.(None): following duly foliated documents:
p.(None): a) Letter communicating the change of sponsor or
p.(None): of OIC.
p.(None): b) Report justifying the reasons for the change of sponsor or OIC.
p.(None): El Peruano / Friday, June 30, 2017
p.(None): LEGAL STANDARDS 53
p.(None): c) Letter of resignation from the sponsor or the ICO.
p.(None): d) Letter of acceptance from the sponsor or new OIC.
p.(None): e) Copy of the letter of knowledge of the CIEI that approved the study, having learned of the new
p.(None): sponsor or the new ICO.
p.(None): f) Copy of delegation of responsibilities of the foreign sponsor to the new ICO, issued with a
p.(None): age not greater than ninety (90) calendar days, duly apostilled as established by the
p.(None): Apostille Convention or Hague Convention of October 5, 1961, when applicable, or legalized by the
p.(None): Peruvian Ministry of Foreign Affairs.
p.(None): g) Proof of payment of processing fees.
p.(None): Article 79. Change of principal investigator
p.(None): To communicate the change of the principal investigator, the sponsor or the ICO must submit the following
p.(None): documents, duly foliated:
p.(None): a) Request to change the principal investigator.
p.(None): b) Report justifying the reasons for the change of principal investigator.
p.(None): c) Letter of resignation from the previous principal investigator.
p.(None): d) Letter of acceptance from the principal investigator
p.(None): proposed.
p.(None): e) Undocumented updated curriculum vitae of the proposed principal investigator, according to model
p.(None): established in the Manual of Clinical Trial Procedures.
p.(None): f) New informed consent forms (s) approved by the CIEI that approved the study, recording the
p.(None): data from the proposed principal investigator.
p.(None): g) Copy of the document issued by the CIEI that approved the study, where it is indicated that the knowledge of the
p.(None): proposed principal investigator or the CIEI informed consent form approval document
p.(None): referenced by literal f.
p.(None): h) Proof of payment of processing fees.
p.(None): Article 80. Request for an extension of the time to carry out the clinical trial
p.(None): To request the extension of the time to conduct the clinical trial, the sponsor or OIC, with thirty (30) days
p.(None): calendar prior to the end of the clinical trial, must present the following
p.(None): documents, duly foliated:
p.(None): a) Request for extension of time.
...
p.(None): conducted in different animal species with the following titles when appropriate:
p.(None): - Single dose.
p.(None): - Multiple dose.
p.(None): - Carcinogenicity.
p.(None): - Special Studies (for example, irritation and sensitization).
p.(None): - Reproductive toxicity.
p.(None): - Genotoxicity (mutagenicity).
p.(None): CLINICAL STUDIES
p.(None): Introduction:
p.(None): An in-depth discussion of the known effects of the investigational product should be provided in
p.(None): human, including information on pharmacokinetics, metabolism, pharmacodynamics, dose response
p.(None): (dose / response), safety, efficacy and other pharmacological activities. Whenever possible,
p.(None): provide a summary of each specific clinical study. Information must also be provided
p.(None): Regarding the results of any use of the product in research other than that of the studies
p.(None): clinical, such as experience during marketing.
p.(None): (a) Pharmacokinetics and Product Metabolism in Humans
p.(None): El Peruano / Friday, June 30, 2017
p.(None): LEGAL STANDARDS 63
p.(None): A summary of the information on the pharmacokinetics of the investigational product must be presented,
p.(None): including the following, if available:
p.(None): - Pharmacokinetics (including metabolism, as appropriate, and absorption, binding of plasma proteins,
p.(None): distribution and disposal).
p.(None): - Bioavailability of the product under investigation
p.(None): ANNEX 3
p.(None): MINIMUM REQUIREMENTS OF A RESEARCH CENTER
p.(None): CONDITIONING OBSERVATIONS
p.(None): Hospitalization area
p.(None): It is an independent environment
p.(None): (absolute, where possible and / or relative) using a reference dosage form. Subgroups
p.(None): population (for example, sex, age and altered organic function).
p.(None): - Interactions (for example, interactions between the investigational product and other medicinal products and the effects of
p.(None): the food).
p.(None): - Other pharmacokinetic data (for example, results of population studies conducted within
p.(None): Clinical studies).
p.(None): (b) Safety and Efficacy
p.(None): A summary of information on safety, pharmacodynamics, efficacy, and dose response should be provided.
p.(None): (dose / response) of the investigational product (including metabolites, when applicable) that has been
p.(None): obtained in previous studies in humans (healthy volunteers and / or patients). The
p.(None): implications of this information. In these cases in which several clinical studies have been
p.(None): completed, using safety and efficacy summaries across multiple indication studies
p.(None): in subgroups it can provide a clear presentation of the data. They could be useful
p.(None): tabular summaries of adverse reactions of all indications studied). Should be discussed
p.(None): significant differences in patterns / incidence of adverse reactions through indications or
p.(None): subgroups.
p.(None): The Investigator's Manual should provide a description of the possible risks and reactions
p.(None): adverse events that are anticipated, based on previous experiences with the product under investigation and with
p.(None): related products. A description of the precautions or special monitoring that must be
p.(None): will be carried out as part of the use of the research product.
p.(None): EXPERIENCE AFTER ITS MARKETING
p.(None): The Investigator's Manual should identify the countries where it has been commercialized or approved
p.(None): the product under investigation.
p.(None): Any significant information arising from the commercialized use should be summarized, for example,
...
Social / Child
Searching for indicator child:
(return to top)
p.(None): Health and Law No. 29158, Organic Law of the Executive Power;
p.(None): DECREES:
p.(None): Article 1.- Approval
p.(None): Approve the Clinical Trials Regulation, which consists of twelve (12) titles, one hundred thirty-seven (137)
p.(None): articles, eight (8) final complementary provisions, two transitory complementary provisions and five (5)
p.(None): annexes, which is an integral part of this Supreme Decree.
p.(None): Article 2.- Endorsement
p.(None): This Supreme Decree is endorsed by the Minister of Health.
p.(None): SUPPLEMENTARY DEROGATORY PROVISION
p.(None): Sole.- Repeal
p.(None): Repeal Supreme Decree No. 017-2006-SA, which approved the Regulation of Clinical Trials in Peru and its
p.(None): amending, as well as Supreme Decree No. 020-2015-SA, which dictates temporary preventive measures, inspection
p.(None): and supervision of clinical trials.
p.(None): Given at the Government House, in Lima, on the twenty-eighth day of the month of June of the year two thousand seventeen.
p.(None): PEDRO PABLO KUCZYNSKI GODARD
p.(None): Republic President
p.(None): PATRICIA J. GARCIA FUNEGRA
p.(None): Minister of Health
p.(None): TITLE I CLINICAL TRIALS REGULATION
p.(None): GENERAL DISPOSITION
p.(None): Article 1. Purpose
p.(None): The purpose of this Regulation is to establish the procedure for authorization, execution and actions
p.(None): after the execution of clinical trials in the country.
p.(None): Article 2. Operational definitions and abbreviations
p.(None): For the purposes of these Regulations, the
p.(None): following operational definitions and abbreviations
p.(None): 2.1 Operational definitions
p.(None): 1. Assent.- It is the process by which the authorization or permission granted in the form
p.(None): Documented the child or adolescent under 18 years, subject of research, to participate in the research. I know
p.(None): requests the assent of children who can understand the explanations. Generally considered
p.(None): that children from 8 years to adolescents under 18 years of age can give their assent.
p.(None): 2. Good Clinical Practices.- It is a standard for the design, conduction, realization, monitoring, audit,
p.(None): registration, analysis and reporting of clinical trials that provides assurance that data and
p.(None): results
p.(None): reported are credible and accurate, and that rights, integrity and confidentiality are protected
p.(None): of the subjects under investigation, as provided by the International Conference on Harmonization of Requirements
p.(None): Technicians for the Registration of Pharmaceutical Products for Human Use.
p.(None): 3. Cancellation of the clinical trial.- It is the definitive interruption of all the activities of
p.(None): a clinical trial in all research centers, for justified reasons. This procedure is given upon request
p.(None): of the sponsor or as a sanction applied by the INS OGITT.
p.(None): 4. Cancellation of the registration of a Research Center.- Procedure under which the
p.(None): permanent deactivation of the registration of the research center in the Peruvian Registry of Clinical Trials
p.(None): (REPEC) implying the disqualification of the research center to execute clinical trials. The
p.(None): Registration of a research center will be canceled at the request of the legal representative of the institution of
p.(None): investigation or as a sanction imposed by the INS OGITT.
...
p.(None): genotoxicity, reproductive and developmental toxicity and available clinical information on intrauterine exposure to
p.(None): research product, researcher and sponsor will ensure accessibility to a method
p.(None): effective contraception at no cost to the research subject, chosen by him and other than
p.(None): incompatible with the clinical trial, which must be specified in the research protocol and in the
p.(None): informed consent. The researcher will ensure their commitment to prevent the conception of
p.(None): the couple during the development of the study, using the chosen contraceptive method.
p.(None): In case the partner of the research subject becomes pregnant, the monitoring and control of the
p.(None): gestation, as well as the newborn up to at least six (6) months of age, with the aim of
p.(None): identify any effect related to the product under investigation.
p.(None): Article 21. Clinical trials in pregnant women
p.(None): Carrying out clinical trials in pregnant women can only be carried out when they are completed, in addition to
p.(None): provided in Title II of these Regulations, the following conditions:
p.(None): a) The informed consent of the pregnant woman and the father of the intended child will be required, with prior information from the
p.(None): possible risks for the embryo, fetus or newborn, as the case may be.
p.(None): b) The informed consent of the father of the child conceived in the case set forth in the preceding paragraph
p.(None): may only be excepted in case of death, irrefutable impossibility, loss of rights
p.(None): in accordance with current regulations or, when there is an imminent risk to the health or life of the
p.(None): woman or conceived.
p.(None): c) Informed consent may be withdrawn at the request of the pregnant woman or the father of the child conceived in
p.(None): any time, without prejudice to them, as long as it does not affect or put into
p.(None): risk to the conceived or the mother.
p.(None): d) In the case of pregnant adolescents, the procedure established in article 18 hereof shall be followed.
p.(None): Regulation.
p.(None): e) Research in pregnant women must be preceded by trials carried out on women not
p.(None): pregnant women who demonstrate their safety, with the exception of specific tests that require this condition.
p.(None): f) When they are intended to improve the health of pregnant women and represent only a minimal risk to
p.(None): designed or intended to increase the viability of the product of pregnancy, with minimal risk
p.(None): for the pregnant woman.
p.(None): g) During the execution of investigations in pregnant women, the investigators will not have authority to
p.(None): decide on the time, method or procedure used to end the pregnancy, nor will they participate in
p.(None): decisions on the viability of the conceived.
p.(None): Article 22. Clinical trials during labor, postpartum and lactation
p.(None): Carrying out clinical trials in women during labor, the puerperium and lactation can only be done
p.(None): carry out when, in addition to the provisions of Title II of these Regulations, the
p.(None): following conditions:
p.(None): a) Informed consent for research during labor must be obtained according to the
p.(None): stipulated in Chapter II of this Title, before labor begins.
p.(None): b) The clinical trial has the potential to generate direct benefits greater than the risks for women
p.(None): breastfeeding or child after birth.
p.(None): c) The risk to the infant is minimal.
p.(None): d) In the case of adolescents, proceed according to
p.(None): the provisions of article 18 of these Regulations.
p.(None): e) Informed consent may be withdrawn at the request of the woman or the father of the person conceived in any
p.(None): moment, without prejudice to them, as long as
p.(None): 44 LEGAL STANDARDS Friday, June 30, 2017 /
p.(None): A Peruvian man
p.(None): when it does not affect or put at risk the conceived or the
p.(None): mother.
p.(None): Article 23. Clinical Trials in fetuses and deaths
p.(None): Carrying out clinical trials on fetuses and deaths can only be carried out, in addition to the provisions of Title II
p.(None): of this Regulation according to the following criteria:
p.(None): a) Investigations into embryos are found
p.(None): prohibited.
p.(None): b) Research on fetuses can only be carried out if the techniques and means used provide the maximum
p.(None): safety for the fetus and the pregnant woman.
p.(None): c) Investigations with deaths, natimes, macerated fetal matter, cells, tissues, placenta, cord
p.(None): umbilical, embryonic remains and organs removed from them, will be made observing due respect
p.(None): the pregnant woman or the product of pregnancy in a situation of death or corpse and the applicable provisions
...
Searching for indicator children:
(return to top)
p.(None): Approve the Clinical Trials Regulation, which consists of twelve (12) titles, one hundred thirty-seven (137)
p.(None): articles, eight (8) final complementary provisions, two transitory complementary provisions and five (5)
p.(None): annexes, which is an integral part of this Supreme Decree.
p.(None): Article 2.- Endorsement
p.(None): This Supreme Decree is endorsed by the Minister of Health.
p.(None): SUPPLEMENTARY DEROGATORY PROVISION
p.(None): Sole.- Repeal
p.(None): Repeal Supreme Decree No. 017-2006-SA, which approved the Regulation of Clinical Trials in Peru and its
p.(None): amending, as well as Supreme Decree No. 020-2015-SA, which dictates temporary preventive measures, inspection
p.(None): and supervision of clinical trials.
p.(None): Given at the Government House, in Lima, on the twenty-eighth day of the month of June of the year two thousand seventeen.
p.(None): PEDRO PABLO KUCZYNSKI GODARD
p.(None): Republic President
p.(None): PATRICIA J. GARCIA FUNEGRA
p.(None): Minister of Health
p.(None): TITLE I CLINICAL TRIALS REGULATION
p.(None): GENERAL DISPOSITION
p.(None): Article 1. Purpose
p.(None): The purpose of this Regulation is to establish the procedure for authorization, execution and actions
p.(None): after the execution of clinical trials in the country.
p.(None): Article 2. Operational definitions and abbreviations
p.(None): For the purposes of these Regulations, the
p.(None): following operational definitions and abbreviations
p.(None): 2.1 Operational definitions
p.(None): 1. Assent.- It is the process by which the authorization or permission granted in the form
p.(None): Documented the child or adolescent under 18 years, subject of research, to participate in the research. I know
p.(None): requests the assent of children who can understand the explanations. Generally considered
p.(None): that children from 8 years to adolescents under 18 years of age can give their assent.
p.(None): 2. Good Clinical Practices.- It is a standard for the design, conduction, realization, monitoring, audit,
p.(None): registration, analysis and reporting of clinical trials that provides assurance that data and
p.(None): results
p.(None): reported are credible and accurate, and that rights, integrity and confidentiality are protected
p.(None): of the subjects under investigation, as provided by the International Conference on Harmonization of Requirements
p.(None): Technicians for the Registration of Pharmaceutical Products for Human Use.
p.(None): 3. Cancellation of the clinical trial.- It is the definitive interruption of all the activities of
p.(None): a clinical trial in all research centers, for justified reasons. This procedure is given upon request
p.(None): of the sponsor or as a sanction applied by the INS OGITT.
p.(None): 4. Cancellation of the registration of a Research Center.- Procedure under which the
p.(None): permanent deactivation of the registration of the research center in the Peruvian Registry of Clinical Trials
p.(None): (REPEC) implying the disqualification of the research center to execute clinical trials. The
p.(None): Registration of a research center will be canceled at the request of the legal representative of the institution of
p.(None): investigation or as a sanction imposed by the INS OGITT.
p.(None): 5. Blinding.- Procedure in which one or more parts of the study do not know the assignments to the
p.(None): treatment. Generally, simple blinding refers to the fact that the research subjects are unaware of the
p.(None): assignment; double blinding refers to the fact that research subjects and researchers are unaware of the
p.(None): allocation to treatment; and, triple blinding refers to the research subjects, researchers and
...
Social / Fetus/Neonate
Searching for indicator fetus:
(return to top)
p.(None): research product, researcher and sponsor will ensure accessibility to a method
p.(None): effective contraception at no cost to the research subject, chosen by him and other than
p.(None): incompatible with the clinical trial, which must be specified in the research protocol and in the
p.(None): informed consent. The researcher will ensure their commitment to prevent the conception of
p.(None): the couple during the development of the study, using the chosen contraceptive method.
p.(None): In case the partner of the research subject becomes pregnant, the monitoring and control of the
p.(None): gestation, as well as the newborn up to at least six (6) months of age, with the aim of
p.(None): identify any effect related to the product under investigation.
p.(None): Article 21. Clinical trials in pregnant women
p.(None): Carrying out clinical trials in pregnant women can only be carried out when they are completed, in addition to
p.(None): provided in Title II of these Regulations, the following conditions:
p.(None): a) The informed consent of the pregnant woman and the father of the intended child will be required, with prior information from the
p.(None): possible risks for the embryo, fetus or newborn, as the case may be.
p.(None): b) The informed consent of the father of the child conceived in the case set forth in the preceding paragraph
p.(None): may only be excepted in case of death, irrefutable impossibility, loss of rights
p.(None): in accordance with current regulations or, when there is an imminent risk to the health or life of the
p.(None): woman or conceived.
p.(None): c) Informed consent may be withdrawn at the request of the pregnant woman or the father of the child conceived in
p.(None): any time, without prejudice to them, as long as it does not affect or put into
p.(None): risk to the conceived or the mother.
p.(None): d) In the case of pregnant adolescents, the procedure established in article 18 hereof shall be followed.
p.(None): Regulation.
p.(None): e) Research in pregnant women must be preceded by trials carried out on women not
p.(None): pregnant women who demonstrate their safety, with the exception of specific tests that require this condition.
...
p.(None): stipulated in Chapter II of this Title, before labor begins.
p.(None): b) The clinical trial has the potential to generate direct benefits greater than the risks for women
p.(None): breastfeeding or child after birth.
p.(None): c) The risk to the infant is minimal.
p.(None): d) In the case of adolescents, proceed according to
p.(None): the provisions of article 18 of these Regulations.
p.(None): e) Informed consent may be withdrawn at the request of the woman or the father of the person conceived in any
p.(None): moment, without prejudice to them, as long as
p.(None): 44 LEGAL STANDARDS Friday, June 30, 2017 /
p.(None): A Peruvian man
p.(None): when it does not affect or put at risk the conceived or the
p.(None): mother.
p.(None): Article 23. Clinical Trials in fetuses and deaths
p.(None): Carrying out clinical trials on fetuses and deaths can only be carried out, in addition to the provisions of Title II
p.(None): of this Regulation according to the following criteria:
p.(None): a) Investigations into embryos are found
p.(None): prohibited.
p.(None): b) Research on fetuses can only be carried out if the techniques and means used provide the maximum
p.(None): safety for the fetus and the pregnant woman.
p.(None): c) Investigations with deaths, natimes, macerated fetal matter, cells, tissues, placenta, cord
p.(None): umbilical, embryonic remains and organs removed from them, will be made observing due respect
p.(None): the pregnant woman or the product of pregnancy in a situation of death or corpse and the applicable provisions
p.(None): in the Regulations of the Cemeteries and Funeral Services Law, as appropriate.
p.(None): Article 24. Of clinical trials in subordinate groups
p.(None): The performance of clinical trials in subordinate groups can only be carried out when they are completed, in addition
p.(None): of the provisions of Title II of these Regulations, the following conditions:
p.(None): a) When research is carried out in subordinate groups, one or more members must participate in the CIEI
p.(None): of the study population, or another person in society capable of protecting the conditions and rights
p.(None): humans that correspond to the group in question.
p.(None): b) Participation, rejection or withdrawal of their consent during the study of the subjects
p.(None): under investigation, do not affect your academic, work, military or judicial situation
p.(None): to which they were subject and the conditions of compliance with the judgment, if applicable; and that
p.(None): research results are not used to their detriment.
p.(None): Article 25. Clinical trials in indigenous or native peoples
...
p.(None): have completed, unless your storage is contemplated for future use.
p.(None): d) Storage of biological samples or their remnants for future studies: If you plan to store samples
p.(None): remnants beyond the end of the clinical trial and / or biological samples will be removed for
p.(None): storage and future studies, should be incorporated into a specific informed consent form for
p.(None): such an end.
p.(None): e) Information on the results of the tests carried out. It should include:
p.(None): - Your results will be explained to you
p.(None): - Who will inform you
p.(None): - At what time will you be informed
p.(None): - Justification in case of not revealing data temporarily or permanently.
p.(None): 12) Risks and inconveniences derived from the trial
p.(None): clinical
p.(None): a) Risks of the experimental research product, the comparator and any other medication
p.(None): used for clinical trial purposes. Clearly indicate, in a language and language that the subject understands, the
p.(None): reasonably expected risks or discomforts (according to the Investigator's Manual or technical sheet) as well as the possibility
p.(None): of serious events or other unexpected events, or the non-relief or worsening of the symptoms of the pathology of
p.(None): study.
p.(None): b) Risks and inconveniences of the procedures of the
p.(None): clinical trial.
p.(None): c) Risks and measures of prevention and protection against pregnancy of the research subject or his partner. Should
p.(None): include:
p.(None): - Potential risks in case of pregnancy for the
p.(None): fetus or lactating embryo.
p.(None): - Pregnancy tests: initial and additional
p.(None): - Free access and list of contraceptive methods to be chosen by the research subject and his partner,
p.(None): that they are suitable for the test, as well as the time that their use is necessary.
p.(None): - Procedure to follow in case of pregnancy of the research subject or his partner: communication
p.(None): immediately to the investigator, suspension of treatment, withdrawal of the study, monitoring of pregnancy and
p.(None): newborn for 6 months, compensation in case of damage as a result of the clinical trial.
p.(None): 13) Commitments assumed by the research subject if he agrees to participate in the study.
p.(None): 14) Available alternatives.
p.(None): Specify if there are therapeutic, prevention or diagnostic alternatives currently available in the
p.(None): country.
p.(None): El Peruano / Friday, June 30, 2017
p.(None): LEGAL STANDARDS 65
p.(None): 15) Benefits derived from the study
p.(None): In general, it cannot be guaranteed that the product under investigation will directly benefit the subject, since
p.(None): this is what you want to try, so it is more appropriate to use the phrase: "you may or may not benefit from the
p.(None): study medication ”or“ your medical condition may improve, stay the same, and even worsen with
p.(None): study medication ”.
p.(None): The benefits can be divided into benefits for the individual and benefits for their community or for the
p.(None): entire society if an answer to the research question is found.
p.(None): 16) Compensation and treatment in case of damage or injury for your participation in the trial.
p.(None): a) Free medical attention and treatment in case of injury or any adverse event as a result of the
...
Searching for indicator fetuses:
(return to top)
p.(None): decide on the time, method or procedure used to end the pregnancy, nor will they participate in
p.(None): decisions on the viability of the conceived.
p.(None): Article 22. Clinical trials during labor, postpartum and lactation
p.(None): Carrying out clinical trials in women during labor, the puerperium and lactation can only be done
p.(None): carry out when, in addition to the provisions of Title II of these Regulations, the
p.(None): following conditions:
p.(None): a) Informed consent for research during labor must be obtained according to the
p.(None): stipulated in Chapter II of this Title, before labor begins.
p.(None): b) The clinical trial has the potential to generate direct benefits greater than the risks for women
p.(None): breastfeeding or child after birth.
p.(None): c) The risk to the infant is minimal.
p.(None): d) In the case of adolescents, proceed according to
p.(None): the provisions of article 18 of these Regulations.
p.(None): e) Informed consent may be withdrawn at the request of the woman or the father of the person conceived in any
p.(None): moment, without prejudice to them, as long as
p.(None): 44 LEGAL STANDARDS Friday, June 30, 2017 /
p.(None): A Peruvian man
p.(None): when it does not affect or put at risk the conceived or the
p.(None): mother.
p.(None): Article 23. Clinical Trials in fetuses and deaths
p.(None): Carrying out clinical trials on fetuses and deaths can only be carried out, in addition to the provisions of Title II
p.(None): of this Regulation according to the following criteria:
p.(None): a) Investigations into embryos are found
p.(None): prohibited.
p.(None): b) Research on fetuses can only be carried out if the techniques and means used provide the maximum
p.(None): safety for the fetus and the pregnant woman.
p.(None): c) Investigations with deaths, natimes, macerated fetal matter, cells, tissues, placenta, cord
p.(None): umbilical, embryonic remains and organs removed from them, will be made observing due respect
p.(None): the pregnant woman or the product of pregnancy in a situation of death or corpse and the applicable provisions
p.(None): in the Regulations of the Cemeteries and Funeral Services Law, as appropriate.
p.(None): Article 24. Of clinical trials in subordinate groups
p.(None): The performance of clinical trials in subordinate groups can only be carried out when they are completed, in addition
p.(None): of the provisions of Title II of these Regulations, the following conditions:
p.(None): a) When research is carried out in subordinate groups, one or more members must participate in the CIEI
p.(None): of the study population, or another person in society capable of protecting the conditions and rights
p.(None): humans that correspond to the group in question.
p.(None): b) Participation, rejection or withdrawal of their consent during the study of the subjects
p.(None): under investigation, do not affect your academic, work, military or judicial situation
p.(None): to which they were subject and the conditions of compliance with the judgment, if applicable; and that
p.(None): research results are not used to their detriment.
...
Social / Infant
Searching for indicator infant:
(return to top)
p.(None): designed or intended to increase the viability of the product of pregnancy, with minimal risk
p.(None): for the pregnant woman.
p.(None): g) During the execution of investigations in pregnant women, the investigators will not have authority to
p.(None): decide on the time, method or procedure used to end the pregnancy, nor will they participate in
p.(None): decisions on the viability of the conceived.
p.(None): Article 22. Clinical trials during labor, postpartum and lactation
p.(None): Carrying out clinical trials in women during labor, the puerperium and lactation can only be done
p.(None): carry out when, in addition to the provisions of Title II of these Regulations, the
p.(None): following conditions:
p.(None): a) Informed consent for research during labor must be obtained according to the
p.(None): stipulated in Chapter II of this Title, before labor begins.
p.(None): b) The clinical trial has the potential to generate direct benefits greater than the risks for women
p.(None): breastfeeding or child after birth.
p.(None): c) The risk to the infant is minimal.
p.(None): d) In the case of adolescents, proceed according to
p.(None): the provisions of article 18 of these Regulations.
p.(None): e) Informed consent may be withdrawn at the request of the woman or the father of the person conceived in any
p.(None): moment, without prejudice to them, as long as
p.(None): 44 LEGAL STANDARDS Friday, June 30, 2017 /
p.(None): A Peruvian man
p.(None): when it does not affect or put at risk the conceived or the
p.(None): mother.
p.(None): Article 23. Clinical Trials in fetuses and deaths
p.(None): Carrying out clinical trials on fetuses and deaths can only be carried out, in addition to the provisions of Title II
p.(None): of this Regulation according to the following criteria:
p.(None): a) Investigations into embryos are found
p.(None): prohibited.
p.(None): b) Research on fetuses can only be carried out if the techniques and means used provide the maximum
p.(None): safety for the fetus and the pregnant woman.
p.(None): c) Investigations with deaths, natimes, macerated fetal matter, cells, tissues, placenta, cord
p.(None): umbilical, embryonic remains and organs removed from them, will be made observing due respect
p.(None): the pregnant woman or the product of pregnancy in a situation of death or corpse and the applicable provisions
p.(None): in the Regulations of the Cemeteries and Funeral Services Law, as appropriate.
p.(None): Article 24. Of clinical trials in subordinate groups
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.(None): a) The information disseminated makes it clear that the participation of the potential research subject occurs in
p.(None): the framework of a clinical trial.
p.(None): b) The information disseminated is not coercive and a favorable result or others are not affirmed with certainty
p.(None): benefits beyond what is stated in the protocol and informed consent format.
p.(None): c) It is not stated implicitly or explicitly that the product under investigation is effective and / or safe or that it is
p.(None): equivalent or better than other existing products.
p.(None): d) The advertisements do not offer “free medical treatment”, when the intention is to say that participating in
p.(None): the research does not represent any cost to the research subject.
p.(None): CHAPTER II
p.(None): OF INFORMED CONSENT
p.(None): Article 33. Obtaining informed consent
p.(None): To obtain informed consent,
p.(None): They should follow the following considerations:
p.(None): a) The informed consent process must be conducted by the principal investigator or a
p.(None): researcher trained and authorized to do so in the delegation of functions form.
p.(None): b) Verbal and written information related to the clinical trial must be provided to the potential subject
p.(None): of investigation or, failing that, to your legal representative before obtaining your informed consent.
p.(None): This information must be presented in a clear, accurate, complete, truthful and understandable language and language for
p.(None): he, during a previous interview. During the informed consent process, new
p.(None): Evidence-based tools and strategies that improve the understanding of research subjects. I know
p.(None): You must verify that the latter has understood the information received.
p.(None): c) The research subject, or failing that to his legal representative, will be provided with the time
p.(None): enough for you to reflect on your decision to participate in the clinical trial, have the
p.(None): opportunity to ask questions and answer your questions to your satisfaction and to discuss your
p.(None): Participation, if you wish, with relatives or a treating doctor.
p.(None): d) Informed consent must be obtained before proceeding with the evaluation of the criteria
p.(None): of eligibility or any other specific study procedure.
p.(None): e) Informed consent is given in writing
p.(None): through the respective format. This format must be
p.(None): signed, dated and with the time indicated by the research subject or his legal representative and by the researcher
p.(None): who drove the process. A copy must be given to the research subject.
p.(None): f) If the research subject cannot read and write, they will print their fingerprint as a sign of compliance.
p.(None): In the event that the research subject has a disability that prevents him from signing or printing his
p.(None): fingerprint, another means that evidences your consent may be accepted. In both cases, additionally,
p.(None): Another person he designates and who does not belong to the investigation team must sign as a witness.
p.(None): g) The process of obtaining informed consent must be part of the medical history
p.(None): of the research subject, including start date and time, which was provided to the research subject
p.(None): enough time to reflect and ask questions, the understanding of the information was verified, two were signed
p.(None): copies of the informed consent form and one of them was given to the research subject or his representative
p.(None): legal.
p.(None): The informed consent of minors must meet the same consent requirements
p.(None): informed as appropriate and should be done using language that takes into account the evolution of
p.(None): faculties according to their age and maturity to allow their understanding, having to register their name and / or signature in
p.(None): sign of your authorization.
p.(None): Article 34. Requirements for the informed consent format
p.(None): The informed consent form of the subject of
p.(None): Research is subject to the following requirements:
p.(None): a) Be prepared by the main researcher, sponsor or both, with the information indicated in
p.(None): literal d) of this article and according to the model of the Informed Consent Form established in
p.(None): Annex 4 of these Regulations.
p.(None): b) Be reviewed and approved by a CIEI of the institution where the clinical trial will be conducted, accredited by
p.(None): the INS, in accordance with the provisions of Chapter VII of Title IV of these Regulations.
p.(None): c) The consent must be written in Spanish and in the language that the research subject identifies as
p.(None): own; the wording must be understandable to him.
p.(None): d) You must enter, among others, the following information:
p.(None): - The title of the clinical trial.
p.(None): - The explicit invitation to participate in an experimental research study and the
p.(None): voluntary nature of participation.
p.(None): - The justification, objectives and purpose of the clinical trial.
p.(None): - Trial treatments or interventions: investigational product, active comparator and do
p.(None): reference to placebo and blinding if applicable, as well as the probability of allocation for
p.(None): each intervention.
p.(None): - The procedures to be used and their purpose, as well as the time, means and responsible for
p.(None): inform the research subject of the results of the examinations carried out or the justification for not doing so.
p.(None): - Approximate number of research subjects to
p.(None): include worldwide and in Peru.
p.(None): - The expected duration of the subject's participation
p.(None): research.
p.(None): - The inconvenience, the expected risks or the risks
p.(None): unpredictable.
p.(None): - Free treatment and procedures
p.(None): used as part of the clinical trial design.
p.(None): - The expected benefits that can be obtained.
p.(None): - If there are alternative procedures that could be advantageous to the research subject.
p.(None): - The commitments assumed by the subject of
p.(None): research if you agree to participate in the study.
p.(None): - The guarantee of receiving answers to any questions and clarification of any doubts about
p.(None): the procedures, risks, benefits and other matters related to the clinical trial and the
p.(None): treatment of
p.(None): 46 LEGAL STANDARDS Friday, June 30, 2017 /
p.(None): A Peruvian man
...
p.(None): party responsible for the clinical trial, in the case of damages that directly affect it, caused by
p.(None): the investigation, pointing out the existence of the insurance contracted by the sponsor.
p.(None): - The detail of the financial compensation for additional expenses, such as transportation, accommodation, communication, and
p.(None): food if they exist; which will be covered by the budget of the clinical trial.
p.(None): - In the event that the woman or the man are in reproductive capacity, the
p.(None): potential risks in the event of her or his partner's pregnancy, and that a
p.(None): effective contraceptive method chosen by the participant and their partner.
p.(None): - That in the event of a pregnancy of the research subject or his partner, he must report the fact to the
p.(None): investigator. In addition, the format must establish whether such condition is considered grounds for exclusion from the
p.(None): clinical trial. Likewise, it will indicate the application of the procedures for the monitoring and control of the
p.(None): gestation and newborn to at least six
p.(None): (6) months of age in order to identify any effect related to the research product. The
p.(None): expenses that such monitoring demands will be financed by the sponsor. The sponsor will be
p.(None): responsible for the respective compensation for damages produced during the pregnancy or that had been
p.(None): caused to the newborn as a consequence of the clinical trial.
p.(None): - Specify the time, means and responsible for which the research subject will be provided
p.(None): the final results of the clinical trial, which must be in a language understandable to him.
p.(None): - Inform the research subject about post-study access and according to the considerations
p.(None): indicated in Title X of these Regulations.
p.(None): - The existence of a description of the clinical trial available in the Peruvian Registry of Clinical Trials and accessible
p.(None): through the INS institutional web portal
p.(None): - The contact information of the OGITT of the INS, according to what is indicated in number 21 of Annex 4 of the
p.(None): these Regulations.
p.(None): The informed consent form for minors must meet the same requirements as the
p.(None): informed consent where appropriate.
p.(None): If the clinical trial contemplates the collection and storage of biological samples for future use,
p.(None): It must be explained in an additional informed consent format as indicated in the Manual of
p.(None): Clinical trial procedures.
p.(None): Article 35. Compensation to research subjects
p.(None): Research subjects may receive reasonable compensation from the sponsor for expenses
p.(None): extraordinary causes and loss of productivity arising from your participation, which will be specified
p.(None): in the informed consent. The CIEI will evaluate said compensation according to each case; and, will evaluate that no
p.(None): unduly influences the consent of the research subject.
p.(None): Article 36. Subject of minor investigation
p.(None): When the research subject is a minor
p.(None): is required:
...
p.(None): Clinical Trial Procedures Manual.
p.(None): e) Affidavit from the sponsor indicating compliance with the responsibilities set forth in the
p.(None): these Regulations, according to the model established in the Manual of Clinical Trials Procedures for Trials
p.(None): Clinicians.
p.(None): f) In case of foreign sponsor: Copy of the proof of the delegation of functions to the representative
p.(None): from the sponsor authenticated with The Hague Apostille.
p.(None): g) Affidavit signed by the principal investigator indicating compliance with the obligations and
p.(None): requirements established in these Regulations, according to the model established in the Test Procedures Manual
p.(None): Clinicians.
p.(None): h) Affidavit according to the model established in the Manual of Clinical Trial Procedures, signed by the
p.(None): sponsor and principal investigator, which establishes that there is no financial conflict of interest in the execution of the
p.(None): clinical trial.
p.(None): i) Affidavit signed by the sponsor and main researcher on the conditioning of the
p.(None): research center where the clinical trial will be carried out, according to the model established in the Manual
p.(None): of Clinical Trial Procedures.
p.(None): j) Copy of the current insurance policy (insurance contract) acquired by the sponsor.
p.(None): k) Affidavit by the sponsor that it has a financial fund that guarantees
p.(None): immediate care and free treatment of the research subject, in the event of an adverse event
p.(None): as a consequence of the clinical trial, as long as the insurance policy is activated and
p.(None): according to the model established in the Manual of Clinical Trial Procedures.
p.(None): l) Investigation protocol, in Spanish version and in original language if different from Spanish
p.(None): (printed and electronic means) according to Annex 1 of this Regulation.
p.(None): m) Informed consent form (s) according to Annex 4 of these Regulations, approved by the CIEI.
p.(None): n) Updated Investigator's Manual, in Spanish version and in original language, if it is
p.(None): different from Spanish (printed and electronic media). This may be replaced according to the conditions
p.(None): indicated in Annex 2 of these Regulations.
p.(None): o) Information related to the quality of the product under investigation according to Annex 5 of this Regulation.
p.(None): p) Curriculum vitae updated, undocumented of the entire research team of each center
p.(None): research, according to the model established in the Manual of Clinical Trial Procedures.
p.(None): q) Copy of the documents that prove training in Good Clinical Practices and Ethics in Research on beings
p.(None): humans from the entire research team, valid for no more than three (3) years.
p.(None): r) Detailed national total budget of the clinical trial, according to the model established in the
p.(None): Clinical Trial Procedures.
p.(None): s) List of supplies necessary for the development of the clinical trial, according to the format established in the
p.(None): Clinical Trial Procedures Manual.
p.(None): t) Proof of payment of the right to process. In the case of multicenter clinical trials, the right of payment
p.(None): It will be carried out by each of the research centers in Peru.
p.(None): Article 68. Research products of authorized clinical trials
p.(None): The authorization of clinical trials can only be requested when the research products used
p.(None): meet any of the following conditions:
p.(None): a) Have authorization for research in human beings by Regulatory Authorities of
p.(None): Medicines from countries with high health surveillance.
p.(None): b) Are produced in our country, have pre-clinical research and comply with policies and / or
p.(None): research priorities determined by MINSA.
p.(None): c) To establish therapeutic equivalence of pharmaceutical products or similarity of products
p.(None): biological.
...
p.(None): authorization from the INS OGITT.
p.(None): Article 86. Of the non-provenance of the amendments to the investigation protocol
p.(None): The INS OGITT will not authorize amendments to the research protocol that compromise safety and
p.(None): rights of research subjects or the reliability and soundness of the data obtained in the clinical trial.
p.(None): Article 87. Request for authorization to change the title of a clinical trial
p.(None): When the amendment is made in the title of the clinical trial, authorization will be required with a resolution granted by the
p.(None): INS OGITT, for which the sponsor or the ICO must present the following documents, duly foliated:
p.(None): a) Request to change the title of a clinical trial
p.(None): b) Report justifying the change of title to the clinical trial.
p.(None): c) Approval of the change of title of the clinical trial by a CIEI accredited by the INS.
p.(None): d) Have a valid insurance policy
p.(None): e) Proof of payment of processing fee.
p.(None): Article 88. Request for authorization of amendment report
p.(None): Other amendments will be authorized ex officio, for which the sponsor or the ICO must present the following
p.(None): documents, duly foliated:
p.(None): 54 LEGAL STANDARDS Friday, June 30, 2017 /
p.(None): A Peruvian man
p.(None): a) Request for amendment report, including the list of documents to be amended (document, version and
p.(None): date).
p.(None): b) List of changes to the amendment.
p.(None): c) Justification of the proposed changes.
p.(None): d) Protocol and / or respective informed consent with highlighted changes or change control, in Spanish version and
p.(None): in original language if different from Spanish.
p.(None): e) Protocol and / or final informed consent with the integrated amendment in Spanish and language version
p.(None): Original if it is different from Spanish (printed and electronic media).
p.(None): f) Document approving the amendment to the research protocol and / or informed consent by
p.(None): an INS accredited CIEI.
p.(None): g) Have a valid insurance policy
p.(None): h) Proof of payment of the right to process.
p.(None): TITLE VI
p.(None): OF THE PRODUCT UNDER INVESTIGATION
p.(None): Article 89. Financing of research products
p.(None): Research products for use in clinical trials will be funded by the sponsor and
p.(None): provided free of charge to the research subject.
p.(None): Article 90. Manufacture in the country of the products under investigation
p.(None): The manufacture in the country of research products for use in the field of a clinical trial
p.(None): It will be authorized by the ANM, and will be subject to Good Manufacturing Practices and other regulations issued by MINSA.
p.(None): Article 91. Labeling of the products under investigation
p.(None): The mediate labeling of the products under investigation and of complementary products that do not have
p.(None): Marketing authorization in Peru must be printed in indelible ink and in Spanish or
p.(None): English indicating at a minimum: Data identifying the sponsor, the clinical trial and the product, indicating: Date
p.(None): expiration or re-analysis, manufacturing lot number, dosage form, route of administration,
p.(None): special storage and conservation conditions, and record the phrases: “For use only in
p.(None): investigation ”and“ Prohibited sale ”or similar consideration.
p.(None): The immediate labeling of the products under investigation must contain as information: Product name,
p.(None): concentration of the active substance, route of administration, manufacturer's name or logo, batch number and date of
...
p.(None): questionnaires, auxiliary exams, diet to follow): Describe or explain the procedures
p.(None): will perform and all medications given (including premedication, rescue medication, or other
p.(None): medication necessary for any study procedure, such as local anesthesia in case of biopsies)
p.(None): being able to include a simplified scheme and / or calendar of visits and procedures.
p.(None): b) Biological samples to be collected: type, quantity and number of times to be extracted. It is necessary
p.(None): explain how many times and how much is needed, in measures that the subject understands.
p.(None): c) Final destination of remaining biological samples. Explicitly mention that biological samples
p.(None): obtained will be used only for ongoing research and will be destroyed when the clinical trial is
p.(None): have completed, unless your storage is contemplated for future use.
p.(None): d) Storage of biological samples or their remnants for future studies: If you plan to store samples
p.(None): remnants beyond the end of the clinical trial and / or biological samples will be removed for
p.(None): storage and future studies, should be incorporated into a specific informed consent form for
p.(None): such an end.
p.(None): e) Information on the results of the tests carried out. It should include:
p.(None): - Your results will be explained to you
p.(None): - Who will inform you
p.(None): - At what time will you be informed
p.(None): - Justification in case of not revealing data temporarily or permanently.
p.(None): 12) Risks and inconveniences derived from the trial
p.(None): clinical
p.(None): a) Risks of the experimental research product, the comparator and any other medication
p.(None): used for clinical trial purposes. Clearly indicate, in a language and language that the subject understands, the
p.(None): reasonably expected risks or discomforts (according to the Investigator's Manual or technical sheet) as well as the possibility
p.(None): of serious events or other unexpected events, or the non-relief or worsening of the symptoms of the pathology of
p.(None): study.
p.(None): b) Risks and inconveniences of the procedures of the
p.(None): clinical trial.
p.(None): c) Risks and measures of prevention and protection against pregnancy of the research subject or his partner. Should
p.(None): include:
p.(None): - Potential risks in case of pregnancy for the
p.(None): fetus or lactating embryo.
p.(None): - Pregnancy tests: initial and additional
p.(None): - Free access and list of contraceptive methods to be chosen by the research subject and his partner,
p.(None): that they are suitable for the test, as well as the time that their use is necessary.
p.(None): - Procedure to follow in case of pregnancy of the research subject or his partner: communication
p.(None): immediately to the investigator, suspension of treatment, withdrawal of the study, monitoring of pregnancy and
p.(None): newborn for 6 months, compensation in case of damage as a result of the clinical trial.
p.(None): 13) Commitments assumed by the research subject if he agrees to participate in the study.
p.(None): 14) Available alternatives.
p.(None): Specify if there are therapeutic, prevention or diagnostic alternatives currently available in the
p.(None): country.
p.(None): El Peruano / Friday, June 30, 2017
p.(None): LEGAL STANDARDS 65
p.(None): 15) Benefits derived from the study
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Social / Literacy
Searching for indicator illiterate:
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p.(None): following email: consultaensayos@ins.gob. eg, or through a formal document presented through
p.(None): table of parties of the institution or go in person to the OGITT at the following address: Cápac Yupanqui 1400, Jesús
p.(None): María, Lima 11 ”.
p.(None): Section to be completed by the research subject:
p.(None): - I ...................... (Name and surname) ....................
p.(None): .........................
p.(None): - I have read (or someone has read to me) the information provided in this document.
p.(None): - I have been informed about the objectives of this study, the procedures, the risks, what is expected of me and
p.(None): my rights.
p.(None): - I have been able to ask questions about the study and they have all been answered appropriately. I think I understand
p.(None): all information provided about this clinical trial.
p.(None): - I understand that my participation is voluntary.
p.(None): - I understand that I can withdraw from the study whenever I want, without having to give explanations and without this
p.(None): affect my medical care.
p.(None): - By signing this document, I agree to participate in this clinical trial. I am not giving up any rights.
p.(None): - I understand that I will receive a signed and dated copy of this document.
p.(None): Full name of the research subject .............
p.(None): ....................................
p.(None): Signature of the research subject ...............................
p.(None): .......................
p.(None): Date and Time................................
p.(None): Full name of the legal representative (according to
p.(None): case) ……………………
p.(None): Signature of the legal representative
p.(None): ……………………………………………
p.(None): Date and Time................................
p.(None): In the case of an illiterate person, you must print
p.(None): your fingerprint on informed consent.
p.(None): Section to be completed by the witness (as the case may be) I have witnessed the exact reading of the format of
p.(None): informed consent for the potential research subject and the latter has had the opportunity to
p.(None): do
p.(None): questions.
p.(None): I confirm that the research subject has freely given his consent.
p.(None): Full name of the witness ………………………… ...
p.(None): Witness signature………………………………………….
p.(None): Date and Time............................................... ..................
p.(None): Section to be completed by the investigator
p.(None): I have explained the clinical trial to the research subject and answered all his questions.
p.(None): I confirm that he understands the information described
p.(None): 66 LEGAL STANDARDS Friday, June 30, 2017 /
p.(None): A Peruvian man
p.(None): in this document and agree to participate in the form
p.(None): voluntary.
p.(None): Investigator's Name ..........................................
p.(None): Investigator's Signature .............................................
p.(None): Date and time (the same date when the participant signs) .....................................
p.(None): ANNEX 5
p.(None): INFORMATION RELATED TO THE QUALITY OF THE RESEARCH PRODUCT TO BE PRESENTED AS PART OF THE REQUIREMENTS
p.(None): FOR THE AUTHORIZATION OF A CLINICAL TRIAL
p.(None): For the purposes of authorization of a clinical trial
p.(None): Submission of the following documents is required:
p.(None): 1. Regarding the research product (not including the comparator):
p.(None): a) Project labeling of the product under investigation, as established in Article 91 of this
p.(None): Regulation.
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Social / Marital Status
Searching for indicator single:
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p.(None): opticians, among others; that describe the study methods and conduct, factors that affect it, and
p.(None): taken actions. It also includes: the protocol, copies of the requirements presented to the authority
p.(None): regulatory, clinical trial authorization and approval of the Institutional Research Ethics Committee (CIEI),
p.(None): Resume of the researchers, informed consent form, researcher's manual,
p.(None): monitoring reports, audit certificates, correspondence, benchmarks, reporting form
p.(None): case record, periodic communications and final communication, original records such as medical history,
p.(None): laboratory tests, clinical reports, diaries of the subjects, among others related to the clinical trial.
p.(None): 10. Amendment.- Written description of change (s) or formal clarification of a research protocol and / or
p.(None): informed consent.
p.(None): 11. Clinical Trial.- For the purposes of these Regulations, a clinical trial is understood to be any investigation that
p.(None): perform in humans to determine or confirm clinical, pharmacological, and / or other effects
p.(None): pharmacodynamic effects; detect adverse reactions; study absorption, distribution,
p.(None): metabolism and
p.(None): 40 LEGAL STANDARDS Friday, June 30, 2017 /
p.(None): A Peruvian man
p.(None): elimination of one or more products under investigation, in order to determine their efficacy and / or safety.
p.(None): Research subjects are previously assigned to the research product and the assignment is
p.(None): determined by the research protocol.
p.(None): 12. Multicenter clinical trial.- Clinical trial conducted according to a single protocol but in more
p.(None): of a center and, therefore, carried out by more than one researcher and a coordinator who is in charge of
p.(None): processing of all data and analysis of results.
p.(None): 13. Research team.- Group made up of professionals with skills and knowledge in the
p.(None): execution of a clinical trial and that fulfill a direct and significant role in said execution, includes
p.(None): doctors, nurses, pharmaceutical chemists, among other professionals led by a principal investigator.
p.(None): 14. Extension study.- Clinical trial by which the treatment or monitoring of the
p.(None): research subjects who give their informed consent to do so. It is performed based on a protocol of
p.(None): research and its objective is to obtain long-term safety or tolerability data.
p.(None): 15. Adverse event.- Any event or situation detrimental to the subject's health
p.(None): research, who is being administered a research product, and who does not necessarily
p.(None): it has a causal relationship with its administration. Therefore, an adverse event (EA) can be
p.(None): any unfavorable and unintended signs; including an abnormal laboratory finding, symptom, or
p.(None): disease temporarily associated with the use of an investigational product; whether or not related to it.
p.(None): 16. Serious adverse event.- Any adverse event that produces death, threatens the life of the subject of
p.(None): investigation, requires hospitalization or its prolongation, produces disability or
p.(None): permanent or significant disability, or a congenital anomaly or malformation. For the purposes of his
p.(None): Notification will be treated as serious those events that from the medical point of view, can put
...
p.(None): of Research Ethics.
p.(None): Eighth.- Creation of the National Registry of Institutional Committees for Research Ethics accredited
p.(None): Create the National Registry of Accredited Institutional Research Ethics Committees. A
p.(None): maximum period of one year (1), from the approval of the Manual of Clinical Trial Procedures,
p.(None): so that the registered CIEI comply with the requirements established in article 63 of these Regulations.
p.(None): TRANSITIONAL SUPPLEMENTARY PROVISIONS
p.(None): First.- Transitory regulation
p.(None): a) The administrative procedures initiated before the entry into force of these regulations will be governed by the
p.(None): previous regulations until their conclusion.
p.(None): b) However, the provisions of these regulations that are applicable to the procedures in process
p.(None): recognize rights or powers to the administered against the administration.
p.(None): Second.- Dissemination of these Regulations
p.(None): The INS, under the responsibility of its owner, must carry out dissemination, information and training actions for the
p.(None): content and scope of this Regulation in favor of its staff and the user public. Said actions
p.(None): Print copies of these Regulations, talks, posters or other means that
p.(None): ensure the proper dissemination of it.
p.(None): ANNEXES ANNEX 1
p.(None): GUIDE TO THE RESEARCH PROTOCOL
p.(None): The clinical trial protocol must include the following aspects:
p.(None): 1. GENERAL INFORMATION
p.(None): to. Title of the clinical trial indicating the design, population, interventions and, where applicable, the
p.(None): acronym or abbreviation of the essay. If the original title is in English, a single title must be assigned
p.(None): in Spanish for all purposes.
p.(None): b. Protocol code assigned by the sponsor specifically for each Research protocol and
p.(None): identical for all versions of it
p.(None): c. Other clinical trial identifiers and registry name. If you have not yet registered, name of
p.(None): register where it is proposed to register it.
p.(None): d. The date and version number, which will be updated in case of amendments to this document.
p.(None): 2. SUMMARY OF THE PROTOCOL
p.(None): Containing the following information:
p.(None): - Title of the clinical trial.
p.(None): - Protocol Code.
p.(None): - Name of the product under investigation.
p.(None): - Clinical trial phase.
p.(None): - Estimated duration of the clinical trial.
p.(None): - Study objectives.
p.(None): - Study hypothesis.
p.(None): - Justification of the use of the product in clinical research.
p.(None): - Study design.
p.(None): - Treatment with the product under investigation in evaluation and comparator: Specify concentration,
p.(None): dosage, routes of administration and duration of treatment.
p.(None): - Sample size: Specify the sample size.
p.(None): - Valuation criteria or results and method of
p.(None): analysis of the same.
p.(None): 3. BACKGROUND AND JUSTIFICATION
p.(None): to. Description of the research question and justification for undertaking the clinical trial as well as the
p.(None): rationale for the proposed development phase.
p.(None): b. Summary or detailed description of
p.(None): product research background in
p.(None): 60 LEGAL STANDARDS Friday, June 30, 2017 /
p.(None): A Peruvian man
p.(None): evaluation, relevant to pharmacokinetics, tolerance, safety and efficacy in the treatment of
p.(None): proposed pathology to investigate. All relevant and specific information must be recorded
...
p.(None): 4. OBJECTIVES, VALUATION CRITERIA OR
p.(None): SPECIFIC RESULTS AND HYPOTHESES.
p.(None): to. Objectives: Based on the justification developed and the study design, specify the
p.(None): objectives of the trial, differentiating it where appropriate, the general from the specific or the primary from the
p.(None): secondary. For multi-arm trials, objectives should clarify how they will be compared.
p.(None): all treatment groups (for example: A versus B; A versus C).
p.(None): b. Hypothesis: If the proposition is feasible in the problem statement.
p.(None): c. Primary and secondary assessment criteria, and other assessments of evolution or outcome, including
p.(None): the specific measurement variable (for example, systolic blood pressure), the analysis metric (for
p.(None): example, change from baseline or baseline value, end value, or time to event), the method of
p.(None): aggregation (for example, median, proportion) and the moment of measurement of each variable. The critery
p.(None): primary endpoint is the variable capable of providing the most clinically relevant and convincing evidence
p.(None): directly related to the primary objective of the trial. The primary endpoint should be the
p.(None): variable used in sample size calculations, or the main result used to
p.(None): determine the effect of the intervention. Secondary endpoints correspond to other
p.(None): variables used to measure the effect or influence of the studied intervention. A result
p.(None): Secondary may involve the same event, variable, or experience as the primary outcome, but measured
p.(None): at different time points than the primary result.
p.(None): 5. DESIGN OF THE TEST
p.(None): to. Type of test (eg parallel group, crossover group, factorial, single group), ratio of
p.(None): assignment and framework (eg superiority, equivalence, non-inferiority, exploratory)
p.(None): including a schematic diagram of the design, procedures and periods.
p.(None): b. The expected duration of participation of the research subjects and a description of the sequence and
p.(None): duration of all trial periods.
p.(None): c. Description of measures taken to minimize or avoid bias, such as randomization, which includes the
p.(None): method to generate the allocation sequence and mechanisms for its concealment, and blinding, that
p.(None): includes who will be blinded, how the blinding will be implemented and maintained, the circumstances under which
p.(None): which the blind opening is allowed according to the present regulation and the way to proceed in those cases.
p.(None): d. Description of the dose, the dosage regimen, the route and method of administration and the duration of the
p.(None): treatment.
p.(None): and. Pre-inclusion or washing periods; waiting time for drug purification, if applicable.
p.(None): F. Description of the criteria for termination or interruption of the clinical trial.
p.(None): 6. SELECTION OF THE INVESTIGATION SUBJECTS
p.(None): to. Description of the inclusion and exclusion criteria of the subjects.
p.(None): b. Criteria for withdrawal of individual research subjects from treatment or clinical trial, including
p.(None): the procedures for collecting data on the retired research subjects, the
p.(None): procedures for subject substitution and follow-up of subjects who have been withdrawn from the
p.(None): treatment or clinical trial.
p.(None): 7. DESCRIPTION OF THE TREATMENT
p.(None): to. Description of treatments or interventions for each group with sufficient details to allow
p.(None): reproduce them.
...
p.(None): of the presentation.
p.(None): The following sections should discuss the most important findings of the studies, including the response to the
p.(None): dose (dose / response) of observed effects, relevance to humans and any other
p.(None): aspect to be studied in human beings. If applicable, the findings of the effective dose should be compared and not
p.(None): toxic in the same animal species (eg therapeutic index will be analyzed). The
p.(None): relevance of this information to the proposed human dose. Whenever possible,
p.(None): comparisons in terms of blood / tissue levels rather than mg / kg.
p.(None): (a) Non-Clinical Pharmacology
p.(None): A summary of the pharmacological aspects of the product under investigation and, when
p.(None): appropriate of its significant metabolites studied in animals. Said summary shall
p.(None): incorporate studies evaluating potential therapeutic activity (eg efficacy model, binding to
p.(None): receptors and specificity), as well as those evaluating safety (for example special studies for
p.(None): evaluate pharmacological actions different from the desired therapeutic effects).
p.(None): (b) Pharmacokinetics and metabolism of the product in
p.(None): animal research
p.(None): A summary of the pharmacokinetics and transformation and biological disposition of the
p.(None): research product in all species studied. The discussion of the findings should
p.(None): mention the local and systemic absorption and bioavailability of the product under investigation and its metabolites
p.(None): and its relationship with pharmacological and toxicological findings in animal species.
p.(None): (c) Toxicology
p.(None): A summary of the toxicological effects found in relevant studies should be described.
p.(None): conducted in different animal species with the following titles when appropriate:
p.(None): - Single dose.
p.(None): - Multiple dose.
p.(None): - Carcinogenicity.
p.(None): - Special Studies (for example, irritation and sensitization).
p.(None): - Reproductive toxicity.
p.(None): - Genotoxicity (mutagenicity).
p.(None): CLINICAL STUDIES
p.(None): Introduction:
p.(None): An in-depth discussion of the known effects of the investigational product should be provided in
p.(None): human, including information on pharmacokinetics, metabolism, pharmacodynamics, dose response
p.(None): (dose / response), safety, efficacy and other pharmacological activities. Whenever possible,
p.(None): provide a summary of each specific clinical study. Information must also be provided
p.(None): Regarding the results of any use of the product in research other than that of the studies
p.(None): clinical, such as experience during marketing.
p.(None): (a) Pharmacokinetics and Product Metabolism in Humans
p.(None): El Peruano / Friday, June 30, 2017
p.(None): LEGAL STANDARDS 63
p.(None): A summary of the information on the pharmacokinetics of the investigational product must be presented,
p.(None): including the following, if available:
p.(None): - Pharmacokinetics (including metabolism, as appropriate, and absorption, binding of plasma proteins,
p.(None): distribution and disposal).
p.(None): - Bioavailability of the product under investigation
p.(None): ANNEX 3
p.(None): MINIMUM REQUIREMENTS OF A RESEARCH CENTER
p.(None): CONDITIONING OBSERVATIONS
p.(None): Hospitalization area
p.(None): It is an independent environment
p.(None): (absolute, where possible and / or relative) using a reference dosage form. Subgroups
p.(None): population (for example, sex, age and altered organic function).
p.(None): - Interactions (for example, interactions between the investigational product and other medicinal products and the effects of
p.(None): the food).
...
Social / Occupation
Searching for indicator job:
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p.(None): If the comparator is a product with a current sanitary registration in Peru, only a declaration will be necessary
p.(None): sworn issued by the sponsor indicating the name and address of the manufacturer, the name of the owner
p.(None): of the sanitary registry and the sanitary registry number. If necessary, the sponsor or executor of the
p.(None): Authorized clinical trial will be able to locally acquire medicines with sanitary registration in the country used as
p.(None): comparators, for use in clinical research.
p.(None): 3. In the case of complementary products. Complementary products that do not have sanitary registration
p.(None): in Peru or in countries with high health surveillance and / or countries with mutual recognition must
p.(None): present the requirements indicated in the numeral
p.(None): 1. If the product has a current health registry in Peru or in countries with high health surveillance and / or
p.(None): from countries with mutual recognition, only an affidavit issued by the sponsor will be necessary
p.(None): indicating the name and address of the manufacturer, the name of the holder of the sanitary registration or of the
p.(None): marketing authorization and the number of the health registration or marketing authorization,
p.(None): indicating the regulatory authority of the country from which it comes.
p.(None): El Peruano / Friday, June 30, 2017
p.(None): LEGAL STANDARDS 67
p.(None): In the case of biological products and medical devices, the ANM will establish the certificates or other
p.(None): documents that for sanitary necessity are required.
p.(None): 1538902-2
p.(None): TRANSPORTATION AND COMMUNICATIONS
p.(None): Appointed official responsible for submitting job offers from the Ministry of Transport and Communications
p.(None): (Executing Unit 001: General Administration) to the General Directorate of the National Employment Service of the
p.(None): Ministry of Labor and Employment Promotion
p.(None): MINISTERIAL RESOLUTION
p.(None): N ° 546-2017 MTC / 01
p.(None): Lima, June 28, 2017
p.(None): SEEN: Los Memorandos N ° s. 0969 and 0970-2017- MTC / 10.07 of the General Office of Administration; and,
p.(None): CONSIDERING:
p.(None): That, Law No. 27736, Law for the Radio and Television Transmission of Job Offers, regulates the notices of
p.(None): public service in which public and private jobs are offered;
p.(None): That, article 2 of Supreme Decree No. 012-2004-TR, Dictate regulatory provisions of Law No. 27736,
p.(None): referring to the radio and television transmission of job offers from the public and private sectors, establishes that
p.(None): Every public body and State company is obliged to refer to the Cil Proempleo Red Program of the
p.(None): Ministry of Labor and Employment Promotion offers of public positions that are scheduled to compete.
p.(None): Positions classified as trustworthy are excluded from this obligation to compete and submit the offer.
p.(None): according to the rules of the current public labor regulations;
p.(None): That, also, the aforementioned legal provision establishes that public bodies and State companies
p.(None): They will designate the official responsible for submitting the entity's job offers, and that the
p.(None): designation must be made by resolution of the owner of the entity published in the Official Gazette
p.(None): Peruvian;
p.(None): That, Article 2 of Executive Presidency Resolution No. 107-2011-SERVIR / PE, Approve rules and
p.(None): guidelines for the adequacy of internal instruments under which entities exercise
p.(None): the disciplinary power over the workers hired under the special labor regime of the Decree
p.(None): Legislative No. 1057, approves the Call Form for the Administrative Contracting of Services, in
p.(None): where it is indicated that the publication of the hiring process will be carried out in the National Employment Service;
p.(None): That, through Ministerial Resolution No. 105-2017- MTC / 01, Mr. Stalin Elizalde Zeballos was appointed
p.(None): Rodríguez, Director of the Personnel Office of the General Administration Office, as
p.(None): official responsible for submitting job offers from the Ministry of Transport and Communications (Unit
p.(None): Executor 001: General Administration) to the General Directorate of the National Employment Service of the Ministry of
p.(None): Work and Employment Promotion;
p.(None): That, through Ministerial Resolution No. 450-2017- MTC / 01.04, the resignation made by the
p.(None): Mr. Stalin Elizalde Zeballos Rodríguez; and Mr. Nicandro Agustín Vásquez Reyes was appointed in the
p.(None): Position of Director of the Personnel Office of the General Administration Office of the Ministry of
p.(None): Transportation and Communications;
p.(None): That, the Regulation of Organization and Functions of the Ministry of Transport and Communications, approved by
p.(None): Supreme Decree No. 021-2007-MTC, in article
p.(None): 41, establishes that the Personnel Office is the organic unit in charge of managing human resources
p.(None): of the Ministry;
p.(None): That, in response to the request made by the General Administration Office through the
p.(None): Memorandum No. 0970-2017-MTC / 10.07, it is necessary to terminate the designation made by Resolution
p.(None): Ministerial No. 105-2017-MTC / 01 and designate the official responsible for submitting the job offers of the
p.(None): Ministry of Transport and Communications (Executing Unit 001: General Administration) to the General Directorate
p.(None): the National Employment Service of the Ministry of Labor and Employment Promotion;
p.(None): In accordance with the provisions of Law No. 29370, the Organization and Functions Law of the Ministry of
p.(None): Transportation and Communications; its Organization and Functions Regulations approved by Decree
p.(None): Supreme N ° 021-2007-MTC; Law No. 27736, Law for the Radio and Television Transmission of Job Offers and its
p.(None): regulatory provisions, approved by Supreme Decree No. 012-2004-TR;
p.(None): RESOLVES:
p.(None): Article 1.- To terminate the appointment made by Ministerial Resolution No. 105-2017-
p.(None): MTC / 01.
p.(None): Article 2.- Appoint the Director of the Personnel Office of the General Administration Office, as
p.(None): official responsible for submitting job offers from the Ministry of Transport and Communications (Unit
p.(None): Executor 001: General Administration) to the General Directorate of the National Employment Service of the
p.(None): Ministry of Labor and Employment Promotion.
p.(None): Article 3.- Notify this Ministerial Resolution to the Director of the Personnel Office of the General Office
p.(None): of administration.
p.(None): Article 4.- Order the publication of this Ministerial Resolution in the Transparency Portal of the
p.(None): Ministry of Transport and Communications, the same day of its publication in the Official Gazette El Peruano.
p.(None): Register, communicate and publish. BRUNO GIUFFRA MONTEVERDE
p.(None): Minister of Transport and Communications
p.(None): 1538846-1
p.(None): EXECUTING AGENCIES
p.(None): PRIVATE INVESTMENT PROMOTION AGENCY
p.(None): Director of the Investor Services Department of PROINVERSIÓN appointed
p.(None): RESOLUTION OF THE EXECUTIVE DIRECTION N ° 115-2017
p.(None): Lima, June 26, 2017
p.(None): VISTA, the resignation presented on June 12, 2017 by Mr. Carlos Alberto Herrera Perret in charge of
p.(None): Director of the Investor Services Department;
p.(None): CONSIDERING:
p.(None): That, according to numeral 37.1 of article 37 of Legislative Decree No. 1224, Legislative Decree of the Framework
p.(None): Promotion of Private Investment through Public Private Associations and Projects in Assets,
...
Social / Police Officer
Searching for indicator police:
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p.(None): Phase III: Trials aimed at evaluating the efficacy and safety of the experimental treatment,
p.(None): trying to reproduce the usual conditions of use and considering the alternatives
p.(None): Therapeutics available in the indication studied. They are performed on a larger sample of patients
p.(None): that in the previous phase and that is representative of the general population to which the
p.(None): product in research or in healthy volunteers for prevention studies.
p.(None): Phase IV: Tests that are carried out once the product under investigation has a sanitary registration for its
p.(None): marketing and according to the conditions established in it. Provide additional information on effectiveness
p.(None): and
p.(None): safety profile (benefit - risk) after use in large populations for a prolonged period of
p.(None): weather.
p.(None): 19. Re-analysis date.-. Date assigned by the manufacturer to carry out a new analysis on the product
p.(None): under investigation, before the expiration date, to verify that the product under investigation retains its
p.(None): physical-chemical and pharmaceutical properties, and is still appropriate for exclusive use in clinical trials.
p.(None): 20. Expiration date.- Date provided by the manufacturer in an uncoded way that is based
p.(None): in the stability studies of the investigational product and after which the product in
p.(None): Research should not be used. This date is set for each batch by adding a life span.
p.(None): useful at the manufacturing date.
p.(None): 21. Subordinate groups.- Includes students, health facility workers, sector employees
p.(None): public or private, members of the armed forces and the Peruvian National Police, inmates in prisons or centers
p.(None): of social rehabilitation and other special groups of the population, in which their participation can be
p.(None): influenced by some authority or hierarchical structure.
p.(None): 22. Reliable impossibility: Situation in which it is not materially possible for one of the parents to grant the
p.(None): consent for duly supported or documented reasons, and under the responsibility of the researcher.
p.(None): 23. Progress report.- Periodic report of each of the research centers that carry out a
p.(None): certain clinical trial, which must be submitted to the INS from the date of authorization of the
p.(None): study, containing, among others, the following information: Number of patients screened, enrolled, in
p.(None): treatment, withdrawn, who completed the study, still to be enrolled; summary of adverse events
p.(None): serious, non-serious adverse events related to the product under investigation and deviations occurred
p.(None): in the corresponding period.
p.(None): 24. Final report of the research center.- Final report of each of the research centers that
p.(None): they run a certain clinical trial containing, among others, the following information: Number of patients
p.(None): screened, enrolled, withdrawn, completed clinical trial, summary of serious adverse events,
p.(None): non-serious adverse events related to the product under investigation and deviations from
p.(None): as stated in the last progress report.
p.(None): 25. National final report.- Report presented after the end of the clinical trial in all the centers of
p.(None): research at the national level, containing, among others, the following information: Number of patients
...
Social / Soldier
Searching for indicator armed forces:
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p.(None): Phase III: Trials aimed at evaluating the efficacy and safety of the experimental treatment,
p.(None): trying to reproduce the usual conditions of use and considering the alternatives
p.(None): Therapeutics available in the indication studied. They are performed on a larger sample of patients
p.(None): that in the previous phase and that is representative of the general population to which the
p.(None): product in research or in healthy volunteers for prevention studies.
p.(None): Phase IV: Tests that are carried out once the product under investigation has a sanitary registration for its
p.(None): marketing and according to the conditions established in it. Provide additional information on effectiveness
p.(None): and
p.(None): safety profile (benefit - risk) after use in large populations for a prolonged period of
p.(None): weather.
p.(None): 19. Re-analysis date.-. Date assigned by the manufacturer to carry out a new analysis on the product
p.(None): under investigation, before the expiration date, to verify that the product under investigation retains its
p.(None): physical-chemical and pharmaceutical properties, and is still appropriate for exclusive use in clinical trials.
p.(None): 20. Expiration date.- Date provided by the manufacturer in an uncoded way that is based
p.(None): in the stability studies of the investigational product and after which the product in
p.(None): Research should not be used. This date is set for each batch by adding a life span.
p.(None): useful at the manufacturing date.
p.(None): 21. Subordinate groups.- Includes students, health facility workers, sector employees
p.(None): public or private, members of the armed forces and the Peruvian National Police, inmates in prisons or centers
p.(None): of social rehabilitation and other special groups of the population, in which their participation can be
p.(None): influenced by some authority or hierarchical structure.
p.(None): 22. Reliable impossibility: Situation in which it is not materially possible for one of the parents to grant the
p.(None): consent for duly supported or documented reasons, and under the responsibility of the researcher.
p.(None): 23. Progress report.- Periodic report of each of the research centers that carry out a
p.(None): certain clinical trial, which must be submitted to the INS from the date of authorization of the
p.(None): study, containing, among others, the following information: Number of patients screened, enrolled, in
p.(None): treatment, withdrawn, who completed the study, still to be enrolled; summary of adverse events
p.(None): serious, non-serious adverse events related to the product under investigation and deviations occurred
p.(None): in the corresponding period.
p.(None): 24. Final report of the research center.- Final report of each of the research centers that
p.(None): they run a certain clinical trial containing, among others, the following information: Number of patients
p.(None): screened, enrolled, withdrawn, completed clinical trial, summary of serious adverse events,
p.(None): non-serious adverse events related to the product under investigation and deviations from
p.(None): as stated in the last progress report.
p.(None): 25. National final report.- Report presented after the end of the clinical trial in all the centers of
...
Searching for indicator military:
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p.(None): of this Regulation according to the following criteria:
p.(None): a) Investigations into embryos are found
p.(None): prohibited.
p.(None): b) Research on fetuses can only be carried out if the techniques and means used provide the maximum
p.(None): safety for the fetus and the pregnant woman.
p.(None): c) Investigations with deaths, natimes, macerated fetal matter, cells, tissues, placenta, cord
p.(None): umbilical, embryonic remains and organs removed from them, will be made observing due respect
p.(None): the pregnant woman or the product of pregnancy in a situation of death or corpse and the applicable provisions
p.(None): in the Regulations of the Cemeteries and Funeral Services Law, as appropriate.
p.(None): Article 24. Of clinical trials in subordinate groups
p.(None): The performance of clinical trials in subordinate groups can only be carried out when they are completed, in addition
p.(None): of the provisions of Title II of these Regulations, the following conditions:
p.(None): a) When research is carried out in subordinate groups, one or more members must participate in the CIEI
p.(None): of the study population, or another person in society capable of protecting the conditions and rights
p.(None): humans that correspond to the group in question.
p.(None): b) Participation, rejection or withdrawal of their consent during the study of the subjects
p.(None): under investigation, do not affect your academic, work, military or judicial situation
p.(None): to which they were subject and the conditions of compliance with the judgment, if applicable; and that
p.(None): research results are not used to their detriment.
p.(None): Article 25. Clinical trials in indigenous or native peoples
p.(None): The carrying out of clinical trials in indigenous or native peoples may only be carried out when
p.(None): In addition to the provisions of Title II of these Regulations, they comply with the following conditions:
p.(None): a) When the product or knowledge generated by the research is available or applied for benefit
p.(None): potential of these communities.
p.(None): b) When the principal investigator has the approval of the regional authority of
p.(None): corresponding health and the authorities belonging to the community to study. These approvals
p.(None): they must be obtained prior to the informed consent of the research subjects included in the
p.(None): clinical trial.
p.(None): c) Sponsors and researchers should develop culturally appropriate ways and means with
p.(None): anthropologists, sociologists, translators and interpreters to communicate the necessary information and complete the process
p.(None): of informed consent. In addition, the research protocol must describe and justify
p.(None): the procedure they plan to use to communicate the information to the research subjects.
p.(None): d) It will not be appropriate to include them as research subjects when the individuals that make up a
...
Social / Trade Union Membership
Searching for indicator union:
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p.(None): Article 58. Institutional Research Ethics Committees
p.(None): The Institutional Committee for Research Ethics (CIEI) is the non-profit instance of a
p.(None): research institution, public research institute or Peruvian university, constituted by
p.(None): professionals from various disciplines and members of the community willing to participate, in charge
p.(None): from ensuring the protection of the rights, safety and well-being of research subjects to
p.(None): Through, among other things, review and approval / favorable opinion of the study protocol, the
p.(None): competence of researchers and the adequacy of the facilities, methods and material that
p.(None): they will use when obtaining and documenting the informed consent of the research subjects.
p.(None): Article 59. Institutional Research Ethics Committees and Research Institutions
p.(None): Each research institution may establish a CIEI and register it with the INS. Those institutions
p.(None): Research that do not have a CIEI may make use, at their choice, of another CIEI accredited by the
p.(None): INS, preferably located in the same region.
p.(None): Institutions must provide all necessary resources, such as human resources,
p.(None): infrastructure, logistics and financial for the CIEI to fulfill its mandate. To fulfill his mandate
p.(None): Furthermore, it is imperative that the institutions guarantee that the committees enjoy autonomy and independence.
p.(None): institutional, professional, union, political, commercial and economic.
p.(None): Conflict procedures should be established and described in CIEI regulations
p.(None): of interest, independence and transparency. Regarding independence, all kinds of influence should be prohibited.
p.(None): undue to obtain particular results, decisions or actions of the committee, its members or staff.
p.(None): Regarding transparency, independent internal and external evaluations of the CIEI should be considered.
p.(None): 50 LEGAL STANDARDS Friday, June 30, 2017 /
p.(None): A Peruvian man
p.(None): carried out periodically by professionals without
p.(None): biases and with specific knowledge in the area.
p.(None): Article 60. Functions of Institutional Research Ethics Committees
p.(None): CIEIs have the following functions:
p.(None): a) Evaluate the methodological, ethical and legal aspects
p.(None): of the research protocols that are sent to it.
p.(None): b) Evaluate the amendments to the protocols of
p.(None): authorized research.
p.(None): c) Evaluate the suitability of the principal investigator and his team considering, among other things, the
p.(None): availability of time of the principal investigator and an adequate delegation of responsibilities within the
p.(None): equipment.
p.(None): d) Evaluate the suitability of the facilities of the
p.(None): research centers.
p.(None): e) Conduct supervision, including active supervision at research sites, of trials
p.(None): INS authorized clinicians, from inception to receipt of final report, at appropriate intervals
p.(None): according to the degree of risk for the research subjects, at least one (1) time a year. For
...
Social / Women
Searching for indicator women:
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p.(None): these Regulations.
p.(None): Article 18. Clinical trials in minors
p.(None): Clinical trials may be carried out on minors in accordance with the provisions of Title II of this
p.(None): Regulation and when:
p.(None): a) The protocol has been approved by a CIEI that has a pediatric specialist or has received
p.(None): advice on clinical, ethical and psychosocial aspects in the field of pediatrics if required.
p.(None): b) Obtaining informed consent is adjusted
p.(None): to what is specified in Chapter II of this Title.
p.(None): c) The minor who reaches the age of majority during the clinical trial, must provide their
p.(None): express informed consent before said research subject can continue participating in the
p.(None): clinical trial.
p.(None): Article 19. Clinical trials in people with disabilities
p.(None): Carrying out clinical trials in those who are not in a position to give their informed consent and who
p.(None): have not given it prior to the start of their disability, requires in addition to the provisions of the Title
p.(None): II of these Regulations:
p.(None): a) That informed consent is in accordance with
p.(None): specified in Chapter II of this Title.
p.(None): b) That the protocol be approved by a CIEI that has experts in the disease under study or has
p.(None): collected advice on clinical, ethical and psycho-social aspects in the field of disease and
p.(None): group of affected patients.
p.(None): Article 20. Clinical trials in women and men with reproductive capacity
p.(None): Carrying out clinical trials in women and men with reproductive capacity, except those
p.(None): clinical trials in which the objective of the study is to evaluate the product under investigation in population
p.(None): pregnant or planning to leave, can only be done when they are met in addition to what
p.(None): provided in Title II of these Regulations, the following conditions:
p.(None): a) For research in women with reproductive capacity, the principal investigator will perform a test of
p.(None): pregnancy to rule out pregnancy prior to study start and both investigator and sponsor
p.(None): assure counseling on the importance of avoiding pregnancy for the duration of your study participation and
p.(None): accessibility to an effective contraceptive method at no cost to the research subject, chosen by
p.(None): this and that it is not incompatible with the clinical trial. The researcher will ensure their commitment
p.(None): to use the chosen method. This must be specified in the research protocol and in the consent
p.(None): informed.
p.(None): If a pregnancy occurs during the study, the research protocol should establish:
p.(None): 1) The exclusion of the pregnant woman and 2) The application of the procedures for monitoring and
p.(None): control of the pregnancy, as well as of the newborn up to at least six (6) months of age, with the aim of
p.(None): identify any effect related to the product under investigation.
p.(None): Only in exceptional cases and after evaluation, the pregnant woman may continue participating in
p.(None): the clinical trial, as long as the conditions established in article 21 hereof are complied with
p.(None): Regulation.
p.(None): b) For research in males with reproductive capacity, and according to pharmacology, studies of
p.(None): genotoxicity, reproductive and developmental toxicity and available clinical information on intrauterine exposure to
p.(None): research product, researcher and sponsor will ensure accessibility to a method
p.(None): effective contraception at no cost to the research subject, chosen by him and other than
p.(None): incompatible with the clinical trial, which must be specified in the research protocol and in the
p.(None): informed consent. The researcher will ensure their commitment to prevent the conception of
p.(None): the couple during the development of the study, using the chosen contraceptive method.
p.(None): In case the partner of the research subject becomes pregnant, the monitoring and control of the
p.(None): gestation, as well as the newborn up to at least six (6) months of age, with the aim of
p.(None): identify any effect related to the product under investigation.
p.(None): Article 21. Clinical trials in pregnant women
p.(None): Carrying out clinical trials in pregnant women can only be carried out when they are completed, in addition to
p.(None): provided in Title II of these Regulations, the following conditions:
p.(None): a) The informed consent of the pregnant woman and the father of the intended child will be required, with prior information from the
p.(None): possible risks for the embryo, fetus or newborn, as the case may be.
p.(None): b) The informed consent of the father of the child conceived in the case set forth in the preceding paragraph
p.(None): may only be excepted in case of death, irrefutable impossibility, loss of rights
p.(None): in accordance with current regulations or, when there is an imminent risk to the health or life of the
p.(None): woman or conceived.
p.(None): c) Informed consent may be withdrawn at the request of the pregnant woman or the father of the child conceived in
p.(None): any time, without prejudice to them, as long as it does not affect or put into
p.(None): risk to the conceived or the mother.
p.(None): d) In the case of pregnant adolescents, the procedure established in article 18 hereof shall be followed.
p.(None): Regulation.
p.(None): e) Research in pregnant women must be preceded by trials carried out on women not
p.(None): pregnant women who demonstrate their safety, with the exception of specific tests that require this condition.
p.(None): f) When they are intended to improve the health of pregnant women and represent only a minimal risk to
p.(None): designed or intended to increase the viability of the product of pregnancy, with minimal risk
p.(None): for the pregnant woman.
p.(None): g) During the execution of investigations in pregnant women, the investigators will not have authority to
p.(None): decide on the time, method or procedure used to end the pregnancy, nor will they participate in
p.(None): decisions on the viability of the conceived.
p.(None): Article 22. Clinical trials during labor, postpartum and lactation
p.(None): Carrying out clinical trials in women during labor, the puerperium and lactation can only be done
p.(None): carry out when, in addition to the provisions of Title II of these Regulations, the
p.(None): following conditions:
p.(None): a) Informed consent for research during labor must be obtained according to the
p.(None): stipulated in Chapter II of this Title, before labor begins.
p.(None): b) The clinical trial has the potential to generate direct benefits greater than the risks for women
p.(None): breastfeeding or child after birth.
p.(None): c) The risk to the infant is minimal.
p.(None): d) In the case of adolescents, proceed according to
p.(None): the provisions of article 18 of these Regulations.
p.(None): e) Informed consent may be withdrawn at the request of the woman or the father of the person conceived in any
p.(None): moment, without prejudice to them, as long as
p.(None): 44 LEGAL STANDARDS Friday, June 30, 2017 /
p.(None): A Peruvian man
p.(None): when it does not affect or put at risk the conceived or the
p.(None): mother.
p.(None): Article 23. Clinical Trials in fetuses and deaths
p.(None): Carrying out clinical trials on fetuses and deaths can only be carried out, in addition to the provisions of Title II
p.(None): of this Regulation according to the following criteria:
p.(None): a) Investigations into embryos are found
p.(None): prohibited.
p.(None): b) Research on fetuses can only be carried out if the techniques and means used provide the maximum
p.(None): safety for the fetus and the pregnant woman.
p.(None): c) Investigations with deaths, natimes, macerated fetal matter, cells, tissues, placenta, cord
p.(None): umbilical, embryonic remains and organs removed from them, will be made observing due respect
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Social / Youth/Minors
Searching for indicator minor:
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p.(None): respond to the health needs or priorities of this group.
p.(None): Likewise, it must be justified that the investigation cannot be carried out in a non-vulnerable population.
p.(None): TITLE III
p.(None): OF THE SUBJECTS OF INVESTIGATION CHAPTER I
p.(None): OF THE PROTECTION OF SUBJECTS OF INVESTIGATION
p.(None): Article 16. Subject of investigation
p.(None): The research subject is the individual who participates
p.(None): in a clinical trial and can be:
p.(None): El Peruano / Friday, June 30, 2017
p.(None): LEGAL STANDARDS 43
p.(None): a) A healthy person.
p.(None): b) A person (usually a patient) whose condition is relevant to the use of the product in
p.(None): investigation.
p.(None): Article 17. Protection of the research subject
p.(None): The performance of clinical trials in research subjects is carried out in accordance with the provisions of the
p.(None): this Chapter, without prejudice to the application of the general provisions established in Title II of the
p.(None): these Regulations.
p.(None): Article 18. Clinical trials in minors
p.(None): Clinical trials may be carried out on minors in accordance with the provisions of Title II of this
p.(None): Regulation and when:
p.(None): a) The protocol has been approved by a CIEI that has a pediatric specialist or has received
p.(None): advice on clinical, ethical and psychosocial aspects in the field of pediatrics if required.
p.(None): b) Obtaining informed consent is adjusted
p.(None): to what is specified in Chapter II of this Title.
p.(None): c) The minor who reaches the age of majority during the clinical trial, must provide their
p.(None): express informed consent before said research subject can continue participating in the
p.(None): clinical trial.
p.(None): Article 19. Clinical trials in people with disabilities
p.(None): Carrying out clinical trials in those who are not in a position to give their informed consent and who
p.(None): have not given it prior to the start of their disability, requires in addition to the provisions of the Title
p.(None): II of these Regulations:
p.(None): a) That informed consent is in accordance with
p.(None): specified in Chapter II of this Title.
p.(None): b) That the protocol be approved by a CIEI that has experts in the disease under study or has
p.(None): collected advice on clinical, ethical and psycho-social aspects in the field of disease and
p.(None): group of affected patients.
p.(None): Article 20. Clinical trials in women and men with reproductive capacity
p.(None): Carrying out clinical trials in women and men with reproductive capacity, except those
p.(None): clinical trials in which the objective of the study is to evaluate the product under investigation in population
p.(None): pregnant or planning to leave, can only be done when they are met in addition to what
p.(None): provided in Title II of these Regulations, the following conditions:
...
p.(None): the final results of the clinical trial, which must be in a language understandable to him.
p.(None): - Inform the research subject about post-study access and according to the considerations
p.(None): indicated in Title X of these Regulations.
p.(None): - The existence of a description of the clinical trial available in the Peruvian Registry of Clinical Trials and accessible
p.(None): through the INS institutional web portal
p.(None): - The contact information of the OGITT of the INS, according to what is indicated in number 21 of Annex 4 of the
p.(None): these Regulations.
p.(None): The informed consent form for minors must meet the same requirements as the
p.(None): informed consent where appropriate.
p.(None): If the clinical trial contemplates the collection and storage of biological samples for future use,
p.(None): It must be explained in an additional informed consent format as indicated in the Manual of
p.(None): Clinical trial procedures.
p.(None): Article 35. Compensation to research subjects
p.(None): Research subjects may receive reasonable compensation from the sponsor for expenses
p.(None): extraordinary causes and loss of productivity arising from your participation, which will be specified
p.(None): in the informed consent. The CIEI will evaluate said compensation according to each case; and, will evaluate that no
p.(None): unduly influences the consent of the research subject.
p.(None): Article 36. Subject of minor investigation
p.(None): When the research subject is a minor
p.(None): is required:
p.(None): a) Obtain the informed consent of both parents or the minor's guardian, which may
p.(None): withdraw at any time without prejudice to them. The consent of one of the parents can only
p.(None): dispense in the event of death, loss of rights in accordance with current regulations or
p.(None): duly documented irrefutable impossibility.
p.(None): b) In the event that one of the parents is a minor, the consent of the immediate family member is additionally required
p.(None): ascendant in a straight line unless the father is a minor of 16 years or more and his relative disability has
p.(None): terminated by marriage or by obtaining an official title authorizing you to exercise a profession or trade,
p.(None): in accordance with the provisions of the Civil Code.
p.(None): c) Obtain the consent of the minor, from
p.(None): 8 years old, to participate as a research subject.
p.(None): d) Give the minor information appropriate to their ability to understand the clinical trial, the risks, the
p.(None): discomforts and benefits.
p.(None): e) Accept the withdrawal of informed consent or assent at the request of a parent / guardian
p.(None): or the minor at any time, without prejudice to them, as long as it does not affect or put
p.(None): your health at risk.
p.(None): f) Opt for the exclusion of the minor from considering a conflict of opinion between the parent (s) and
p.(None): the minor on participation in the clinical trial.
p.(None): Informed parental consent is not required if the research subject is a minor
p.(None): age of 16 years or more and whose relative disability has ceased by marriage or by obtaining an official title that
p.(None): authorize you to exercise a profession or trade, in accordance with the provisions of the Civil Code.
p.(None): Article 37. Research subject with mental or intellectual disability
p.(None): When the research subject is a person with a mental or intellectual disability, it must be taken into account
p.(None): the next:
p.(None): a) Obtain the informed written consent of the research subject to participate in the clinical trial,
p.(None): after having received all the relevant information adapted to your level of understanding. Consent must
p.(None): employ tools and strategies to ensure understanding of research subjects. The
p.(None): Informed consent may be withdrawn at any time, without prejudice to it, as long as it is not
p.(None): affect or jeopardize your health.
p.(None): b) In the case of research subjects whose mental disability prevents them from expressing their free will,
p.(None): based on a full understanding of informed consent, it will be granted through your representative
p.(None): legal, after being informed about the possible risks, discomforts and benefits of the trial
p.(None): clinical. The consent may be withdrawn at any time, through its legal representative, without prejudice
...
Social / education
Searching for indicator education:
(return to top)
p.(None): research based on his scientific background and professional experience.
p.(None): 29. Principal investigator.- Investigator responsible for a team of investigators who carry out a
p.(None): clinical trial in a clinical trial center.
p.(None): 30. Investigator's Manual.- Confidential document that describes in detail and in a manner
p.(None): updated physical-chemical and pharmaceutical data, pre-
p.(None): El Peruano / Friday, June 30, 2017
p.(None): LEGAL STANDARDS 41
p.(None): and clinical features of the investigational product that are relevant to the study in humans.
p.(None): Its aim is to provide researchers and other authorized persons participating in the
p.(None): clinical trial, information that facilitates your understanding and compliance with the protocol.
p.(None): 31. Countries with high health surveillance.- Germany, Australia, Belgium, are considered as such.
p.(None): Canada, Republic of Korea, Denmark, Spain, United States of America, France, Holland, Italy,
p.(None): Japan, Norway, Portugal, United Kingdom, Sweden and Switzerland, according to the Regulation for Registration, Control
p.(None): and Health Surveillance of Pharmaceutical Products, Medical Devices and Health Products.
p.(None): 32. Placebo.- Product with pharmaceutical form, without active principle and therefore devoid of action
p.(None): specific pharmacological, which can be used as a control in the clinical trial or for the purpose of maintaining the
p.(None): blinding.
p.(None): 33. Vulnerable population.- They are people who relatively or totally cannot protect their
p.(None): own interests. Specifically they may have insufficient power, education, resources, strength or
p.(None): other attributes necessary to protect your interests. They can also be considered vulnerable to
p.(None): people whose consent to volunteer in a research study
p.(None): may be excessively influenced by expectations, justified or not, of benefits associated with
p.(None): participation, or by a retaliatory response by senior members of a hierarchy if
p.(None): refuse to participate.
p.(None): 34. Insurance policy.- Contract between the insured and an insurance company in which the rights are established,
p.(None): obligations of both parties and coverage, which includes the risks assumed by the insurer and which
p.(None): described in the policy, in relation to the contracted insurance. Among other information, it must contain the
p.(None): necessary to identify the insured, insurer, date of issue, period of validity, description of the
p.(None): insurance, the risks covered and the amounts insured, the specification of the premium to be paid, the
p.(None): grounds for termination of the contract, the procedure to claim compensation if it occurs
p.(None): the claim, clauses that clarify or modify part of the content of the policy contract, as well as the
p.(None): definition of the most important terms used in the policy and the other clauses that must appear in the
p.(None): policy, policy annexes, policy endorsements, in accordance with current legal provisions.
p.(None): 35. Biological product.- They are defined as pharmaceutical products that contain a substance.
p.(None): biological, obtained from microorganisms, blood or other tissues, whose manufacturing methods
...
Social / embryo
Searching for indicator embryo:
(return to top)
p.(None): research product, researcher and sponsor will ensure accessibility to a method
p.(None): effective contraception at no cost to the research subject, chosen by him and other than
p.(None): incompatible with the clinical trial, which must be specified in the research protocol and in the
p.(None): informed consent. The researcher will ensure their commitment to prevent the conception of
p.(None): the couple during the development of the study, using the chosen contraceptive method.
p.(None): In case the partner of the research subject becomes pregnant, the monitoring and control of the
p.(None): gestation, as well as the newborn up to at least six (6) months of age, with the aim of
p.(None): identify any effect related to the product under investigation.
p.(None): Article 21. Clinical trials in pregnant women
p.(None): Carrying out clinical trials in pregnant women can only be carried out when they are completed, in addition to
p.(None): provided in Title II of these Regulations, the following conditions:
p.(None): a) The informed consent of the pregnant woman and the father of the intended child will be required, with prior information from the
p.(None): possible risks for the embryo, fetus or newborn, as the case may be.
p.(None): b) The informed consent of the father of the child conceived in the case set forth in the preceding paragraph
p.(None): may only be excepted in case of death, irrefutable impossibility, loss of rights
p.(None): in accordance with current regulations or, when there is an imminent risk to the health or life of the
p.(None): woman or conceived.
p.(None): c) Informed consent may be withdrawn at the request of the pregnant woman or the father of the child conceived in
p.(None): any time, without prejudice to them, as long as it does not affect or put into
p.(None): risk to the conceived or the mother.
p.(None): d) In the case of pregnant adolescents, the procedure established in article 18 hereof shall be followed.
p.(None): Regulation.
p.(None): e) Research in pregnant women must be preceded by trials carried out on women not
p.(None): pregnant women who demonstrate their safety, with the exception of specific tests that require this condition.
...
p.(None): d) Storage of biological samples or their remnants for future studies: If you plan to store samples
p.(None): remnants beyond the end of the clinical trial and / or biological samples will be removed for
p.(None): storage and future studies, should be incorporated into a specific informed consent form for
p.(None): such an end.
p.(None): e) Information on the results of the tests carried out. It should include:
p.(None): - Your results will be explained to you
p.(None): - Who will inform you
p.(None): - At what time will you be informed
p.(None): - Justification in case of not revealing data temporarily or permanently.
p.(None): 12) Risks and inconveniences derived from the trial
p.(None): clinical
p.(None): a) Risks of the experimental research product, the comparator and any other medication
p.(None): used for clinical trial purposes. Clearly indicate, in a language and language that the subject understands, the
p.(None): reasonably expected risks or discomforts (according to the Investigator's Manual or technical sheet) as well as the possibility
p.(None): of serious events or other unexpected events, or the non-relief or worsening of the symptoms of the pathology of
p.(None): study.
p.(None): b) Risks and inconveniences of the procedures of the
p.(None): clinical trial.
p.(None): c) Risks and measures of prevention and protection against pregnancy of the research subject or his partner. Should
p.(None): include:
p.(None): - Potential risks in case of pregnancy for the
p.(None): fetus or lactating embryo.
p.(None): - Pregnancy tests: initial and additional
p.(None): - Free access and list of contraceptive methods to be chosen by the research subject and his partner,
p.(None): that they are suitable for the test, as well as the time that their use is necessary.
p.(None): - Procedure to follow in case of pregnancy of the research subject or his partner: communication
p.(None): immediately to the investigator, suspension of treatment, withdrawal of the study, monitoring of pregnancy and
p.(None): newborn for 6 months, compensation in case of damage as a result of the clinical trial.
p.(None): 13) Commitments assumed by the research subject if he agrees to participate in the study.
p.(None): 14) Available alternatives.
p.(None): Specify if there are therapeutic, prevention or diagnostic alternatives currently available in the
p.(None): country.
p.(None): El Peruano / Friday, June 30, 2017
p.(None): LEGAL STANDARDS 65
p.(None): 15) Benefits derived from the study
p.(None): In general, it cannot be guaranteed that the product under investigation will directly benefit the subject, since
p.(None): this is what you want to try, so it is more appropriate to use the phrase: "you may or may not benefit from the
p.(None): study medication ”or“ your medical condition may improve, stay the same, and even worsen with
p.(None): study medication ”.
p.(None): The benefits can be divided into benefits for the individual and benefits for their community or for the
p.(None): entire society if an answer to the research question is found.
p.(None): 16) Compensation and treatment in case of damage or injury for your participation in the trial.
p.(None): a) Free medical attention and treatment in case of injury or any adverse event as a result of the
p.(None): administration of the investigational product (experimental and comparator) or any of the procedures or
...
Social / parents
Searching for indicator parent:
(return to top)
p.(None): withdraw at any time without prejudice to them. The consent of one of the parents can only
p.(None): dispense in the event of death, loss of rights in accordance with current regulations or
p.(None): duly documented irrefutable impossibility.
p.(None): b) In the event that one of the parents is a minor, the consent of the immediate family member is additionally required
p.(None): ascendant in a straight line unless the father is a minor of 16 years or more and his relative disability has
p.(None): terminated by marriage or by obtaining an official title authorizing you to exercise a profession or trade,
p.(None): in accordance with the provisions of the Civil Code.
p.(None): c) Obtain the consent of the minor, from
p.(None): 8 years old, to participate as a research subject.
p.(None): d) Give the minor information appropriate to their ability to understand the clinical trial, the risks, the
p.(None): discomforts and benefits.
p.(None): e) Accept the withdrawal of informed consent or assent at the request of a parent / guardian
p.(None): or the minor at any time, without prejudice to them, as long as it does not affect or put
p.(None): your health at risk.
p.(None): f) Opt for the exclusion of the minor from considering a conflict of opinion between the parent (s) and
p.(None): the minor on participation in the clinical trial.
p.(None): Informed parental consent is not required if the research subject is a minor
p.(None): age of 16 years or more and whose relative disability has ceased by marriage or by obtaining an official title that
p.(None): authorize you to exercise a profession or trade, in accordance with the provisions of the Civil Code.
p.(None): Article 37. Research subject with mental or intellectual disability
p.(None): When the research subject is a person with a mental or intellectual disability, it must be taken into account
p.(None): the next:
p.(None): a) Obtain the informed written consent of the research subject to participate in the clinical trial,
p.(None): after having received all the relevant information adapted to your level of understanding. Consent must
p.(None): employ tools and strategies to ensure understanding of research subjects. The
p.(None): Informed consent may be withdrawn at any time, without prejudice to it, as long as it is not
p.(None): affect or jeopardize your health.
p.(None): b) In the case of research subjects whose mental disability prevents them from expressing their free will,
...
Searching for indicator parents:
(return to top)
p.(None): Phase IV: Tests that are carried out once the product under investigation has a sanitary registration for its
p.(None): marketing and according to the conditions established in it. Provide additional information on effectiveness
p.(None): and
p.(None): safety profile (benefit - risk) after use in large populations for a prolonged period of
p.(None): weather.
p.(None): 19. Re-analysis date.-. Date assigned by the manufacturer to carry out a new analysis on the product
p.(None): under investigation, before the expiration date, to verify that the product under investigation retains its
p.(None): physical-chemical and pharmaceutical properties, and is still appropriate for exclusive use in clinical trials.
p.(None): 20. Expiration date.- Date provided by the manufacturer in an uncoded way that is based
p.(None): in the stability studies of the investigational product and after which the product in
p.(None): Research should not be used. This date is set for each batch by adding a life span.
p.(None): useful at the manufacturing date.
p.(None): 21. Subordinate groups.- Includes students, health facility workers, sector employees
p.(None): public or private, members of the armed forces and the Peruvian National Police, inmates in prisons or centers
p.(None): of social rehabilitation and other special groups of the population, in which their participation can be
p.(None): influenced by some authority or hierarchical structure.
p.(None): 22. Reliable impossibility: Situation in which it is not materially possible for one of the parents to grant the
p.(None): consent for duly supported or documented reasons, and under the responsibility of the researcher.
p.(None): 23. Progress report.- Periodic report of each of the research centers that carry out a
p.(None): certain clinical trial, which must be submitted to the INS from the date of authorization of the
p.(None): study, containing, among others, the following information: Number of patients screened, enrolled, in
p.(None): treatment, withdrawn, who completed the study, still to be enrolled; summary of adverse events
p.(None): serious, non-serious adverse events related to the product under investigation and deviations occurred
p.(None): in the corresponding period.
p.(None): 24. Final report of the research center.- Final report of each of the research centers that
p.(None): they run a certain clinical trial containing, among others, the following information: Number of patients
p.(None): screened, enrolled, withdrawn, completed clinical trial, summary of serious adverse events,
p.(None): non-serious adverse events related to the product under investigation and deviations from
p.(None): as stated in the last progress report.
p.(None): 25. National final report.- Report presented after the end of the clinical trial in all the centers of
p.(None): research at the national level, containing, among others, the following information: Number of patients
p.(None): screened, enrolled, withdrawn, completed clinical trial, summary of serious adverse events,
p.(None): non-serious adverse events related to the product under investigation and deviations occurred. In the case of
p.(None): clinical trials executed only in Peru, this report must also include the final results and the
p.(None): clinical trial conclusions.
p.(None): 26. International final report.- Report that records the final results and conclusions of the
...
p.(None): indicated in Title X of these Regulations.
p.(None): - The existence of a description of the clinical trial available in the Peruvian Registry of Clinical Trials and accessible
p.(None): through the INS institutional web portal
p.(None): - The contact information of the OGITT of the INS, according to what is indicated in number 21 of Annex 4 of the
p.(None): these Regulations.
p.(None): The informed consent form for minors must meet the same requirements as the
p.(None): informed consent where appropriate.
p.(None): If the clinical trial contemplates the collection and storage of biological samples for future use,
p.(None): It must be explained in an additional informed consent format as indicated in the Manual of
p.(None): Clinical trial procedures.
p.(None): Article 35. Compensation to research subjects
p.(None): Research subjects may receive reasonable compensation from the sponsor for expenses
p.(None): extraordinary causes and loss of productivity arising from your participation, which will be specified
p.(None): in the informed consent. The CIEI will evaluate said compensation according to each case; and, will evaluate that no
p.(None): unduly influences the consent of the research subject.
p.(None): Article 36. Subject of minor investigation
p.(None): When the research subject is a minor
p.(None): is required:
p.(None): a) Obtain the informed consent of both parents or the minor's guardian, which may
p.(None): withdraw at any time without prejudice to them. The consent of one of the parents can only
p.(None): dispense in the event of death, loss of rights in accordance with current regulations or
p.(None): duly documented irrefutable impossibility.
p.(None): b) In the event that one of the parents is a minor, the consent of the immediate family member is additionally required
p.(None): ascendant in a straight line unless the father is a minor of 16 years or more and his relative disability has
p.(None): terminated by marriage or by obtaining an official title authorizing you to exercise a profession or trade,
p.(None): in accordance with the provisions of the Civil Code.
p.(None): c) Obtain the consent of the minor, from
p.(None): 8 years old, to participate as a research subject.
p.(None): d) Give the minor information appropriate to their ability to understand the clinical trial, the risks, the
p.(None): discomforts and benefits.
p.(None): e) Accept the withdrawal of informed consent or assent at the request of a parent / guardian
p.(None): or the minor at any time, without prejudice to them, as long as it does not affect or put
p.(None): your health at risk.
p.(None): f) Opt for the exclusion of the minor from considering a conflict of opinion between the parent (s) and
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.(None): Clinicians must adhere to the special legislation on the matter and the ethical postulates contained
p.(None): in the Declaration of Helsinki, as well as the successive declarations that update the aforementioned postulates.
p.(None): Likewise, the ethical postulates contained in the national and international regulations that are
p.(None): in force and are applicable to them.
p.(None): Article 6. Authorization to carry out clinical trials
p.(None): Carrying out clinical trials requires prior authorization through a Directorial Resolution issued by the
p.(None): General Office for Research and Technology Transfer (OGITT) of the National Institute of Health (INS), or
p.(None): Whoever takes his place, under the conditions and under the requirements established in these Regulations.
p.(None): Any modification of the conditions in which the authorization was granted and the amendments indicated in the
p.(None): Article 85 of these Regulations must also be previously authorized.
p.(None): Article 7. Regulatory authority in clinical trials
p.(None): The INS is the authority charged at the national level to ensure compliance with these Regulations and
p.(None): the related norms that govern the authorization and execution of clinical trials, as well as dictate the
p.(None): complementary provisions that are required for its application.
p.(None): Article 8. Responsibilities of the National Authority of Pharmaceutical Products, Medical Devices and
p.(None): Sanitary Products (ANM)
p.(None): Corresponds to the National Authority of Pharmaceutical Products, Medical Devices and Health Products
p.(None): (ANM) issue binding technical opinion on the safety and quality of the product under investigation that corresponds
p.(None): within the scope of its competence, on the research protocol of bioequivalence studies
p.(None): to demonstrate interchangeability, as part of the requirement for sanitary registration in the country, as well
p.(None): how to authorize, for exclusive research purposes, the import or manufacture of products in
p.(None): research and complementary products; and authorize the use of a research product under the
p.(None): post-study access conditions.
p.(None): TITLE II
p.(None): RESPECT FOR ETHICAL POSTULATES
p.(None): Article 9. Conditions to the clinical trial
p.(None): All clinical trials must be carried out under conditions of respect for dignity, protection of
p.(None): rights and welfare of research subjects; their physical and mental integrity must be safeguarded, as well as their
p.(None): privacy and protection of your data; and, be carried out with scientific integrity.
p.(None): Article 10. Initiation of the clinical trial
p.(None): A clinical trial can only be started when you have authorization to carry it out according to the
p.(None): indicated in article 6 of these Regulations. This authorization will be granted after the CIEI that
p.(None): corresponds and the INS consider that the benefit / risk balance is favorable for the research subject or for
p.(None): the society; Likewise, it can only continue if compliance with this criterion is permanently maintained.
p.(None): Article 11. Informed consent
...
p.(None): duly documented irrefutable impossibility.
p.(None): b) In the event that one of the parents is a minor, the consent of the immediate family member is additionally required
p.(None): ascendant in a straight line unless the father is a minor of 16 years or more and his relative disability has
p.(None): terminated by marriage or by obtaining an official title authorizing you to exercise a profession or trade,
p.(None): in accordance with the provisions of the Civil Code.
p.(None): c) Obtain the consent of the minor, from
p.(None): 8 years old, to participate as a research subject.
p.(None): d) Give the minor information appropriate to their ability to understand the clinical trial, the risks, the
p.(None): discomforts and benefits.
p.(None): e) Accept the withdrawal of informed consent or assent at the request of a parent / guardian
p.(None): or the minor at any time, without prejudice to them, as long as it does not affect or put
p.(None): your health at risk.
p.(None): f) Opt for the exclusion of the minor from considering a conflict of opinion between the parent (s) and
p.(None): the minor on participation in the clinical trial.
p.(None): Informed parental consent is not required if the research subject is a minor
p.(None): age of 16 years or more and whose relative disability has ceased by marriage or by obtaining an official title that
p.(None): authorize you to exercise a profession or trade, in accordance with the provisions of the Civil Code.
p.(None): Article 37. Research subject with mental or intellectual disability
p.(None): When the research subject is a person with a mental or intellectual disability, it must be taken into account
p.(None): the next:
p.(None): a) Obtain the informed written consent of the research subject to participate in the clinical trial,
p.(None): after having received all the relevant information adapted to your level of understanding. Consent must
p.(None): employ tools and strategies to ensure understanding of research subjects. The
p.(None): Informed consent may be withdrawn at any time, without prejudice to it, as long as it is not
p.(None): affect or jeopardize your health.
p.(None): b) In the case of research subjects whose mental disability prevents them from expressing their free will,
...
p.(None): outpatient and does not carry an additional risk than expected for that ailment or disease to be treated or
p.(None): prevented.
p.(None): b) The main researcher must ensure the resolution capacity of the health establishment in
p.(None): emergency care or unexpected adverse reaction, including equipment, supplies and professional
p.(None): trained to allow cardiopulmonary resuscitation and stabilization of the participant and his
p.(None): Adequate and timely transfer to an inpatient health facility that can serve you.
p.(None): In addition to what is stated in paragraphs a) and b) above, the INS, through the OGITT, will evaluate all the
p.(None): considerations of the research study so that the benefit-risk balance is favorable for the subject
p.(None): research.
p.(None): CHAPTER VII
p.(None): OF THE INSTITUTIONAL COMMITTEES OF ETHICS IN INVESTIGATION
p.(None): Article 58. Institutional Research Ethics Committees
p.(None): The Institutional Committee for Research Ethics (CIEI) is the non-profit instance of a
p.(None): research institution, public research institute or Peruvian university, constituted by
p.(None): professionals from various disciplines and members of the community willing to participate, in charge
p.(None): from ensuring the protection of the rights, safety and well-being of research subjects to
p.(None): Through, among other things, review and approval / favorable opinion of the study protocol, the
p.(None): competence of researchers and the adequacy of the facilities, methods and material that
p.(None): they will use when obtaining and documenting the informed consent of the research subjects.
p.(None): Article 59. Institutional Research Ethics Committees and Research Institutions
p.(None): Each research institution may establish a CIEI and register it with the INS. Those institutions
p.(None): Research that do not have a CIEI may make use, at their choice, of another CIEI accredited by the
p.(None): INS, preferably located in the same region.
p.(None): Institutions must provide all necessary resources, such as human resources,
p.(None): infrastructure, logistics and financial for the CIEI to fulfill its mandate. To fulfill his mandate
p.(None): Furthermore, it is imperative that the institutions guarantee that the committees enjoy autonomy and independence.
p.(None): institutional, professional, union, political, commercial and economic.
p.(None): Conflict procedures should be established and described in CIEI regulations
p.(None): of interest, independence and transparency. Regarding independence, all kinds of influence should be prohibited.
p.(None): undue to obtain particular results, decisions or actions of the committee, its members or staff.
p.(None): Regarding transparency, independent internal and external evaluations of the CIEI should be considered.
p.(None): 50 LEGAL STANDARDS Friday, June 30, 2017 /
p.(None): A Peruvian man
p.(None): carried out periodically by professionals without
...
p.(None): c) Administrative personnel that allow CIEI to be able to properly exercise its functions.
p.(None): Article 63. Accreditation of Institutional Research Ethics Committees
p.(None): Accredited CIEIs will be registered in the REPEC led by the INS OGITT.
p.(None): Accreditation is temporary and must be renewed every
p.(None): three (3) years.
p.(None): The requirements for accreditation are as follows:
p.(None): a) Application for accreditation / renewal of accreditation addressed to the INS.
p.(None): b) Resolution of the highest authority of the institution
p.(None): of research that empowers the operation of the CIEI.
p.(None): c) Copy of its regulations and Procedures Manual approved by the research institution to which
p.(None): they belong.
p.(None): d) Sworn statement indicating compliance with the accreditation standards established in the Manual of
p.(None): Clinical Trial Procedures.
p.(None): e) Undocumented curriculum vitae signed by each of the CIEI members.
p.(None): Accreditation will be granted based on the evaluation of the documentation submitted and verification at the CIEI
p.(None): compliance with the accreditation standards established in the Manual of Clinical Trial Procedures.
p.(None): Article 64. Obligations for the operation of Institutional Research Ethics Committees
p.(None): For their operation, CIEI must:
p.(None): a) Have a regulation and a Procedures Manual approved by the institution
p.(None): of research to which they belong.
p.(None): b) Seek advice from specialists in specific diseases or methodologies, or
p.(None): of representatives of civil organizations, which do not participate in preparing the opinion of the
p.(None): research protocol, when the CIEI does not gather the knowledge and experience necessary to evaluate a
p.(None): certain research protocol.
p.(None): c) Replace with an alternate member the principal investigator or collaborators of a
p.(None): investigation, when they are members of the CIEI, leaving a record in the minutes.
p.(None): Article 65. Regulations of the Institutional Research Ethics Committee
p.(None): The CIEI Regulations must establish the following:
p.(None): a) Composition and requirements to be met by its
p.(None): members.
p.(None): b) Periodicity of the meetings.
p.(None): c) Specific quorum requirements to review and decide on an application, including the
p.(None): minimum number of members required, which must not have an exclusive participation of members of a
p.(None): same profession or same sex and must include at least one member of the community, who does not belong to the field of
p.(None): health, or the research institution.
p.(None): Article 66. Procedures Manual of the Institutional Research Ethics Committee
p.(None): The CIEI Procedures Manual must establish the following:
p.(None): a) Administrative requirements for the presentation of
p.(None): records.
p.(None): El Peruano / Friday, June 30, 2017
p.(None): LEGAL STANDARDS 51
p.(None): b) Procedure for monitoring the protocols of
p.(None): authorized research.
p.(None): c) Procedure for preparing and approving the
p.(None): meeting minutes.
p.(None): d) Procedure for filing related documentation.
p.(None): TITLE V
p.(None): OF THE CLINICAL TRIAL AUTHORIZATION CHAPTER I
p.(None): OF THE REQUIREMENTS
p.(None): Article 67. Requirements for the authorization of the clinical trial
p.(None): The sponsor, or ICO, to request authorization of a clinical trial must comply with submit
...
p.(None): s) List of supplies necessary for the development of the clinical trial, according to the format established in the
p.(None): Clinical Trial Procedures Manual.
p.(None): t) Proof of payment of the right to process. In the case of multicenter clinical trials, the right of payment
p.(None): It will be carried out by each of the research centers in Peru.
p.(None): Article 68. Research products of authorized clinical trials
p.(None): The authorization of clinical trials can only be requested when the research products used
p.(None): meet any of the following conditions:
p.(None): a) Have authorization for research in human beings by Regulatory Authorities of
p.(None): Medicines from countries with high health surveillance.
p.(None): b) Are produced in our country, have pre-clinical research and comply with policies and / or
p.(None): research priorities determined by MINSA.
p.(None): c) To establish therapeutic equivalence of pharmaceutical products or similarity of products
p.(None): biological.
p.(None): d) They are considered a priority for the country's public health or are within the policies and / or
p.(None): research priorities determined by MINSA.
p.(None): e) Those products that at the request of the ANM require clinical trials to support their efficacy and
p.(None): security for health registration.
p.(None): Article 69. Evaluation of the product under investigation
p.(None): At the request of the INS, the ANM will evaluate the safety profile of the product under investigation based on
p.(None): to the Investigator's Manual, the Summary of the Protocol, the Bibliography and other information
p.(None): available as required; and, the quality of the research product based on the information related to
p.(None): the quality of the product under investigation according to Annex 5 of this Regulation, issuing a binding opinion
p.(None): through a technical report within a maximum period of thirty (30) business days. In case the product in
p.(None): Research is not included in what corresponds to the ANM, it must be evaluated by the competent body.
p.(None): In clinical trials with biological research products, the maximum period for issuing the report
p.(None): Technician will be forty-five (45) business days.
p.(None): In the case of bioequivalence studies to demonstrate interchangeability as part of the requirement
p.(None): for sanitary registration in the country, the ANM will also issue a binding opinion on the research protocol
p.(None): through a technical report, within the same period in which the opinion of the safety and quality profile is issued
p.(None): of the product under investigation.
p.(None): Article 70. Authorization of the clinical trial
p.(None): The INS OGITT will issue the clinical trial authorization resolution after evaluating the protocol
p.(None): of investigation, technical report containing the binding opinion issued by the ANM and other requirements
p.(None): established in article 67 of these regulations, within a maximum period of forty (40) days
p.(None): business days, which include the 30 days of the evaluation of the safety profile and the quality of the product in
p.(None): investigation by the ANM. If additional information is required to be submitted by the interested party, it will be suspended
p.(None): the calculation of the evaluation period until the requested information is received.
p.(None): 52 LEGAL STANDARDS Friday, June 30, 2017 /
p.(None): A Peruvian man
p.(None): In clinical trials with biological research products and those controversial situations that
p.(None): involve the call of technical commissions, the maximum term for the authorization of the clinical trial will be
p.(None): sixty (60) business days, which include 45 days of the evaluation of the safety profile and the quality of the
p.(None): product under investigation by the ANM.
p.(None): The Directorates General in charge of strategic interventions for prevention, control and
p.(None): reduction of risks and damages in tuberculosis or HIV / AIDS infection the approval of clinical trials whose
p.(None): research product is intended for the prevention, diagnosis or treatment of conditions
p.(None): mentioned doctors.
p.(None): Article 71. Validity of the test authorization
p.(None): clinical
p.(None): The authorization of the clinical trial is granted for the total period of time scheduled for its execution, the
p.(None): which was registered in the authorization request, which is the Registration Form according to REPEC.
p.(None): Article 72. Call for technical commissions
p.(None): The INS may call technical committees made up of health professionals with a recognized track record
...
General/Other / Dependent
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p.(None): It will be authorized by the ANM, and will be subject to Good Manufacturing Practices and other regulations issued by MINSA.
p.(None): Article 91. Labeling of the products under investigation
p.(None): The mediate labeling of the products under investigation and of complementary products that do not have
p.(None): Marketing authorization in Peru must be printed in indelible ink and in Spanish or
p.(None): English indicating at a minimum: Data identifying the sponsor, the clinical trial and the product, indicating: Date
p.(None): expiration or re-analysis, manufacturing lot number, dosage form, route of administration,
p.(None): special storage and conservation conditions, and record the phrases: “For use only in
p.(None): investigation ”and“ Prohibited sale ”or similar consideration.
p.(None): The immediate labeling of the products under investigation must contain as information: Product name,
p.(None): concentration of the active substance, route of administration, manufacturer's name or logo, batch number and date of
p.(None): expiration.
p.(None): In double blind tests, the lot number and the manufacturer's name will not be included on the labeling,
p.(None): but in the document that contains the identification of the treatment, the codes of
p.(None): Product identification.
p.(None): When the expiration dates of the products in comparison differ, or when their conditions of
p.(None): storage are particular and different, must indicate on the labeling of both the most
p.(None): restrictive of either product.
p.(None): Article 92. The Dispensing Unit for Clinical Trials
p.(None): The dispensing of the products under investigation will be carried out compulsorily through a Unit of
p.(None): Dispensation for Clinical Trials dependent on the Service or Department of Pharmacy of the institution of
p.(None): research where the clinical trial is conducted. To maintain the quality of the product under investigation
p.(None): Good Storage Practices and Good Dispensing Practices approved by MINSA and the
p.(None): study sponsor specifications.
p.(None): Article 93. Responsibility of the Dispensing Unit for Clinical Trials.
p.(None): The Dispensing Unit for Clinical Trials dependent on the Service or Department of Pharmacy is
p.(None): responsible of:
p.(None): a) Keep a record of entry and exit dates, quantities of the product under investigation.
p.(None): b) Make the inventory of the products in
p.(None): investigation.
p.(None): c) Control leftover research products, used and unused, for final disposal according to the
p.(None): established in the protocol.
p.(None): Article 94. Of the authorization to import the product under investigation and products
p.(None): complementary
p.(None): The ANM authorizes the importation of the product under investigation and complementary products, when required,
p.(None): by means of a directorial resolution, the same one that will specify the validity of the authorization. The ANM will grant this
p.(None): authorization within three (3) business days of submitting the request.
p.(None): To request the import authorization of the product under investigation, the
p.(None): upon presentation of the following documents:
p.(None): a) Application for import authorization of the product (s) under investigation and complementary products.
p.(None): b) Copy of the authorization of the clinical trial granted by the OGITT of the INS.
p.(None): c) List of products under investigation, complementary products and supplies to be used in the trial
p.(None): clinical.
p.(None): d) Proof of payment of processing fees to ANM.
p.(None): Article 95. Manufacture or import of special products
p.(None): The manufacture or import of pharmaceutical products, narcotic drugs,
p.(None): psychotropics, precursors for medical use and other substances subject to health control, as well as blood products,
p.(None): they are governed by the specific regulations approved by MINSA.
p.(None): Article 96. Final destination of unused and / or returned research products
p.(None): a) The sponsor or OIC is responsible for the destruction of the unused research product
...
General/Other / Impaired Autonomy
Searching for indicator autonomy:
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p.(None): OF THE INSTITUTIONAL COMMITTEES OF ETHICS IN INVESTIGATION
p.(None): Article 58. Institutional Research Ethics Committees
p.(None): The Institutional Committee for Research Ethics (CIEI) is the non-profit instance of a
p.(None): research institution, public research institute or Peruvian university, constituted by
p.(None): professionals from various disciplines and members of the community willing to participate, in charge
p.(None): from ensuring the protection of the rights, safety and well-being of research subjects to
p.(None): Through, among other things, review and approval / favorable opinion of the study protocol, the
p.(None): competence of researchers and the adequacy of the facilities, methods and material that
p.(None): they will use when obtaining and documenting the informed consent of the research subjects.
p.(None): Article 59. Institutional Research Ethics Committees and Research Institutions
p.(None): Each research institution may establish a CIEI and register it with the INS. Those institutions
p.(None): Research that do not have a CIEI may make use, at their choice, of another CIEI accredited by the
p.(None): INS, preferably located in the same region.
p.(None): Institutions must provide all necessary resources, such as human resources,
p.(None): infrastructure, logistics and financial for the CIEI to fulfill its mandate. To fulfill his mandate
p.(None): Furthermore, it is imperative that the institutions guarantee that the committees enjoy autonomy and independence.
p.(None): institutional, professional, union, political, commercial and economic.
p.(None): Conflict procedures should be established and described in CIEI regulations
p.(None): of interest, independence and transparency. Regarding independence, all kinds of influence should be prohibited.
p.(None): undue to obtain particular results, decisions or actions of the committee, its members or staff.
p.(None): Regarding transparency, independent internal and external evaluations of the CIEI should be considered.
p.(None): 50 LEGAL STANDARDS Friday, June 30, 2017 /
p.(None): A Peruvian man
p.(None): carried out periodically by professionals without
p.(None): biases and with specific knowledge in the area.
p.(None): Article 60. Functions of Institutional Research Ethics Committees
p.(None): CIEIs have the following functions:
p.(None): a) Evaluate the methodological, ethical and legal aspects
p.(None): of the research protocols that are sent to it.
p.(None): b) Evaluate the amendments to the protocols of
p.(None): authorized research.
p.(None): c) Evaluate the suitability of the principal investigator and his team considering, among other things, the
p.(None): availability of time of the principal investigator and an adequate delegation of responsibilities within the
p.(None): equipment.
p.(None): d) Evaluate the suitability of the facilities of the
p.(None): research centers.
p.(None): e) Conduct supervision, including active supervision at research sites, of trials
p.(None): INS authorized clinicians, from inception to receipt of final report, at appropriate intervals
...
General/Other / Relationship to Authority
Searching for indicator authority:
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p.(None): which are canceled in advance, all the activities of a clinical trial being run
p.(None): in a research center. This procedure is for just cause, at the request of the
p.(None): sponsor or as a sanction applied by the OGITT.
p.(None): 7. Confidentiality.- Obligation to maintain, on the part of all participating persons and entities, the
p.(None): privacy of research subjects including their identity, personal medical information and all
p.(None): information generated in the clinical trial unless its disclosure has been expressly authorized by the person
p.(None): affected or, in extraordinary circumstances and with fully justified reasons, by the authorities
p.(None): competent.
p.(None): 8. Informed consent.- It is the process by which the individual voluntarily expresses the acceptance of
p.(None): participate in a clinical trial, after having received the detailed information and explanation about all
p.(None): aspects of the investigation. The decision to participate in the investigation has been made without having
p.(None): been subjected to coercion, undue influence or intimidation. Informed consent is documented by
p.(None): of a written, signed and dated consent form.
p.(None): 9. Documentation.- Includes all records of any kind, such as documents, magnetic records,
p.(None): opticians, among others; that describe the study methods and conduct, factors that affect it, and
p.(None): taken actions. It also includes: the protocol, copies of the requirements presented to the authority
p.(None): regulatory, clinical trial authorization and approval of the Institutional Research Ethics Committee (CIEI),
p.(None): Resume of the researchers, informed consent form, researcher's manual,
p.(None): monitoring reports, audit certificates, correspondence, benchmarks, reporting form
p.(None): case record, periodic communications and final communication, original records such as medical history,
p.(None): laboratory tests, clinical reports, diaries of the subjects, among others related to the clinical trial.
p.(None): 10. Amendment.- Written description of change (s) or formal clarification of a research protocol and / or
p.(None): informed consent.
p.(None): 11. Clinical Trial.- For the purposes of these Regulations, a clinical trial is understood to be any investigation that
p.(None): perform in humans to determine or confirm clinical, pharmacological, and / or other effects
p.(None): pharmacodynamic effects; detect adverse reactions; study absorption, distribution,
p.(None): metabolism and
p.(None): 40 LEGAL STANDARDS Friday, June 30, 2017 /
p.(None): A Peruvian man
p.(None): elimination of one or more products under investigation, in order to determine their efficacy and / or safety.
p.(None): Research subjects are previously assigned to the research product and the assignment is
p.(None): determined by the research protocol.
p.(None): 12. Multicenter clinical trial.- Clinical trial conducted according to a single protocol but in more
p.(None): of a center and, therefore, carried out by more than one researcher and a coordinator who is in charge of
p.(None): processing of all data and analysis of results.
...
p.(None): that in the previous phase and that is representative of the general population to which the
p.(None): product in research or in healthy volunteers for prevention studies.
p.(None): Phase IV: Tests that are carried out once the product under investigation has a sanitary registration for its
p.(None): marketing and according to the conditions established in it. Provide additional information on effectiveness
p.(None): and
p.(None): safety profile (benefit - risk) after use in large populations for a prolonged period of
p.(None): weather.
p.(None): 19. Re-analysis date.-. Date assigned by the manufacturer to carry out a new analysis on the product
p.(None): under investigation, before the expiration date, to verify that the product under investigation retains its
p.(None): physical-chemical and pharmaceutical properties, and is still appropriate for exclusive use in clinical trials.
p.(None): 20. Expiration date.- Date provided by the manufacturer in an uncoded way that is based
p.(None): in the stability studies of the investigational product and after which the product in
p.(None): Research should not be used. This date is set for each batch by adding a life span.
p.(None): useful at the manufacturing date.
p.(None): 21. Subordinate groups.- Includes students, health facility workers, sector employees
p.(None): public or private, members of the armed forces and the Peruvian National Police, inmates in prisons or centers
p.(None): of social rehabilitation and other special groups of the population, in which their participation can be
p.(None): influenced by some authority or hierarchical structure.
p.(None): 22. Reliable impossibility: Situation in which it is not materially possible for one of the parents to grant the
p.(None): consent for duly supported or documented reasons, and under the responsibility of the researcher.
p.(None): 23. Progress report.- Periodic report of each of the research centers that carry out a
p.(None): certain clinical trial, which must be submitted to the INS from the date of authorization of the
p.(None): study, containing, among others, the following information: Number of patients screened, enrolled, in
p.(None): treatment, withdrawn, who completed the study, still to be enrolled; summary of adverse events
p.(None): serious, non-serious adverse events related to the product under investigation and deviations occurred
p.(None): in the corresponding period.
p.(None): 24. Final report of the research center.- Final report of each of the research centers that
p.(None): they run a certain clinical trial containing, among others, the following information: Number of patients
p.(None): screened, enrolled, withdrawn, completed clinical trial, summary of serious adverse events,
p.(None): non-serious adverse events related to the product under investigation and deviations from
p.(None): as stated in the last progress report.
p.(None): 25. National final report.- Report presented after the end of the clinical trial in all the centers of
p.(None): research at the national level, containing, among others, the following information: Number of patients
p.(None): screened, enrolled, withdrawn, completed clinical trial, summary of serious adverse events,
p.(None): non-serious adverse events related to the product under investigation and deviations occurred. In the case of
...
p.(None): technique.
p.(None): 43. Suspected serious and unexpected adverse reaction.- It is any serious adverse event in the
p.(None): that there is at least a reasonable possibility of a causal relationship with the product under investigation and whose
p.(None): nature or severity is not described in the researcher's manual and / or technical sheet.
p.(None): 44. Controversial situations.- That situation in which it is identified during the evaluation process of the
p.(None): clinical trial, that the benefit / risk balance is debatable.
p.(None): 45. Suspension of the clinical trial.- It is the temporary interruption of enrollment and / or
p.(None): administration of the investigational product, or of all clinical trial activities in all
p.(None): research centers. This procedure is given for just cause, at the request of the sponsor or
p.(None): as a security measure applied by OGITT.
p.(None): 46. Suspension of the registration of a Research center.- Procedure under which the
p.(None): temporary deactivation of the registration of the research center in REPEC, implying the disqualification
p.(None): research center to run new clinical trials or ongoing clinical trials.
p.(None): The registration of a research center will be suspended as a security measure imposed by the INS OGITT.
p.(None): 47. Witness.- Person of legal age, independent of the investigation team, who participates in the
p.(None): process of obtaining informed consent as a guarantee that it respects the rights and interests of a
p.(None): potential research subject.
p.(None): 2.2 Abbreviations
p.(None): 1. ANM: National Authority for Pharmaceutical Products, Medical Devices and Products
p.(None): Sanitary.
p.(None): 2. PCB: Good Clinical Practice.
p.(None): 3. BPM: Good Manufacturing Practices.
p.(None): 4. CIEI: Institutional Research Ethics Committee.
p.(None): 5. CIOMS: Council of International Organizations of Medical Sciences in Collaboration with WHO.
p.(None): 6. FCI: Informed consent form.
p.(None): 42 LEGAL STANDARDS Friday, June 30, 2017 /
p.(None): A Peruvian man
p.(None): 7. ICH: International Conference on Harmonization of Technical Requirements for Product Registration
p.(None): Pharmaceuticals for Human Use.
p.(None): 8. INS: National Institute of Health.
p.(None): 9. MINSA: Ministry of Health.
p.(None): 10. OGITT: General Office for Research and Technology Transfer.
p.(None): 11. OIC: Contract Research Organization.
p.(None): 12. REAS-NET: Virtual Reporting System of Serious Adverse Events.
p.(None): 13. RENIPRESS: National Registry of Institutions that Provide Health Services.
p.(None): 14. REPEC: Peruvian Registry of Clinical Trials.
p.(None): Article 3. Scope
p.(None): Natural or legal, public or natural persons are subject to the provisions of these regulations.
p.(None): private, national or foreign that carry out or are linked to clinical trials in human beings
p.(None): humans in the national territory
p.(None): Article 4. Purpose
p.(None): Compliance with these regulations is intended to protect the rights, security,
p.(None): dignity and well-being of research subjects, determine the obligations of individuals and entities that
p.(None): participate in the approval and execution of clinical trials, as well as ensuring that data
p.(None): obtained in a clinical trial are reliable and robust.
p.(None): Article 5. Ethical Postulates
p.(None): In accordance with the provisions of article 28 of Law No. 26842, General Health Law, tests
p.(None): Clinicians must adhere to the special legislation on the matter and the ethical postulates contained
p.(None): in the Declaration of Helsinki, as well as the successive declarations that update the aforementioned postulates.
p.(None): Likewise, the ethical postulates contained in the national and international regulations that are
p.(None): in force and are applicable to them.
p.(None): Article 6. Authorization to carry out clinical trials
p.(None): Carrying out clinical trials requires prior authorization through a Directorial Resolution issued by the
p.(None): General Office for Research and Technology Transfer (OGITT) of the National Institute of Health (INS), or
p.(None): Whoever takes his place, under the conditions and under the requirements established in these Regulations.
p.(None): Any modification of the conditions in which the authorization was granted and the amendments indicated in the
p.(None): Article 85 of these Regulations must also be previously authorized.
p.(None): Article 7. Regulatory authority in clinical trials
p.(None): The INS is the authority charged at the national level to ensure compliance with these Regulations and
p.(None): the related norms that govern the authorization and execution of clinical trials, as well as dictate the
p.(None): complementary provisions that are required for its application.
p.(None): Article 8. Responsibilities of the National Authority of Pharmaceutical Products, Medical Devices and
p.(None): Sanitary Products (ANM)
p.(None): Corresponds to the National Authority of Pharmaceutical Products, Medical Devices and Health Products
p.(None): (ANM) issue binding technical opinion on the safety and quality of the product under investigation that corresponds
p.(None): within the scope of its competence, on the research protocol of bioequivalence studies
p.(None): to demonstrate interchangeability, as part of the requirement for sanitary registration in the country, as well
p.(None): how to authorize, for exclusive research purposes, the import or manufacture of products in
p.(None): research and complementary products; and authorize the use of a research product under the
p.(None): post-study access conditions.
p.(None): TITLE II
p.(None): RESPECT FOR ETHICAL POSTULATES
p.(None): Article 9. Conditions to the clinical trial
p.(None): All clinical trials must be carried out under conditions of respect for dignity, protection of
p.(None): rights and welfare of research subjects; their physical and mental integrity must be safeguarded, as well as their
p.(None): privacy and protection of your data; and, be carried out with scientific integrity.
p.(None): Article 10. Initiation of the clinical trial
p.(None): A clinical trial can only be started when you have authorization to carry it out according to the
p.(None): indicated in article 6 of these Regulations. This authorization will be granted after the CIEI that
p.(None): corresponds and the INS consider that the benefit / risk balance is favorable for the research subject or for
p.(None): the society; Likewise, it can only continue if compliance with this criterion is permanently maintained.
...
p.(None): any time, without prejudice to them, as long as it does not affect or put into
p.(None): risk to the conceived or the mother.
p.(None): d) In the case of pregnant adolescents, the procedure established in article 18 hereof shall be followed.
p.(None): Regulation.
p.(None): e) Research in pregnant women must be preceded by trials carried out on women not
p.(None): pregnant women who demonstrate their safety, with the exception of specific tests that require this condition.
p.(None): f) When they are intended to improve the health of pregnant women and represent only a minimal risk to
p.(None): designed or intended to increase the viability of the product of pregnancy, with minimal risk
p.(None): for the pregnant woman.
p.(None): g) During the execution of investigations in pregnant women, the investigators will not have authority to
p.(None): decide on the time, method or procedure used to end the pregnancy, nor will they participate in
p.(None): decisions on the viability of the conceived.
p.(None): Article 22. Clinical trials during labor, postpartum and lactation
p.(None): Carrying out clinical trials in women during labor, the puerperium and lactation can only be done
p.(None): carry out when, in addition to the provisions of Title II of these Regulations, the
p.(None): following conditions:
p.(None): a) Informed consent for research during labor must be obtained according to the
p.(None): stipulated in Chapter II of this Title, before labor begins.
p.(None): b) The clinical trial has the potential to generate direct benefits greater than the risks for women
p.(None): breastfeeding or child after birth.
p.(None): c) The risk to the infant is minimal.
p.(None): d) In the case of adolescents, proceed according to
p.(None): the provisions of article 18 of these Regulations.
p.(None): e) Informed consent may be withdrawn at the request of the woman or the father of the person conceived in any
p.(None): moment, without prejudice to them, as long as
p.(None): 44 LEGAL STANDARDS Friday, June 30, 2017 /
p.(None): A Peruvian man
p.(None): when it does not affect or put at risk the conceived or the
p.(None): mother.
p.(None): Article 23. Clinical Trials in fetuses and deaths
...
p.(None): in the Regulations of the Cemeteries and Funeral Services Law, as appropriate.
p.(None): Article 24. Of clinical trials in subordinate groups
p.(None): The performance of clinical trials in subordinate groups can only be carried out when they are completed, in addition
p.(None): of the provisions of Title II of these Regulations, the following conditions:
p.(None): a) When research is carried out in subordinate groups, one or more members must participate in the CIEI
p.(None): of the study population, or another person in society capable of protecting the conditions and rights
p.(None): humans that correspond to the group in question.
p.(None): b) Participation, rejection or withdrawal of their consent during the study of the subjects
p.(None): under investigation, do not affect your academic, work, military or judicial situation
p.(None): to which they were subject and the conditions of compliance with the judgment, if applicable; and that
p.(None): research results are not used to their detriment.
p.(None): Article 25. Clinical trials in indigenous or native peoples
p.(None): The carrying out of clinical trials in indigenous or native peoples may only be carried out when
p.(None): In addition to the provisions of Title II of these Regulations, they comply with the following conditions:
p.(None): a) When the product or knowledge generated by the research is available or applied for benefit
p.(None): potential of these communities.
p.(None): b) When the principal investigator has the approval of the regional authority of
p.(None): corresponding health and the authorities belonging to the community to study. These approvals
p.(None): they must be obtained prior to the informed consent of the research subjects included in the
p.(None): clinical trial.
p.(None): c) Sponsors and researchers should develop culturally appropriate ways and means with
p.(None): anthropologists, sociologists, translators and interpreters to communicate the necessary information and complete the process
p.(None): of informed consent. In addition, the research protocol must describe and justify
p.(None): the procedure they plan to use to communicate the information to the research subjects.
p.(None): d) It will not be appropriate to include them as research subjects when the individuals that make up a
p.(None): community do not have the capacity to understand the implications of participating in an investigation, despite the
p.(None): employment of a translator or interpreter.
p.(None): e) In the case of including the storage of biological samples, additionally,
p.(None): You must have the authorization of the corresponding regional and local government, and the authorities
p.(None): respective communities, who must consider the interest of the community involved.
p.(None): Article 26. Clinical trials without direct benefit to the health of the research subjects or
p.(None): healthy volunteers
p.(None): Carrying out clinical trials in healthy volunteers can only be carried out when the
p.(None): following conditions:
...
p.(None): The research centers of the public and private sector will be registered in the REPEC led by the OGITT of the
p.(None): INS, at the request of the research institution, for conducting clinical trials.
p.(None): The registration will be valid for three (3) years. The requirements for registration or renewal are:
p.(None): a) Registration request issued by the legal representative of the research institution.
p.(None): b) Form prepared according to Annex 3 of these Regulations, duly completed.
p.(None): c) National Registry of Institutions that Provide Health Services - RENIPRESS in force from the
p.(None): research institution where the research center and its categorization will operate.
p.(None): d) Proof of payment for registration as a center
p.(None): research.
p.(None): Registration will be granted based on the evaluation of the documentation presented and verification at the center of the
p.(None): characteristics required by these Regulations.
p.(None): In case of category changes of the research institution or modifications of the research center, you must
p.(None): communicate to the OGITT to adopt the respective actions.
p.(None): Article 55. Approval of research centers
p.(None): Research centers must have the approval of the research institution for the
p.(None): conducting the clinical trial.
p.(None): The research institution will manage the research centers that operate in its facilities without
p.(None): affect the normal performance of care work, meeting the minimum requirements stipulated in the
p.(None): Annex 3 of these Regulations.
p.(None): CHAPTER VI
p.(None): OF THE INVESTIGATION INSTITUTION
p.(None): Article 56. The research institution
p.(None): A research institution is a public health facility or
p.(None): duly authorized and categorized by the
p.(None): corresponding health authority, or whoever takes its place, such as hospitals, clinics, health institutes
p.(None): specialized, as well as those mentioned in article 57 of these Regulations where the centers of
p.(None): research conducting clinical trials.
p.(None): One or more research centers may operate in the research institution, provided they comply with
p.(None): the minimum requirements established in Annex 3 of these Regulations
p.(None): Article 57. Health establishments of the first level of care as institutions of
p.(None): investigation
p.(None): Health establishments not included in article 56 may function as an institution
p.(None): research if:
p.(None): a) The clinical trial evaluates an investigational product intended for a treatment
p.(None): outpatient and does not carry an additional risk than expected for that ailment or disease to be treated or
p.(None): prevented.
p.(None): b) The main researcher must ensure the resolution capacity of the health establishment in
p.(None): emergency care or unexpected adverse reaction, including equipment, supplies and professional
p.(None): trained to allow cardiopulmonary resuscitation and stabilization of the participant and his
p.(None): Adequate and timely transfer to an inpatient health facility that can serve you.
p.(None): In addition to what is stated in paragraphs a) and b) above, the INS, through the OGITT, will evaluate all the
p.(None): considerations of the research study so that the benefit-risk balance is favorable for the subject
p.(None): research.
p.(None): CHAPTER VII
p.(None): OF THE INSTITUTIONAL COMMITTEES OF ETHICS IN INVESTIGATION
...
p.(None): research institution.
p.(None): e) Alternate members whose number should be considered
p.(None): establish the internal regulations of the CIEI.
p.(None): f) The CIEI will independently establish the procedure to select and define the positions among
p.(None): its members, indicating the requirements and processes for the replacement and maintenance and responsibilities of each
p.(None): position.
p.(None): g) The renewal of CIEI members will be defined in the regulations of each CIEI.
p.(None): All members must have at least a certificate of basic training in research ethics and one
p.(None): of its members must have training in Bioethics.
p.(None): Article 62. Infrastructure requirements for Institutional Research Ethics Committees
p.(None): The following are minimum infrastructure requirements for the operation of the CIEI:
p.(None): a) Specific areas or environments that allow the performance of their work, under conditions that guarantee the
p.(None): confidentiality.
p.(None): b) Computer equipment with sufficient capacity to handle all the information generated by the CIEI.
p.(None): c) Administrative personnel that allow CIEI to be able to properly exercise its functions.
p.(None): Article 63. Accreditation of Institutional Research Ethics Committees
p.(None): Accredited CIEIs will be registered in the REPEC led by the INS OGITT.
p.(None): Accreditation is temporary and must be renewed every
p.(None): three (3) years.
p.(None): The requirements for accreditation are as follows:
p.(None): a) Application for accreditation / renewal of accreditation addressed to the INS.
p.(None): b) Resolution of the highest authority of the institution
p.(None): of research that empowers the operation of the CIEI.
p.(None): c) Copy of its regulations and Procedures Manual approved by the research institution to which
p.(None): they belong.
p.(None): d) Sworn statement indicating compliance with the accreditation standards established in the Manual of
p.(None): Clinical Trial Procedures.
p.(None): e) Undocumented curriculum vitae signed by each of the CIEI members.
p.(None): Accreditation will be granted based on the evaluation of the documentation submitted and verification at the CIEI
p.(None): compliance with the accreditation standards established in the Manual of Clinical Trial Procedures.
p.(None): Article 64. Obligations for the operation of Institutional Research Ethics Committees
p.(None): For their operation, CIEI must:
p.(None): a) Have a regulation and a Procedures Manual approved by the institution
p.(None): of research to which they belong.
p.(None): b) Seek advice from specialists in specific diseases or methodologies, or
p.(None): of representatives of civil organizations, which do not participate in preparing the opinion of the
p.(None): research protocol, when the CIEI does not gather the knowledge and experience necessary to evaluate a
p.(None): certain research protocol.
p.(None): c) Replace with an alternate member the principal investigator or collaborators of a
p.(None): investigation, when they are members of the CIEI, leaving a record in the minutes.
p.(None): Article 65. Regulations of the Institutional Research Ethics Committee
p.(None): The CIEI Regulations must establish the following:
p.(None): a) Composition and requirements to be met by its
p.(None): members.
p.(None): b) Periodicity of the meetings.
...
p.(None): request authorization from the ANM.
p.(None): Article 117. Requirements for post-study access to the research product in case of
p.(None): require authorization by the ANM
p.(None): ANM authorization is granted for each specific case. This request will be made by the sponsor who
p.(None): conducted the clinical trial. The requirements for this authorization are:
p.(None): a) Request for authorization addressed to the ANM
p.(None): b) Written informed consent of the research subject or his legal representative (signed by the subject
p.(None): research and principal investigator)
p.(None): c) Clinical report in which the principal investigator justifies the need for said treatment.
p.(None): d) Official medical prescription duly completed.
p.(None): e) Compliance of the person in charge of the institution or establishment where the treatment will be applied, according
p.(None): it corresponds.
p.(None): f) Updated researcher manual, according to
p.(None): it corresponds.
p.(None): g) Copy of the directorial resolution authorizing the
p.(None): clinical trial from which the specific case is derived.
p.(None): Article 118. Communication of results
p.(None): The sponsor will communicate to the ANM the results of the treatment within the established period, as well as suspicions of
p.(None): adverse drug reactions that may be due to it, without prejudice to the communication of
p.(None): adverse reactions to the decentralized health dependency at the corresponding territorial level.
p.(None): TITLE XI
p.(None): OF THE SUPERVISION OF CLINICAL TRIALS
p.(None): Article 119. Authority in charge of supervision In order to ensure the quality and integrity of the data or
p.(None): other elements related to a clinical trial and protect the rights and well-being of the subjects
p.(None): of research, the OGITT of the INS will supervise the execution of the clinical trials that are carried out in the
p.(None): country.
p.(None): Article 120. Supervision
p.(None): It is understood by supervision to the technical administrative diligence ordered by the INS OGITT, with the
p.(None): object of verifying that the clinical trial performance complies with the provisions of these Regulations.
p.(None): Article 121. Inspections
p.(None): Supervision is carried out through ordinary and extraordinary inspections and with qualified personnel
p.(None): multi-disciplinary.
p.(None): The inspections will be carried out based on the Inspection Guide approved by INS resolution.
p.(None): Inspections may be carried out at the beginning, during the execution and at the end of the clinical trial in the respective
p.(None): research center, at the place of manufacture of the product under investigation and / or in the
p.(None): facilities of the sponsor, the ICO, the CIEI and the principal investigator.
p.(None): The INS will publish the results of the inspections according to the procedures established in the
p.(None): Inspections.
p.(None): Article 122. Powers of inspectors
p.(None): a) Review the documentation of the clinical trial to verify compliance with the protocol and its amendments.
p.(None): b) Review the informed consent of the research subjects to verify that security,
p.(None): welfare and the rights of patients are protected.
p.(None): c) Review the record of data reported and analyzed according to the protocol, to verify the quality and
...
p.(None): participation in the inspection visit as an observer.
p.(None): Article 125. Extraordinary inspections
p.(None): Extraordinary inspections are carried out at any time with the purpose of anticipating or
p.(None): correct any circumstance that endangers the health of the research subject and in the event of a complaint.
p.(None): Article 126. Notification for carrying out inspections
p.(None): In order to carry out ordinary inspections, prior and by
p.(None): writing, to the establishment or service object of the inspection, as well as to the sponsor or OIC, of
p.(None): correspond, the date and time in which it will take place. The notification will be made with a
p.(None): not less than two (2) business days in advance.
p.(None): Extraordinary inspections will be carried out without the
p.(None): prior notification requirement.
p.(None): Article 127. Participation of the ANM
p.(None): To verify compliance with Good Manufacturing Practices standards, Good Manufacturing Practices
p.(None): Storage and other related regulations, the INS OGITT will coordinate with the ANM the participation of personnel from that area
p.(None): in the inspection team.
p.(None): Article 128. Inspection certificate
p.(None): Once the inspection is completed, the inspector will draw up the corresponding report in duplicate, indicating
p.(None): 58 LEGAL STANDARDS Friday, June 30, 2017 /
p.(None): A Peruvian man
p.(None): place, date and time of the inspection, the detail of the findings found, the recommendations of
p.(None): be the case, the manifestation of the parties, as well as the subjects under investigation to correspond.
p.(None): TITLE XII
p.(None): ABOUT SECURITY MEASURES,
p.(None): INFRINGEMENTS AND SANCTIONS
p.(None): Article 129. Competent authority
p.(None): In application of the rules that guarantee the safety of the research subject established
p.(None): By this Regulation and other mandatory norms that emanate from it, the INS OGITT, will apply security measures and
p.(None): sanctions directed at the sponsor, OIC, research institution or principal investigator.
p.(None): Article 130. Security measures
p.(None): Before, during or after the clinical trial, the INS OGITT, depending on the severity of the case,
p.(None): apply one or more security measures that include, among others:
p.(None): a) Intensification of monitoring.
p.(None): b) Notification to the sponsor of the clinical trial.
p.(None): c) Notification to CIEI.
p.(None): d) Notification to the Research Institution.
p.(None): e) Notification to the National Health Authority.
p.(None): f) Notification to the ANM.
p.(None): g) Notification to the corresponding professional associations.
p.(None): h) Immobilization of the product under investigation.
p.(None): i) Suspension of the clinical trial.
p.(None): j) Suspension of the clinical trial in a research center.
p.(None): k) Suspension of the registration of a research center for new clinical trials or
p.(None): ongoing clinical trials.
p.(None): Article 131. Offenses
p.(None): They constitute violations of the provisions
p.(None): contained in these Regulations the following:
p.(None): a) Prevent the action of duly accredited regulatory authority inspectors.
p.(None): b) Use a research product in the subjects without the authorization referred
p.(None): in article 67 of these Regulations.
p.(None): c) Conduct clinical trials without the prior authorization of the regulatory authority.
p.(None): d) Make modifications to the conditions of authorization of the clinical trial or amendments to the protocol of
p.(None): investigation without having been previously authorized by the regulatory authority. A violation does not constitute
p.(None): deviation from protocol in a research subject required to eliminate an immediate risk or change
p.(None): approved by the CIEI applicable to a research subject that does not constitute an amendment to the protocol.
p.(None): e) Breach of the obligation to communicate to the OGITT of the INS, the adverse events of the product in
p.(None): investigation.
p.(None): f) Notify the INS OGITT of the adverse effects detected after the deadline established in this
p.(None): Regulation.
p.(None): g) Non-compliance by persons and entities participating in the clinical trial of the duty to
p.(None): guarantee the confidentiality and privacy of the research subject.
p.(None): h) Carry out the promotion, information or advertising of the product under investigation.
p.(None): i) Breach of the security measures established by the OGITT.
p.(None): j) Carry out the clinical trial without adjusting to the content of the protocols based on which the
p.(None): authorization.
p.(None): k) Conduct the clinical trial without the informed consent of the subject of
p.(None): investigation or, where appropriate, of the person legally indicated to grant it.
p.(None): l) Breach of the duty to inform the person about the clinical trial in which he participates as a subject of
p.(None): investigation.
p.(None): m) Manufacture or falsify the information required by these Regulations or the data related to the
p.(None): test.
p.(None): n) Failure to comply with the other mandatory observance provisions established in the
p.(None): this Regulation and the norms that emanate from it.
p.(None): Article 132. Sanctions
p.(None): Without prejudice to consider compliance with the principle called non bis in idem as mandatory, except
p.(None): the concurrence of a case of continuation of infractions, those who incur in typified infractions in the
p.(None): article 131 of these Regulations; will be liable to one of the following administrative sanctions:
p.(None): a) Warning.
p.(None): b) Fine comprised between half (0.5) and one hundred (100) Tax Units.
p.(None): c) Closure of a research center for a trial
p.(None): clinical.
p.(None): d) Cancellation of the registration of the research center
p.(None): e) Cancellation of the clinical trial
p.(None): f) Restricting the investigator to carry out future trials for a period to be determined by the INS OGITT
p.(None): according to the level of seriousness of the infraction.
p.(None): The scale of fines for each type of infraction is determined by Supreme Decree. The fine must be paid within
p.(None): of the maximum term of fifteen (15) business days, counted from the day after the sanction is notified.
p.(None): In case of non-compliance, the authority that imposed the fine will order its coercive collection according to
p.(None): law procedure.
p.(None): Article 133. Criteria for the imposition of sanctions
p.(None): The sanctions will be imposed by the INS OGITT by means of a Directorial Resolution applying the criteria indicated in the
p.(None): Article 135 of the General Health Law.
p.(None): Article 134. Clinical trials without authorization
p.(None): In the event that the INS OGITT detects the conduct of a clinical trial without the corresponding authorization, it will have
p.(None): the cancellation of the clinical trial and / or invalidation of the data obtained in it, without prejudice to the actions
p.(None): civil and / or criminal offenses and / or communication to the Public Ministry, the ANM and / or the schools
p.(None): corresponding professionals.
p.(None): Article 135. Clinical trials in which there is falsification or manufacture of the required information or of
p.(None): the data.
p.(None): In the event that the INS OGITT detects the falsification or fabrication of the information required by this
p.(None): Regulations or data related to the study, as well as any other offense or crime related to
p.(None): the clinical trial in accordance with these Regulations, will provide for the cancellation and / or invalidation of said trial
p.(None): clinical, in accordance with the provisions of article 132 of these Regulations, without prejudice to actions
p.(None): civil and / or criminal offenses and / or communication to the Public Ministry, the ANM and the schools
p.(None): corresponding professionals.
p.(None): Article 136. Infringement by foreign sponsors
p.(None): If the sponsor (s) participating in the cases established in articles 134 and
p.(None): 135 of these Regulations, if they were foreigners, the INS will inform the authorities of their respective country (ies)
p.(None): so that they have the corresponding legal actions.
p.(None): Article 137. Notification and publication of sanctions
p.(None): 137.1 The INS OGITT will notify the security measure and / or the sanction imposed on people and
p.(None): entities participating in the execution of the trial
p.(None): El Peruano / Friday, June 30, 2017
p.(None): LEGAL STANDARDS 59
p.(None): clinical, without prejudice to the civil and / or criminal actions that may take place and / or the communication to the
p.(None): Public Ministry, the National Level Health Authority, the ANM and the professional associations
p.(None): corresponding.
p.(None): 137.2 Once the resolution that determines the imposition of a sanction is final or the route has been exhausted
p.(None): Administrative, the INS OGITT will publish, on the INS institutional website, the name of the person or
p.(None): institution that has been subject to the sanction. Said publication will be kept for one year, unless the sanction is for
p.(None): a longer period, being withdrawn automatically or at the request of a party at the end of said period.
p.(None): FINAL SUPPLEMENTARY PROVISIONS
p.(None): First.- Aspects not provided for in these Regulations
p.(None): The aspects not foreseen in these Regulations will be resolved by the INS OGITT within the framework of the regulations
p.(None): of Good Clinical Practices of the International Conference on Harmonization of Technical Requirements for the
p.(None): Registration of Pharmaceutical Products for Human Use, as well as national regulations and
p.(None): international that are in force and are applicable to it.
p.(None): Second.- From the Manual of Clinical Trial Procedures
p.(None): Within a maximum period of ninety (90) calendar days from the effective date of these Regulations, the INS OGITT
p.(None): will elaborate the Manual of Procedures of Clinical Trials, which will be approved by Resolution of the INS.
p.(None): Third.- Term for the constitution of Dispensing Units
p.(None): A maximum period of one year from the validity of this Regulation will be granted so that
p.(None): the research institutions comply with the conformation of the Dispensing Units to which
p.(None): refers to article 92 of this Regulation.
p.(None): Fourth.- Temporary application of these Regulations for research products that
p.(None): correspond to herbal medicines, dietary products and sweeteners, galenic products and
...
p.(None): Clinic available on the research product. You should also be given guidelines for the
p.(None): recognition and treatment of possible overdose and adverse reactions based on previous experience in
p.(None): and in the pharmacology of the research product.
p.(None): SUMMARY OF INFORMATION AND GUIDE FOR THE INVESTIGATOR
p.(None): BIBLIOGRAPHIC REFERENCES
p.(None): Publications and Reports References. These references should be at the end of each chapter.
p.(None): (1) These are minimum requirements, and may require
p.(None): others according to the complexity of the clinical trial (s) and the product under investigation.
p.(None): (2) For research centers without internment, it is not a minimum requirement to have a hospitalization area,
p.(None): but there must be an agreement with a health facility with hospitalization within a nearby area.
p.(None): (3) The clinical laboratory must comply with quality standards and Good Laboratory Practices, duly
p.(None): certified or accredited. Research institutions that do not have a clinical laboratory within
p.(None): its facilities may have the external support of said service. In the case of clinical laboratories
p.(None): nationals must also be registered with RENIPRESS.
p.(None): 64 LEGAL STANDARDS Friday, June 30, 2017 /
p.(None): A Peruvian man
p.(None): ANNEX 4
p.(None): GUIDE TO THE INFORMED CONSENT FORMAT
p.(None): 1) Title of the Clinical Trial.
p.(None): 2) Informed Consent - Peru Version /
p.(None): Date.
p.(None): 3) Sponsor (s), research institution, principal investigator, Institutional Ethics Committee in
p.(None): Research (CIEI) and local Regulatory Authority.
p.(None): 4) Introduction:
p.(None): a) Invitation to participate in the clinical trial, explain the differences between an investigation and the
p.(None): routine medical care and those aspects of the study that are experimental.
p.(None): b) Reasons why the person has been chosen to invite them to participate in the clinical trial.
p.(None): c) Voluntary participation free of coercion and undue influence and freedom to finish their
p.(None): participation. Make it clear that participation is voluntary and include the measures that will be taken to avoid
p.(None): coercion of research subjects:
p.(None): - Ask all the questions you consider.
p.(None): - Take the time to decide whether or not you want to participate.
p.(None): - Take an unsigned copy to read again, if necessary.
p.(None): - Talk about the study with their relatives,
p.(None): friends and / or your GP, if you wish.
p.(None): - That you can choose to participate or not in the study, without
p.(None): none of your rights are affected.
p.(None): - That you can withdraw your participation at any time without giving explanations and without sanction or loss of the
p.(None): benefits to which you would be entitled.
p.(None): 5) Justification, Objectives and purpose of the Research:
p.(None): Explain in local and simplified terms Why is this study being carried out? and what are the
p.(None): objectives?
p.(None): 6) Number of people to enroll (worldwide and in Peru)
p.(None): 7) Expected duration of participation of the research subject
p.(None): Including number and duration of visits to the research center and total time involved).
p.(None): 8) The circumstances and / or anticipated reasons under which the study or the
p.(None): subject participation in the study.
...
p.(None): b) Use that will be given to the data of the subject of
p.(None): investigation.
p.(None): c) How will the data of the research subject be stored and protected? And who will have access?
p.(None): d) Access to your data by the representatives
p.(None): from the sponsor, CIEI and INS.
p.(None): e) Management of your data and biological samples in case
p.(None): withdrawal of informed consent.
p.(None): f) Non-identification of the subject in case of publications or scientific presentations of the clinical trial.
p.(None): 20) Situation after completion of the clinical trial, post-study access to the product under investigation.
p.(None): If the product under investigation will be available to the research subjects in which it has been shown to be
p.(None): beneficial, after you have completed your participation in the clinical trial, when and how you will be
p.(None): available.
p.(None): 21) Clinical trial information
p.(None): a) Availability of publicly available clinical trial information available at REPEC,
p.(None): should point to the address of their website: http://www.ensayosclinicos-repec.ins.gob.pe
p.(None): b) Information on the final results of the clinical trial. Specify the time, means and responsible for the
p.(None): which will provide the research subject with the final results of the clinical trial.
p.(None): 22) Contact details
p.(None): a) Contacts to answer any questions or doubts and in case of injuries
p.(None): - Principal investigator (s): Address, email and telephone numbers.
p.(None): - CIEI President: Address, email and telephone.
p.(None): b) Contact details of the Regulatory Authority
p.(None): (INS). Include the following text:
p.(None): "When you consider that your rights are violated or before any complaint, you can
p.(None): contact the INS (General Office for Research and Technology Transfer, OGITT), the regulatory body for
p.(None): clinical trials, through the following telephone number: 7481111 annex 2191 or by written communication through the
p.(None): following email: consultaensayos@ins.gob. eg, or through a formal document presented through
p.(None): table of parties of the institution or go in person to the OGITT at the following address: Cápac Yupanqui 1400, Jesús
p.(None): María, Lima 11 ”.
p.(None): Section to be completed by the research subject:
p.(None): - I ...................... (Name and surname) ....................
p.(None): .........................
p.(None): - I have read (or someone has read to me) the information provided in this document.
p.(None): - I have been informed about the objectives of this study, the procedures, the risks, what is expected of me and
p.(None): my rights.
p.(None): - I have been able to ask questions about the study and they have all been answered appropriately. I think I understand
p.(None): all information provided about this clinical trial.
p.(None): - I understand that my participation is voluntary.
p.(None): - I understand that I can withdraw from the study whenever I want, without having to give explanations and without this
p.(None): affect my medical care.
p.(None): - By signing this document, I agree to participate in this clinical trial. I am not giving up any rights.
p.(None): - I understand that I will receive a signed and dated copy of this document.
p.(None): Full name of the research subject .............
p.(None): ....................................
p.(None): Signature of the research subject ...............................
p.(None): .......................
p.(None): Date and Time................................
...
p.(None): I confirm that the research subject has freely given his consent.
p.(None): Full name of the witness ………………………… ...
p.(None): Witness signature………………………………………….
p.(None): Date and Time............................................... ..................
p.(None): Section to be completed by the investigator
p.(None): I have explained the clinical trial to the research subject and answered all his questions.
p.(None): I confirm that he understands the information described
p.(None): 66 LEGAL STANDARDS Friday, June 30, 2017 /
p.(None): A Peruvian man
p.(None): in this document and agree to participate in the form
p.(None): voluntary.
p.(None): Investigator's Name ..........................................
p.(None): Investigator's Signature .............................................
p.(None): Date and time (the same date when the participant signs) .....................................
p.(None): ANNEX 5
p.(None): INFORMATION RELATED TO THE QUALITY OF THE RESEARCH PRODUCT TO BE PRESENTED AS PART OF THE REQUIREMENTS
p.(None): FOR THE AUTHORIZATION OF A CLINICAL TRIAL
p.(None): For the purposes of authorization of a clinical trial
p.(None): Submission of the following documents is required:
p.(None): 1. Regarding the research product (not including the comparator):
p.(None): a) Project labeling of the product under investigation, as established in Article 91 of this
p.(None): Regulation.
p.(None): b) Certificate of batch release analysis or documents that include technical specifications of the
p.(None): batch / series result of the finished product.
p.(None): c) Accelerated or long-term stability studies
p.(None): as appropriate.
p.(None): d) Current certificate of Good Manufacturing Practices from the manufacturer of the product under investigation,
p.(None): issued by the competent authority of the country of origin or a document that guarantees compliance.
p.(None): 2. In the case of products under investigation (comparators):
p.(None): a) Unmodified Comparator: If the comparator is a marketed product that comes from
p.(None): countries with high health surveillance and / or countries with mutual recognition, to be used in the same
p.(None): authorized conditions, without any modification in its packaging, except for a reconditioning that does not affect the
p.(None): original conditions of the primary packaging, the following is presented:
p.(None): i. Draft labeling as established in article 91 of these Regulations.
p.(None): ii. A document issued by the manufacturer or sponsor indicating the name and address
p.(None): of the manufacturer, the name of the marketing authorization holder and the number of the
p.(None): marketing authorization, indicating the regulatory authority of the country from which it comes.
p.(None): iii. Certificate of batch release analysis or document issued by the manufacturer or
p.(None): sponsor signed by the Technical Director or qualified person responsible for product quality
p.(None): b) Repackaging Comparator: If the comparator is a marketed product that comes from countries with high vigilance
p.(None): health and / or countries with mutual recognition, to be used under the same authorized conditions, and
p.(None): that has been modified in the packaging to allow blinding, the following appears:
p.(None): i. Draft labeling as established in article 91 of these Regulations.
p.(None): ii. Document issued by the manufacturer or sponsor indicating the modification made to the packaging, the
p.(None): name (s), address (es) and responsibilities of all manufacturers involved in the modification; the name of the
p.(None): marketing authorization holder and the marketing authorization number, indicating
p.(None): the regulatory authority of the country from which it comes.
p.(None): iii. Re-packaged comparator batch analysis certificate, including proof of identification
p.(None): of the product, indicating the analytical method, signed by the Technical Director or responsible qualified person
p.(None): of the quality of the product, that the manufacturing was carried out in compliance with the BPM.
p.(None): iv. Documentation from the competent authorities certifying that the person in charge of repackaging is
p.(None): Authorized to manufacture investigational or comparator medicinal products (Manufacturing License).
p.(None): These requirements may also apply to used comparators (research products)
p.(None): in open label, as long as they are commercialized products, which come from countries with
p.(None): high sanitary surveillance and / or from countries with mutual recognition, used without any modification in
p.(None): its packaging except for a repackaging.
p.(None): In the case of comparators whose repackaging may affect the finished product, it must be submitted
p.(None): support that the authorization conditions have not been altered.
p.(None): c) Modified Comparator: If the comparator is a marketed product that comes from countries with high
p.(None): health surveillance and / or countries with mutual recognition, to be used under the same conditions
p.(None): authorized, and which has been modified in its pharmaceutical form to allow blinding, what is presented
p.(None): following:
p.(None): i. Document issued by the manufacturer or sponsor indicating the modification
p.(None): made in the pharmaceutical form, the name (s), address (es) and responsibilities of the manufacturers
p.(None): involved in the modification; the name of the marketing authorization holder and the number
p.(None): of the marketing authorization, indicating the regulatory authority of the country from which it comes.
p.(None): ii. Modified comparator batch analysis certificate or document issued by the manufacturer or
p.(None): sponsor that includes the tests and acceptance criteria, depending on the degree of modification of the
p.(None): authorized product and according to the corresponding pharmaceutical form, signed by the Technical Director or person
p.(None): qualified responsible for the quality of the product, that the corresponding modification was made in compliance
p.(None): with GMP and scientific support that the stability and bioavailability of the
p.(None): product.
p.(None): iii. Documentation from the competent authorities certifying that the person in charge of the modification is
p.(None): Authorized to manufacture investigational or comparator medicinal products (Manufacturing License).
p.(None): If the comparator is a marketed product and does not come from countries with high health surveillance and / or
p.(None): countries with mutual recognition, all the quality documentation indicated for the products must be provided in
p.(None): non-comparators research.
p.(None): If the comparator is a placebo, you must present an official document issued by the manufacturer in which
p.(None): indicate the name of the substance used and its corresponding certificate of analysis.
p.(None): If the comparator is a product with a current sanitary registration in Peru, only a declaration will be necessary
p.(None): sworn issued by the sponsor indicating the name and address of the manufacturer, the name of the owner
p.(None): of the sanitary registry and the sanitary registry number. If necessary, the sponsor or executor of the
p.(None): Authorized clinical trial will be able to locally acquire medicines with sanitary registration in the country used as
p.(None): comparators, for use in clinical research.
p.(None): 3. In the case of complementary products. Complementary products that do not have sanitary registration
p.(None): in Peru or in countries with high health surveillance and / or countries with mutual recognition must
p.(None): present the requirements indicated in the numeral
p.(None): 1. If the product has a current health registry in Peru or in countries with high health surveillance and / or
p.(None): from countries with mutual recognition, only an affidavit issued by the sponsor will be necessary
p.(None): indicating the name and address of the manufacturer, the name of the holder of the sanitary registration or of the
p.(None): marketing authorization and the number of the health registration or marketing authorization,
p.(None): indicating the regulatory authority of the country from which it comes.
p.(None): El Peruano / Friday, June 30, 2017
p.(None): LEGAL STANDARDS 67
p.(None): In the case of biological products and medical devices, the ANM will establish the certificates or other
p.(None): documents that for sanitary necessity are required.
p.(None): 1538902-2
p.(None): TRANSPORTATION AND COMMUNICATIONS
p.(None): Appointed official responsible for submitting job offers from the Ministry of Transport and Communications
p.(None): (Executing Unit 001: General Administration) to the General Directorate of the National Employment Service of the
p.(None): Ministry of Labor and Employment Promotion
p.(None): MINISTERIAL RESOLUTION
p.(None): N ° 546-2017 MTC / 01
p.(None): Lima, June 28, 2017
p.(None): SEEN: Los Memorandos N ° s. 0969 and 0970-2017- MTC / 10.07 of the General Office of Administration; and,
p.(None): CONSIDERING:
p.(None): That, Law No. 27736, Law for the Radio and Television Transmission of Job Offers, regulates the notices of
p.(None): public service in which public and private jobs are offered;
p.(None): That, article 2 of Supreme Decree No. 012-2004-TR, Dictate regulatory provisions of Law No. 27736,
p.(None): referring to the radio and television transmission of job offers from the public and private sectors, establishes that
p.(None): Every public body and State company is obliged to refer to the Cil Proempleo Red Program of the
p.(None): Ministry of Labor and Employment Promotion offers of public positions that are scheduled to compete.
p.(None): Positions classified as trustworthy are excluded from this obligation to compete and submit the offer.
p.(None): according to the rules of the current public labor regulations;
...
General/Other / Undue Influence
Searching for indicator undue influence:
(return to top)
p.(None): investigation or as a sanction imposed by the INS OGITT.
p.(None): 5. Blinding.- Procedure in which one or more parts of the study do not know the assignments to the
p.(None): treatment. Generally, simple blinding refers to the fact that the research subjects are unaware of the
p.(None): assignment; double blinding refers to the fact that research subjects and researchers are unaware of the
p.(None): allocation to treatment; and, triple blinding refers to the research subjects, researchers and
p.(None): the one who analyzes the results does not know the treatment allocation.
p.(None): 6. Closure of a Research Center for a clinical trial.- Administrative procedure through the
p.(None): which are canceled in advance, all the activities of a clinical trial being run
p.(None): in a research center. This procedure is for just cause, at the request of the
p.(None): sponsor or as a sanction applied by the OGITT.
p.(None): 7. Confidentiality.- Obligation to maintain, on the part of all participating persons and entities, the
p.(None): privacy of research subjects including their identity, personal medical information and all
p.(None): information generated in the clinical trial unless its disclosure has been expressly authorized by the person
p.(None): affected or, in extraordinary circumstances and with fully justified reasons, by the authorities
p.(None): competent.
p.(None): 8. Informed consent.- It is the process by which the individual voluntarily expresses the acceptance of
p.(None): participate in a clinical trial, after having received the detailed information and explanation about all
p.(None): aspects of the investigation. The decision to participate in the investigation has been made without having
p.(None): been subjected to coercion, undue influence or intimidation. Informed consent is documented by
p.(None): of a written, signed and dated consent form.
p.(None): 9. Documentation.- Includes all records of any kind, such as documents, magnetic records,
p.(None): opticians, among others; that describe the study methods and conduct, factors that affect it, and
p.(None): taken actions. It also includes: the protocol, copies of the requirements presented to the authority
p.(None): regulatory, clinical trial authorization and approval of the Institutional Research Ethics Committee (CIEI),
p.(None): Resume of the researchers, informed consent form, researcher's manual,
p.(None): monitoring reports, audit certificates, correspondence, benchmarks, reporting form
p.(None): case record, periodic communications and final communication, original records such as medical history,
p.(None): laboratory tests, clinical reports, diaries of the subjects, among others related to the clinical trial.
p.(None): 10. Amendment.- Written description of change (s) or formal clarification of a research protocol and / or
p.(None): informed consent.
p.(None): 11. Clinical Trial.- For the purposes of these Regulations, a clinical trial is understood to be any investigation that
p.(None): perform in humans to determine or confirm clinical, pharmacological, and / or other effects
p.(None): pharmacodynamic effects; detect adverse reactions; study absorption, distribution,
p.(None): metabolism and
p.(None): 40 LEGAL STANDARDS Friday, June 30, 2017 /
p.(None): A Peruvian man
...
p.(None): (1) These are minimum requirements, and may require
p.(None): others according to the complexity of the clinical trial (s) and the product under investigation.
p.(None): (2) For research centers without internment, it is not a minimum requirement to have a hospitalization area,
p.(None): but there must be an agreement with a health facility with hospitalization within a nearby area.
p.(None): (3) The clinical laboratory must comply with quality standards and Good Laboratory Practices, duly
p.(None): certified or accredited. Research institutions that do not have a clinical laboratory within
p.(None): its facilities may have the external support of said service. In the case of clinical laboratories
p.(None): nationals must also be registered with RENIPRESS.
p.(None): 64 LEGAL STANDARDS Friday, June 30, 2017 /
p.(None): A Peruvian man
p.(None): ANNEX 4
p.(None): GUIDE TO THE INFORMED CONSENT FORMAT
p.(None): 1) Title of the Clinical Trial.
p.(None): 2) Informed Consent - Peru Version /
p.(None): Date.
p.(None): 3) Sponsor (s), research institution, principal investigator, Institutional Ethics Committee in
p.(None): Research (CIEI) and local Regulatory Authority.
p.(None): 4) Introduction:
p.(None): a) Invitation to participate in the clinical trial, explain the differences between an investigation and the
p.(None): routine medical care and those aspects of the study that are experimental.
p.(None): b) Reasons why the person has been chosen to invite them to participate in the clinical trial.
p.(None): c) Voluntary participation free of coercion and undue influence and freedom to finish their
p.(None): participation. Make it clear that participation is voluntary and include the measures that will be taken to avoid
p.(None): coercion of research subjects:
p.(None): - Ask all the questions you consider.
p.(None): - Take the time to decide whether or not you want to participate.
p.(None): - Take an unsigned copy to read again, if necessary.
p.(None): - Talk about the study with their relatives,
p.(None): friends and / or your GP, if you wish.
p.(None): - That you can choose to participate or not in the study, without
p.(None): none of your rights are affected.
p.(None): - That you can withdraw your participation at any time without giving explanations and without sanction or loss of the
p.(None): benefits to which you would be entitled.
p.(None): 5) Justification, Objectives and purpose of the Research:
p.(None): Explain in local and simplified terms Why is this study being carried out? and what are the
p.(None): objectives?
p.(None): 6) Number of people to enroll (worldwide and in Peru)
p.(None): 7) Expected duration of participation of the research subject
p.(None): Including number and duration of visits to the research center and total time involved).
p.(None): 8) The circumstances and / or anticipated reasons under which the study or the
p.(None): subject participation in the study.
p.(None): 9) Trial treatments or interventions
p.(None): clinical.
p.(None): a) Description of the product under investigation
p.(None): experimental. It should include:
p.(None): - Name of the research product
p.(None): - Explanation of the reasons for its development
p.(None): - Previous experience with the product
p.(None): - If it is approved or not in Peru and in other countries.
p.(None): b) Comparator description
...
General/Other / cultural difference
Searching for indicator culturally:
(return to top)
p.(None): of the study population, or another person in society capable of protecting the conditions and rights
p.(None): humans that correspond to the group in question.
p.(None): b) Participation, rejection or withdrawal of their consent during the study of the subjects
p.(None): under investigation, do not affect your academic, work, military or judicial situation
p.(None): to which they were subject and the conditions of compliance with the judgment, if applicable; and that
p.(None): research results are not used to their detriment.
p.(None): Article 25. Clinical trials in indigenous or native peoples
p.(None): The carrying out of clinical trials in indigenous or native peoples may only be carried out when
p.(None): In addition to the provisions of Title II of these Regulations, they comply with the following conditions:
p.(None): a) When the product or knowledge generated by the research is available or applied for benefit
p.(None): potential of these communities.
p.(None): b) When the principal investigator has the approval of the regional authority of
p.(None): corresponding health and the authorities belonging to the community to study. These approvals
p.(None): they must be obtained prior to the informed consent of the research subjects included in the
p.(None): clinical trial.
p.(None): c) Sponsors and researchers should develop culturally appropriate ways and means with
p.(None): anthropologists, sociologists, translators and interpreters to communicate the necessary information and complete the process
p.(None): of informed consent. In addition, the research protocol must describe and justify
p.(None): the procedure they plan to use to communicate the information to the research subjects.
p.(None): d) It will not be appropriate to include them as research subjects when the individuals that make up a
p.(None): community do not have the capacity to understand the implications of participating in an investigation, despite the
p.(None): employment of a translator or interpreter.
p.(None): e) In the case of including the storage of biological samples, additionally,
p.(None): You must have the authorization of the corresponding regional and local government, and the authorities
p.(None): respective communities, who must consider the interest of the community involved.
p.(None): Article 26. Clinical trials without direct benefit to the health of the research subjects or
p.(None): healthy volunteers
p.(None): Carrying out clinical trials in healthy volunteers can only be carried out when the
p.(None): following conditions:
p.(None): a) When the risk they assume is justified by reason of an expected benefit for the community.
p.(None): b) When the interventions to which the research subjects are going to be subjected are comparable to
p.(None): those that correspond to the usual medical practice depending on your medical, psychological or social situation and are taken
p.(None): adequate security protection measures.
...
General/Other / participants in a control group
Searching for indicator placebo:
(return to top)
p.(None): clinical trial after the end of it all research centers internationally.
p.(None): 27. Inspection.- Official review carried out by the INS of the documents, facilities, records, systems of
p.(None): quality assurance and any other source that the INS considers; and that is related to the clinical trial
p.(None): at the research center, at the facilities of the sponsor or the Research Organization by
p.(None): Contract (OIC), CIEI or any other involving the clinical trial.
p.(None): 28. Researcher.- Professional in charge of conducting the clinical trial in a center
p.(None): research based on his scientific background and professional experience.
p.(None): 29. Principal investigator.- Investigator responsible for a team of investigators who carry out a
p.(None): clinical trial in a clinical trial center.
p.(None): 30. Investigator's Manual.- Confidential document that describes in detail and in a manner
p.(None): updated physical-chemical and pharmaceutical data, pre-
p.(None): El Peruano / Friday, June 30, 2017
p.(None): LEGAL STANDARDS 41
p.(None): and clinical features of the investigational product that are relevant to the study in humans.
p.(None): Its aim is to provide researchers and other authorized persons participating in the
p.(None): clinical trial, information that facilitates your understanding and compliance with the protocol.
p.(None): 31. Countries with high health surveillance.- Germany, Australia, Belgium, are considered as such.
p.(None): Canada, Republic of Korea, Denmark, Spain, United States of America, France, Holland, Italy,
p.(None): Japan, Norway, Portugal, United Kingdom, Sweden and Switzerland, according to the Regulation for Registration, Control
p.(None): and Health Surveillance of Pharmaceutical Products, Medical Devices and Health Products.
p.(None): 32. Placebo.- Product with pharmaceutical form, without active principle and therefore devoid of action
p.(None): specific pharmacological, which can be used as a control in the clinical trial or for the purpose of maintaining the
p.(None): blinding.
p.(None): 33. Vulnerable population.- They are people who relatively or totally cannot protect their
p.(None): own interests. Specifically they may have insufficient power, education, resources, strength or
p.(None): other attributes necessary to protect your interests. They can also be considered vulnerable to
p.(None): people whose consent to volunteer in a research study
p.(None): may be excessively influenced by expectations, justified or not, of benefits associated with
p.(None): participation, or by a retaliatory response by senior members of a hierarchy if
p.(None): refuse to participate.
p.(None): 34. Insurance policy.- Contract between the insured and an insurance company in which the rights are established,
p.(None): obligations of both parties and coverage, which includes the risks assumed by the insurer and which
p.(None): described in the policy, in relation to the contracted insurance. Among other information, it must contain the
p.(None): necessary to identify the insured, insurer, date of issue, period of validity, description of the
p.(None): insurance, the risks covered and the amounts insured, the specification of the premium to be paid, the
p.(None): grounds for termination of the contract, the procedure to claim compensation if it occurs
...
p.(None): faculties according to their age and maturity to allow their understanding, having to register their name and / or signature in
p.(None): sign of your authorization.
p.(None): Article 34. Requirements for the informed consent format
p.(None): The informed consent form of the subject of
p.(None): Research is subject to the following requirements:
p.(None): a) Be prepared by the main researcher, sponsor or both, with the information indicated in
p.(None): literal d) of this article and according to the model of the Informed Consent Form established in
p.(None): Annex 4 of these Regulations.
p.(None): b) Be reviewed and approved by a CIEI of the institution where the clinical trial will be conducted, accredited by
p.(None): the INS, in accordance with the provisions of Chapter VII of Title IV of these Regulations.
p.(None): c) The consent must be written in Spanish and in the language that the research subject identifies as
p.(None): own; the wording must be understandable to him.
p.(None): d) You must enter, among others, the following information:
p.(None): - The title of the clinical trial.
p.(None): - The explicit invitation to participate in an experimental research study and the
p.(None): voluntary nature of participation.
p.(None): - The justification, objectives and purpose of the clinical trial.
p.(None): - Trial treatments or interventions: investigational product, active comparator and do
p.(None): reference to placebo and blinding if applicable, as well as the probability of allocation for
p.(None): each intervention.
p.(None): - The procedures to be used and their purpose, as well as the time, means and responsible for
p.(None): inform the research subject of the results of the examinations carried out or the justification for not doing so.
p.(None): - Approximate number of research subjects to
p.(None): include worldwide and in Peru.
p.(None): - The expected duration of the subject's participation
p.(None): research.
p.(None): - The inconvenience, the expected risks or the risks
p.(None): unpredictable.
p.(None): - Free treatment and procedures
p.(None): used as part of the clinical trial design.
p.(None): - The expected benefits that can be obtained.
p.(None): - If there are alternative procedures that could be advantageous to the research subject.
p.(None): - The commitments assumed by the subject of
p.(None): research if you agree to participate in the study.
p.(None): - The guarantee of receiving answers to any questions and clarification of any doubts about
p.(None): the procedures, risks, benefits and other matters related to the clinical trial and the
p.(None): treatment of
p.(None): 46 LEGAL STANDARDS Friday, June 30, 2017 /
p.(None): A Peruvian man
p.(None): research subject; about your rights as a research subject or contact in case of injury,
p.(None): for which the name, address and telephone number of the principal investigator and those of the president of the
p.(None): CIEI as appropriate.
p.(None): - The freedom to withdraw your consent at any time and stop participating in the study without it
p.(None): damages are created to continue their care and treatment.
p.(None): - The security that the research subject will not be identified and that the confidentiality of the
p.(None): information related to your privacy.
...
p.(None): coercion of research subjects:
p.(None): - Ask all the questions you consider.
p.(None): - Take the time to decide whether or not you want to participate.
p.(None): - Take an unsigned copy to read again, if necessary.
p.(None): - Talk about the study with their relatives,
p.(None): friends and / or your GP, if you wish.
p.(None): - That you can choose to participate or not in the study, without
p.(None): none of your rights are affected.
p.(None): - That you can withdraw your participation at any time without giving explanations and without sanction or loss of the
p.(None): benefits to which you would be entitled.
p.(None): 5) Justification, Objectives and purpose of the Research:
p.(None): Explain in local and simplified terms Why is this study being carried out? and what are the
p.(None): objectives?
p.(None): 6) Number of people to enroll (worldwide and in Peru)
p.(None): 7) Expected duration of participation of the research subject
p.(None): Including number and duration of visits to the research center and total time involved).
p.(None): 8) The circumstances and / or anticipated reasons under which the study or the
p.(None): subject participation in the study.
p.(None): 9) Trial treatments or interventions
p.(None): clinical.
p.(None): a) Description of the product under investigation
p.(None): experimental. It should include:
p.(None): - Name of the research product
p.(None): - Explanation of the reasons for its development
p.(None): - Previous experience with the product
p.(None): - If it is approved or not in Peru and in other countries.
p.(None): b) Comparator description
p.(None): c) Explanation in case of use of inactive drug or placebo and the reasons for its use: It is important
p.(None): make sure the participant understands what a placebo is or what it means to use an inactive drug
p.(None): as well as the reasons for its use.
p.(None): 10) Randomization and blinding.
p.(None): It should include:
p.(None): a) Explanation of randomization and how likely they are to receive one drug or another
p.(None): in terms understandable to the research subject.
p.(None): b) Explanation of blinding, reasons for its use as well as the possibility of obtaining information from the
p.(None): assigned treatment in emergencies.
p.(None): 11) Study procedures:
p.(None): a) Explanation of the study procedures to be followed (interviews,
p.(None): questionnaires, auxiliary exams, diet to follow): Describe or explain the procedures
p.(None): will perform and all medications given (including premedication, rescue medication, or other
p.(None): medication necessary for any study procedure, such as local anesthesia in case of biopsies)
p.(None): being able to include a simplified scheme and / or calendar of visits and procedures.
p.(None): b) Biological samples to be collected: type, quantity and number of times to be extracted. It is necessary
p.(None): explain how many times and how much is needed, in measures that the subject understands.
p.(None): c) Final destination of remaining biological samples. Explicitly mention that biological samples
p.(None): obtained will be used only for ongoing research and will be destroyed when the clinical trial is
p.(None): have completed, unless your storage is contemplated for future use.
p.(None): d) Storage of biological samples or their remnants for future studies: If you plan to store samples
p.(None): remnants beyond the end of the clinical trial and / or biological samples will be removed for
...
p.(None): health surveillance and / or countries with mutual recognition, to be used under the same conditions
p.(None): authorized, and which has been modified in its pharmaceutical form to allow blinding, what is presented
p.(None): following:
p.(None): i. Document issued by the manufacturer or sponsor indicating the modification
p.(None): made in the pharmaceutical form, the name (s), address (es) and responsibilities of the manufacturers
p.(None): involved in the modification; the name of the marketing authorization holder and the number
p.(None): of the marketing authorization, indicating the regulatory authority of the country from which it comes.
p.(None): ii. Modified comparator batch analysis certificate or document issued by the manufacturer or
p.(None): sponsor that includes the tests and acceptance criteria, depending on the degree of modification of the
p.(None): authorized product and according to the corresponding pharmaceutical form, signed by the Technical Director or person
p.(None): qualified responsible for the quality of the product, that the corresponding modification was made in compliance
p.(None): with GMP and scientific support that the stability and bioavailability of the
p.(None): product.
p.(None): iii. Documentation from the competent authorities certifying that the person in charge of the modification is
p.(None): Authorized to manufacture investigational or comparator medicinal products (Manufacturing License).
p.(None): If the comparator is a marketed product and does not come from countries with high health surveillance and / or
p.(None): countries with mutual recognition, all the quality documentation indicated for the products must be provided in
p.(None): non-comparators research.
p.(None): If the comparator is a placebo, you must present an official document issued by the manufacturer in which
p.(None): indicate the name of the substance used and its corresponding certificate of analysis.
p.(None): If the comparator is a product with a current sanitary registration in Peru, only a declaration will be necessary
p.(None): sworn issued by the sponsor indicating the name and address of the manufacturer, the name of the owner
p.(None): of the sanitary registry and the sanitary registry number. If necessary, the sponsor or executor of the
p.(None): Authorized clinical trial will be able to locally acquire medicines with sanitary registration in the country used as
p.(None): comparators, for use in clinical research.
p.(None): 3. In the case of complementary products. Complementary products that do not have sanitary registration
p.(None): in Peru or in countries with high health surveillance and / or countries with mutual recognition must
p.(None): present the requirements indicated in the numeral
p.(None): 1. If the product has a current health registry in Peru or in countries with high health surveillance and / or
p.(None): from countries with mutual recognition, only an affidavit issued by the sponsor will be necessary
p.(None): indicating the name and address of the manufacturer, the name of the holder of the sanitary registration or of the
p.(None): marketing authorization and the number of the health registration or marketing authorization,
p.(None): indicating the regulatory authority of the country from which it comes.
p.(None): El Peruano / Friday, June 30, 2017
p.(None): LEGAL STANDARDS 67
p.(None): In the case of biological products and medical devices, the ANM will establish the certificates or other
p.(None): documents that for sanitary necessity are required.
p.(None): 1538902-2
...
Orphaned Trigger Words
p.(None): adequate security protection measures.
p.(None): c) When relevant knowledge about the disease or situation under investigation can be obtained, it is vital
p.(None): importance to understand, alleviate or cure it and that they cannot be obtained in any other way.
p.(None): Article 27. On care and compensation for the research subject
p.(None): Principal Investigator and Sponsor are responsible for providing medical care and treatment
p.(None): Free of charge for the research subject in case of any damage as a consequence of the clinical trial.
p.(None): Sponsor is obligated to award compensation for damage that a research subject
p.(None): may suffer as a result of using the product under investigation or by a procedure or
p.(None): intervention performed for the purpose of research, such as non-therapeutic procedures.
p.(None): Article 28. Of the insurance policy and the financial fund for the immediate and timely attention of the subject of
p.(None): investigation
p.(None): For the purposes of the liability regime provided for in article 27, the sponsor must contract a policy of
p.(None): insurance that covers damages to the research subject, as a result of their participation in the
p.(None): clinical trial. As long as the policy is activated, the sponsor must have a financial fund
p.(None): that immediately and timely guarantees free medical attention and treatment of the subject of
p.(None): investigation, in the event of an adverse event as a consequence of the clinical trial. The insurance policy must
p.(None): have coverage in the country. In the case of being an insurance policy of a foreign company, it must have a
p.(None): legal representative in Peru. In both cases, such information must appear in the informed consent. The
p.(None): The insurance policy must remain valid until the date of the National Final Report submission. Concluding said
p.(None): period, the validity must be renewed whenever there is a possibility of late damage up to and including
p.(None): culmination of a judicial process that could have been initiated as a result of damage to the subject of investigation
p.(None): as a direct consequence of the clinical trial.
p.(None): Article 29. Compensation to the research subject
p.(None): For the purposes of the liability regime provided for in this Chapter, it will be subject to compensation or
p.(None): compensation:
p.(None): a) Any damage to the research subject as a consequence of their participation in the clinical trial.
p.(None): b) Any damage produced during the pregnancy or that would have been caused to the newborn if it had occurred
p.(None): a pregnancy in the female research subject or in the partner of the male research subject, provided that it results
p.(None): as a consequence of their participation in the clinical trial.
p.(None): c) The economic damages that are derived directly from said damage provided that it does not
p.(None): whether it is inherent to the pathology under study or to the evolution of the research subject's disease
p.(None): The sponsor's obligation to award compensation is independent of the validity or available coverage of the
p.(None): contracted insurance policy.
p.(None): El Peruano / Friday, June 30, 2017
p.(None): LEGAL STANDARDS 45
p.(None): Article 30. Clinical trial in diseases with an impact on public health
p.(None): When a public entity sponsors a clinical trial related to an area of importance in health
p.(None): public or that comply with the health research policies and / or priorities determined by MINSA,
p.(None): will be exempt from the requirement established in the literal
...
p.(None): The sponsor may legally transfer any or all of their tasks and functions related to the trial
p.(None): clinician to an ICO, with final responsibility for executing the protocol remaining with the sponsor
p.(None): research and clinical trial results.
p.(None): Article 43. Foreign Contract Research Organizations
p.(None): Foreign ICOs must have a branch in Peru, established according to the laws
p.(None): in force and will assume all the responsibilities of the sponsor established in the contract.
p.(None): Article 44. Obligations of Contract Research Organizations
p.(None): The ICO's obligations are:
p.(None): a) Send the INS OGITT an annual report of the total number of clinical trials that are being carried out in the country, as well as
p.(None): the specific responsibilities that have been assumed by the sponsor in each clinical trial.
p.(None): 48 LEGAL STANDARDS Friday, June 30, 2017 /
p.(None): A Peruvian man
p.(None): b) Have standardized operating procedures for processes, before, during
p.(None): and after conducting a clinical trial.
p.(None): Article 45. Registration of Contract Research Organizations.
p.(None): The ICOs will be registered in the REPEC led by the INS OGITT, for which they must present:
p.(None): a) Application for registration.
p.(None): b) Legalized copy of the public deed.
p.(None): c) Curriculum vitae of the legal representative of the OIC, who will accredit such condition with a simple copy of the
p.(None): current registration document that records said position, and of the monitors.
p.(None): d) Institutional description (brochure), containing institutional objectives, structural organization chart
p.(None): and functional, procedures for selecting research centers and researchers to execute
p.(None): clinical trials, staff training plan in aspects related to clinical trials, good
p.(None): clinical practices and research ethics and a summary of the studies in which he has participated.
p.(None): e) Affidavit stating that they are running clinical trials according to local Peruvian regulations and to the good
p.(None): clinical practices.
p.(None): f) Proof of payment of the right to process.
p.(None): MONITOR CHAPTER III
p.(None): Article 46. The monitor
p.(None): The person chosen by the sponsor or OIC who is in charge of monitoring is called the monitor.
p.(None): direct from conducting the trial. Serves as a link between the sponsor and the principal investigator, when these
p.(None): do not coincide in the same person, and must meet the following requirements:
p.(None): a) Be a professional in the health sciences
p.(None): b) Be suitable for their academic training, training and experience to adequately monitor the clinical trial.
p.(None): c) Know the guidelines of Good Clinical Practice, Research Ethics in human beings and the
p.(None): Peruvian regulations for conducting clinical trials.
p.(None): Article 47. Obligations of the monitor before the clinical trial
p.(None): Before the clinical trial begins, the monitor is required to:
p.(None): a) Ensure that the research team is informed about the content of the protocol
p.(None): and the obligations that derive from it.
p.(None): b) Know the procedures for handling the product under investigation, in addition to the circumstances in which
p.(None): patient treatment codes can be opened.
p.(None): Article 48. Obligations of the monitor during the clinical trial
p.(None): During the clinical trial, the monitor is required to:
p.(None): a) Be in permanent contact with the researcher and
p.(None): make regular visits to the research center.
p.(None): b) Check that all patients have given their written informed consent before starting
p.(None): any test procedure.
p.(None): c) Verify the documents in which the clinical trial data have been collected, to
p.(None): identify possible errors, as well as to check that some information has not been omitted.
p.(None): d) Perform random checks of the recordable data compared to the original data,
p.(None): according to the study monitoring plan.
p.(None): e) Check that the product under investigation is
p.(None): managed according to the research protocol.
p.(None): f) Document and record the relevant communications and visits that the monitor maintains with the
p.(None): investigator.
p.(None): g) Ensure that the researcher has up-to-date documentation related to the clinical trial.
p.(None): Article 49. Obligations of the monitor at the end of the clinical trial
p.(None): At the end of the clinical trial, the monitor is obliged
p.(None): to:
p.(None): a) Recover the medication and the material of clinical use left over or not used during the study, the envelopes with
p.(None): treatment codes and all relevant documentation.
p.(None): b) Verify that all the information related to the clinical trial is correctly filed by the investigator and
p.(None): ensure the review of the reports so that they can be sent to the CIEI and the INS OGITT.
p.(None): CHAPTER IV
p.(None): FROM THE PRINCIPAL INVESTIGATOR
p.(None): Article 50. Of the principal investigator
p.(None): Is the natural person, medical professional or dental surgeon responsible for conducting the clinical trial in a
p.(None): research center, belongs to the research institution and leads the research team.
p.(None): Article 51. Requirements of the principal investigator
p.(None): To be a principal investigator it is required:
p.(None): a) Be a medical professional surgeon or dental surgeon who investigates in the area of their specialty and
p.(None): competence, registered and qualified for their exercise in the respective professional college.
p.(None): b) Be suitable for their academic training, training and experience to assume responsibility for the
p.(None): proper conduct of the clinical trial.
p.(None): c) Have sufficient time to properly conduct the study within the agreed period.
p.(None): d) Know the guidelines of Good Clinical Practice, Research Ethics in human beings and the
p.(None): Peruvian regulations for conducting clinical trials.
p.(None): Article 52. Obligations of the principal investigator
p.(None): The main investigator's obligations are the following:
p.(None): a) Know all the information available on the product under investigation and the contents of the protocol of the
p.(None): clinical trial.
p.(None): b) Comply with the guidelines of the Good Clinical Practices and the Peruvian regulations for the
p.(None): conducting clinical trials.
p.(None): c) Ensure that personnel and equipment are suitable and have sufficient time to attend
p.(None): research subjects and that staff are knowledgeable about the clinical trial and procedures
p.(None): to be followed in any situation.
p.(None): d) Obtain authorization from the research institution where the clinical trial will be carried out,
p.(None): prior to its start.
p.(None): e) Obtain approval of the clinical trial by the CIEI of the research institution where it will be carried out
p.(None): the clinical trial, before its start.
p.(None): f) Start the clinical trial only after obtaining the approval by the CIEI and the authorization of the INS for the
p.(None): execution of the clinical trial in the research center.
p.(None): g) Properly inform the potential research subject, giving them enough time to
p.(None): He will discuss his participation, if he wishes, with relatives or the treating doctor, so that the recruitment is carried out
p.(None): conducted according to the research protocol.
p.(None): h) Obtain and document the informed consent of the research subject.
p.(None): i) Ensure the follow-up of the established guidelines
p.(None): in the protocol and facilitate the supervision of the CIEI.
p.(None): El Peruano / Friday, June 30, 2017
p.(None): LEGAL STANDARDS 49
...
p.(None): b) Periodicity of the meetings.
p.(None): c) Specific quorum requirements to review and decide on an application, including the
p.(None): minimum number of members required, which must not have an exclusive participation of members of a
p.(None): same profession or same sex and must include at least one member of the community, who does not belong to the field of
p.(None): health, or the research institution.
p.(None): Article 66. Procedures Manual of the Institutional Research Ethics Committee
p.(None): The CIEI Procedures Manual must establish the following:
p.(None): a) Administrative requirements for the presentation of
p.(None): records.
p.(None): El Peruano / Friday, June 30, 2017
p.(None): LEGAL STANDARDS 51
p.(None): b) Procedure for monitoring the protocols of
p.(None): authorized research.
p.(None): c) Procedure for preparing and approving the
p.(None): meeting minutes.
p.(None): d) Procedure for filing related documentation.
p.(None): TITLE V
p.(None): OF THE CLINICAL TRIAL AUTHORIZATION CHAPTER I
p.(None): OF THE REQUIREMENTS
p.(None): Article 67. Requirements for the authorization of the clinical trial
p.(None): The sponsor, or ICO, to request authorization of a clinical trial must comply with submit
p.(None): the following duly foliated documents:
p.(None): a) Request for authorization of the clinical trial, according to the Registration Sheet established in the REPEC.
p.(None): b) Copy of the current registration certificate of the research center (s) authorized to carry out
p.(None): clinical trials.
p.(None): c) Copy of the approval document issued by the legal representative of the institution (s) of
p.(None): research where the clinical trial will be carried out according to the model established in the Trial Procedures Manual
p.(None): Clinicians.
p.(None): d) Copy of the research protocol approval document and consent form (s)
p.(None): informed issued by the respective CIEI accredited by the INS according to the model established in the
p.(None): Clinical Trial Procedures Manual.
p.(None): e) Affidavit from the sponsor indicating compliance with the responsibilities set forth in the
p.(None): these Regulations, according to the model established in the Manual of Clinical Trials Procedures for Trials
p.(None): Clinicians.
p.(None): f) In case of foreign sponsor: Copy of the proof of the delegation of functions to the representative
p.(None): from the sponsor authenticated with The Hague Apostille.
p.(None): g) Affidavit signed by the principal investigator indicating compliance with the obligations and
p.(None): requirements established in these Regulations, according to the model established in the Test Procedures Manual
p.(None): Clinicians.
p.(None): h) Affidavit according to the model established in the Manual of Clinical Trial Procedures, signed by the
p.(None): sponsor and principal investigator, which establishes that there is no financial conflict of interest in the execution of the
p.(None): clinical trial.
p.(None): i) Affidavit signed by the sponsor and main researcher on the conditioning of the
p.(None): research center where the clinical trial will be carried out, according to the model established in the Manual
p.(None): of Clinical Trial Procedures.
p.(None): j) Copy of the current insurance policy (insurance contract) acquired by the sponsor.
p.(None): k) Affidavit by the sponsor that it has a financial fund that guarantees
p.(None): immediate care and free treatment of the research subject, in the event of an adverse event
p.(None): as a consequence of the clinical trial, as long as the insurance policy is activated and
p.(None): according to the model established in the Manual of Clinical Trial Procedures.
...
p.(None): and researchers, product under investigation, condition studied, study design, number of subjects to
p.(None): include and others that have been considered within the data set of the trial registry of the
p.(None): World Health Organization.
p.(None): CHAPTER II
p.(None): OF THE MODIFICATION OF THE CONDITIONS OF AUTHORIZATION OF THE CLINICAL TRIAL
p.(None): Article 75. Grounds for modification of the conditions for authorization of the clinical trial
p.(None): The following are causes for the modification of the conditions for authorization of the clinical trial:
p.(None): a) Expansion of the number of research centers.
p.(None): b) Expansion or modification of the list of supplies to import.
p.(None): c) Change of sponsor or OIC.
p.(None): d) Change of principal investigator.
p.(None): e) Extension of the time to carry out the test
p.(None): clinical.
p.(None): f) Closure of research center for a trial
p.(None): clinical.
p.(None): g) Suspension of clinical trial.
p.(None): h) Cancellation of the clinical trial.
p.(None): Article 76. Modification by expansion of the number of research centers
p.(None): To request modification by expansion of the number of research centers, the sponsor or OIC
p.(None): You must present the following documents, duly
p.(None): foliated:
p.(None): a) Request to expand the number of research centers.
p.(None): b) Report justifying the reasons for the expansion of the number of research centers.
p.(None): c) Copy of the current registration certificate of the research center (s) authorized to carry out
p.(None): clinical trials.
p.(None): d) Copy of the approval document issued by the legal representative of the institution (s) of
p.(None): research where the clinical trial will be carried out, according to the model established in the Trial Procedures Manual
p.(None): Clinicians.
p.(None): e) Copy of the research protocol approval document and consent form (s)
p.(None): informed issued by the respective CIEI accredited by the INS, according to the model established in the
p.(None): Manual of Clinical Trials Procedures, for the additional research center.
p.(None): f) Informed consent form (s) according to Annex 4 of these Regulations, approved by the CIEI.
p.(None): g) Affidavit signed by the principal investigator indicating compliance with the obligations and
p.(None): requirements established in these Regulations, according to the model established in the Test Procedures Manual
p.(None): Clinicians.
p.(None): h) Affidavit according to the model established in the Manual of Clinical Trial Procedures, signed by the
p.(None): sponsor and principal investigator, which establishes that there is no financial conflict of interest in the execution of the
p.(None): clinical trial.
p.(None): i) Affidavit signed by the sponsor and main researcher on the conditioning of the
p.(None): research center where the clinical trial will be carried out, according to the model established in the Manual
p.(None): of Clinical Trial Procedures.
p.(None): j) Updated, undocumented curriculum vitae of the entire research team of each center
p.(None): research, according to the model established in the Manual of Clinical Trial Procedures.
p.(None): k) Copy of the documents that prove training in Good Clinical Practices and Research Ethics in beings
p.(None): humans from the entire research team, valid for no more than three (3) years.
p.(None): l) Have a valid insurance policy
p.(None): m) List of additional supplies necessary for the execution of the clinical trial (if required),
p.(None): according to the format established in the Manual of Clinical Trial Procedures.
p.(None): n) Proof of payment of processing fees for each additional research center.
p.(None): Article 77. Modification by extension or modification of the list of supplies to import.
p.(None): To request the modification by extension or modification of the list of supplies to import,
p.(None): the sponsor or the ICO must present the following documents, duly foliated:
...
p.(None): e) Copy of the letter of knowledge of the CIEI that approved the study.
p.(None): Article 82. Request to close a center
p.(None): research for a clinical trial
p.(None): To request the closure of the research center, the sponsor or OIC must submit the following
p.(None): documents, duly foliated:
p.(None): a) Request to close the research center.
p.(None): b) Report justifying the reasons, duly substantiated, for which the
p.(None): closure of research center for clinical trial.
p.(None): c) Report including all the data obtained up to the moment of closing.
p.(None): d) Report on the measures to be adopted with the research subjects, if applicable.
p.(None): e) Copy of the letter of knowledge of the CIEI that approved the study.
p.(None): f) Final report of the research center (except if it was submitted prior to the closure request
p.(None): in the center.)
p.(None): Article 83. Request for suspension of the trial
p.(None): clinical
p.(None): To request the suspension of the clinical trial, the sponsor or the ICO must submit the following
p.(None): duly foliated documents:
p.(None): a) Request for suspension of the clinical trial.
p.(None): b) Report justifying the reasons, duly substantiated, for which the suspension is being requested
p.(None): of the clinical trial.
p.(None): c) Report including all the data obtained up to the moment of the suspension.
p.(None): d) Report on the measures to be adopted with the research subjects, if applicable.
p.(None): e) Copy of the letter of knowledge of the CIEI that approved the study.
p.(None): Article 84. Formalization of authorized modifications
p.(None): The modifications of the authorization conditions will be formalized with the respective Director Resolution.
p.(None): CHAPTER III
p.(None): OF THE AMENDMENTS
p.(None): Article 85. Authorization of amendments to the research protocol and / or consent
p.(None): informed.
p.(None): Amendments to the research protocol and / or informed consent only proceed after
p.(None): authorization from the INS OGITT.
p.(None): Article 86. Of the non-provenance of the amendments to the investigation protocol
p.(None): The INS OGITT will not authorize amendments to the research protocol that compromise safety and
p.(None): rights of research subjects or the reliability and soundness of the data obtained in the clinical trial.
p.(None): Article 87. Request for authorization to change the title of a clinical trial
p.(None): When the amendment is made in the title of the clinical trial, authorization will be required with a resolution granted by the
p.(None): INS OGITT, for which the sponsor or the ICO must present the following documents, duly foliated:
p.(None): a) Request to change the title of a clinical trial
p.(None): b) Report justifying the change of title to the clinical trial.
p.(None): c) Approval of the change of title of the clinical trial by a CIEI accredited by the INS.
p.(None): d) Have a valid insurance policy
p.(None): e) Proof of payment of processing fee.
p.(None): Article 88. Request for authorization of amendment report
p.(None): Other amendments will be authorized ex officio, for which the sponsor or the ICO must present the following
p.(None): documents, duly foliated:
p.(None): 54 LEGAL STANDARDS Friday, June 30, 2017 /
p.(None): A Peruvian man
p.(None): a) Request for amendment report, including the list of documents to be amended (document, version and
p.(None): date).
p.(None): b) List of changes to the amendment.
p.(None): c) Justification of the proposed changes.
p.(None): d) Protocol and / or respective informed consent with highlighted changes or change control, in Spanish version and
...
p.(None): premature or sensational, treatments of efficacy not yet determined, nor will the
p.(None): results obtained.
p.(None): TITLE IX
p.(None): OF THE SECURITY SURVEILLANCE OF THE PRODUCT UNDER INVESTIGATION
p.(None): CHAPTER I
p.(None): OF THE RESPONSIBILITIES
p.(None): Article 108. Responsibility of the sponsor or research organization by contract
p.(None): The sponsor or ICO is responsible for:
p.(None): a) Continuously assess the safety of the products under investigation, using all the information to
p.(None): its scope.
p.(None): b) Implement a security monitoring system for the product under investigation.
p.(None): c) Notify the INS OGITT of all serious adverse events, serious adverse reactions and
p.(None): Suspected unexpected serious adverse reactions occurred in an authorized clinical trial in the country.
p.(None): d) Report to CIEI suspected serious and unexpected adverse reactions in a trial
p.(None): licensed clinician in the country.
p.(None): e) Submit the reports to the OGITT of the INS and the CIEI, according to the format of the Council of Organizations
p.(None): International Medical Sciences in Collaboration with WHO (CIOMS), of all serious adverse reactions
p.(None): and suspicions of serious and unexpected adverse reactions occurring worldwide.
p.(None): f) Send updates to the Manual to the INS OGITT, the CIEI and the main researchers
p.(None): of the Investigator.
p.(None): g) Send the OGITT and the ANM the annual safety reports of the products under investigation.
p.(None): h) Notify the INS OGITT, the CIEI and the principal investigators of any finding that
p.(None): could
p.(None): 56 LEGAL STANDARDS Friday, June 30, 2017 /
p.(None): A Peruvian man
p.(None): adversely affect the safety of research subjects, have an impact on driving
p.(None): of the study or alter the benefit / risk balance. A report will be prepared independently, without prejudice to
p.(None): the periodicity indicated in Chapter II of this Title and sent to the INS and the corresponding CIEI within a period
p.(None): maximum of seven (7) calendar days.
p.(None): i) Maintain detailed records of all adverse events reported to them by investigators
p.(None): main.
p.(None): Article 109. Responsibility of the investigator
p.(None): principal
p.(None): It is up to the principal investigator:
p.(None): a) Report serious adverse events, serious adverse reactions and suspected serious adverse reactions
p.(None): and unexpected to the sponsor or to the ICO and the CIEI, when the event occurs or becomes known within a period not exceeding
p.(None): one (1) calendar day. The initial notification will be followed by detailed written reports. In the
p.(None): Initial and follow-up notification will identify the research subjects using a number
p.(None): of specific code for each of them.
p.(None): b) Notify the sponsor or the OIC and CIEI of any serious adverse reaction of the investigational product that is
p.(None): has produced after the completion of the clinical trial in a research subject treated by him, of having
p.(None): knowledge.
p.(None): c) Notify the sponsor or the ICO of the non-serious adverse events classified in the protocol
p.(None): of research as determinants for safety evaluations, within the periods specified in the
p.(None): mentioned protocol.
p.(None): d) Provide the sponsor or the OIC, the INS OGITT and the CIEI all the additional information that
p.(None): request.
p.(None): CHAPTER II
p.(None): NOTIFICATION OF ADVERSE EVENTS AND ADVERSE REACTIONS
p.(None): Article 110. Of the notification of serious adverse events, serious adverse reactions and suspected reactions
p.(None): serious and unexpected adverse events.
...
p.(None): of Good Clinical Practices of the International Conference on Harmonization of Technical Requirements for the
p.(None): Registration of Pharmaceutical Products for Human Use, as well as national regulations and
p.(None): international that are in force and are applicable to it.
p.(None): Second.- From the Manual of Clinical Trial Procedures
p.(None): Within a maximum period of ninety (90) calendar days from the effective date of these Regulations, the INS OGITT
p.(None): will elaborate the Manual of Procedures of Clinical Trials, which will be approved by Resolution of the INS.
p.(None): Third.- Term for the constitution of Dispensing Units
p.(None): A maximum period of one year from the validity of this Regulation will be granted so that
p.(None): the research institutions comply with the conformation of the Dispensing Units to which
p.(None): refers to article 92 of this Regulation.
p.(None): Fourth.- Temporary application of these Regulations for research products that
p.(None): correspond to herbal medicines, dietary products and sweeteners, galenic products and
p.(None): medical devices.
p.(None): Specific aspects for the execution of clinical trials with herbal medicines, products
p.(None): dietetics and sweeteners, galenic products and medical devices will be determined by
p.(None): Supreme decret. Said standard proposal will be prepared by the INS OGITT within a maximum period of one hundred and eighty
p.(None): (180) calendar days counted from the validity of this Regulation. As long as the standard is approved
p.(None): pertinent, clinical trials with these research products are governed by the standards indicated
p.(None): in these Regulations, as appropriate.
p.(None): Fifth.- Use of radiopharmaceuticals
p.(None): In addition to these Regulations, the use of radiopharmaceuticals will be governed by the rules on protection
p.(None): radiology of the competent body.
p.(None): Sixth.- Issuance of standards on biological samples
p.(None): The standards related to biological samples in
p.(None): Clinical trials will be approved by INS Resolution.
p.(None): Seventh.- Intangible Fund for research purposes and subject protection
p.(None): research
p.(None): Funds from the contract between the public sector research institution and the sponsor will be
p.(None): considered as an intangible fund only for the purposes of research and operation of the Institutional Committees
p.(None): of Research Ethics.
p.(None): Eighth.- Creation of the National Registry of Institutional Committees for Research Ethics accredited
p.(None): Create the National Registry of Accredited Institutional Research Ethics Committees. A
p.(None): maximum period of one year (1), from the approval of the Manual of Clinical Trial Procedures,
p.(None): so that the registered CIEI comply with the requirements established in article 63 of these Regulations.
p.(None): TRANSITIONAL SUPPLEMENTARY PROVISIONS
p.(None): First.- Transitory regulation
p.(None): a) The administrative procedures initiated before the entry into force of these regulations will be governed by the
p.(None): previous regulations until their conclusion.
p.(None): b) However, the provisions of these regulations that are applicable to the procedures in process
p.(None): recognize rights or powers to the administered against the administration.
p.(None): Second.- Dissemination of these Regulations
p.(None): The INS, under the responsibility of its owner, must carry out dissemination, information and training actions for the
p.(None): content and scope of this Regulation in favor of its staff and the user public. Said actions
p.(None): Print copies of these Regulations, talks, posters or other means that
p.(None): ensure the proper dissemination of it.
p.(None): ANNEXES ANNEX 1
p.(None): GUIDE TO THE RESEARCH PROTOCOL
p.(None): The clinical trial protocol must include the following aspects:
p.(None): 1. GENERAL INFORMATION
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| HIV | HIV/AIDS |
| access | Access to Social Goods |
| access to information | Access to information |
| age | Age |
| armed forces | Soldier |
| authority | Relationship to Authority |
| autonomy | Impaired Autonomy |
| child | Child |
| children | Child |
| crime | Illegal Activity |
| criminal | criminal |
| culturally | cultural difference |
| dependency | Drug Dependence |
| dependent | Dependent |
| disability | Mentally Disabled |
| drug | Drug Usage |
| education | education |
| embryo | embryo |
| emergencies | patients in emergency situations |
| family | Motherhood/Family |
| fetus | Fetus/Neonate |
| fetuses | Fetus/Neonate |
| healthy volunteers | Healthy People |
| illiterate | Literacy |
| indigenous | Indigenous |
| infant | Infant |
| influence | Drug Usage |
| job | Occupation |
| language | Linguistic Proficiency |
| military | Soldier |
| minor | Youth/Minors |
| nation | stateless persons |
| native | Indigenous |
| opinion | philosophical differences/differences of opinion |
| parent | parents |
| parents | parents |
| party | political affiliation |
| placebo | participants in a control group |
| police | Police Officer |
| political | political affiliation |
| pregnant | Pregnant |
| single | Marital Status |
| substance | Drug Usage |
| undue influence | Undue Influence |
| union | Trade Union Membership |
| usage | Drug Usage |
| vulnerable | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| armed forces | ['military'] |
| child | ['children'] |
| children | ['child'] |
| drug | ['influence', 'substance', 'usage'] |
| fetus | ['fetuses'] |
| fetuses | ['fetus'] |
| indigenous | ['native'] |
| influence | ['drug', 'substance', 'usage'] |
| military | ['armedXforces'] |
| native | ['indigenous'] |
| parent | ['parents'] |
| parents | ['parent'] |
| party | ['political'] |
| political | ['party'] |
| substance | ['drug', 'influence', 'usage'] |
| usage | ['drug', 'influence', 'substance'] |
Trigger Words
capacity
coercion
consent
ethics
protect
protection
risk
volunteer
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input