Clinical Research Regulation For Peru
Regulatory Authority
Regulatory Authority
Scope of Assessment
Regulatory Fees
Ethics Committee
Ethics Committee
Scope of Review
Ethics Committee Fees
Authorizing Body
Clinical Trial Lifecycle
Submission Process
Submission Content
Timeline of Review
Trial Initiation
Safety Reporting
Progress Reporting
Sponsorship
Definition of Sponsor
Trial Authorization
Insurance
Compensation
Quality, Data & Records Management
Site/Investigator Selection
Informed Consent
Documentation Requirements
Required Elements
Compensation Disclosure
Participant Rights
Special Circumstances/Emergencies
Vulnerable Populations
Children/Minors
Pregnant Women, Fetuses & Neonates
Prisoners
Mentally Impaired
Investigational Products
Definition of Investigational Product
Manufacturing & Import
IMP/IND Quality Requirements
Labeling & Packaging
Product Management
Specimens
Definition of Specimen
Specimen Import & Export
QUICK FACTS
Clinical trial application language Spanish
Regulatory authority & ethics committee review may be conducted at the same time No
Clinical trial registration required Yes
In-country sponsor presence/representation required Yes
Age of minors Under 18
Specimens export allowed Unspecified
Regulatory Authority > Regulatory Authority
Last content review/update: November 19, 2020
Requirements
(1) (Legislation) Law No. 27657 – Law of the Ministry of Health (LawNo27657 - Spanish) (Effective January 28, 2002)
Congress of the Republic
Relevant Sections: Articles 6 and 32
(2) (Regulation) Supreme Decree No. 001-2003-SA: Approves the Regulation of Organization and Functions of the National Institute of Health (DecreeNo001-2003 - Spanish) (January 9, 2003)
Ministry of Health
Relevant Sections: Preamble, Introduction, Title I (Articles 4, 5, and 6) and Title II (Chapters I and III)
(3) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo021-2017 - Spanish) (GoogleTranslate-DecreeNo021-2017) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 6, 7, 70, and 119-128
(4) (Guidance) Guide for Inspections of Clinical Trials (G-ClinTrialInspection - Spanish) (April 30, 2019)
General Office of Research and of Health Technology Transfer, National Institute of Health, Ministry of Health
Relevant Sections: Preamble, Introduction, 4, 6.2-8, and Annex 1
(5) (Guidance) Guideline for the Procedure for Requesting Authorization of the Clinical Trial (G-CTApplicProc - Spanish) (Edition No. 02) (November 15, 2019)
National Institute of Health, Ministry of Health
Relevant Sections: 2
(6) (Guidance) Procedures Manual of Clinical Trials (MAN-INS-001) (INS-CTManual - Spanish) (3rd Edition) (November 17, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Chapter VII (7.5 and 7.12) and Flow Chart No. 04
Summary

Overview

As per DecreeNo021-2017, the G-CTApplicProc, the G-ClinTrialInspection, and PER-62, Peru’s National Institute of Health (Instituto Nacional de Salud (INS)) is the regulatory authority responsible for clinical trial approvals, oversight, and inspections. The INS, through the General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnológica (OGITT)), grants permission for clinical trials to be conducted in Peru in accordance with DecreeNo021-2017, the G-CTApplicProc, the INS-CTManual, and PER-74.

As indicated in LawNo27657, DecreeNo001-2003, PER-64, PER-75, and PER-65, the INS is a decentralized public executive agency within the Ministry of Health of Peru (Ministerio de Salud del Perú (MINSA)), and was granted authority to approve clinical trials by the MINSA in 2003. The INS’s OGITT carries out the INS’s mandate to review, record, and authorize clinical trials, to regulate research in Peru, and to ensure the implementation of international ethical guidelines and good clinical practice (GCP) in the conduct of clinical trials. In addition, the OGITT implements the INS’s objectives to promote, develop, and disseminate scientific and technological research, propose policies and standards, and provide health services to the Peruvian population. For information on OGITT’s role in clinical trial oversight, see Articles 119 through 128 of DecreeNo021-2017 and the G-ClinTrialInspection.

According to PER-65, the OGITT is also responsible for organizing and maintaining the Peruvian Clinical Trials Registry (Registro Peruano de Ensayos Clínicos (REPEC)), the registration system for clinical trials, institutional ethics committees (ECs) (El Comité Institucional de Ética en Investigacións (CIEIs)), research sites, and contract research organizations (CROs) on the national level. (See PER-58 for detailed information on REPEC.)

Please note: Peru is party to the Nagoya Protocol on Access and Benefit-sharing (PER-11), which may have implications for studies of investigational products developed using certain non-human genetic resources (e.g., plants, animals, and microbes). For more information, see PER-57.

INS Contact Information
Instituto Nacional de Salud
Cápac Yupanqui 1400 - Jesus María
Lima 11
Perú
Phone: (511) 748 1111

or

Av. Defensores del Morro 2268 (Former Huaylas) Chorrillos
Lima 9
Peru
Phone: (511) 748 0000
Email: comunicaciones@ins.gob.pe

OGITT Contact Information
Instituto Nacional de Salud
Oficina General de Investigación y Transferencia Tecnológica
Capac Yupanqui 1400 - Jesus María
Lima 11
Perú
Phone: (511) 748 1111 Annex: 2616
Email: jparillo@ins.gob.pe
Clinical Trial Phone: 511 748 1111 (Ext. 2191)
Clinical Trial Email: consultaensayos@ins.gob.pe

Additional Resources
(1) (Document) Nagoya Protocol on Access and Benefit-sharing (PER-11) (2011)
Convention on Biological Diversity, United Nations
(2) (Webpage) About OGITT - Introduction (PER-65 - Spanish) (Current as of November 19, 2020)
National Institute of Health, Ministry of Health
(3) (Webpage) About the Executive Research Office (OGITT) (PER-75 - Spanish) (Current as of November 19, 2020)
National Institute of Health, Ministry of Health
(4) (Webpage) About the Regulatory Authority (PER-74 - Spanish) (Current as of November 19, 2020)
REPEC, National Institute of Health, Ministry of Health
(5) (Webpage) Country Profile: Peru (PER-57) (Current as of November 19, 2020)
Access and Benefit-sharing Clearing-house, Convention on Biological Diversity, United Nations
(6) (Webpage) History of the Processes Involved in the Legislation of Clinical Trials in Peru (PER-62 - Spanish) (Current as of November 19, 2020)
REPEC, National Institute of Health, Ministry of Health
(7) (Webpage) INS - About Us (PER-64 - Spanish) (Current as of November 19, 2020)
National Institute of Health, Ministry of Health
(8) (Webpage) INS - Contact Us (PER-63 - Spanish) (Current as of November 19, 2020)
National Institute of Health, Ministry of Health
(9) (Webpage) Peruvian Clinical Trials Registry (REPEC) (PER-58 - Spanish) (English) (Current as of November 19, 2020)
REPEC, National Institute of Health, Ministry of Health
Regulatory Authority > Scope of Assessment
Last content review/update: November 19, 2020
Requirements
(1) (Legislation) Law No. 27444 – Law of the General Administrative Procedure (LawNo27444 - Spanish) (Effective April 10, 2001)
Congress of the Republic
Relevant Sections: Article 35
(2) (Regulation) Ministerial Resolution No. 233-2020 – Ethical Considerations for Health Research with Human Beings (ResolutionNo233-2020 - Spanish) (April 28, 2020)
Ministry of Health
Relevant Sections: Introduction
(3) (Regulation) Ministerial Resolution No. 686-2020/MINSA - Approves the Technical Health Standard for the Research and Development of Vaccines against Infectious Diseases (ResolutionNo686-2020 - Spanish) (September 1, 2020)
Ministry of Health
Relevant Sections: 5.2
(4) (Regulation) Directoral Resolution 0423-2019/OGITT/INS – Provides for the Amendment of Administrative Procedure Requirements Specified in the Supreme Decree No. 021-2017-SA by the National Institute of Health (INS) for the Authorization of Clinical Trials (ResolutionNo0423-2019 - Spanish) (September 24, 2019)
National Institute of Health, Ministry of Health
Relevant Sections: Preamble, Article 1, and Annexes (3 and 5)
(5) (Regulation) Ministerial Resolution No. 655-2019/MINSA – Provides for the Elimination of Administrative Procedure Requirements Specified in the Supreme Decree No. 021-2017-SA by the National Institute of Health (INS) (ResolutionNo655-2019 - Spanish) (July 27, 2019)
Ministry of Health
Relevant Sections: Annexes A and B
(6) (Regulation) Supreme Decree 004-2019-JUS – Approving the Single Text Ordered of Law No. 27444 - Law of General Administrative Procedure (DecreeNo004-2019 - Spanish) (Effective July 24, 2019)
Ministry of Labor and Employment Promotion
Relevant Sections: Article 39
(7) (Regulation) Supreme Decree No. 016-2011-SA: Regulatory Approval for the Registration, Control and Sanitary Surveillance of Pharmaceutical Products, Medical Devices and Health Products (DecreeNo016-2011 - Spanish) (July 27, 2011)
Ministry of Health
Relevant Sections: Title I (Article 2) and Title II (Chapters I and V)
(8) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo021-2017 - Spanish) (GoogleTranslate-DecreeNo021-2017) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 2, 6, 7, 8, 10, 40, 74, 76, 52, 59, 63, 67-74, 80, 94, 119-121, Complementary Provisions - Final (Eighth), and Annexes 1-5
(9) (Guidance) Guide of General Guidelines for the Submission of Procedures Related to the Regulation of Clinical Trials (G-CTSubmissionProcs - Spanish) (Edition No. 01) (November 28, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: 1, 2, 4, and 5
(10) (Guidance) Guideline for the Procedure for Requesting Authorization of the Clinical Trial (G-CTApplicProc - Spanish) (Edition No. 02) (November 15, 2019)
National Institute of Health, Ministry of Health
Relevant Sections: 2, 4, and 6
(11) (Guidance) Procedures Manual of Clinical Trials (MAN-INS-001) (INS-CTManual - Spanish) (3rd Edition) (November 17, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Chapter VII (7.1, 7.2, 7.3, and 7.5), Flow Chart No. 01, 02, and 04, and Annexes 1 and 3
Summary

Overview

In accordance with DecreeNo021-2017, the INS-CTManual, the G-CTApplicProc, the G-CTSubmissionProcs, and PER-71, Peru’s National Institute of Health (Instituto Nacional de Salud (INS)) is responsible for reviewing and approving clinical trial applications for drugs to be registered in Peru. As per DecreeNo021-2017 and DecreeNo016-2011, the scope of the INS’s assessment includes Phases I through IV clinical trials for pharmaceuticals including medicines, herbal medicines and other complementary products, dietetic products and sweeteners, biological products, and compounded (galenic) products. In addition, per ResolutionNo233-2020, the INS must ensure the governance of all health research involving human beings (e.g., clinical trials, epidemiological, behavioral, and observational research, etc.) is conducted ethically.

ResolutionNo686-2020, an INS technical health standard for preclinical and clinical research with vaccines in Peru, further states that clinical studies of vaccines in humans must be conducted in accordance with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (PER-53) and current national clinical trial regulations (DecreeNo021-2017). Per ResolutionNo686-2020, clinical trials in vaccines are recommended to demonstrate the efficacy and safety of new vaccines as long as they are not licensed for their use by regulatory agencies. Prospective observational studies could also be carried out later to estimate the effectiveness of the new vaccine. Refer to ResolutionNo686-2020 for detailed information and requirements associated with the clinical studies of vaccines.

As specified in DecreeNo021-2017, the INS-CTManual, the G-CTApplicProc, and PER-61, the INS’s review and approval of a clinical trial application is dependent upon obtaining proof of approval from an accredited institutional ethics committee (EC) (El Comité Institucional de Ética en Investigación (CIEI)). Therefore, the INS and EC reviews may not be conducted in parallel. Per the INS-CTManual and the G-CTApplicProc, EC approval of the research protocol and informed consent form must be submitted as part of the clinical trial application dossier in order for the INS to conduct its review. Refer to the INS-CTManual and the G-CTApplicProc for additional submission information. Per ResolutionNo0423-2019, the application for clinical trial authorization and corresponding instructions are in PER-24 and PER-10, respectively.

Per the INS-CTManual, the G-CTApplicProc, PER-60, and PER-59, the sponsor and his/her contract research organization (CRO) must also register with the Peruvian Clinical Trials Registry (Registro Peruano de Ensayos Clínicos (REPEC)) prior to submitting an application for clinical trial authorization. Refer to the INS-CTManual, the G-CTApplicProc, PER-60, and PER-59 for detailed registration instructions, and PER-37 and PER-36 for the sponsor and CRO registration forms. See also the Sponsorship topic, Trial Authorization subtopic for more detailed sponsor/CRO registration information. In addition, per DecreeNo021-2017 and the G-CTApplicProc, the sponsor must also ensure authorization by the research institution where the clinical trial will be carried out.

DecreeNo021-2017 states that the investigational product (IP) must meet at least one (1) of the following conditions to be authorized for use in clinical trials in Peru:

  • Must be approved for use in humans by drug regulatory authorities of countries with high health surveillance
  • Will serve to establish pharmaceutical therapeutic equivalence
  • Is considered a priority for the country’s public health or is within the scope of MINSA policies and/or research priorities
  • At the request of the National Authority for Pharmaceutical Products, Medical Devices and Medical Products (la Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (ANM)), requires a clinical trial to support its efficacy and safety for the health registry

Clinical Trial Review Process

As per the INS-CTManual, the G-CTApplicProc, the G-CTSubmissionProcs, and PER-71, the sponsor or his/her CRO must submit the application electronically using the REPEC, at which time a registration code is assigned to the application. According to DecreeNo021-2017, DecreeNo016-2011, the INS-CTManual, the G-CTApplicProc, and the G-CTSubmissionProcs, the sponsor or his/her CRO must also obtain approval from the ANM to manufacture or import IPs in Peru. (Note: The ANM is also referred to as the General Directorate of Medicines, Supplies and Drugs (La Dirección General de Medicamentos Insumos y Drogas (DIGEMID)). As per DecreeNo021-2017, Peru’s INS must approve the clinical trial application prior to ANM’s approval of an IP. However, the INS does request that ANM assess the safety and quality profile of the IP to be used in a clinical trial as part of its application review and approval process.

As per LawNo27444, and DecreeNo004-2019 which modifies LawNo27444, the INS is required to complete its review and approval of a clinical trial application in a maximum of 30 working days (including the 30 days for the ANM per DecreeNo021-2017). In addition, per DecreeNo021-2017 and the INS-CTManual, if the clinical trial is related to an IP for the prevention, diagnosis, or treatment of tuberculosis or HIV/AIDS infection, the specific technical opinion of the General Directorate of Strategic Public Health Interventions will be requested to ensure the study does not interfere with its strategic interventions regarding these diseases.

DecreeNo021-2017 also notes that the INS will be able to convene a technical commission of experts when controversial situations arise during the authorization process. In addition, the sponsor has the right to appeal when the INS does not grant authorization.

DecreeNo021-2017 and the INS-CTManual state that the INS’s General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnológica (OGITT)) grants clinical trial authorization for the total period of time scheduled for its completion as indicated in the REPEC registration form submission.

Further, per DecreeNo021-2017, once the INS has completed the authorization process, the agency will post the following information regarding an authorized and unauthorized clinical trial on its website: study title, sponsor and investigators, IP, condition under study, study design, and number of participants included that have been considered within the World Health Organization test data set. (See the Clinical Trial Lifecycle topic, Submission Process, Submission Content, and Timeline of Review subtopics for detailed submission and review requirements.)

In addition, as indicated in DecreeNo021-2017, the clinical trial authorization will be valid for a maximum of 12 months from the date of its issuance. This period of validity is valid for all research centers, regardless of the authorization date of its operation. The clinical trial authorization is granted by the total period of time scheduled for execution, which was registered in the authorization request.

DecreeNo021-2017, ResolutionNo655-2019 which modifies DecreeNo021-2017, PER-67, and PER-27 provide information on how the sponsor or his/her CRO should request a trial extension. The following documents must be submitted within 30 calendar days prior to the trial’s expiration:

  • Application for extension of time (using the REPEC e-form (PER-27) (amended version per ResolutionNo0423-2019))
  • Report justifying the reasons for submitting the request
  • Approval of the extension granted by the legal representative of the research institution(s) where trial will be conducted
  • Approval of the extension by an INS-accredited EC
  • Proof of payment of processing fees
  • Current insurance policy

The authorized trial extension will be valid for a maximum of 12 months from the date of issue.

Additional Resources
(1) (Document) Instructions for Filling Out Form FOR-OGITT-028 Edition No. 03 – Request for Clinical Trial Authorization (PER-10 - Spanish) (Edition No. 03) (May 8, 2019)
National Institute of Health, Ministry of Health
(2) (Form) Application for Clinical Trial Authorization (FOR-OGITT-028 (PER-24 - Spanish) (Edition No. 02) (September 24, 2019)
National Institute of Health, Ministry of Health
(3) (Form) Application for Contract Research Organization Registration (FOR-OGITT-021) (PER-37 - Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
(4) (Form) Application for Extension of the Clinical Trial (FOR-OGITT-037) (PER-27 - Spanish) (Edition No. 02) (September 24, 2019)
National Institute of Health, Ministry of Health
(5) (Form) Application for Sponsor Registration (FOR-OGITT-020) (PER-36 - Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
(6) (Form) List of Products and Supplies to be Used in the Clinical Trial (FOR-OGITT-033) (PER-42 - Spanish) (Edition No. 02) (April 9, 2018)
National Institute of Health, Ministry of Health
(7) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (PER-53) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
(8) (Webpage) Organization of the Ministry of Health (PER-67 - Spanish) (Last Updated December 20, 2019)
Ministry of Health
Relevant Sections: Bodies of the Vice Ministerial Office of Public Health - General Directorate of Strategic Public Health Interventions
(9) (Webpage) General Directorate of Medicines, Supplies and Drugs (DIGEMID) (PER-56 - Spanish) (Current as of November 19, 2020)
Ministry of Health
(10) (Webpage) List of Procedures (PER-72) (Spanish) (Current as of November 19, 2020)
REPEC, National Institute of Health, Ministry of Health
Relevant Sections: Extension of Clinical Trial Time
(11) (Webpage) National Registry of Accredited Institutional Ethics Committees (PER-61 - Spanish) (Current as of November 19, 2020)
REPEC, National Institute of Health, Ministry of Health
(12) (Webpage) Peruvian Clinical Trials Registry (REPEC) (PER-58 - Spanish) (English) (Current as of November 19, 2020)
REPEC, National Institute of Health, Ministry of Health
(13) (Webpage) Registration of a Clinical Trial - Authorization (PER-71 - Spanish) (Current as of November 19, 2020)
REPEC, National Institute of Health, Ministry of Health
(14) (Webpage) Registration of a Sponsor (PER-60 - Spanish) (Current as of November 19, 2020)
REPEC, National Institute of Health, Ministry of Health
(15) (Webpage) Registration of Contract Research Organization (CRO) (PER-59 - Spanish) (Current as of November 19, 2020)
REPEC, National Institute of Health, Ministry of Health
Regulatory Authority > Regulatory Fees
Last content review/update: November 19, 2020
Requirements
(1) (Regulation) Directoral Resolution 0423-2019/OGITT/INS – Provides for the Amendment of Administrative Procedure Requirements Specified in the Supreme Decree No. 021-2017-SA by the National Institute of Health (INS) for the Authorization of Clinical Trials (ResolutionNo0423-2019 - Spanish) (September 24, 2019)
National Institute of Health, Ministry of Health
Relevant Sections: Preamble, Article 1, and Annexes (4-6, 8, and 10)
(2) (Regulation) Ministerial Resolution No. 655-2019/MINSA – Provides for the Elimination of Administrative Procedure Requirements Specified in the Supreme Decree No. 021-2017-SA by the National Institute of Health (INS) (ResolutionNo655-2019 - Spanish) (July 27, 2019)
Ministry of Health
Relevant Sections: Annexes A and B
(3) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo021-2017 - Spanish) (GoogleTranslate-DecreeNo021-2017) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 67, 76, 78-80, 87, and 88
(4) (Guidance) Guide of General Guidelines for the Submission of Procedures Related to the Regulation of Clinical Trials (G-CTSubmissionProcs - Spanish) (Edition No. 01) (November 28, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: 5
(5) (Guidance) Guideline for the Procedure for Requesting Authorization of the Clinical Trial (G-CTApplicProc - Spanish) (Edition No. 02) (November 15, 2019)
National Institute of Health, Ministry of Health
Relevant Sections: 6
Summary

Overview

According to PER-77, new regulatory fees are going to be approved. Currently, the National Institute of Health (Instituto Nacional de Salud (INS)) is not receiving payments. An email may also be sent to consultaensayos@ins.gob.pe for any additional fee-related questions.

While the INS is not currently receiving payments, per DecreeNo021-2017, the G-CTSubmissionProcs, and PER-77, the sponsor or his/her contract research organization (CRO) is typically responsible for paying a fee, as applicable, to the INS to submit a clinical trial application for authorization. Additionally, per DecreeNo021-2017, INS payment is required to modify the trial as follows: to increase the number of research centers participating in a study; to change the sponsor or CRO under contract; to change the principal investigator; to request a time extension for the trial; to request authorization to change the trial name; or to request authorization to amend a report. Per ResolutionNo0423-2019, the forms required to modify the trial may be obtained from PER-26, PER-27, PER-28, PER-43, and PER-31. The G-CTSubmissionProcs also indicates that the INS reimburses processing fees when an application is cancelled.

Pursuant to ResolutionNo655-2019, which modifies DecreeNo021-2017 and the G-CTApplicProc, in the case of multicenter clinical trials, the sponsor or his/her CRO must submit a clinical trial application along with proof of payment information for the processing fee rather than requiring each of the participating research sites in Peru to submit their payment separately, as originally required.

Additional Resources
(1) (Form) Application for Clinical Trial Cancellation (FOR-OGITT-042) (PER-31 - Spanish) (Edition No. 02) (September 24, 2019)
National Institute of Health, Ministry of Health
(2) (Form) Application for Extension of the Clinical Trial (FOR-OGITT-037) (PER-27 - Spanish) (Edition No. 02) (September 24, 2019)
National Institute of Health, Ministry of Health
(3) (Form) Application for Principal Investigator Change (FOR-OGITT-038) (PER-28 - Spanish) (Edition No. 02) (September 24, 2019)
National Institute of Health, Ministry of Health
(4) (Form) Application for Research Center Closure for a Clinical Trial (FOR-OGITT-040) (PER-43 - Spanish) (Edition No. 02) (September 24, 2019)
National Institute of Health, Ministry of Health
(5) (Form) Application for the Extension of the Number of Research Centers (FOR-OGITT-036) (PER-26 - Spanish) (Edition No. 02) (September 24, 2019)
National Institute of Health, Ministry of Health
(6) (Not Available Online) NIAID Communication with Peru’s National Institute of Health (January 2020) (PER-77)
(7) (Webpage) List of Procedures (PER-72) (Spanish) (Current as of November 19, 2020)
REPEC, National Institute of Health, Ministry of Health
Relevant Sections: Clinical Trial Authorization Renewal, Extension for a Clinical Trial, Addition of New Research Sites
(8) (Webpage) Registration of a Clinical Trial - Authorization (PER-71 - Spanish) (Current as of November 19, 2020)
REPEC, National Institute of Health, Ministry of Health
Ethics Committee > Ethics Committee
Last content review/update: November 19, 2020
Requirements
(1) (Regulation) Ministerial Resolution No. 233-2020 – Ethical Considerations for Health Research with Human Beings (ResolutionNo233-2020 - Spanish) (April 28, 2020)
Ministry of Health
Relevant Sections: VII (7.2) and VIII (8.2 and 8.3)
(2) (Regulation) Ministerial Resolution No. 655-2019/MINSA – Provides for the Elimination of Administrative Procedure Requirements Specified in the Supreme Decree No. 021-2017-SA by the National Institute of Health (INS) (ResolutionNo655-2019 - Spanish) (July 27, 2019)
Ministry of Health
Relevant Sections: Annex B
(3) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo021-2017 - Spanish) (GoogleTranslate-DecreeNo021-2017) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 40, 59, 61-66, 71, 102, and Complementary Provisions - Final (Eighth)
(4) (Guidance) Guideline for the Procedure for Requesting Authorization of the Clinical Trial (G-CTApplicProc - Spanish) (Edition No. 02) (November 15, 2019)
National Institute of Health, Ministry of Health
Relevant Sections: 4 and 6
(5) (Guidance) Procedures Manual of Clinical Trials (MAN-INS-001) (INS-CTManual - Spanish) (3rd Edition) (November 17, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Annexes 1 and 3
Summary

Overview

As set forth in DecreeNo021-2017, the INS-CTManual, the G-CTApplicProc, PER-71, and PER-61, Peru requires clinical trial approval from an institutional ethics committee (EC) (El Comité Institucional de Ética en Investigación (CIEI)) that is accredited by the National Institute of Health (Instituto Nacional de Salud (INS))’s National Registry of Accredited Institutional Ethics Committees (PER-61). There are no stated requirements regarding which EC the sponsor should choose to conduct the clinical protocol review. As noted in DecreeNo021-2017, those research institutions that do not have an accredited EC may select another INS-accredited EC, preferably located in the same region. Per ResolutionNo655-2019, which amends DecreeNo021-2017, the application for accreditation/renewal of accreditation has been modified to be only an application for accreditation. Refer to PER-61, PER-20, and PER-21 for additional EC accreditation requirements and standards.

In addition, ResolutionNo233-2020, which now requires all ECs that conduct human health research be registered with the INS, explains that if the entities or institutions do not have an EC, they may select another INS-registered EC to evaluate their investigations. This arrangement may occur following a written agreement between the authorities of the entities or institutions involved and the respective EC. According to PER-77, INS-registered ECs are only required to obtain accreditation if they are conducting a review of a clinical trial protocol.

ResolutionNo233-2020 further states that ECs should have the goal of carrying out scientific research as one (1) of their main objectives. An EC may be constituted within a public, private, or mixed health institution that provides health services and is registered with the National Registry of Institutions that Provide Health Services (Registro Nacional de Instituciones Prestadoras de Servicios de Salud (RENIPRESS)) (see PER-55). An EC may also be an entity within the Ministry of Health of Peru (Ministerio de Salud del Perú (MINSA)), one (1) of the Peruvian universities, or a non-profit legal organization. Per ResolutionNo233-2020, ECs are constituted by statute, resolution, or other document that establishes, as a minimum, among others, the committee’s mission, its members, and their respective positions. The health institutions or entities may constitute more than one (1) EC in order to fulfill their requirements in the field of health research with human beings. DecreeNo021-2017, PER-21, and ResolutionNo233-2020 note that infrastructure requirements for the operation of institutional ECs must include ensuring work environments that guarantee confidentiality and computer equipment with sufficient capacity, providing administrative staff, and ensuring the availability other resources necessary for its operation.

Peru’s Institutional Research Ethics Committee of the National Institute of Health (El Comité Institucional de Ética en Investigación del Instituto Nacional de Salud (CIEI-INS)) does not approve clinical trials.

Institutional EC Composition

As delineated in DecreeNo021-2017 and ResolutionNo233-2020, institutional ECs should consist of at least five (5) members represented by a multidisciplinary group of professionals and community members, including (Note: the regulations provide overlapping and unique elements so each of the items listed below will not necessarily be in each source):

  • Persons with knowledge in research methodology and with scientific expertise in the health field, including those with expertise in behavioral or social sciences
  • Persons with expertise in ethical matters
  • Persons with expertise in legal matters
  • Community representatives, whose primary function is to share their views on the communities where the research participants are likely to come from
  • At least one (1) titular member that must be from the community and not belong to the field of health or to the research institution

In addition, all members must have at least one (1) certificate of basic training in research ethics and one (1) of its members must have training in bioethics. The EC should seek the assistance of expert consultants on different topics when it lacks the knowledge and experience necessary to evaluate the protocol. Furthermore, the authorities, managers, or the main persons in charge of the entities and institutions that constitute the ECs cannot be members or preside over the members; the list of all members must be publicly accessible.

Terms of Reference, Review Procedures, and Meeting Schedule for Institutional ECs

Pursuant to DecreeNo021-2017 and ResolutionNo233-2020, ECs must have stated rules and prepare a procedures manual that is approved by the research institution. The rules should establish composition, procedures, and internal requirements, and other acts for the EC’s operation. Per DecreeNo021-2017 and ResolutionNo233-2020, the manual must provide rules and procedures for the following (Note: the regulations provide overlapping and unique elements so each of the items listed below will not necessarily be in each source):

  • Conditions and terms of member appointments
  • EC structure
  • Member responsibilities
  • Meeting frequency
  • Specific quorum requirements
  • Filing dossier administrative requirements
  • Monitoring authorized research protocols
  • Preparing and approving meeting minutes
  • Filing related documentation
  • Submitting research projects for review
  • Assessing the types of review (i.e., whether a project requires ethical review or should be exempt)
  • Classifying decisions adopted and processes to communicate these decisions
  • Developing the mechanism for reconsidering decisions adopted by the EC
  • The follow-up and monitoring of research investigations, from the moment approved until terminated early or terminated (including presenting amendments, deviations, adverse events, etc.)
  • Seeking specialist(s) advice on diseases or methodologies outside the EC’s expertise
  • Ensuring alternate committee members have been selected
  • Replacing a member with a conflict of interest
  • Documenting EC activities in meeting minutes
  • Promoting collaboration with other ECs and other stakeholders involved in health research with human beings

See Title IV, Chapter 7 of DecreeNo021-2017 and ResolutionNo233-2020 for detailed EC requirements.

Additional Resources
(1) (Form) Application for Accreditation/Renewal of the Accreditation of the Institutional Ethics Committees (CIEI) (FOR-OGITT-025) (PER-20 - Spanish) (Edition No. 02) (September 24, 2019)
National Institute of Health, Ministry of Health
(2) (Form) Affidavit of Compliance with the Accreditation Standards of the Institutional Ethics Committees (CIEI) (FOR-OGITT-026) (PER-21 - Spanish) (Edition No. 02) (September 24, 2019)
National Institute of Health, Ministry of Health
(3) (Form) Verification of Compliance with the Accreditation Standards of the Institutional Ethics Committees (CIEI) (FOR-OGITT-027) (PER-22 - Spanish) (Edition No. 1) (January 29, 2020)
National Institute of Health, Ministry of Health
(4) (Not Available Online) NIAID Communication with Peru’s National Institute of Health (January 2020) (PER-77)
(5) (Webpage) National Registry of Accredited Institutional Ethics Committees (PER-61 - Spanish) (Current as of November 19, 2020)
REPEC, National Institute of Health, Ministry of Health
(6) (Webpage) National Registry of Institutions that Provide Health Services (Registro Nacional de Instituciones Prestadoras de Servicios de Salud (RENIPRESS)) (PER-55 - Spanish) (Current as of November 19, 2020)
Ministry of Health
(7) (Webpage) Peruvian Clinical Trials Registry (REPEC) (PER-58 - Spanish) (English) (Current as of November 19, 2020)
REPEC, National Institute of Health, Ministry of Health
(8) (Webpage) Registration of a Clinical Trial - Authorization (PER-71 - Spanish) (Current as of November 19, 2020)
REPEC, National Institute of Health, Ministry of Health
Ethics Committee > Scope of Review
Last content review/update: November 19, 2020
Requirements
(1) (Legislation) Political Constitution of Peru of 1993 (PeruConstitution - Spanish) (Amended through March 2019)
Congress of the Republic
Relevant Sections: Chapter 1 (Articles 1 and 2) and Chapter 2 (Article 7)
(2) (Regulation) Ministerial Resolution No. 233-2020 – Ethical Considerations for Health Research with Human Beings (ResolutionNo233-2020 - Spanish) (April 28, 2020)
Ministry of Health
Relevant Sections: I, VII (7.2-7.4), and VIII (8.2 and 8.3)
(3) (Regulation) Ministerial Resolution No. 686-2020/MINSA - Approves the Technical Health Standard for the Research and Development of Vaccines against Infectious Diseases (ResolutionNo686-2020 - Spanish) (September 1, 2020)
Ministry of Health
Relevant Sections: 5.2
(4) (Regulation) Directoral Resolution 0423-2019/OGITT/INS – Provides for the Amendment of Administrative Procedure Requirements Specified in the Supreme Decree No. 021-2017-SA by the National Institute of Health (INS) for the Authorization of Clinical Trials (ResolutionNo0423-2019 - Spanish) (September 24, 2019)
National Institute of Health, Ministry of Health
Relevant Sections: Preamble, Article 1, and Annexes (8 and 10)
(5) (Regulation) Supreme Decree No. 011-2011-JUS: Guidelines to Guarantee the Implementation of Bioethics to Ensure the Protection of the Human Rights (DecreeNo011-2011-JUS - Spanish) (July 27, 2011)
Ministry of Justice and Human Rights
Relevant Sections: Preamble, Introduction, II (1 and 3), and V (1)
(6) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo021-2017 - Spanish) (GoogleTranslate-DecreeNo021-2017) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 9, 24, 58-60, 67, and 70
(7) (Guidance) Guide for the Ethical Review of Clinical Trials by Institutional Research Ethics Committees (G-EC-CTReview - Spanish) (Edition No. 1) (January 8, 2020)
Executive Office of Research, General Office for Research and Technology Transfer, National Institute of Health, Ministry of Health
Relevant Sections: Preamble, VII, Ethical Criterion 1, Ethical Criterion 5, and Annex 3
(8) (Guidance) Guideline for the Procedure for Requesting Authorization of the Clinical Trial (G-CTApplicProc - Spanish) (Edition No. 02) (November 15, 2019)
National Institute of Health, Ministry of Health
Relevant Sections: 4, 6, and Annexes 1 and 3
(9) (Guidance) Procedures Manual of Clinical Trials (MAN-INS-001) (INS-CTManual - Spanish) (3rd Edition) (November 17, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Annexes 1 and 3
Summary

Overview

According to DecreeNo021-2017, ResolutionNo233-2020, and the G-EC-CTReview, the primary scope of information assessed by institutional ethics committees (ECs) (El Comité Institucional de Ética en Investigacións (CIEIs)) relates to maintaining and protecting the dignity and rights of research participants and ensuring their safety throughout their participation in a clinical trial. The EC scope also aligns with the principles delineated in the PeruConstitution and DecreeNo011-2011-JUS, which assert that the defense of the human person and respect for his/her dignity are the supreme goal of society and the state.

As per DecreeNo021-2017, DecreeNo011-2011-JUS, and the G-EC-CTReview, ECs must also pay special attention to reviewing informed consent and to protecting the welfare of certain classes of participants deemed to be vulnerable. Per DecreeNo021-2017, when a clinical trial is proposed for subordinate groups (e.g., students, health workers, employees, military members, police, prisoners, etc.), one or more members of the population under study, or another person within this community capable of guarding the conditions and human rights that correspond to the group in question, should participate in the EC review. (See Informed Consent topic, and the subtopics of Vulnerable Populations; Children/Minors; Pregnant Women, Fetuses & Neonates; and Mentally Impaired for additional information about these populations).

DecreeNo021-2017, the G-EC-CTReview, and ResolutionNo233-2020 also state that the National Institute of Health (Instituto Nacional de Salud (INS))-registered and accredited institutional ECs are responsible for ensuring an independent, timely, and competent review of all ethical aspects of the clinical trial protocol. They must act in the interests of the potential research participants and the communities involved by evaluating the possible risks and expected benefits to participants; confirming the suitability of the investigator(s), facilities, and methods; and verifying the adequacy of confidentiality and privacy safeguards.

ResolutionNo233-2020 further explains that the research studies should also consider the scientific validity and social value of the research; the equitable selection of research participants; the adequacy of the informed consent process; respect for the participants; and the participation and commitment of the communities. The Council for International Organizations of Medical Sciences’ (CIOMS) International Guidelines for Health-Related Research Involving Humans (PER-78) is referenced for further information on the previously listed ethical criteria. On a related note, ResolutionNo686-2020, an INS technical health standard for preclinical and clinical research with vaccines in Peru, states that in the ethical review of clinical studies of vaccines in humans, ECs must comply with the ethical criteria delineated in ResolutionNo233-2020, which are, in turn, based on the previously discussed CIOMS ethical guidelines (PER-78). As indicated in ResolutionNo686-2020, in all deliberations, ECs must ensure the following ethical criteria are present: social value and scientific validity of the research; favorable benefit/risk balance and risk minimization; fair selection of research subjects; informed consent process; respect for people; and community participation and commitment. Therefore, per ResolutionNo686-2020, an EC decision regarding the approval or disapproval of a vaccine clinical study protocol must have a solid and justified ethical basis in the aforementioned CIOMS criteria (PER-78).

In addition, per ResolutionNo233-2020, research entities or institutions must have policies of scientific integrity, in accordance with international standards on the matter and the National Code of Scientific Integrity (PER-79), which includes appropriate investigation and sanction procedures. Per DecreeNo021-2017, ECs must also conduct regular monitoring, with a frequency based on the degree of risk to participants, but no less than once a year, and suspend or cancel the trial when participants are exposed to uncontrolled risk. ResolutionNo233-2020 also states that the EC should monitor the progress of an approved research project until it has concluded. See DecreeNo021-2017, the G-EC-CTReview, and ResolutionNo233-2020 for detailed ethical review guidelines. Refer to PER-43 and PER-31 to submit an application for research center closure or to cancel a clinical trial using recently amended forms per ResolutionNo0423-2019.

Role in Clinical Trial Approval Process

As per DecreeNo021-2017, the INS-CTManual, the G-CTApplicProc, and the G-EC-CTReview, an INS-accredited EC must approve the clinical trial protocol and informed consent form prior to the sponsor or his/her contract research organization (CRO) submitting the clinical trial application to the INS. Therefore, the INS and EC reviews may not be conducted in parallel.

According to PER-77, each institutional EC determines its own review and approval timeline and continuing review requirements based on its internal regulations and standard operating procedures.

(See the Clinical Trial Lifecycle topic, Submission Process and Timeline of Review subtopics for detailed submission process and timeline details.)

Additional Resources
(1) (Document) National Code of Scientific Integrity (PER-79 - Spanish) (October 30, 2019)
National Council of Science, Technology and Technological Innovation (CONCYTEC)
(2) (Form) Application for Clinical Trial Cancellation (FOR-OGITT-042) (PER-31 - Spanish) (Edition No. 02) (September 24, 2019)
National Institute of Health, Ministry of Health
(3) (Form) Application for Research Center Closure for a Clinical Trial (FOR-OGITT-040) (PER-43 - Spanish) (Edition No. 02) (September 24, 2019)
National Institute of Health, Ministry of Health
(4) (International Guidance) International Guidelines for Health-Related Research Involving Humans (PER-78) (2016)
Council for International Organizations of Medical Sciences (CIOMS) and World Health Organization (WHO)
(5) (Not Available Online) NIAID Communication with Peru’s National Institute of Health (January 2020) (PER-77)
Ethics Committee > Ethics Committee Fees
Last content review/update: November 19, 2020
Requirements
(1) (Regulation) Ministerial Resolution No. 233-2020 – Ethical Considerations for Health Research with Human Beings (ResolutionNo233-2020 - Spanish) (April 28, 2020)
Ministry of Health
Relevant Sections: VII (7.2)
Summary

Although specific ethics committees (EC) fees are not provided in Peru’s regulatory sources, per ResolutionNo233-2020, the entities and institutions that constitute an EC must provide the committee with all the economic, human, logistical, infrastructure, or other resources necessary for its operation.

Please refer to PER-70 for an example of 2020 fees that an accredited institutional EC is currently charging to conduct research reviews.

Additional Resources
(1) (Webpage) Vialibre – Institutional Bioethics Committees - 2020 Rates (PER-70 - Spanish) (Current as of November 19, 2020)
Vialibre
Ethics Committee > Authorizing Body
Last content review/update: November 19, 2020
Requirements
(1) (Regulation) Ministerial Resolution No. 233-2020 – Ethical Considerations for Health Research with Human Beings (ResolutionNo233-2020 - Spanish) (April 28, 2020)
Ministry of Health
Relevant Sections: VII (7.4) and VIII (8.1 and 8.2)
(2) (Regulation) Directoral Resolution 0423-2019/OGITT/INS – Provides for the Amendment of Administrative Procedure Requirements Specified in the Supreme Decree No. 021-2017-SA by the National Institute of Health (INS) for the Authorization of Clinical Trials (ResolutionNo0423-2019 - Spanish) (September 24, 2019)
National Institute of Health, Ministry of Health
Relevant Sections: Preamble, Article 1, and Annexes (2-3)
(3) (Regulation) Ministerial Resolution No. 655-2019/MINSA – Provides for the Elimination of Administrative Procedure Requirements Specified in the Supreme Decree No. 021-2017-SA by the National Institute of Health (INS) (ResolutionNo655-2019 - Spanish) (July 27, 2019)
Ministry of Health
Relevant Sections: Annex B
(4) (Regulation) Supreme Decree No. 001-2003-SA: Approves the Regulation of Organization and Functions of the National Institute of Health (DecreeNo001-2003 - Spanish) (January 9, 2003)
Ministry of Health
Relevant Sections: Title I, Title II (Chapters I and III)
(5) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo021-2017 - Spanish) (GoogleTranslate-DecreeNo021-2017) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Article 63 and Complementary Provisions - Final (Eighth)
(6) (Guidance) Guide for the Ethical Review of Clinical Trials by Institutional Research Ethics Committees (G-EC-CTReview - Spanish) (Edition No. 1) (January 8, 2020)
Executive Office of Research, General Office for Research and Technology Transfer, National Institute of Health, Ministry of Health
Relevant Sections: Preamble and VII
(7) (Guidance) Guideline for the Procedure for Requesting Authorization of the Clinical Trial (G-CTApplicProc - Spanish) (Edition No. 02) (November 15, 2019)
National Institute of Health, Ministry of Health
Relevant Sections: 4 and 6
(8) (Guidance) Procedures Manual of Clinical Trials (MAN-INS-001) (INS-CTManual - Spanish) (3rd Edition) (November 17, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Chapter VII (7.3, 7.4 and 7.9) and Flow Charts No. 02, 03, and 17
Summary

Overview

As set forth in DecreeNo001-2003, Peru’s National Institute of Health (Instituto Nacional de Salud (INS)) is the central body responsible for the oversight, promotion, and coordination of research. The INS is a decentralized public agency of the Ministry of Health of Peru (Ministerio de Salud del Perú (MINSA)).

Registration, Auditing, and Accreditation

As delineated in DecreeNo021-2017, the INS-CTManual, the G-CTApplicProc, the G-EC-CTReview, and PER-61, the INS’s General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnológica (OGITT)) is responsible for registering and accrediting institutional ethics committees (ECs) (El Comité Institucional de Ética en Investigacións (CIEIs)) listed in the INS’s Peruvian Clinical Trials Registry (Registro Peruano de Ensayos Clínicos (REPEC)) to review and approve clinical trials. The OGITT must evaluate and verify the EC‘s compliance with the registration and accreditation standards established in the INS-CTManual. DecreeNo021-2017 created the National Registry of Accredited Institutional Ethics Committees (PER-61) under this regulation in 2017.

ResolutionNo233-2020 further notes that the INS is responsible for managing and maintaining the public database of nationally registered ECs; providing advice, guidance and technical assistance to ECs and their entities or institutions; organizing training and education activities for EC members and researchers; promoting integration and cooperation networks among participating ECs; promoting relations between the ECs and different entities linked to the research ethics field; providing access to international resources to strengthen research ethics; establishing flexible review procedures and mechanisms appropriate for an expedited and rigorous ethical review of human health research in disaster situations and disease outbreaks; and assigning the INS’s OGITT to disseminate information and supervising ECs at the national level per the ethical research guidelines delineated in ResolutionNo233-2020.

Per ResolutionNo655-2019, which amends DecreeNo021-2017, the electronic accreditation application form (FOR-OGITT-025) should only be submitted for the initial accreditation approval and not for accreditation renewal (see PER-20 for the form). In addition to completing form FOR-OGITT-025, the applicant should electronically submit form FOR-OGITT-026 (PER-21) to demonstrate compliance with the accreditation standards delineated in the INS-CTManual. As part of this submission process, the applicant should complete and electronically submit the EC registration application form located on the National Registry of Accredited Institutional Ethics Committees website (PER-61). Once the form is submitted, the user will receive a temporary EC registration number. The completed form should be printed, signed, and attached along with the other accreditation documents required to be sent to the OGITT via the Documentary Procedure Office located in the INS headquarters (refer to PER-61 for detailed information).

DecreeNo021-2017 and the INS-CTManual, state that accreditation is temporary and must be renewed every three (3) years. Per DecreeNo021-2017, ResolutionNo655-2019 (which amends DecreeNo021-2017), and the INS-CTManual, The following accreditation requirements must be completed:

  • Copy of the resolution/decision issued by the highest authority of the research institution authorizing EC operation
  • Copy of institutionally approved EC regulations and its Manual of Procedures submitted in electronic form (editable PDF)
  • Affidavit of compliance with INS-CTManual accreditation standards (PER-21) per ResolutionNo0423-2019
  • Curriculum vitaes signed by each EC member submitted in electronic form (editable PDF)

The INS-CTManual further recommends that applications for EC accreditation renewals be submitted 30 calendar days before the end of term. DecreeNo021-2017 further grants a grace period of one (1) year following the approval of the updated INS-CTManual for ECs to comply with the accreditation requirements listed above.

Refer to the INS-CTManual and PER-61 for detailed submission instructions, and PER-20, PER-21, and PER-35 for the recently amended EC accreditation application and EC affidavit of compliance forms per ResolutionNo0423-2019.

Additionally, the INS-CTManual provides detailed information on the inspections that the INS-accredited ECs may be subject to before, during, and after the registration of an EC.

(Please note that Peru is in the process of finalizing new guidelines as well as the associated forms and instructions to support the ResolutionNo655-2019 and ResolutionNo0423-2019 amendments to DecreeNo021-2017; ClinRegs is monitoring these developments.)

Additional Resources
(1) (Form) Affidavit of Research Center Preparedness for Clinical Trial (FOR-OGITT-064) (PER-35 - Spanish) (Edition No. 01) (September 24, 2019)
National Institute of Health, Ministry of Health
(2) (Form) Application for Accreditation/Renewal of the Accreditation of the Institutional Ethics Committees (CIEI) (FOR-OGITT-025) (PER-20 - Spanish) (Edition No. 02) (September 24, 2019)
National Institute of Health, Ministry of Health
(3) (Form) Affidavit of Compliance with the Accreditation Standards of the Institutional Ethics Committees (CIEI) (FOR-OGITT-026) (PER-21 - Spanish) (Edition No. 02) (September 24, 2019)
National Institute of Health, Ministry of Health
(4) (Form) Verification of Compliance with the Accreditation Standards of the Institutional Ethics Committees (CIEI) (FOR-OGITT-027) (PER-22 - Spanish) (Edition No. 1) (January 29, 2020)
National Institute of Health, Ministry of Health
(5) (Webpage) National Registry of Accredited Institutional Ethics Committees (PER-61 - Spanish) (Current as of November 19, 2020)
REPEC, National Institute of Health, Ministry of Health
(6) (Webpage) Peruvian Clinical Trials Registry (REPEC) (PER-58 - Spanish) (English) (Current as of November 19, 2020)
REPEC, National Institute of Health, Ministry of Health
Clinical Trial Lifecycle > Submission Process
Last content review/update: November 19, 2020
Requirements
(1) (Regulation) Directoral Resolution 0423-2019/OGITT/INS – Provides for the Amendment of Administrative Procedure Requirements Specified in the Supreme Decree No. 021-2017-SA by the National Institute of Health (INS) for the Authorization of Clinical Trials (ResolutionNo0423-2019 - Spanish) (September 24, 2019)
National Institute of Health, Ministry of Health
Relevant Sections: Preamble, Article 1, and Annexes (2-3 and 11)
(2) (Regulation) Ministerial Resolution No. 655-2019/MINSA – Provides for the Elimination of Administrative Procedure Requirements Specified in the Supreme Decree No. 021-2017-SA by the National Institute of Health (INS) (ResolutionNo655-2019 - Spanish) (July 27, 2019)
Ministry of Health
Relevant Sections: Annexes A and B
(3) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo021-2017 - Spanish) (GoogleTranslate-DecreeNo021-2017) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 34, 40, 59, 61, 63, 67, 70, 71, 85-86, 88, 91, Annex 1, and Complementary Provisions Final
(4) (Guidance) Guidance for the Procedure for the Request for Authorization of the Amendment Report (G-AmdAuthRept - Spanish) (Edition No. 01) (April 29, 2019)
National Institute of Health, Ministry of Health
(5) (Guidance) Guide of General Guidelines for the Submission of Procedures Related to the Regulation of Clinical Trials (G-CTSubmissionProcs - Spanish) (Edition No. 01) (November 28, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: 1, 2, 4, 5, and Key Points
(6) (Guidance) Guideline for the Procedure for Requesting Authorization of the Clinical Trial (G-CTApplicProc - Spanish) (Edition No. 02) (November 15, 2019)
National Institute of Health, Ministry of Health
Relevant Sections: 4-6
(7) (Guidance) Procedures Manual of Clinical Trials (MAN-INS-001) (INS-CTManual - Spanish) (3rd Edition) (November 17, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Chapter VI (6.4), VII (7.1, 7.5, 7.8.2, and 7.8.3), Flow Chart No. 04, No. 13, and No. 14, and Annexes 1 and 3
Summary

Overview

In accordance with DecreeNo021-2017, the INS-CTManual, the G-CTApplicProc, Peru requires the sponsor or his/her contract research organization (CRO) to obtain clinical trial authorization from the National Institute of Health (Instituto Nacional de Salud (INS)) and ensure that ethics committee (EC) approval is obtained from an INS-accredited EC.

DecreeNo021-2017 and the G-CTApplicProc also state that if the sponsor is not based in Peru, he/she is required to appoint a legal representative in the country who channels all communication with the INS’s General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnológica (OGITT)) for the trial’s duration, unless such responsibility is delegated to a CRO.

Please refer to PER-71 and PER-61 for detailed information on clinical trial authorization and EC accreditation. See also the INS-CTManual, the G-CTApplicProc, PER-60, and PER-59, for sponsor and contract research organization (CRO) registration instructions, and PER-36 and PER-37 for sponsor and CRO registration forms. According to DecreeNo021-2017, the INS-CTManual, and the G-CTApplicProc, the INS and EC reviews may not be conducted in parallel. The INS-accredited EC must first approve the research protocol and informed consent form (ICF), and the sponsor or his/her CRO must submit this information as part of the application dossier in order for the INS to conduct its review.

(See the Submission Content subtopic for detailed submission requirements).

OGITT Contact Information
Instituto Nacional de Salud
Oficina General de Investigación Y Transferencia Tecnológica
Cápac Yupanqui 1400
Jesus María
Lima 11
Perú

Phone: 511 748 1111
Fax: Not Available
Email:
webmaster@ins.gob.pe

Clinical Trial Phone: 511 748 1111 (Ext. 2191)
Fax: Not Available
Clinical Trial Email:
consultaensayos@ins.gob.pe

Assembly and Number of Copies

Based on information provided in DecreeNo021-2017, the INS-CTManual, the G-CTApplicProc, and the G-CTSubmissionProcs, and PER-71, the sponsor or his/her CRO must submit a request for clinical trial authorization electronically using the Peruvian Clinical Trials Registry (Registro Peruano de Ensayos Clínicos (REPEC)), at which time a registration code is assigned to the application. Per the INS-CTManual, the electronic form should also be printed and signed by the sponsor or his/her CRO and delivered to the INS’s Documentary Processing Area within 20 working days.

As described in the G-CTApplicProc, the clinical trial application must be presented in both print and electronic format. One (1) printed copy of the application must be submitted to the INS as indicated in the requirements listed in DecreeNo021-2017. Per the G-CTApplicProc, the application should be completed using the OGITT approved forms that are available on the REPEC website.

Per the G-CTSubmissionProcs, if submitting procedures or communications for which there are no available forms, information should be provided by letter to the OGITT. Documentation must be clear and legible, with all the fields completed in the respective forms for each procedure as this information is subject to evaluation. All documents must be presented on A4 size bond paper, in a folder of A4 size with a wide spine to allow for unrestricted opening between the sections. The documents must also be organized using separators and foliated in the upper right hand corner according to the order established in the DecreeNo021-2017 requirements. The foliation is arranged from the front to the end, and the numbering assigned to each folio must be consecutive. In addition, the number assigned to each folio must be written legibly without amendments, on a blank page, and without altering texts, letterhead, stamps, originals, etc. The application must also include the address where INS application related notifications should be mailed.

As indicated in the G-CTApplicProc, two (2) CDs should be provided for the electronic submission of the application and include the following documentation:

  • Research protocol
  • Updated Investigator’s Brochure (IB)
  • List of clinical trial supplies (PER-42)
  • Information related to the quality of the investigational product (IP) according to Annex 5 of DecreeNo021-2017 (inside a folder referred to as Annex 05)

One (1) of the CDs should be sent to the National Authority for Pharmaceutical Products, Medical Devices and Medical Products (la Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (ANM)) for the evaluation of the safety profile and the quality of the product under investigation. (Note: The ANM is also referred to as the General Directorate of Medicines, Supplies and Drugs (La Dirección General de Medicamentos Insumos y Drogas (DIGEMID)).

In addition, per the G-CTSubmissionProcs, a printed page listing all of the attached digital media included in the application should accompany the electronic version. The attachment should contain the respective folio number, the clinical trial code, and a brief description of the content included in the digital medium. The applicant should ensure that the application submission complies with all of the requirements delineated in DecreeNo021-2017. If the OGITT’s Office of Documentary Processing requires any corrections, the applicant will have two (2) business days to amend the application, and this time will not be counted towards the period allotted for the OGITT’s review. If the two (2)-day timeframe is exceeded, the application will be discarded, and another application must be submitted to initiate the process again.

Refer to the INS-CTManual, the G-CTApplicProc, the G-CTSubmissionProcs, and PER-71 for additional submission information, PER-24 for the recently amended clinical trial application form per ResolutionNo0423-2019, and PER-10 for detailed instructions on completing the form.

Clinical Trial Application Language Requirements

As delineated in DecreeNo021-2017, the clinical trial application and accompanying material must be provided in Spanish. Any document not in Spanish must be submitted with a corresponding translation. The INS-CTManual specifically states that the sponsor registration application (PER-36) must be submitted in Spanish, or accompanied by a proper translation if issued in a language other than Spanish. Notification reports for IPs should contain a translated summary in English and Spanish.

Further, per ResolutionNo655-2019 (which amends DecreeNo021-2017) and the G-CTApplicProc, the research protocol and the ICF must be in Spanish and in the original language, if different from Spanish, and include a copy of the approval by an INS-accredited EC. All of the documents should be submitted in electronic form as an editable PDF. For amended protocols or ICF submissions, ResolutionNo655-2019 states that any changes should be submitted in tracked change format. The final protocol and ICF should include all of the incorporated amendments and comply with all of the previously discussed protocol submission requirements.

ResolutionNo655-2019 further explains that the updated IB must be written in Spanish, and in the original language, if different from Spanish. These documents are to be submitted in electronic form as an editable PDF. Refer to ResolutionNo655-2019 and the G-AmdAuthRept for detailed protocol amendment requirements. The application for approval of clinical trial amendments is in PER-33.

(Please note that Peru is in the process of finalizing new guidelines as well as the associated forms and instructions to support the ResolutionNo655-2019 amendments to DecreeNo021-2017; ClinRegs is monitoring these developments.)

DecreeNo021-2017 also states that if the protocol title is written in English, a single title in Spanish must be assigned for all purposes. The ICF must also be written in Spanish, and in the language the research participant identifies as his/her own. This requirement is also applicable to the protocol and ICF amendments. In addition, research and complementary IPs media labeling must be printed in indelible ink in Spanish or English.

Additional Resources
(1) (Document) Instructions for Filling Out Form FOR-OGITT-028 Edition No. 03 – Request for Clinical Trial Authorization (PER-10 - Spanish) (Edition No. 03) (May 8, 2019)
National Institute of Health, Ministry of Health
(2) (Form) Affidavit of Absence of Financial Interest Conflict (FOR-OGITT-063) (PER-34 - Spanish) (Edition No. 01) (September 24, 2019)
National Institute of Health, Ministry of Health
(3) (Form) Application for Approval of Clinical Trial Amendments (FOR-OGITT-044) (PER-33 - Spanish) (Edition No. 02) (September 24, 2019)
National Institute of Health, Ministry of Health
(4) (Form) Application for Clinical Trial Authorization (FOR-OGITT-028 (PER-24 - Spanish) (Edition No. 02) (September 24, 2019)
National Institute of Health, Ministry of Health
(5) (Form) Application for Clinical Trial Title Change (FOR-OGITT-043) (PER-32 - Spanish) (Edition No. 02) (September 24, 2019)
National Institute of Health, Ministry of Health
(6) (Form) Application for Contract Research Organization Registration (FOR-OGITT-021) (PER-37 - Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
(7) (Form) Application for Sponsor Registration (FOR-OGITT-020) (PER-36 - Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
(8) (Form) List of Products and Supplies to be Used in the Clinical Trial (FOR-OGITT-033) (PER-42 - Spanish) (Edition No. 02) (April 9, 2018)
National Institute of Health, Ministry of Health
(9) (Webpage) General Directorate of Medicines, Supplies and Drugs (DIGEMID) (PER-56 - Spanish) (Current as of November 19, 2020)
Ministry of Health
(10) (Webpage) INS - Contact Us (PER-63 - Spanish) (Current as of November 19, 2020)
National Institute of Health, Ministry of Health
(11) (Webpage) National Registry of Accredited Institutional Ethics Committees (PER-61 - Spanish) (Current as of November 19, 2020)
REPEC, National Institute of Health, Ministry of Health
(12) (Webpage) Peruvian Clinical Trials Registry (REPEC) (PER-58 - Spanish) (English) (Current as of November 19, 2020)
REPEC, National Institute of Health, Ministry of Health
(13) (Webpage) Registration of a Clinical Trial - Authorization (PER-71 - Spanish) (Current as of November 19, 2020)
REPEC, National Institute of Health, Ministry of Health
(14) (Webpage) Registration of a Sponsor (PER-60 - Spanish) (Current as of November 19, 2020)
REPEC, National Institute of Health, Ministry of Health
(15) (Webpage) Registration of Contract Research Organization (CRO) (PER-59 - Spanish) (Current as of November 19, 2020)
REPEC, National Institute of Health, Ministry of Health
Clinical Trial Lifecycle > Submission Content
Last content review/update: November 19, 2020
Requirements
(1) (Regulation) Ministerial Resolution No. 233-2020 – Ethical Considerations for Health Research with Human Beings (ResolutionNo233-2020 - Spanish) (April 28, 2020)
Ministry of Health
Relevant Sections: VIII (8.4)
(2) (Regulation) Directoral Resolution 0423-2019/OGITT/INS – Provides for the Amendment of Administrative Procedure Requirements Specified in the Supreme Decree No. 021-2017-SA by the National Institute of Health (INS) for the Authorization of Clinical Trials (ResolutionNo0423-2019 - Spanish) (September 24, 2019)
National Institute of Health, Ministry of Health
Relevant Sections: Preamble, Article 1, and Annexes (2-3)
(3) (Regulation) Ministerial Resolution No. 655-2019/MINSA – Provides for the Elimination of Administrative Procedure Requirements Specified in the Supreme Decree No. 021-2017-SA by the National Institute of Health (INS) (ResolutionNo655-2019 - Spanish) (July 27, 2019)
Ministry of Health
Relevant Sections: Annexes A and B
(4) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo021-2017 - Spanish) (GoogleTranslate-DecreeNo021-2017) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 40, 59, 63, 67, 71, Complementary Provisions Final, and Annexes 1-5
(5) (Guidance) Guideline for the Procedure for Requesting Authorization of the Clinical Trial (G-CTApplicProc - Spanish) (Edition No. 02) (November 15, 2019)
National Institute of Health, Ministry of Health
Relevant Sections: 4 and 6
(6) (Guidance) Procedures Manual of Clinical Trials (MAN-INS-001) (INS-CTManual - Spanish) (3rd Edition) (November 17, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Chapter VII (7.1, 7.2, and 7.5), Flow Charts No. 01 and 04, and Annexes 1 and 3
Summary

Overview

As set forth in DecreeNo021-2017, the INS-CTManual, and the G-CTApplicProc, Peru’s National Institute of Health (Instituto Nacional de Salud (INS)) requires the sponsor or his/her contract research organization (CRO) to apply for clinical trial authorization, and the principal investigator (PI) to apply for approval from an INS-accredited ethics committee (EC) to conduct a clinical trial. Please refer to PER-71 and PER-61 for detailed information on clinical trial authorization and EC accreditation. See also the INS-CTManual, the G-CTApplicProc, PER-60, and PER-59 for sponsor and CRO registration instructions, and PER-36 and PER-37 for sponsor and CRO registration forms.

INS Requirements

As specified in DecreeNo021-2017, ResolutionNo655-2019 (which modifies DecreeNo021-2017), the INS-CTManual, the G-CTApplicProc, and PER-71, a clinical trial application submission must include the following documents:

  • Application for clinical trial authorization and proof of payment (PER-24)
  • Approval(s) issued by legal representative of institution(s) where research will be conducted
  • EC approval of the research protocol and informed consent form (ICF)
  • Research protocol in Spanish, and in the original language if different from Spanish, submitted in electronic form as an editable PDF (see Annex 1 in DecreeNo021-2017)
  • ICF in electronic form as an editable PDF (see Annex 4 in DecreeNo021-2017)
  • Updated Investigator’s Brochure (IB) in Spanish, and in the original language if different from Spanish, submitted in electronic form as an editable PDF (See Annex 2 in DecreeNo021-2017)
  • Affidavit stating no conflict of financial interest signed by the sponsor or his/her CRO and the PI (see PER-34)
  • Affidavit signed by the PI and sponsor on preparation of research institution for trial (see PER-35)
  • In the case of foreign sponsor: copy of proof of delegation of functions to the sponsor representative, duly authenticated by Peru’s Ministry of Foreign Affairs
  • Affidavit on compensation for participants signed by the sponsor or his/her CRO and PI (covers budget and expenses for any trial-related injuries) (PER-51)
  • Copy of current insurance policy purchased by the sponsor
  • List of clinical trial supplies
  • Information related to the investigational product (IP) quality (electronic form) (see Annex 5 in DecreeNo021-2017)
  • Updated curriculum vitaes (CVs) of all research team members with attached copies
  • Copy of documents demonstrating training in Good Clinical Practices and Research Ethics in human beings for the entire research team within the past three (3) years (PER-50)
  • Detailed national budget total for trial
  • Copy of current record of authorized research institution(s) for clinical trials
  • Payment receipt for research site registration; in the case of multicenter trials, receipts must be provided to demonstrate each research site has made separate payments

Refer to DecreeNo021-2017, the INS-CTManual, the G-CTApplicProc, and PER-71 for detailed submission information; PER-24 for the recently amended clinical trial application form per ResolutionNo0423-2019; and PER-10 for detailed instructions on completing the form. (Note: the regulations provide overlapping and unique elements so each of the items listed below will not necessarily be in each source.)

See also the Submission Process subtopic for additional submission requirements.

Institutional EC Requirements

According to ResolutionNo233-2020 and PER-77, institutional EC requirements for protocol evaluation are based on their internal regulations and standard operating procedures. However, PER-77 further notes that ECs generally require PIs to submit the following documentation for ethics approval:

  • Letter from the PI to the EC Chairman
  • Basic Format Application
  • Research protocol
  • ICF
  • PI and co-investigator(s) CV(s)
  • Declaration of the PI and research center director/research institution head
  • Declaration of financial details and potential conflicts of interest of the PI
  • Sponsor’s insurance policy
  • PI’s training in good clinical research ethics

Clinical Protocol

As delineated in DecreeNo021-2017, the clinical protocol should contain the following elements:

  • General information
  • Protocol summary
  • Background and justification (including IP description) (See Investigational Products topic for detailed coverage of this subject)
  • Objectives, valuation criteria or specific results and hypotheses
  • Test design
  • Participant selection/withdrawal
  • Participant treatment
  • Study evaluation and procedures
  • Adverse events (See Clinical Trial Lifecycle topic, Safety Reporting subtopic for additional information)
  • Statistical considerations
  • Data collection and monitoring
  • Data management and record maintenance
  • Ethical aspects
  • Publications results
  • Bibliography
  • Appendices

For complete protocol requirements, refer to Annex 1 of DecreeNo021-2017.

Additional Resources
(1) (Document) Instructions for Filling Out Form FOR-OGITT-028 Edition No. 03 – Request for Clinical Trial Authorization (PER-10 - Spanish) (Edition No. 03) (May 8, 2019)
National Institute of Health, Ministry of Health
(2) (Form) Affidavit of Absence of Financial Interest Conflict (FOR-OGITT-063) (PER-34 - Spanish) (Edition No. 01) (September 24, 2019)
National Institute of Health, Ministry of Health
(3) (Form) Affidavit of Compliance with the Responsibilities and Obligations Set Out in the REC and Availability of a Financial Fund – Sponsor (FOR-OGITT-029) (PER-51 - Spanish) (Edition No. 03) (September 24, 2019)
National Institute of Health, Ministry of Health
(4) (Form) Affidavit of Research Center Preparedness for Clinical Trial (FOR-OGITT-064) (PER-35 - Spanish) (Edition No. 01) (September 24, 2019)
National Institute of Health, Ministry of Health
(5) (Form) Application for Clinical Trial Authorization (FOR-OGITT-028 (PER-24 - Spanish) (Edition No. 02) (September 24, 2019)
National Institute of Health, Ministry of Health
(6) (Form) Application for Contract Research Organization Registration (FOR-OGITT-021) (PER-37 - Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
(7) (Form) Application for Sponsor Registration (FOR-OGITT-020) (PER-36 - Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
(8) (Form) Curriculum Vitae of the Research Team (FOR-OGITT-031) (PER-50 - Spanish) (Edition No. 02) (September 24, 2019)
National Institute of Health, Ministry of Health
(9) (Form) Detailed Total National Budget of the Clinical Trial (FOR-OGITT-032) (PER-25 - Spanish) (Edition No. 02) (September 24, 2019)
National Institute of Health, Ministry of Health
(10) (Not Available Online) NIAID Communication with Peru’s National Institute of Health (January 2020) (PER-77)
(11) (Webpage) National Registry of Accredited Institutional Ethics Committees (PER-61 - Spanish) (Current as of November 19, 2020)
REPEC, National Institute of Health, Ministry of Health
(12) (Webpage) Registration of a Clinical Trial - Authorization (PER-71 - Spanish) (Current as of November 19, 2020)
REPEC, National Institute of Health, Ministry of Health
(13) (Webpage) Registration of a Sponsor (PER-60 - Spanish) (Current as of November 19, 2020)
REPEC, National Institute of Health, Ministry of Health
(14) (Webpage) Registration of Contract Research Organization (CRO) (PER-59 - Spanish) (Current as of November 19, 2020)
REPEC, National Institute of Health, Ministry of Health
Clinical Trial Lifecycle > Timeline of Review
Last content review/update: November 19, 2020
Requirements
(1) (Legislation) Law No. 27444 – Law of the General Administrative Procedure (LawNo27444 - Spanish) (Effective April 10, 2001)
Congress of the Republic
Relevant Sections: Article 35
(2) (Regulation) Directoral Resolution 0423-2019/OGITT/INS – Provides for the Amendment of Administrative Procedure Requirements Specified in the Supreme Decree No. 021-2017-SA by the National Institute of Health (INS) for the Authorization of Clinical Trials (ResolutionNo0423-2019 - Spanish) (September 24, 2019)
National Institute of Health, Ministry of Health
Relevant Sections: Preamble, Article 1, and Annexes (3, 5, 8, and 11-12)
(3) (Regulation) Ministerial Resolution No. 655-2019/MINSA – Provides for the Elimination of Administrative Procedure Requirements Specified in the Supreme Decree No. 021-2017-SA by the National Institute of Health (INS) (ResolutionNo655-2019 - Spanish) (July 27, 2019)
Ministry of Health
Relevant Sections: Annexes A and B
(4) (Regulation) Supreme Decree 004-2019-JUS – Approving the Single Text Ordered of Law No. 27444 - Law of General Administrative Procedure (DecreeNo004-2019 - Spanish) (Effective July 24, 2019)
Ministry of Labor and Employment Promotion
Relevant Sections: Article 39
(5) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo021-2017 - Spanish) (GoogleTranslate-DecreeNo021-2017) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 8, 40, 59, 63, 69, 70, 71, 80, and Complementary Provisions Final
(6) (Guidance) Guide of General Guidelines for the Submission of Procedures Related to the Regulation of Clinical Trials (G-CTSubmissionProcs - Spanish) (Edition No. 01) (November 28, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: 5
(7) (Guidance) Guideline for the Procedure for Requesting Authorization of the Clinical Trial (G-CTApplicProc - Spanish) (Edition No. 02) (November 15, 2019)
National Institute of Health, Ministry of Health
Relevant Sections: 5 and 6
(8) (Guidance) Procedures Manual of Clinical Trials (MAN-INS-001) (INS-CTManual - Spanish) (3rd Edition) (November 17, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Chapter VI (6.4), VII (7.1, 7.2, and 7.5), Flow Charts No. 01 and 04, and Annexes 1 and 3
Summary

Overview

Based on DecreeNo021-2017, the INS-CTManual, and the G-CTApplicProc, the National Institute of Health (Instituto Nacional de Salud (INS))’s review and approval of an application to conduct a clinical trial is dependent upon obtaining ethics committee (EC) approval from an INS-accredited EC. Therefore, the INS and EC reviews may not be conducted in parallel.

INS Approval

Clinical Trial Application Submission

As per LawNo27444, and DecreeNo004-2019 which modifies LawNo27444, the INS is required to complete its review and approval of a clinical trial application in a maximum of 30 working days (including the 30 days for the National Authority for Pharmaceutical Products, Medical Devices and Medical Products (la Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (ANM)) review). (Note: The ANM is also referred to as the General Directorate of Medicines, Supplies and Drugs (La Dirección General de Medicamentos Insumos y Drogas (DIGEMID))).

In addition, per DecreeNo021-2017 and the INS-CTManual, if the clinical trial is related to an IP for the prevention, diagnosis, or treatment of tuberculosis or HIV/AIDS infection, the specific technical opinion of General Directorate of Strategic Public Health Interventions will be requested to ensure the study does not interfere with its strategic interventions regarding these diseases.

For specific information on pre-submission registration requirements, see Clinical Trial Lifecycle topic, Submission Process subtopic.

DecreeNo021-2017 and the INS-CTManual state that the INS, through the General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnológica (OGITT)), grants clinical trial authorization for the total period of time scheduled for its completion, which is recorded as “Total duration of the trial” as indicated in the recently amended Application for Clinical Trial Authorization (PER-24) per ResolutionNo0423-2019.

In addition, per the G-CTSubmissionProcs, if any corrections to a clinical trial application submission are required by the OGITT’s Office of Documentary Processing, the applicant will have two (2) business days to amend the application, and this time will not be counted towards the period allotted for the OGITT’s review. If the two (2) day timeframe is exceeded, the application will be discarded, and another application must be submitted to initiate the process again.

In addition, as indicated in DecreeNo021-2017, the clinical trial authorization will be valid for a maximum of 12 months from the date of its issuance. This period of validity is valid for all research centers, regardless of the authorization date of its operation. The clinical trial authorization is granted by the total period of time scheduled for execution, which was registered in the authorization request.

DecreeNo021-2017, ResolutionNo655-2019 (which modifies DecreeNo021-2017), PER-72, and PER-27 also provide information on how the sponsor or his/her CRO should request a trial extension. The following documents must be submitted within 30 calendar days prior to the trial’s expiration:

  • Application for extension of time to conduct the clinical trial, explaining the reasons for such request and stating the number and date of the proof of payment of processing fees (using the REPEC e-form (PER-27)) per PER-72
  • Copy of the document approving the time extension granted by the legal representative of the research institution(s) where the trial will be conducted
  • Copy of the document containing the time extension approval by an INS-accredited EC

The authorized trial extension will be valid for a maximum of 12 months from the date of issue.

As indicated in DecreeNo021-2017 and the G-CTApplicProc, the Investigator’s Brochure (IB) and the protocol are also simultaneously forwarded to the ANM in order to obtain a safety evaluation of the IP. DecreeNo021-2017 states that the ANM must provide a technical opinion within 30 days.

Ethics Committee Approval

The EC review and approval process timeline will vary by institution.

Additional Resources
(1) (Document) Instructions for Filling Out Form FOR-OGITT-028 Edition No. 03 – Request for Clinical Trial Authorization (PER-10 - Spanish) (Edition No. 03) (May 8, 2019)
National Institute of Health, Ministry of Health
(2) (Form) Application for Approval of Clinical Trial Amendments (FOR-OGITT-044) (PER-33 - Spanish) (Edition No. 02) (September 24, 2019)
National Institute of Health, Ministry of Health
(3) (Form) Application for Clinical Trial Authorization (FOR-OGITT-028 (PER-24 - Spanish) (Edition No. 02) (September 24, 2019)
National Institute of Health, Ministry of Health
(4) (Form) Application for Clinical Trial Title Change (FOR-OGITT-043) (PER-32 - Spanish) (Edition No. 02) (September 24, 2019)
National Institute of Health, Ministry of Health
(5) (Form) Application for Extension of the Clinical Trial (FOR-OGITT-037) (PER-27 - Spanish) (Edition No. 02) (September 24, 2019)
National Institute of Health, Ministry of Health
(6) (Form) Application for Research Center Closure for a Clinical Trial (FOR-OGITT-040) (PER-43 - Spanish) (Edition No. 02) (September 24, 2019)
National Institute of Health, Ministry of Health
(7) (Webpage) Organization of the Ministry of Health (PER-67 - Spanish) (Last Updated December 20, 2019)
Ministry of Health
Relevant Sections: Bodies of the Vice Ministerial Office of Public Health - General Directorate of Strategic Public Health Interventions
(8) (Webpage) List of Procedures (PER-72) (Spanish) (Current as of November 19, 2020)
REPEC, National Institute of Health, Ministry of Health
Relevant Sections: Clinical Trial Authorization and Extension for a Clinical Trial (English website); Clinical Trial Time Extension (Spanish website)
(9) (Webpage) Registration of a Clinical Trial - Authorization (PER-71 - Spanish) (Current as of November 19, 2020)
REPEC, National Institute of Health, Ministry of Health
Clinical Trial Lifecycle > Trial Initiation
Last content review/update: November 19, 2020
Requirements
(1) (Regulation) Ministerial Resolution No. 233-2020 – Ethical Considerations for Health Research with Human Beings (ResolutionNo233-2020 - Spanish) (April 28, 2020)
Ministry of Health
Relevant Sections: VIII (8.4)
(2) (Regulation) Ministerial Resolution No. 655-2019/MINSA – Provides for the Elimination of Administrative Procedure Requirements Specified in the Supreme Decree No. 021-2017-SA by the National Institute of Health (INS) (ResolutionNo655-2019 - Spanish) (July 27, 2019)
Ministry of Health
Relevant Sections: Annexes A and B
(3) (Regulation) Supreme Decree No. 016-2011-SA: Regulatory Approval for the Registration, Control and Sanitary Surveillance of Pharmaceutical Products, Medical Devices and Health Products (DecreeNo016-2011 - Spanish) (July 27, 2011)
Ministry of Health
Relevant Sections: Title II (Chapter I and II) and Title III (Chapter I)
(4) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo021-2017 - Spanish) (GoogleTranslate-DecreeNo021-2017) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 2, 8, 40, 51, 52, 59, 63, 67, 70, 71, 94, Complementary Provisions Final, and Annexes 1-5
(5) (Guidance) Guidance for the Procedure for the Request for Authorization of the Amendment Report (G-AmdAuthRept - Spanish) (Edition No. 01) (April 29, 2019)
National Institute of Health, Ministry of Health
(6) (Guidance) Guide of General Guidelines for the Submission of Procedures Related to the Regulation of Clinical Trials (G-CTSubmissionProcs - Spanish) (Edition No. 01) (November 28, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: 1, 2, 4, and 5
(7) (Guidance) Guideline for the Procedure for Requesting Authorization of the Clinical Trial (G-CTApplicProc - Spanish) (Edition No. 02) (November 15, 2019)
National Institute of Health, Ministry of Health
Relevant Sections: 4 and 6
(8) (Guidance) Procedures Manual of Clinical Trials (MAN-INS-001) (INS-CTManual - Spanish) (3rd Edition) (November 17, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Chapter VI (6.4), VII (7.1, 7.2, 7.3, and 7.5), Flow Charts No. 01, 02, and 04, and Annexes 1 and 3
Summary

Overview

In accordance with DecreeNo021-2017, the INS-CTManual, and the G-CTApplicProc, a clinical trial can only commence after the sponsor or his/her contract research organization (CRO) receives authorization from Peru’s National Institute of Health (Instituto Nacional de Salud (INS)), which is dependent on ethics committee (EC) approval from an INS-accredited EC. Therefore, the INS and EC reviews may not be conducted in parallel. No waiting period is required following the applicant’s receipt of these approvals.

According to DecreeNo021-2017 and DecreeNo016-2011, the INS-CTManual, and the G-CTApplicProc, the sponsor or his/her CRO must obtain approval from the National Authority for Pharmaceutical Products, Medical Devices and Medical Products (la Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (ANM)) to manufacture or import investigational products (IPs) and to obtain an import license for the shipment of IPs to be used in the trial. (Note: The ANM is also referred to as the General Directorate of Medicines, Supplies and Drugs (La Dirección General de Medicamentos Insumos y Drogas (DIGEMID))). (See the Investigational Products topic, Manufacturing & Import subtopic for additional information).

As stated in the DecreeNo021-2017, all investigators must possess appropriate qualifications, training, and experience, and per ResolutionNo233-2020, must also have basic training in ethical research with human beings. Furthermore, per the INS-CTManual, the trials should be conducted in compliance with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (PER-53).

Clinical Trial Agreement

According to DecreeNo021-2017, the INS-CTManual, the G-CTApplicProc, and PER-71, the sponsor and principal investigator (PI) must sign an affidavit of compliance with the minimum requirements of the research center where the clinical trial will be executed (see PER-35). Further, per the G-CTApplicProc and PER-71, both the sponsor and the PI must sign an affidavit establishing that there is no conflict of financial interest in executing the trial (PER-34).

EC Confirmation of Review and Approval

DecreeNo021-2017, the INS-CTManual, and the G-CTApplicProc, mandate that the sponsor or his/her CRO obtain written confirmation of review and approval from an INS-accredited EC prior to submitting a clinical trial application for INS approval and before the trial commences. (See Ethics Committee topic, Scope of Review subtopic and Clinical Trial Lifecycle topic, Submission Content subtopic for additional details on the EC review process).

Peruvian Clinical Trials Registry

As per DecreeNo021-2017, the INS-CTManual, the G-CTApplicProc, the G-CTSubmissionProcs, and PER-71, the sponsor or his/her CRO must register the clinical trial application electronically using the INS’s Peruvian Clinical Trials Registry (Registro Peruano de Ensayos Clínicos (REPEC)), at which time, a registration code is assigned to the application.

For details on submitting protocol amendments and the related forms, refer to ResolutionNo655-2019 (which amends DecreeNo021-2017), the G-AmdAuthRept, and PER-33.

Per the INS-CTManual, the G-CTApplicProc, PER-60, and PER-59, the sponsor and his/her contract research organization (CRO) must also register with REPEC prior to submitting an application for clinical trial authorization.

Refer to the INS-CTManual, the G-CTApplicProc, and PER-71 for detailed submission instructions, PER-24 and PER-10 for the clinical trial application form and detailed instructions on completing the form. See also PER-60 and PER-59 for sponsor and CRO registration instructions, and PER-36 and PER-37 for the sponsor and CRO registration forms.

Data Safety Monitoring Board

DecreeNo021-2017 requires the sponsor to provide information on the Data Safety Monitoring Board (DSMB) including its composition, a summary of its role and notification procedure, a statement of independence from the sponsor and any conflicts of interest. Additionally, the sponsor should specify where to find other details about the by-laws not included in the protocol, or, explain why a DSMB is not necessary.

Additional Resources
(1) (Document) Communique No. 001-2018-OGITT/INS Notification of the Deviations to the Protocol of the Critical or Very Serious and Major or Serious Clinical Trial (PER-12 - Spanish) (March 13, 2018)
General Office of Research and of Health Technology Transfer, National Institute of Health, Ministry of Health
(2) (Document) Instructions for Filling Out Form FOR-OGITT-028 Edition No. 03 – Request for Clinical Trial Authorization (PER-10 - Spanish) (Edition No. 03) (May 8, 2019)
National Institute of Health, Ministry of Health
(3) (Document) Communique No. 001-2017-OGITT/INS - Notification of Deviations to the INS OGITT (PER-4 - Spanish) (July 19, 2017)
General Office of Research and of Health Technology Transfer, National Institute of Health, Ministry of Health
(4) (Form) Affidavit of Absence of Financial Interest Conflict (FOR-OGITT-063) (PER-34 - Spanish) (Edition No. 01) (September 24, 2019)
National Institute of Health, Ministry of Health
(5) (Form) Affidavit of Compliance with Minimum Research Center Requirements (FOR-OGITT-023) (PER-44 - Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
(6) (Form) Affidavit of Compliance with the Responsibilities and Obligations Set Out in the REC and Availability of a Financial Fund – Sponsor (FOR-OGITT-029) (PER-51 - Spanish) (Edition No. 03) (September 24, 2019)
National Institute of Health, Ministry of Health
(7) (Form) Affidavit of Research Center Preparedness for Clinical Trial (FOR-OGITT-064) (PER-35 - Spanish) (Edition No. 01) (September 24, 2019)
National Institute of Health, Ministry of Health
(8) (Form) Application for Approval of Clinical Trial Amendments (FOR-OGITT-044) (PER-33 - Spanish) (Edition No. 02) (September 24, 2019)
National Institute of Health, Ministry of Health
(9) (Form) Application for Clinical Trial Authorization (FOR-OGITT-028 (PER-24 - Spanish) (Edition No. 02) (September 24, 2019)
National Institute of Health, Ministry of Health
(10) (Form) Application for Contract Research Organization Registration (FOR-OGITT-021) (PER-37 - Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
(11) (Form) Application for Sponsor Registration (FOR-OGITT-020) (PER-36 - Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
(12) (Form) Notification of Deviations to the Protocol (FOR-OGITT-053) (PER-40 - Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
(13) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (PER-53) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 4
(14) (Webpage) General Directorate of Medicines, Supplies and Drugs (DIGEMID) (PER-56 - Spanish) (Current as of November 19, 2020)
Ministry of Health
(15) (Webpage) National Registry of Accredited Institutional Ethics Committees (PER-61 - Spanish) (Current as of November 19, 2020)
REPEC, National Institute of Health, Ministry of Health
(16) (Webpage) Registration of a Clinical Trial - Authorization (PER-71 - Spanish) (Current as of November 19, 2020)
REPEC, National Institute of Health, Ministry of Health
(17) (Webpage) Registration of a Sponsor (PER-60 - Spanish) (Current as of November 19, 2020)
REPEC, National Institute of Health, Ministry of Health
(18) (Webpage) Registration of Contract Research Organization (CRO) (PER-59 - Spanish) (Current as of November 19, 2020)
REPEC, National Institute of Health, Ministry of Health
Clinical Trial Lifecycle > Safety Reporting
Last content review/update: November 19, 2020
Requirements
(1) (Regulation) Ministerial Resolution No. 233-2020 – Ethical Considerations for Health Research with Human Beings (ResolutionNo233-2020 - Spanish) (April 28, 2020)
Ministry of Health
Relevant Sections: VIII (8.4)
(2) (Regulation) Corrections - Supreme Decree No. 021-2017-SA – Clinical Trials Regulation (DecreeNo021-2017-Corrections - Spanish) (Effective July 12, 2017)
National Institute of Health, Ministry of Health
(3) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo021-2017 - Spanish) (GoogleTranslate-DecreeNo021-2017) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Article 2, 40, 52, and 108-111
(4) (Guidance) External User’s Guide for Safety Reporting in Clinical Trials (G-SafetyRpting - Spanish) (Edition No. 01) (March 22, 2019)
General Office of Research and of Health Technology Transfer, National Institute of Health, Ministry of Health
Relevant Sections: V-VII
(5) (Guidance) Procedures Manual of Clinical Trials (MAN-INS-001) (INS-CTManual - Spanish) (3rd Edition) (November 17, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Chapter VI (6.4), VII (7.8.1-7.8.3), and Flow Charts No. 12, 13, and 14
Summary

Overview

According to DecreeNo021-2017, DecreeNo021-2017-Corrections, and the G-SafetyRpting, the following definitions provide a basis for a common understanding of Peru’s safety reporting requirements:

  • Adverse Event (or Adverse Experience) (AE) – Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product
  • Adverse Drug Reaction (ADR) – Any noxious and unintended response in a participant to an investigational medicinal product which is related to any dose administered to that participant
  • Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (SADR) – Any AE/ADR that results in death, is life threatening, requires or extends hospitalization, results in persistent or significant disability/incapacity, or causes a congenital anomaly/birth defect
  • Unexpected Adverse Drug Reaction – An adverse reaction where the nature or severity is inconsistent with the applicable product information
  • Suspected Unexpected and Serious Adverse Reaction (SUSAR) – Any serious AE/ADR in which there is at least a reasonable possibility of a causal relationship with the investigational product (IP) and the nature and severity of the event/reaction is not described in the investigator’s brochure and/or the fact sheet technique

Reporting Requirements for AEs/ADRs

Investigator Responsibilities

According to DecreeNo021-2017, the INS-CTManual, and the G-SafetyRpting, the principal investigator (PI) and the sponsor or his/her contract research organization (CRO) are responsible for monitoring the safety of the IP. As specified in DecreeNo021-2017 and the G-SafetyRpting, the PI is also responsible for notifying the sponsor or his/her CRO or the ethics committee (EC) of any SAEs/SADRs and SUSARs within a period not exceeding one (1) calendar day from the date the event occurs, or, the PI becomes aware of the incident.

ResolutionNo233-2020 also indicates that investigators should report immediately to the EC and the corresponding authorities any AE or unanticipated risk to research participants related to the research. Furthermore, in cases where protocol or informed consent process changes are necessary to prevent harm to the participants, the investigators must submit report deviations within 24 hours.

DecreeNo021-2017 notes that the PI must also follow up with a detailed written report. Per the G-SafetyRpting, the PI must record the SAEs/SADRs and notify the sponsor according to the procedure described in the study protocol.

Furthermore, per DecreeNo021-2017, the PI must inform the sponsor or his/her CRO and the EC of the following:

  • Any SAE/SADR that has occurred to a participant following the trial’s completion
  • Any non-serious AEs/ADRs identified as determinants of safety assessments in the protocol within the periods specified

In addition, the G-SafetyRpting states that if the PI becomes aware of SAEs/SADRs occurring after the end of the trial, he/she should notify the sponsor or his/her CRO and the EC.

Lastly, per DecreeNo021-2017, the PI must provide the sponsor or his/her CRO, the EC, and the General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnológica (OGITT)) within Peru’s National Institute of Health (Instituto Nacional de Salud (INS)) with any additional safety information requested.

Sponsor Responsibilities

According to DecreeNo021-2017, the INS-CTManual, the G-SafetyRpting, and PER-72, the sponsor or his/her CRO should report IP-related AEs/ADRs, SAEs/SADRs, and SUSARs and provide these reports to the INS’s OGITT.

Per DecreeNo021-2017, DecreeNo021-2017-Corrections, the INS-CTManual, PER-72, PER-66, and PER-38, the sponsor or his/her CRO and the PI are required to submit all expected and unexpected SAEs/SADRs (related or not per PER-72) and SUSAR reports electronically through the Serious Adverse Events Virtual Reporting System (Sistema de Reporte de Eventos Adversos Serios (REAS-NET)) (PER-69) to the OGITT within seven (7) calendar days from the occurrence of the incident, or, as soon as the sponsor is aware of the incident. The G-SafetyRpting specifies that the sponsor or his/her CRO is responsible for evaluating, categorizing, and reporting all SAEs/SADRs and SUSARs that occur within the country through REAS-NET. The notification should be completed using the online form, FOR-OGITT-046 (PER-38).

Per the INS-CTManual, the electronic form (PER-38) submitted via REAS-NET should be printed and signed by the sponsor or his/her CRO. The INS-CTManual and the G-SafetyRpting state that the submitted information above must be updated with any additional relevant information in a follow-up tracking report within eight (8) calendar days. The G-SafetyRpting also notes that if the causality assessment of the SAE conducted by the investigator differs from the causality assessment made by the sponsor, the investigator’s assessment cannot be modified. The INS-CTManual further states that both the follow-up report and the final report completed in REAS-NET should be submitted electronically and in print formats to the OGITT.

In addition, per DecreeNo021-2017, DecreeNo021-2017-Corrections, and PER-72, the sponsor or his/her CRO must notify the OGITT, the ECs, and the PIs within a maximum period of seven (7) calendar days of any findings that could adversely affect the safety of research participants, have an impact on the conduct of the study, or alter the benefit/risk balance. This report should be prepared independently and separately from other required AE/ADR submission deadlines outlined in this subtopic.

The G-SafetyRpting further explains that if the sponsor or his/her CRO is aware of safety findings that are not covered within the scope of an SAE/SADR or SUSAR, these findings require another measure or action such as a security emergency measure, an amendment to the protocol or informed consent, or the suspension or cancellation of the clinical trial. The sponsor should communicate this information to the OGITT through a detailed report that includes the measures and actions taken at the local and international levels, if already established. The ECs and PI should also be notified within seven (7) calendar days. The information must be written in Spanish and English, be contained in an electronic medium (CD), and be presented in the document processing area of the OGITT. The sponsor is subsequently required to initiate administrative procedures that correspond to the measure or action taken, and in accordance with the requirements established by the clinical trial regulations. Refer to the G-SafetyRpting for examples of administrative procedures.

As delineated in DecreeNo021-2017, the G-SafetyRpting, and PER-72, the sponsor is also required to submit, electronically on a quarterly or semi-annual basis, SAE/SADR and SUSAR reports occurring internationally, to the OGITT and the Council for International Organizations of Medical Sciences (CIOMS) whether they have occurred in the authorized trial, in other trials with the same IP, or in a context of different use. The G-SafetyRpting specifies that the information should be presented on magnetic media. Refer to Annex 1 in the G-SafetyRpting for data requirements. PER-72 further indicates that the sponsor should send the SUSAR reports for events that have occurred abroad as soon as possible to the investigator using CIOMS Form I (PER-18). The investigator, in turn, will send the reports to the EC. The INS-CTManual also notes that the sponsor or his/her CRO should submit a printed copy of the CIOMS report in Spanish or English. (See the Investigational Products topic for additional information on IPs.)

Further, per DecreeNo021-2017, the OGITT must notify the National Authority for Pharmaceutical Products, Medical Devices and Medical Products (la Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (ANM)) of any SAEs/SADRs and SUSARs caused by an IP being used in an authorized trial in Peru within a maximum period of 15 working days after receiving notification about the incident. The INS-CTManual also indicates authorized ANM personnel will have access to SAEs/SADRs and SUSARs that have occurred in Peru via REAS-NET. (Note: The ANM is also referred to as the General Directorate of Medicines, Supplies and Drugs (La Dirección General de Medicamentos Insumos y Drogas (DIGEMID))).

According to the INS-CTManual and the G-SafetyRpting, in cases of prenatal exposure due to a pregnant woman’s participation in a clinical trial, the PI, the sponsor or his/her CRO is required to submit an electronic form available in REAS-NET to notify the OGITT of the SAE/SADR or SUSAR. (Refer to PER-39 for the form (FOR-OGITT-047)). Per the G-SafetyRpting, the sponsor submits the form and the procedures for monitoring and controlling the pregnancy and newborn on magnetic media. The notification of a pregnancy must be made within seven (7) calendar days. The INS-CTManual also indicates prenatal monitoring reports must also be prepared during pregnancy, childbirth, and for six (6) months postpartum following the occurrence. See the Informed Consent topic, Pregnant Women, Fetuses & Neonates subtopic for additional information on this vulnerable population.

As delineated in the INS-CTManual and the G-SafetyRpting, the sponsor or his/her CRO must also submit an annual IP safety report (DSUR) to the OGITT. Per the INS-CTManual, the translation of the annual report summary must be presented in English and Spanish. The G-SafetyRpting explains that the DSUR should be prepared after the first authorization of the clinical trial in any country. This is referred to as the Development International Birth Day (DIBD). The report should comply with the ICH Harmonised Tripartite Guideline: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (E2A) (PER-52). The sponsor must complete the online form (FOR-OGITT-048) (see PER-45) in Spanish as well as submit a copy of the DSUR to the OGITT on CD.

In addition, per the G-SafetyRpting, the sponsor or his/her CRO must describe in the protocol the SAEs that will not be reported promptly because they are expected to occur in the study population with a frequency independent from their exposure to the IP. The sponsor or his/her CRO is also required to describe in the protocol the procedures for monitoring SAEs produced by the IP. Moreover, depending on the trial design, the pathology, and the IP, the sponsor or his/her CRO will describe in the protocol the notification procedures for non-serious AEs.

Pursuant to the G-SafetyRpting, to report post-study AEs, the sponsor or his/her CRO should send an email to consultaensayos@ins.gob.be to coordinate with the person in charge of computer systems and grant him/her access to REAS-NET to complete and submit the online form (FOR-OGITT-046) (PER-38). SAEs/SADR notifications following a trial’s completion should remain in the research center archives.

See DecreeNo021-2017, the INS-CTManual, the G-SafetyRpting, PER-66, and PER-38 for detailed sponsor/CRO reporting requirements.

Form Completion & Delivery Requirements

As per DecreeNo021-2017, the INS-CTManual, the G-SafetyRpting, and PER-72, all AEs/ADRs, SAEs/SADRs, and SUSARs must be reported electronically by the sponsor or his/her CRO using REAS-NET. Refer to PER-38 for the OGITT SAE/SADR form, FOR-OGITT-046. All SAEs/SADRs and SUSARs must also be reported on the CIOMS Form I (PER-18).

Data Safety Monitoring Board

DecreeNo021-2017 requires the sponsor to provide information on the Data Safety Monitoring Board (DSMB) including its composition, a summary of its role and notification procedure, a statement of independence from the sponsor and any conflicts of interest. Additionally, the sponsor should specify where to find other details about the by-laws not included in the protocol, or, explain why a DSMB is not necessary.

Additional Resources
(1) (Document) Communique No. 003-2019-OGITT/INS – Publication of Documents Related to Adverse Events and Inspections of Clinical Trials (PER-6 - Spanish) (May 24, 2019)
General Office of Research and of Health Technology Transfer, National Institute of Health, Ministry of Health
(2) (Form) Application for Clinical Trial Cancellation (FOR-OGITT-042) (PER-31 - Spanish) (Edition No. 02) (September 24, 2019)
National Institute of Health, Ministry of Health
(3) (Form) CIOMS Form I (PER-18) (Date Unavailable)
Council for International Organizations of Medical Sciences
(4) (Form) Notification of Pregnant Woman and Newborn in Clinical Trials (FOR-OGITT-047) (PER-39 - Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
(5) (Form) Serious Adverse Event Report (FOR-OGITT-046) (PER-38 - Spanish) (Edition No. 02) (June 4, 2018)
National Institute of Health, Ministry of Health
(6) (Form) Summary of the Annual Security Report of the Research Product (FOR-OGITT-048) (PER-45 - Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
(7) (International Guidance) ICH Harmonised Tripartite Guideline: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (E2A) (PER-52) (Step 4) (October 27, 1994)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
(8) (Webpage) List of Procedures (PER-72) (Spanish) (Current as of November 19, 2020)
REPEC, National Institute of Health, Ministry of Health
Relevant Sections: Serious Adverse Events Report
(9) (Webpage) Serious Adverse Event Reporting - REAS NET (PER-66 - Spanish) (Current as of November 19, 2020)
National Institute of Health, Ministry of Health
(10) (Webpage) Serious Adverse Events Virtual Reporting System (REAS-NET) (PER-69 - Spanish) (Current as of November 19, 2020)
National Institute of Health, Ministry of Health
Clinical Trial Lifecycle > Progress Reporting
Last content review/update: November 19, 2020
Requirements
(1) (Regulation) Ministerial Resolution No. 233-2020 – Ethical Considerations for Health Research with Human Beings (ResolutionNo233-2020 - Spanish) (April 28, 2020)
Ministry of Health
Relevant Sections: VIII (8.4)
(2) (Regulation) Corrections - Supreme Decree No. 021-2017-SA – Clinical Trials Regulation (DecreeNo021-2017-Corrections - Spanish) (Effective July 12, 2017)
National Institute of Health, Ministry of Health
(3) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo021-2017 - Spanish) (GoogleTranslate-DecreeNo021-2017) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 2, 40, 52, and 104-107
(4) (Guidance) Procedures Manual of Clinical Trials (MAN-INS-001) (INS-CTManual - Spanish) (3rd Edition) (November 17, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Chapter VII (7.13.3-7.13.5) and Flow Charts No. 25, 30, 31, and 32
Summary

Overview

In accordance with DecreeNo021-2017, the INS-CTManual, and PER-72, the sponsor or his/her contract research organization (CRO) is responsible for submitting progress and final reports to the General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnológica (OGITT)) within Peru’s National Institute of Health (Instituto Nacional de Salud (INS)). As per DecreeNo021-2017, the principal investigator (PI) is responsible for submitting clinical trial progress and final reports to the research institution and the institutional ethics committee (EC) (El Comité Institucional de Ética en Investigación (CIEI)). ResolutionNo233-2020 further indicates that researchers should submit progress reports, final reports, suspension reports, and early termination reports, among others, per the terms established by the EC.

Interim/Progress Reports

As delineated in DecreeNo021-2017, the INS-CTManual, PER-72, PER-47, and PER-8, the sponsor or his/her CRO must submit a progress report for each institution in which a trial is conducted from the date of the study’s authorization to the INS’s OGITT. The report should be submitted quarterly or biannually to the INS’s Peruvian Clinical Trials Registry (Registro Peruano de Ensayos Clínicos (REPEC)) for each of the approved research centers. Per the INS-CTManual, this report should be submitted regardless of the enrollment status in each center. The INS-CTManual further specifies that the submission deadline is up to seven (7) calendar days after completing the quarterly or half-yearly period. The sponsor or his/her CRO should print and sign the electronic form and deliver it to the INS’s Office of Documentary Procedure within 20 working days. Refer to the INS-CTManual for additional information, and PER-47 and PER-8 for the progress report form and detailed submission instructions.

In addition, DecreeNo021-2017 and PER-72 state that the progress report must be sent in print and electronic media, and include the following information:

  • Number of patients enrolled in the study and status (e.g., in treatment, retired from study, completed study, or who are not ready to enroll) (DecreeNo021-2017)
  • Summary of serious adverse events/adverse drug reactions (SAEs/SADRs) and non-serious AEs/ADRs related to the investigational product (IP), and deviations occurring in the corresponding period (DecreeNo021-2017)
  • Number of patients who failed the screening (PER-72)
  • Number of patients with clinical failure (PER-72)
  • SAEs
  • Non-SAEs

According to PER-72, the following documentation should also be attached to the progress report:

  • Quarterly or half-yearly report of deviations/breaches to the protocol for every research site that occurred during the stated timeframe
  • Quarterly or half-yearly report of the serious and unexpected adverse reactions (SUSARs) related to the IP that have occurred abroad

Final Report

As delineated in DecreeNo021-2017, the INS-CTManual, PER-72, PER-48, and PER-16, the sponsor or his/her CRO must submit a research site final report to the REPEC for each of the participating centers for a specific clinical trial within 30 calendar days following the closing visit made by the monitor. Per the INS-CTManual, this information should be provided regardless of the enrollment status of each center. The INS-CTManual also notes that the electronic form should also be printed and signed by the sponsor or his/her CRO and delivered to the INS’s Office of Documentary Procedure within 20 working days. Refer to the INS-CTManual for additional information, and PER-48 and PER-16 for the final report form and detailed submission instructions.

DecreeNo021-2017 also states that the final report should include the following information:

  • Number of screened, enrolled, and retired patients who completed the trial
  • Summary of serious SAEs/SADRs and non-serious AEs/ADRs related to the IP, and deviations occurring since the date of the last progress report

Further, according to DecreeNo021-2017, the INS, in coordination with the sponsor, must submit a Results Publication after the final national or international report is completed to provide the results of authorized and performed clinical trials through REPEC using the form FOR-OGITT-058 (PER-23). The sponsor is also obligated to submit an article to a national or international scientific journal that strictly reflects the final report submitted to the OGITT using the form FOR-OGITT-059 (PER-41). The published article must also be sent to the INS and the research institution in print and electronic media.

National Final Report

Per DecreeNo021-2017, DecreeNo021-2017-Corrections, the INS-CTManual, and PER-72, national final reports should be submitted to REPEC for the INS’s OGITT review within 60 calendar days following the date of the final report submission of the last research center. Per the INS-CTManual and PER-72, the national final reports should be electronically submitted (refer to PER-49 and PER-17 for the submission form and instructions).

For clinical trials performed only in Peru, the report must be submitted within a maximum period of six (6) months following the trial’s conclusion as indicated in DecreeNo021-2017, DecreeNo021-2017-Corrections, the INS-CTManual, and PER-72. The OGITT will send a copy of the final national report of clinical trials to the National Authority for Pharmaceutical Products, Medical Devices and Medical Products (la Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (ANM)) within 30 business days following receipt of the report.

Per the INS-CTManual, the electronic form should also be printed and signed by the sponsor or his/her CRO and delivered to the INS’s Office of Documentary Procedure within seven (7) working days. If applicable, a report of the study results and conclusions must be attached as established in the INS-CTManual. Refer to the INS-CTManual for additional information, and PER-49 and PER-17 for the national final report form and detailed submission instructions.

DecreeNo021-2017 further explains that the national final report should include the following information:

  • Number of screened, enrolled, retired patients who completed the trial
  • Summary of serious SAEs/SADRs and non-serious AEs/ADRs related to the IP, and deviations that occurred
  • For trials performed only in Peru, the report should also include the final results and conclusions of the trial

International Final Report

As delineated in DecreeNo021-2017, the INS-CTManual, and PER-72, international final reports should be submitted to REPEC within 12 months following the completion of the last clinical trial in all international research centers. Per the INS-CTManual, the sponsor or his/her CRO should also print and sign the electronic form and deliver it to the INS’s Office of Documentary Procedure within 20 working days. In addition, a report of the study results and conclusions should be attached as established in the INS-CTManual. PER-72 also notes that the report should include the results and the study conclusions before publication. Refer to the INS-CTManual for additional information, and PER-46 and PER-9 for the international final report form and detailed submission instructions.

Additional Resources
(1) (Document) Communique No. 003-2018-OGITT/INS - Forms for Reporting Progress and Final Reports (PER-14 - Spanish) (May 7, 2018)
General Office of Research and of Health Technology Transfer, National Institute of Health, Ministry of Health
(2) (Document) Instructions for Filling Out Form FOR-OGITT-054 Edition No. 01 – Clinical Trial Progress Report (PER-8 - Spanish) (Edition No. 01) (Date Unavailable)
National Institute of Health, Ministry of Health
(3) (Document) Instructions for Filling Out Form FOR-OGITT-055 Edition No. 01 - Final Report of the Research Center (PER-16 - Spanish) (Edition No. 01) (Date Unavailable)
National Institute of Health, Ministry of Health
(4) (Document) Instructions for Filling Out Form FOR-OGITT-056 Edition No. 01 - Final National Report (PER-17 - Spanish) (Edition No. 01) (Date Unavailable)
National Institute of Health, Ministry of Health
(5) (Document) Instructions for Filling Out Form FOR-OGITT-057 Edition No. 01 – International Final Report (PER-9 - Spanish) (Edition No. 01) (Date Unavailable)
National Institute of Health, Ministry of Health
(6) (Form) Application for Clinical Trial Cancellation (FOR-OGITT-042) (PER-31 - Spanish) (Edition No. 02) (September 24, 2019)
National Institute of Health, Ministry of Health
(7) (Form) Application for Research Center Closure for a Clinical Trial (FOR-OGITT-040) (PER-43 - Spanish) (Edition No. 02) (September 24, 2019)
National Institute of Health, Ministry of Health
(8) (Form) Clinical Trial Progress Report (FOR-OGITT-054) (PER-47 - Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
(9) (Form) Final National Report (FOR-OGITT-056) (PER-49 - Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
(10) (Form) Final Report of the Research Center (FOR-OGITT-055) (PER-48 - Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
(11) (Form) International Final Report (FOR-OGITT-057) (PER-46 - Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
(12) (Form) Other Relevant Notifications (FOR-OGITT-059) (PER-41 - Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
(13) (Form) Report of Clinical Trial Results to be Published in REPEC (FOR-OGITT-058) (PER-23 - Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
(14) (Webpage) List of Procedures (PER-72) (Spanish) (Current as of November 19, 2020)
REPEC, National Institute of Health, Ministry of Health
Relevant Sections: Clinical Trial Progress Report and Final Reports
(15) (Webpage) Peruvian Clinical Trials Registry (REPEC) (PER-58 - Spanish) (English) (Current as of November 19, 2020)
REPEC, National Institute of Health, Ministry of Health
Sponsorship > Definition of Sponsor
Last content review/update: November 19, 2020
Requirements
(1) (Legislation) Law No. 29733 - Protection of Personal Data (LawNo29733 - Spanish) (Effective July 3, 2011)
Congress of the Republic
Relevant Sections: Article 2
(2) (Legislation) Legislative Decree No. 1353 – Creates the National Authority for Transparency and Access to Public Information, Strengthens the Personal Data Protection Regime and the Regulation of Interest Management (DecreeNo1353 - Spanish) (January 07, 2017) (Updated September 28, 2018)
Congress of the Republic
Relevant Sections: Article 2
(3) (Regulation) Supreme Decree No. 003-2013-JUS of March 21, 2013, Whereby the Regulation of Law No. 29733, Law on Protection of Personal Data is Approved (DecreeNo003-2013 - Spanish) (March 22, 2013)
Ministry of Justice and Human Rights
Relevant Sections: Article 2
(4) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo021-2017 - Spanish) (GoogleTranslate-DecreeNo021-2017) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 41 - 45
(5) (Guidance) Guideline for the Procedure for Requesting Authorization of the Clinical Trial (G-CTApplicProc - Spanish) (Edition No. 02) (November 15, 2019)
National Institute of Health, Ministry of Health
Relevant Sections: 6
Summary

Overview

DecreeNo021-2017 defines a sponsor as an individual, group of individuals, company, institution, or organization with legal representation in the country, and duly registered in the corresponding public registries. The sponsor takes ultimate responsibility for trial initiation, maintenance, conclusion, and financing. When an independent researcher initiates and takes full responsibility for a clinical trial, then he/she assumes the role of sponsor.

DecreeNo021-2017 and the G-CTApplicProc also state that sponsors not based in Peru are required to appoint a legal representative who channels all the communication with the General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnológica (OGITT)) within Peru’s National Institute of Health (Instituto Nacional de Salud (INS)) for the trial’s duration.

DecreeNo021-2017 also explains that a sponsor can authorize a contract research organization (CRO) with legal status and an office in Peru to carry out certain work and obligations regarding the trial. However, the sponsor is ultimately responsible for the execution of the research protocol and the results of the trial.

For the purposes of data protection requirements, LawNo29733 provides that the “person in charge of the personal data bank” is any natural person, private legal entity, or public entity that, alone or acting in conjunction with another, performs the processing of personal data on behalf of the owner of the personal data bank. DecreeNo1353 and DecreeNo003-2013 modify the definition provided by LawNo29733 by stating that the entity “responsible for processing personal data” is any natural person, private legal entity, or public entity that, alone or acting jointly with another, performs the processing of personal data on behalf of the owner of the personal data bank by virtue of a legal relationship that binds him to it and defines the scope of its performance.

Additional Resources
(1) (Article) Changes in the Law on Protection of Personal Data (DL 1353) (PER-2 - Spanish) (January 16, 2017)
GTDI
(2) (Article) Regulation of Law 29733 Approved: Law on Protection of Personal Data (PER-1 - Spanish) (March 22, 2013)
RPP News
(3) (Article) The Protection of Personal Data (Law No. 29733) (PER-3 - Spanish) (May 28, 2019)
Belling, Miguel Ampudia; Peruweek
Sponsorship > Trial Authorization
Last content review/update: November 19, 2020
Requirements
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo021-2017 - Spanish) (GoogleTranslate-DecreeNo021-2017) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 40 and 67
(2) (Guidance) Guide of General Guidelines for the Submission of Procedures Related to the Regulation of Clinical Trials (G-CTSubmissionProcs - Spanish) (Edition No. 01) (November 28, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: 1, 2, 4, 5, and Key Points
(3) (Guidance) Guideline for the Procedure for Requesting Authorization of the Clinical Trial (G-CTApplicProc - Spanish) (Edition No. 02) (November 15, 2019)
National Institute of Health, Ministry of Health
Relevant Sections: 6
(4) (Guidance) Procedures Manual of Clinical Trials (MAN-INS-001) (INS-CTManual - Spanish) (3rd Edition) (November 17, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Chapter VII (7.1, 7.2, 7.3, and 7.5), Flow Charts No. 01, 02, and 04, and Annexes 1 and 3
Summary

Overview

In accordance with DecreeNo021-2017, and the INS-CTManual, the sponsor or his/her contract research organization (CRO) is responsible for ensuring his/her principal investigators (PIs) obtain approval from a National Institute of Health (Instituto Nacional de Salud (INS))-accredited ethics committee (EC). The sponsor or his/her CRO must then submit the clinical trial application to the INS to obtain authorization to conduct a clinical trial. Per the INS-CTManual, the G-CTApplicProc, PER-60, and PER-59, the sponsor and his/her CRO must also register with the INS’s Peruvian Clinical Trials Registry (Registro Peruano de Ensayos Clínicos (REPEC)) prior to submitting an application for clinical trial authorization. See also PER-36 and PER-37 for the sponsor and CRO registration forms.

As delineated in the INS-CTManual, the G-CTApplicProc, the G-CTSubmissionProcs, and PER-71, to complete the clinical trial application package, the sponsor or his/her CRO must submit a request for clinical trial authorization electronically using REPEC, at which time, a registration code is assigned to the application. In addition, per the INS-CTManual and the G-CTApplicProc, the application should be submitted both electronically via REPEC and in print format. The INS-CTManual states that the sponsor or his/her CRO should print and sign the electronic application form and deliver it to the INS’s Office of Documentary Procedure within 20 working days. The G-CTSubmissionProcs further specify that all documents contained in the printed copy must be on A4 size bond paper, in a folder of A4 size with a wide spine to allow for unrestricted opening between the sections, organized using separators, and foliated in the upper right hand corner per the requirements delineated in DecreeNo021-2017. In addition to sending a printed copy of the completed application, the sponsor or his/her CRO must also provide the EC approval letter, clinical protocol, the Investigator’s Brochure (IB), the informed consent form (ICF), and other documentation covered in the Clinical Trial Lifecycle topic, Submission Content subtopic.

Additionally, DecreeNo021-2017 states that the sponsor must inform the INS’s General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnológica (OGITT)) when the first research participant is enrolled in Peru as well as the enrollment termination date in the country.

Additional Resources
(1) (Document) Instructions for Filling Out Form FOR-OGITT-028 Edition No. 03 – Request for Clinical Trial Authorization (PER-10 - Spanish) (Edition No. 03) (May 8, 2019)
National Institute of Health, Ministry of Health
(2) (Form) Application for Clinical Trial Authorization (FOR-OGITT-028 (PER-24 - Spanish) (Edition No. 02) (September 24, 2019)
National Institute of Health, Ministry of Health
(3) (Form) Application for Contract Research Organization Registration (FOR-OGITT-021) (PER-37 - Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
(4) (Form) Application for Sponsor or CRO Change (FOR-OGITT-039) (PER-29 - Spanish) (Edition No. 02) (September 24, 2019)
National Institute of Health, Ministry of Health
(5) (Form) Application for Sponsor Registration (FOR-OGITT-020) (PER-36 - Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
(6) (Webpage) Peruvian Clinical Trials Registry (REPEC) (PER-58 - Spanish) (English) (Current as of November 19, 2020)
REPEC, National Institute of Health, Ministry of Health
(7) (Webpage) Registration of a Clinical Trial - Authorization (PER-71 - Spanish) (Current as of November 19, 2020)
REPEC, National Institute of Health, Ministry of Health
(8) (Webpage) Registration of a Sponsor (PER-60 - Spanish) (Current as of November 19, 2020)
REPEC, National Institute of Health, Ministry of Health
(9) (Webpage) Registration of Contract Research Organization (CRO) (PER-59 - Spanish) (Current as of November 19, 2020)
REPEC, National Institute of Health, Ministry of Health
Sponsorship > Insurance
Last content review/update: November 19, 2020
Requirements
(1) (Regulation) Directoral Resolution 0423-2019/OGITT/INS – Provides for the Amendment of Administrative Procedure Requirements Specified in the Supreme Decree No. 021-2017-SA by the National Institute of Health (INS) for the Authorization of Clinical Trials (ResolutionNo0423-2019 - Spanish) (September 24, 2019)
National Institute of Health, Ministry of Health
Relevant Sections: Annex (1)
(2) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo021-2017 - Spanish) (GoogleTranslate-DecreeNo021-2017) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 2 and 28
(3) (Guidance) Guideline for the Procedure for Requesting Authorization of the Clinical Trial (G-CTApplicProc - Spanish) (Edition No. 02) (November 15, 2019)
National Institute of Health, Ministry of Health
Relevant Sections: 6
(4) (Guidance) Procedures Manual of Clinical Trials (MAN-INS-001) (INS-CTManual - Spanish) (3rd Edition) (November 17, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Chapter VII (7.14)
Summary

Overview

As set forth in DecreeNo021-2017, the G-CTApplicProc, and PER-71, it is a legal requirement for the sponsor or his/her contract research organization (CRO) to carry a valid insurance policy for the expected duration of the study for any unforeseen injury to research participants. Per ResolutionNo0423-2019 the sponsor or his/her CRO should sign an affidavit (PER-51) guaranteeing an active insurance policy is in place according to requirements in the INS-CTManual.

DecreeNo021-2017 also specifies that the sponsor or his/her CRO must obtain insurance coverage in Peru, or have a legal representative in Peru who will represent the sponsor or his/her CRO if the policy is from a foreign company. The insurance policy must be in force until the date of submission of the National Final Report. At the end of this period, it should be renewed whenever there is still a possibility of late damages arising from the adjudication of injuries resulting from the clinical trial.

See the Sponsorship topic, Compensation subtopic and Informed Consent topic, Compensation Disclosure subtopic for specific details related to sponsorship compensation obligations.

(Please note that Peru is in the process of finalizing new guidelines as well as the associated forms and instructions to support the ResolutionNo0423-2019 amendments to DecreeNo021-2017; ClinRegs is monitoring these developments.)

Additional Resources
(1) (Form) Affidavit of Compliance with the Responsibilities and Obligations Set Out in the REC and Availability of a Financial Fund – Sponsor (FOR-OGITT-029) (PER-51 - Spanish) (Edition No. 03) (September 24, 2019)
National Institute of Health, Ministry of Health
(2) (Webpage) Registration of a Clinical Trial - Authorization (PER-71 - Spanish) (Current as of November 19, 2020)
REPEC, National Institute of Health, Ministry of Health
Sponsorship > Compensation
Last content review/update: November 19, 2020
Requirements
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo021-2017 - Spanish) (GoogleTranslate-DecreeNo021-2017) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 27-29, 40, 115 - 118, and Annex 4
(2) (Guidance) Guideline for the Procedure for Requesting Authorization of the Clinical Trial (G-CTApplicProc - Spanish) (Edition No. 02) (November 15, 2019)
National Institute of Health, Ministry of Health
Relevant Sections: 6
Summary

Overview

As specified in DecreeNo021-2017 and the G-CTApplicProc, the sponsor or his/her contract research organization (CRO) is responsible for providing compensation to research participants and/or their legal heirs in the event of trial-related injuries or death.

DecreeNo021-2017 also specifies that the sponsor or his/her CRO must obtain insurance coverage in Peru or have a legal representative in Peru who will represent the sponsor or his/her CRO if the policy is from another country. DecreeNo021-2017, the G-CTApplicProc, and PER-71 further state that the sponsor or his/her CRO must also submit an affidavit (PER-51) guaranteeing a financial fund is immediately and conveniently available. The fund ensures free medical treatment to participants who suffer any trial-related injuries, as long as the insurance policy is activated, and the sponsor or his/her CRO signs a statement to that effect. The G-CTApplicProc also explains that the amount designated for the financial fund is different from the amount indicated for the insurance policy coverage. The sponsor determines the financial fund amount based upon the number of participants to be included in the study and the possible adverse event risks. DecreeNo021-2017 also notes that participants must be ensured free access to the investigational product (IP) following the trial’s conclusion. Before the study commences, post-study access should be anticipated, and this information must be provided during the informed consent process.

In addition, as described in DecreeNo021-2017, compensation will be awarded in the following circumstances:

  • Any damage to the research participant as a result of his/her participation in the clinical trial
  • Any damage that occurred during pregnancy or that would have occurred to the newborn in the case of pregnancy in a female research participant or in the couple of the male research participant, as long as it is a result of their participation in the trial
  • Economic damages derived directly from earlier stated damages, provided that the damage is not inherent to the pathology under study, or to the individual evolution of the research participant

The sponsor’s obligation to award compensation is independent of the validity or available coverage of the contracted insurance.

(See Informed Consent topic, Compensation Disclosure subtopic for more information on participant compensation rights).

Additional Resources
(1) (Document) Communique No. 005-2018-OGITT/INS - Application of Article 35 of the Approved Clinical Trials Regulation: Compensation to Research Subjects (PER-15 - Spanish) (July 3, 2018)
General Office of Research and of Health Technology Transfer, National Institute of Health, Ministry of Health
(2) (Form) Affidavit of Compliance with the Responsibilities and Obligations Set Out in the REC and Availability of a Financial Fund – Sponsor (FOR-OGITT-029) (PER-51 - Spanish) (Edition No. 03) (September 24, 2019)
National Institute of Health, Ministry of Health
(3) (Webpage) Registration of a Clinical Trial - Authorization (PER-71 - Spanish) (Current as of November 19, 2020)
REPEC, National Institute of Health, Ministry of Health
Sponsorship > Quality, Data & Records Management
Last content review/update: November 19, 2020
Requirements
(1) (Legislation) Law No. 29733 - Protection of Personal Data (LawNo29733 - Spanish) (Effective July 3, 2011)
Congress of the Republic
Relevant Sections: Article 17, Title IV (Article 28)
(2) (Legislation) Legislative Decree No. 1353 – Creates the National Authority for Transparency and Access to Public Information, Strengthens the Personal Data Protection Regime and the Regulation of Interest Management (DecreeNo1353 - Spanish) (January 07, 2017) (Updated September 28, 2018)
Congress of the Republic
Relevant Sections: Article 28
(3) (Regulation) Ministerial Resolution No. 655-2019/MINSA – Provides for the Elimination of Administrative Procedure Requirements Specified in the Supreme Decree No. 021-2017-SA by the National Institute of Health (INS) (ResolutionNo655-2019 - Spanish) (July 27, 2019)
Ministry of Health
Relevant Sections: Annexes A and B
(4) (Regulation) Supreme Decree No. 003-2013-JUS of March 21, 2013, Whereby the Regulation of Law No. 29733, Law on Protection of Personal Data is Approved (DecreeNo003-2013 - Spanish) (March 22, 2013)
Ministry of Justice and Human Rights
Relevant Sections: Article 2, 11, and 14
(5) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo021-2017 - Spanish) (GoogleTranslate-DecreeNo021-2017) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 2, 40, 83, and Annex 1
(6) (Guidance) Guide for Inspections of Clinical Trials (G-ClinTrialInspection - Spanish) (April 30, 2019)
General Office of Research and of Health Technology Transfer, National Institute of Health, Ministry of Health
Relevant Sections: 6.2 and 7.5
(7) (Guidance) Procedures Manual of Clinical Trials (MAN-INS-001) (INS-CTManual - Spanish) (3rd Edition) (November 17, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Chapter VII (7.9)
Summary

Overview

As stated in DecreeNo021-2017, the sponsor or his/her contract research organization (CRO) is responsible for ensuring that all information on the investigational product and additional documentation corresponds to the research protocol and complies with good clinical practices (GCPs), as well as the requirements established in DecreeNo021-2017.

DecreeNo021-2017 also specifies that the sponsor or his/her CRO is responsible for obtaining agreement from the investigators to ensure that they will allow monitoring, audits, ethics committee (EC) monitoring, and trial inspections by the National Institute of Health (Instituto Nacional de Salud (INS))'s General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnológica (OGITT)).

Data Protection

As delineated in LawNo29733, the person in charge of the personal data bank in data protection legislation, is required to protect the confidentiality of the owner of the personal data and his/her background. This obligation continues even after the conclusion of the relationship between the owner of the personal data and the person in charge. However, the person in charge of the personal data may be relieved of his/her obligation to uphold the owner’s confidentiality when there is prior, informed, explicit, and unequivocal consent by the owner, or, when there are justifiable reasons related to national defense, public safety, or public health.

According to LawNo29733, the person in charge of the personal data bank has the following obligations:

  • To carry out the processing of personal data, only with prior informed, explicit, and unequivocal consent of the owner of the personal data
  • To not collect personal data by fraudulent, unfair, or illegal means
  • To collect personal data that is updated, necessary, relevant, and adequate, in relation to specific, explicit, and lawful purposes for which the data was obtained
  • To not use the personal data processed for purposes other than those that motivated its collection, unless there is an anonymization or dissociation procedure
  • To store personal data in a way that allows the exercise of the owner’s rights
  • To delete and replace, or, where appropriate, correct the personal data subject to processing when he/she becomes aware of its inaccurate or incomplete nature, without prejudice to the rights of the owner in this regard
  • To delete personal data subject to processing when it is no longer necessary or relevant to the purpose for which it had been collected, or, the deadline for its treatment has expired, unless there is an anonymization or dissociation procedure
  • To provide the National Authority for the Protection of Personal Data with information related to the processing of personal data that it requires, and allow access to the personal data banks that it manages, for the exercise of its functions, within the framework of an administrative procedure in case it is requested by the affected party

DecreeNo1353 restates the obligations included in LawNo29733 above, however, the “person in charge of the personal data bank” is referred to as the “person in charge of processing personal data.”

DecreeNo003-2013 similarly states that the owner of the personal data bank or the person in charge of processing personal data must obtain the consent of the data holder to process his/her data in accordance with the provisions of LawNo29733 and this regulation. In cases involving sensitive data, consent must be granted in writing, through the personal data holder’s signature, digital signature, or any other authentication mechanism that guarantees the unequivocal will of the holder. Per DecreeNo003-2013, sensitive data is information related to personal data referring to physical, moral, or emotional characteristics, facts, or circumstances of an individual’s emotional or family life, personal habits that correspond to the most intimate sphere, or information related to physical health or mental or other analogs that affect an individual’s privacy.

Electronic Data Processing System

No relevant regulatory provisions

Record Management

As set forth in DecreeNo021-2017, the sponsor or his/her CRO is required to possess a documented monitoring record, including the provision of specially selected and specialized personnel (monitors). Additionally, the sponsor or his/her CRO is responsible for filing in the country all documentation and data obtained for at least 10 years after the conclusion of the study. After two (2) years, the documentation/data may be filed electronically, after communication with the INS.

Audit Requirements

As part of the clinical protocol requirements, DecreeNo021-2017 notes that the following data collection and monitoring activities should be implemented:

  • Develop plans to evaluate and collect baseline, outcome, and other study data, including a process to improve data quality and a description of instruments used in the study along with their reliability and validity, if known
  • Prepare plans to promote participant retention and complete follow up, including a list of data to be collected from participants who leave the trial or deviate from it
  • Document (or provide) data monitoring committee details including its composition, a summary of its role and notification procedure, a statement of its independence from the sponsor, and its conflicts of interest. Details about by-laws not included in the protocol should be specified, or an explanation about why this committee is not needed
  • Describe trial monitoring arrangements/audits and sponsor’s statement to ensure that investigators will allow monitoring, audits, EC monitoring, and INS’s OGITT trial inspections, including direct access to clinical trial documentation
  • Provide plans to enter, encode, protect and save data, including any process to improve its quality
  • Specify where data management procedure details not included in the protocol can be found

No specific timeframe is provided for the audit process.

The G-ClinTrialInspection explains that the INS’s OGITT inspection team carries out GCP inspections in accordance with DecreeNo021-2017. Trial inspection findings are based on the severity of the clinical trial conditions, practices, or processes and their potential to affect adversely the rights, safety, or well-being of the research participants and/or data quality and integrity. Inspections are carried out through ordinary and extraordinary inspections, with qualified personnel (multidisciplinary, if applicable) and may be conducted at the beginning, the middle, or the end of the trial. Ordinary inspections are conducted according to the OGITT’s Annual Schedule of Ordinary Inspections. Extraordinary inspections are performed in response to a complaint received by phone, written communication, formal document submitted through the INS reception desk, or from any relevant information received through safety reports, progress reports, and/or a justified request by a clinical trial evaluation team that has obtained OGITT approval. If required, the OGITT coordinates with the National Authority for Pharmaceutical Products, Medical Devices and Medical Products (la Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (ANM)) for the agency’s assistance in verifying compliance with good manufacturing practices standards, good storage practices, and other investigational product (IP) related standards. (Note: The ANM is also known as the General Directorate of Medicines, Supplies and Drugs (La Dirección General de Medicamentos Insumos y Drogas (DIGEMID))).

In addition, during an inspection, the evaluation of biological samples is conducted in accordance with the provisions in DecreeNo021-2017. Please refer to the G-ClinTrialInspection for detailed clinical trial inspection procedures.

The INS-CTManual and the G-ClinTrialInspection indicate that when a regulatory medicines agency of high health surveillance notifies a research center to carry out an inspection visit in Peru, the sponsor or his/her contract research organization (CRO) is required to inform the INS’s OGITT of the date and time of this visit within five (5) business days of receiving the notification. The OGITT will then coordinate with the regulatory medicines agency of high health surveillance to arrange for their participation in the inspection visit as an observer.

Per the INS-CTManual, for regular clinical trial inspections scheduled by the INS’s OGITT, when inspection findings are critical, the sponsor or his/her CRO is required to submit a defense within a period of no more than seven (7) working days following receipt of the inspection report. If the inspection observations are minor or major, the sponsor or his/her CRO should submit his/her defense within a period of no more than 15 working days, after receiving the inspection report. The inspector will issue an official notice of compliance within a period of no more than 15 business days if the sponsor or his/her CRO addresses the issues identified in the report in a timely way. Please refer to section 7.9 of the INS-CTManual for detailed information on preparing for the INS’s OGITT scheduled clinical trial inspections and responding to the inspection reports received.

Premature Study Termination/Suspension

DecreeNo021-2017 states that the sponsor or his/her CRO is responsible for submitting the required documentation to Peru's INS to request a trial’s suspension. Per DecreeNo021-2017 and ResolutionNo655-2019 (which modifies DecreeNo021-2017), an application must be submitted that substantiates the reasons for the suspension and describes the data obtained until the time of the suspension.

Multicenter Studies

Per DecreeNo021-2017, multicenter clinical trials require an appointed coordinator responsible for processing all of the data and analyzing the results.

Additional Resources
(1) (Article) Changes in the Law on Protection of Personal Data (DL 1353) (PER-2 - Spanish) (January 16, 2017)
GTDI
(2) (Article) Regulation of Law 29733 Approved: Law on Protection of Personal Data (PER-1 - Spanish) (March 22, 2013)
RPP News
(3) (Article) The Protection of Personal Data (Law No. 29733) (PER-3 - Spanish) (May 28, 2019)
Belling, Miguel Ampudia; Peruweek
(4) (Document) Communique No. 003-2019-OGITT/INS – Publication of Documents Related to Adverse Events and Inspections of Clinical Trials (PER-6 - Spanish) (May 24, 2019)
General Office of Research and of Health Technology Transfer, National Institute of Health, Ministry of Health
(5) (Form) Application for Clinical Trial Suspension (FOR-OGITT-041) (PER-30 - Spanish) (Edition No. 02) (September 24, 2019)
National Institute of Health, Ministry of Health
(6) (Form) Application for Research Center Closure for a Clinical Trial (FOR-OGITT-040) (PER-43 - Spanish) (Edition No. 02) (September 24, 2019)
National Institute of Health, Ministry of Health
Sponsorship > Site/Investigator Selection
Last content review/update: November 19, 2020
Requirements
(1) (Regulation) Directoral Resolution 0423-2019/OGITT/INS – Provides for the Amendment of Administrative Procedure Requirements Specified in the Supreme Decree No. 021-2017-SA by the National Institute of Health (INS) for the Authorization of Clinical Trials (ResolutionNo0423-2019 - Spanish) (September 24, 2019)
National Institute of Health, Ministry of Health
Relevant Sections: Preamble, Article 1, and Annexes (1)
(2) (Regulation) Ministerial Resolution No. 655-2019/MINSA – Provides for the Elimination of Administrative Procedure Requirements Specified in the Supreme Decree No. 021-2017-SA by the National Institute of Health (INS) (ResolutionNo655-2019 - Spanish) (July 27, 2019)
Ministry of Health
Relevant Sections: Annexes A and B
(3) (Regulation) Ministerial Resolution No. 546/2011 – Technical Health Standard Categories of Health Sector Establishments (ResolutionNo546-2011 - Spanish) (July 13, 2011)
Ministry of Health
(4) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo021-2017 - Spanish) (GoogleTranslate-DecreeNo021-2017) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 2, 40-42, 53-57, 108, and Annexes 3 and 4
(5) (Guidance) Guideline for the Procedure for Requesting Authorization of the Clinical Trial (G-CTApplicProc - Spanish) (Edition No. 02) (November 15, 2019)
National Institute of Health, Ministry of Health
Relevant Sections: 6
Summary

Overview

As set forth in DecreeNo021-2017, the sponsor or his/her contract research organization (CRO) is responsible for selecting the investigator(s) and the institution(s) for the clinical trial, taking into account the appropriateness and availability of the study site and facilities. The sponsor or his/her CRO must also ensure that the investigator(s) are qualified based on training and experience.

As delineated in DecreeNo021-2017, prior to entering into an agreement with the investigator(s) and the institution(s) to conduct a study, the sponsor or his/her CRO should provide the investigator(s) with the protocol and an investigator’s brochure (IB), and ensure that they agree to comply with good clinical practices and ethical standards.

Further, per DecreeNo021-2017 and ResolutionNo655-2019, which modifies DecreeNo021-2017, research centers must register with the Peruvian Clinical Trials Registry (Registro Peruano de Ensayos Clínicos (REPEC)), but are no longer required to provide proof of this registration in the clinical trial authorization application. As delineated in ResolutionNo655-2019, the research institution’s legal representative must submit an application for registration that includes the following:

  • A code from the National Registry of Institutions that Provide Health Services (Registro Nacional de Instituciones Prestadoras de Servicios de Salud (RENIPRESS)) (PER-55)
  • Details of the categorization level assigned to the health institution interested in obtaining registration as a research site to conduct clinical trials; (per ResolutionNo546-2011, categorization is based on the institution’s levels of complexity and functional characteristics)
  • Number and date of proof of payment of processing fees

According to PER-73, research centers should apply using the recently updated application form provided in PER-19 per ResolutionNo0423-2019, and complete the affidavit form in PER-44. Research center registration is valid for three (3) years. Refer to PER-73 for detailed registration instructions. Per DecreeNo021-2017, multicenter clinical trials require an appointed coordinator responsible for processing all of the data and analyzing the results.

Foreign Sponsor Responsibilities

DecreeNo021-2017 and the G-CTApplicProc state that if the sponsor is not based in Peru, he/she is required to appoint a legal representative in the country for the trial’s duration. As specified in DecreeNo021-2017, the sponsor may transfer any or all of his/her study related duties and functions to a CRO. However, he/she is ultimately responsible for the execution of the research protocol and results of the clinical trial.

Data Safety Monitoring Board (DSMB)

DecreeNo021-2017 requires the sponsor to provide data on the Data Safety Monitoring Board (DSMB) including its composition, a summary of its role and notification procedure, a statement of independence from the sponsor, and any conflicts of interest. Additionally, the sponsor should specify where to find other details about the by-laws not included in the protocol, or, explain why a DSMB is not necessary.

Additional Resources
(1) (Document) Communique No. 001-2019-OGITT/INS – Legal Representative/Foreign Sponsor Representative Responsibilities (PER-7 - Spanish) (March 6, 2019)
General Office of Research and of Health Technology Transfer, National Institute of Health, Ministry of Health
(2) (Document) Instructions for Filling Out Form FOR-OGITT-028 Edition No. 03 – Request for Clinical Trial Authorization (PER-10 - Spanish) (Edition No. 03) (May 8, 2019)
National Institute of Health, Ministry of Health
(3) (Form) Affidavit of Compliance with Minimum Research Center Requirements (FOR-OGITT-023) (PER-44 - Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
(4) (Form) Affidavit of Research Center Preparedness for Clinical Trial (FOR-OGITT-064) (PER-35 - Spanish) (Edition No. 01) (September 24, 2019)
National Institute of Health, Ministry of Health
(5) (Form) Application for Clinical Trial Authorization (FOR-OGITT-028 (PER-24 - Spanish) (Edition No. 02) (September 24, 2019)
National Institute of Health, Ministry of Health
(6) (Form) Application for Clinical Trial Cancellation (FOR-OGITT-042) (PER-31 - Spanish) (Edition No. 02) (September 24, 2019)
National Institute of Health, Ministry of Health
(7) (Form) Application for Principal Investigator Change (FOR-OGITT-038) (PER-28 - Spanish) (Edition No. 02) (September 24, 2019)
National Institute of Health, Ministry of Health
(8) (Form) Application for Registration of the Research Center (FOR-OGITT-022) (PER-19 - Spanish) (Edition No. 02) (September 24, 2019)
National Institute of Health, Ministry of Health
(9) (Form) Application for Research Center Closure for a Clinical Trial (FOR-OGITT-040) (PER-43 - Spanish) (Edition No. 02) (September 24, 2019)
National Institute of Health, Ministry of Health
(10) (Form) Application for Sponsor or CRO Change (FOR-OGITT-039) (PER-29 - Spanish) (Edition No. 02) (September 24, 2019)
National Institute of Health, Ministry of Health
(11) (Form) Application for the Extension of the Number of Research Centers (FOR-OGITT-036) (PER-26 - Spanish) (Edition No. 02) (September 24, 2019)
National Institute of Health, Ministry of Health
(12) (Form) Curriculum Vitae of the Research Team (FOR-OGITT-031) (PER-50 - Spanish) (Edition No. 02) (September 24, 2019)
National Institute of Health, Ministry of Health
(13) (Webpage) National Registry of Institutions that Provide Health Services (Registro Nacional de Instituciones Prestadoras de Servicios de Salud (RENIPRESS)) (PER-55 - Spanish) (Current as of November 19, 2020)
Ministry of Health
(14) (Webpage) Registration of Research Centers (PER-73 - Spanish) (Current as of November 19, 2020)
REPEC, National Institute of Health, Ministry of Health
Informed Consent > Documentation Requirements
Last content review/update: November 19, 2020
Requirements
(1) (Legislation) Law No. 26842 – General Health Law (LawNo26842 - Spanish) (Effective January 5, 1998)
Congress of the Republic
Relevant Sections: Title I (Articles 4-5) and Title II (Articles 25, and 27-28)
(2) (Legislation) Law No. 29733 - Protection of Personal Data (LawNo29733 - Spanish) (Effective July 3, 2011)
Congress of the Republic
Relevant Sections: Articles 3, 13, 18, and Title IV (Article 28)
(3) (Legislation) Legislative Decree No. 1353 – Creates the National Authority for Transparency and Access to Public Information, Strengthens the Personal Data Protection Regime and the Regulation of Interest Management (DecreeNo1353 - Spanish) (January 07, 2017) (Updated September 28, 2018)
Congress of the Republic
Relevant Sections: Articles 2 and 18
(4) (Regulation) Ministerial Resolution No. 233-2020 – Ethical Considerations for Health Research with Human Beings (ResolutionNo233-2020 - Spanish) (April 28, 2020)
Ministry of Health
Relevant Sections: VIII (8.4)
(5) (Regulation) Regulation of Law No. 29414 – Law that Establishes the Rights of the Users of Health Services – (Issued by Supreme Decree No. 027-2015-SA) (RegLawNo29414 - Spanish) (August 13, 2015)
Ministry of Health, Ministry of Labor and Employment Promotion, Ministry of Defense, and Ministry of Interior
Relevant Sections: Article 24
(6) (Regulation) Supreme Decree No. 003-2013-JUS of March 21, 2013, Whereby the Regulation of Law No. 29733, Law on Protection of Personal Data is Approved (DecreeNo003-2013 - Spanish) (March 22, 2013)
Ministry of Justice and Human Rights
Relevant Sections: Article 2 and 18
(7) (Regulation) Supreme Decree No. 011-2011-JUS: Guidelines to Guarantee the Implementation of Bioethics to Ensure the Protection of the Human Rights (DecreeNo011-2011-JUS - Spanish) (July 27, 2011)
Ministry of Justice and Human Rights
Relevant Sections: II (3)
(8) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo021-2017 - Spanish) (GoogleTranslate-DecreeNo021-2017) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 2, 11, 32, 33, 34, and Annex 4
(9) (Guidance) Guide for the Ethical Review of Clinical Trials by Institutional Research Ethics Committees (G-EC-CTReview - Spanish) (Edition No. 1) (January 8, 2020)
Executive Office of Research, General Office for Research and Technology Transfer, National Institute of Health, Ministry of Health
Relevant Sections: Ethical Criterion 4, and Annexes 2 and 3
Summary

Overview

In all Peruvian clinical trials, a freely given informed consent must be obtained from each participant in accordance with the principles set forth in LawNo26842, DecreeNo021-2017, the G-EC-CTReview, and the Declaration of Helsinki (PER-76). DecreeNo011-2011-JUS further states that all scientific and technological research and applications will be developed with respect for the prior, free, express, and informed consent of the person concerned, based on adequate information. Consent in such terms implies the recognition of the patient's right to be treated as a free person and capable of making their own decisions.

Per DecreeNo021-2017 and the G-EC-CTReview, the informed consent form (ICF) is viewed as an essential document that must be reviewed and approved by an institutional ethics committee (EC) and provided to Peru’s National Institute of Health (Instituto Nacional de Salud (INS)) with the clinical trial application. (See the Informed Consent topic, Required Elements subtopic for details on what should be included in the form.) Per ResolutionNo233-2020, investigators must also submit any modifications or amendments to the initially approved research project and informed consent processes in a report to the EC in a timely manner, except in cases where these changes are necessary to prevent harm to the research participants when ECs must be informed within 24 hours. ResolutionNo233-2020 further indicates that participants must be kept constantly informed about the changes, progress, and results of the research according to the applicable regulations.

As delineated in DecreeNo021-2017, RegLawNo29414, the G-EC-CTReview, and ResolutionNo233-2020, investigator(s) must provide detailed research study information to the participant and/or his/her legal representative(s) or guardian(s). The ICF content should be presented briefly and clearly in writing, in a manner that is easy to understand, commensurate with the comprehension level of the research participants, and without coercion or unduly influencing a potential participant to enroll in the clinical trial. The participant and his/her legal representative(s) or guardian(s) should also be given adequate time to consider whether to participate. Per DecreeNo021-2017, when drafting and presenting the ICF, special consideration must be taken with regard to the participant’s culture, traditional values, intelligence, and education.

Re-Consent

As indicated in DecreeNo021-2017, the participant and/or his/her legal representative(s) or guardian(s) is required to sign a revised ICF if any changes occur in the protocol or in the treatment methods or procedures.

Language Requirements

Per DecreeNo021-2017, the ICF must be written in Spanish and in the language of the research participant.

Documentation Copies

DecreeNo021-2017 and the G-EC-CTReview state that the participant and/or the participant’s legal representative(s) or guardian(s), and the investigator(s) must sign and date the ICF. Where the participant is illiterate and/or his/her legal representative(s) or guardian(s) is illiterate, his/her fingerprint will serve as a signature, and should be obtained in the presence of and countersigned by an impartial witness who does not belong to the research team. Before participating in the study, the participant should receive a copy of the signed and dated ICF.

Consent for Processing Personal Data

Per LawNo29733, DecreeNo1353 (which modifies LawNo29733), and DecreeNo003-2013, consent to participate in research is not the same as consent as the legal basis for processing personal data under the data protection legislation.

However, LawNo29733 and DecreeNo003-2013 do provide definitions to address health related data. Per LawNo29733 and DecreeNo1353, sensitive data is defined as personal data constituted by biometric data that by themselves can identify the holder; data referring to racial and ethnic origin; economic income, opinions or political, religious, philosophical or moral convictions; union affiliation; and information related to health or sexual life. DecreeNo003-2013, in turn, provides the following definitions:

  • Personal data related to health – information concerning the past, present, or forecasted, physical or mental health of a person, including the degree of disability and their genetic information
  • Sensitive data – information related to personal data referring to physical, moral, or emotional characteristics, facts or circumstances of an individual’s emotional or family life, personal habits that correspond to the most intimate sphere, or information related to physical health or mental or other analogs that affect an individual’s privacy

The entity responsible for processing personal data must obtain the data holder’s consent per the provisions of DecreeNo003-2013, LawNo29733, and DecreeNo1353. However, in cases involving sensitive data, DecreeNo003-2013 specifies that consent must be granted in writing, through the data holder’s handwritten signature, digital signature, or any other authentication mechanism that guarantees the unequivocal will of the holder.

LawNo29733 and DecreeNo1353 also indicate that sensitive data is subject to special protection, and consent for the purposes of its treatment must also be made in writing. Even if the owner does not consent, the processing of sensitive data can be carried out when authorized by law, provided that it addresses important reasons of public interest.

In addition, LawNo29733 and DecreeNo1353 further explain that prior to the collection of his/her data, the holder of the personal data has the right to be informed of the following information in a detailed, simple, express, and unambiguous manner:

  • The purpose for which the personal data will be processed
  • Who the recipients are or may be
  • The existence of the databank in which his/her data will be stored, as well as the identity and address of the owner, and, if applicable, the person in charge of the processing of his/her personal data
  • The obligatory or optional nature of his/her answers to the questionnaire that is presented, especially regarding sensitive data
  • The transfer of personal data
  • The consequences of providing his/her personal data and his/her refusal to do so
  • The time during which his/her personal data is kept, and
  • The possibility of exercising the rights granted by law and the means provided for it
Additional Resources
(1) (International Guidance) Declaration of Helsinki (PER-76) (October 19, 2013)
World Medical Association
Informed Consent > Required Elements
Last content review/update: November 19, 2020
Requirements
(1) (Regulation) Regulation of Law No. 29414 – Law that Establishes the Rights of the Users of Health Services – (Issued by Supreme Decree No. 027-2015-SA) (RegLawNo29414 - Spanish) (August 13, 2015)
Ministry of Health, Ministry of Labor and Employment Promotion, Ministry of Defense, and Ministry of Interior
Relevant Sections: Article 24
(2) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo021-2017 - Spanish) (GoogleTranslate-DecreeNo021-2017) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 32, 34, 40, 67, 115-118, and Annex 4
(3) (Guidance) Guide for the Ethical Review of Clinical Trials by Institutional Research Ethics Committees (G-EC-CTReview - Spanish) (Edition No. 1) (January 8, 2020)
Executive Office of Research, General Office for Research and Technology Transfer, National Institute of Health, Ministry of Health
Relevant Sections: Preamble, VII, Ethical Criterion 4, Ethical Criterion 5, and Annex 2
Summary

Overview

As delineated in DecreeNo021-2017 and the G-EC-CTReview, prior to beginning a clinical trial, the sponsor or his/her contract research organization (CRO) is required to obtain ethics committee (EC) approval from an accredited institutional EC for the written informed consent form (ICF) and any other information being provided to the research participant and/or his/her legal representative(s) or guardian(s).

No Coercion

DecreeNo021-2017, RegLawNo29414, and the G-EC-CTReview state that none of the information concerning the research study, including the written ICF, should contain any language that causes the participant and/or his/her legal representative(s) or guardian(s) to waive or to appear to waive his/her legal rights, or that releases or appears to release the investigator(s), the institution, the sponsor, or their representatives from their liabilities for any negligence.

ICF Required Elements

Per DecreeNo021-2017 and the G-EC-CTReview, the ICF should include the following statements or descriptions, as applicable (Note: the regulations provide overlapping and unique elements so each of the items listed below will not necessarily be in each source.):

  • Trial title (include version and date)
  • Sponsor(s), research institution, principal investigator (PI), EC, and the INS's General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnológica (OGITT)) contact information
  • Explicit invitation to participate in an experimental research study and the voluntary nature of participation
  • Trial rationale, objectives, and purpose
  • Trial treatments or interventions
  • Randomization and blinding procedures
  • Trial procedures and purpose
  • Expected duration of research participant’s involvement in trial­
  • The approximate number of participants in the study
  • Expected or unforeseeable risks and discomforts arising from the trial
  • Free treatment and procedures used as part of the trial design
  • The expected benefits that can be obtained from the study
  • If there are alternative procedures that could be advantageous to the participant
  • The commitments assumed by the participant if he/she agrees to participate in the study
  • The guarantee of receiving answer to any question and clarification to any doubt about the procedures, risks, benefits, and other trial related matters and the treatment of the participant
  • In the event of trial-related injuries, contact information for the PI, the EC president, and the OGITT
  • Participant’s right to withdraw his/her consent at any time and to stop participating in the study without creating any detriment to continue his/her care and treatment
  • The extent to which confidentiality of records identifying the participant will be maintained and the possibility of record access by National who may have access to these records
  • The participant and/or his/her legal representative agrees to authorize access to his/her personal data to verify procedures and/or trial data without violating the participant’s confidentiality
  • The extent to which confidentiality of records identifying the participant will be maintained, and the possibility of record access by the National Institute of Health (Instituto Nacional de Salud (INS)) and the EC
  • The commitment to provide up-to-date information about the investigational product (IP) or procedure, or when the participant requests this information, although this may affect the participant’s willingness to continue participating
  • Foreseeable circumstances and/or reasons under which the investigator(s) may remove the participant without his/her consent
  • Medical treatment and compensation available to the participant in the case of trial-related injuries and proof of the sponsor’s insurance contract
  • Economic compensation for additional expenses (e.g., transportation, accommodation, communication, and food)
  • Specify when final trial results will be provided to participant
  • Inform the participant of post-study access to IP after trial completion
  • Provide a trial description in the INS’s Peruvian Clinical Trials Registry (Registro Peruano de Ensayos Clínicos (REPEC))

The G-EC-CTReview states that the participant should be provided with detailed information on the biological samples to be collected and stored. Per DecreeNo021-2017, if biological sample storage and collection is being considered for future use, then this point should be made explicit in an additional ICF. Refer to the Specimens topic, Consent for Specimens subtopic for further information on participant consent requirements for use of biological samples.

See the Informed Consent topic, Compensation Disclosure and Vulnerable Populations subtopics for further information.

Additional Resources
No additional resources
Informed Consent > Compensation Disclosure
Last content review/update: November 19, 2020
Requirements
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo021-2017 - Spanish) (GoogleTranslate-DecreeNo021-2017) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 34, 35, 40, 115-118, and Annex 4
(2) (Guidance) Guide for the Ethical Review of Clinical Trials by Institutional Research Ethics Committees (G-EC-CTReview - Spanish) (Edition No. 1) (January 8, 2020)
Executive Office of Research, General Office for Research and Technology Transfer, National Institute of Health, Ministry of Health
Relevant Sections: Ethical Criterion 5 and Annex 2
Summary

Overview

In accordance with DecreeNo021-2017 and the G-EC-CTReview, the informed consent form (ICF) should contain a statement describing the compensation and medical treatment a participant can receive for participating in a clinical trial.

Compensation for Participation in Research

As delineated in Annex 4 of the DecreeNo021-2017 and Annex 2 of the G-EC-CTReview, the ICF should contain a statement describing the financial compensation participants can receive for additional expenses (travel, accommodations, communication, and food) incurred while participating in the trial. The ICF must also explicitly list the specific amount to be provided for each additional expense.

DecreeNo021-2017 also states that participants must be ensured free access to the investigational product (IP) following the trial’s conclusion. Before the study commences, post-study access should be anticipated, and this information must be provided during the informed consent process. The G-EC-CTReview further specifies that the ICF should explain if the IP will be made available to participant(s) for whom the product has proven to be beneficial. A trial clinician will indicate when and how the participant may obtain the product once the trial has concluded.

Compensation for Injury

Per DecreeNo021-2017 and the G-EC-CTReview, the ICF should include a statement advising the participant that compensation and free medical treatment are available in the event of any trial-related injury. In addition, the G-EC-CTReview states that the ICF should also state that compensation for the participant’s and/or his/her legal representative(s) or guardian(s) should also be provided in the event of the participant’s death or disability resulting from the trial.

The G-EC-CTReview further notes that insurance coverage should also be provided to the participants.

(See the Informed Consent topic, Required Elements subtopic for additional details on what should be included in the ICF.)

Additional Resources
No additional resources
Informed Consent > Participant Rights
Last content review/update: November 19, 2020
Requirements
(1) (Legislation) Law No. 26842 – General Health Law (LawNo26842 - Spanish) (Effective January 5, 1998)
Congress of the Republic
Relevant Sections: Title I (Articles 4 and 5) and Title II (Articles 25, 27, and 28)
(2) (Legislation) Law No. 29733 - Protection of Personal Data (LawNo29733 - Spanish) (Effective July 3, 2011)
Congress of the Republic
Relevant Sections: Articles 5, 9, 13, 17-18, and Title IV (Article 28)
(3) (Legislation) Political Constitution of Peru of 1993 (PeruConstitution - Spanish) (Amended through March 2019)
Congress of the Republic
Relevant Sections: Chapter 1 (Articles 1 and 2) and Chapter 2 (Article 7)
(4) (Legislation) Legislative Decree No. 1353 – Creates the National Authority for Transparency and Access to Public Information, Strengthens the Personal Data Protection Regime and the Regulation of Interest Management (DecreeNo1353 - Spanish) (January 07, 2017) (Updated September 28, 2018)
Congress of the Republic
Relevant Sections: Article 18
(5) (Regulation) Ministerial Resolution No. 233-2020 – Ethical Considerations for Health Research with Human Beings (ResolutionNo233-2020 - Spanish) (April 28, 2020)
Ministry of Health
Relevant Sections: I and VIII (8.4)
(6) (Regulation) Regulation of Law No. 29414 – Law that Establishes the Rights of the Users of Health Services – (Issued by Supreme Decree No. 027-2015-SA) (RegLawNo29414 - Spanish) (August 13, 2015)
Ministry of Health, Ministry of Labor and Employment Promotion, Ministry of Defense, and Ministry of Interior
Relevant Sections: Articles 18 and 24
(7) (Regulation) Supreme Decree No. 003-2013-JUS of March 21, 2013, Whereby the Regulation of Law No. 29733, Law on Protection of Personal Data is Approved (DecreeNo003-2013 - Spanish) (March 22, 2013)
Ministry of Justice and Human Rights
Relevant Sections: Articles 11 and 14
(8) (Regulation) Supreme Decree No. 011-2011-JUS: Guidelines to Guarantee the Implementation of Bioethics to Ensure the Protection of the Human Rights (DecreeNo011-2011-JUS - Spanish) (July 27, 2011)
Ministry of Justice and Human Rights
Relevant Sections: Preamble, Article 2, II (1-3), and V (1 and 6)
(9) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo021-2017 - Spanish) (GoogleTranslate-DecreeNo021-2017) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 4, 9, 34, and 40, and Annex 4
(10) (Guidance) Guide for the Ethical Review of Clinical Trials by Institutional Research Ethics Committees (G-EC-CTReview - Spanish) (Edition No. 1) (January 8, 2020)
Executive Office of Research, General Office for Research and Technology Transfer, National Institute of Health, Ministry of Health
Relevant Sections: VII, Ethical Criterion 4, Ethical Criterion 5, Annex 2
Summary

Overview

In accordance with LawNo26842, DecreeNo021-2017, the G-EC-CTReview, ResolutionNo233-2020, the PeruConstitution, DecreeNo011-2011-JUS, and the Declaration of Helsinki (PER-76), Peru’s ethical standards promote respect for all human beings and safeguard the rights of research participants. Per DecreeNo021-2017, the G-EC-CTReview, and ResolutionNo233-2020, a participant’s rights must also be clearly addressed in the informed consent form (ICF) and during the informed consent process.

The Right to Participate, Abstain, or Withdraw

DecreeNo021-2017, RegLawNo29414, and the G-EC-CTReview state that the participant or his/her legal representative(s) or guardian(s) should be informed that participation is voluntary, that he/she may withdraw from the research study at any time, and that refusal to participate will not involve any penalty or loss of benefits to which the participant is otherwise entitled.

The Right to Information

As explained in DecreeNo021-2017, RegLawNo29414, and the G-EC-CTReview, a potential research participant and/or his/her legal representative(s) or guardian(s) has the right to be informed about the nature and purpose of the research study, its anticipated duration, study procedures, any potential benefits or risks, any compensation for participation or injury/treatment, and any significant new information regarding the research study.

The Right to Privacy and Confidentiality

Pursuant to DecreeNo021-2017 and the G-EC-CTReview, all participants must be afforded the right to privacy and confidentiality, and the ICF must provide a statement that recognizes this right. The ICF must also incorporate the following items related to privacy:

  • Data the participant will have access to and what information will be collected
  • How collected data will be used, stored and protected, and who will have access
  • That representatives of the sponsor, ethics committee (EC) and the National Institute of Health (Instituto Nacional de Salud (INS)) will have access to the data
  • How biological data and samples are handled if consent is withdrawn
  • That participants’ data will be de-identified in the case of publications and presentations of the clinical trial results

Per LawNo29733, DecreeNo1353 (which modifies LawNo29733), and DecreeNo003-2013, participants have the right to be informed about the collection and use of their personal data. LawNo29733 further states that the owner of the personal data bank, the person in charge, and others involved in any way with processing an individual’s personal data are obligated to protect the confidentiality of his/her background and data. This obligation continues even after the conclusion of the relationship between the personal data holder and the entity responsible for the data. However, the person in charge of the personal data may be relieved of his/her obligation to uphold the owner’s confidentiality when there is prior, informed, explicit, and unequivocal consent by the owner, or, when there are justifiable reasons related to national defense, public safety or public health.

The Right of Inquiry/Appeal

Per DecreeNo021-2017 and the G-EC-CTReview, the research participant and/or his/her legal representative(s) or guardian(s) should be provided with contact information for the sponsor and the investigator(s) to address trial-related inquiries and/or to appeal against a violation of his/her rights.

The ICF must guarantee that the participant will receive answers to any questions and clarification to any doubt about the procedures, risks, benefits and other matters related to the clinical trial and the treatment of the participant. There must also be a commitment to provide up-to-date information about the product or procedure under investigation when the participant requests it.

The Right to Safety and Welfare

DecreeNo021-2017, the G-EC-CTReview, and DecreeNo001-2011-JUS indicate that the research participant’s dignity, safety, and welfare must be guaranteed while ensuring the quality of the research process in developing new products. The G-EC-CTReview further states that the interests of science cannot take precedence over the interests of the research participants.

Additional Resources
(1) (International Guidance) Declaration of Helsinki (PER-76) (October 19, 2013)
World Medical Association
Informed Consent > Special Circumstances/Emergencies
Last content review/update: November 19, 2020
Requirements
(1) (Legislation) Legislative Decree No. 1384 - Recognizing and Regulating the Legal Capacity of Persons with Disabilities in Equal Conditions (LawNo1384 - Spanish) (September 3, 2018)
Congress of the Republic
Relevant Sections: Article 2
(2) (Legislation) Legislative Decree No. 295 – Civil Code (LawNo295 - Spanish) (Effective November 14, 1984)
Congress of the Republic
Relevant Sections: Title V (Articles 44-45)
(3) (Guidance) Guide for the Ethical Review of Clinical Trials by Institutional Research Ethics Committees (G-EC-CTReview - Spanish) (Edition No. 1) (January 8, 2020)
Executive Office of Research, General Office for Research and Technology Transfer, National Institute of Health, Ministry of Health
Relevant Sections: Ethical Criterion 4
Summary

Overview

The G-EC-CTReview and LawNo1384, which amends LawNo295, make provisions to protect the rights of a research participant during the informed consent process when the procedure is complicated by special circumstances. Special circumstances include when a participant is mentally incapacitated.

Research Involving Persons in a Coma

As delineated in the G-EC-CTReview, persons in a comatose state may be involved in a clinical study as long as the appropriate legal representative(s) or guardian(s) are in place that comply with LawNo1384, which amends LawNo295. According to LawNo1384, any legal representative(s) or guardian(s) designated prior to a person becoming comatose will be upheld. However, for those persons who have not designated a legal representative(s) or guardian(s), a judge shall designate the necessary supports and safeguards. This measure will only be taken after efforts have been made to obtain the person’s consent and when the designation of legal representative(s) or guardian(s) is necessary for the exercise and protection of his/her rights.

Additional Resources
No additional resources
Informed Consent > Vulnerable Populations
Last content review/update: November 19, 2020
Requirements
(1) (Legislation) Legislative Decree No. 1384 - Recognizing and Regulating the Legal Capacity of Persons with Disabilities in Equal Conditions (LawNo1384 - Spanish) (September 3, 2018)
Congress of the Republic
Relevant Sections: Articles 1 and 2
(2) (Legislation) Legislative Decree No. 295 – Civil Code (LawNo295 - Spanish) (Effective November 14, 1984)
Congress of the Republic
Relevant Sections: Title II (Article 3) and Title V (Articles 42-44, and 46-47)
(3) (Regulation) Corrections - Supreme Decree No. 021-2017-SA – Clinical Trials Regulation (DecreeNo021-2017-Corrections - Spanish) (Effective July 12, 2017)
National Institute of Health, Ministry of Health
(4) (Regulation) Supreme Decree No. 011-2011-JUS: Guidelines to Guarantee the Implementation of Bioethics to Ensure the Protection of the Human Rights (DecreeNo011-2011-JUS - Spanish) (July 27, 2011)
Ministry of Justice and Human Rights
Relevant Sections: II (1-3)
(5) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo021-2017 - Spanish) (GoogleTranslate-DecreeNo021-2017) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 2, 19, 24, 25, 33 and 38
(6) (Guidance) Guide for the Ethical Review of Clinical Trials by Institutional Research Ethics Committees (G-EC-CTReview - Spanish) (Edition No. 1) (January 8, 2020)
Executive Office of Research, General Office for Research and Technology Transfer, National Institute of Health, Ministry of Health
Relevant Sections: Ethical Criterion 4, Ethical Criterion 5, and Ethical Criterion 6
Summary

Overview

As per DecreeNo021-2017, in all Peruvian clinical trials, research participants selected from vulnerable populations must be provided additional protections to safeguard their health and welfare during the informed consent process. Additionally, the G-EC-CTReview specifies that the ethics committee (EC) should identify the vulnerabilities of the research participants to determine the additional protections required and to protect their welfare and rights.

DecreeNo021-2017 defines vulnerable populations are those who are relatively (or absolutely) incapable of protecting their own interests due to a lack of autonomy, intelligence, education, resources, strength, or other necessary attributes. This may include those in subordinate groups, indigenous or native peoples, and those who cannot give their consent. In addition, per DecreeNo011-2011-JUS, in the case of individuals who do not have the capacity to exercise their autonomy, measures will be taken to safeguard their rights, always ensuring what is most favorable to them. The protection of human life considers the protection of health, as well as taking into account vulnerability and personal integrity. DecreeNo011-2011-JUS further explains that the cultural and plural diversities of Peru cannot represent a justification for transgressing legitimate limits established by the recognition of the principle of respect for human dignity.

See the Informed Consent topic, and the subtopics of Children/Minors; Pregnant Women, Fetuses & Neonates; and Mentally Impaired for additional information about these vulnerable populations. Information on the other vulnerable populations specified in DecreeNo021-2017 is provided below.

Persons in Subordinate or Dependent Groups

Clinical trials involving participants who are involved in subordinate or dependent relationships must meet the following requirements:

  • One or more of the ethics committee (EC)’s members must represent the population under study or work with someone who has expertise in addressing social, cultural, and other issues related to the group in question
  • A participant’s refusal or withdrawal of consent during the trial should not affect his/her performance review or result in any negative consequences to the participant

These relationships include participants who are in junior or subordinate positions in hierarchically structured groups, such as students and teachers, employees and their supervisors, and soldiers and their superiors in military settings.

Research Involving Indigenous Communities

As explained in DecreeNo021-2017, clinical trials involving participants from indigenous communities may only be conducted under the following conditions:

  • When the expected benefit is reasonably assured; that is, when the product or knowledge generated by research is available or applied for the benefit of the community
  • The principal investigator (PI) has the approval to conduct the trial from the regional health authority and other authorities in the community, in addition to obtaining informed consent from trial participants
  • Sponsors and investigators develop culturally appropriate ways through working with anthropologists, sociologists, and translators to communicate the necessary information, and to meet the standards required in the informed consent process. In addition, the research protocol must describe and justify the methods the investigators plan to use to communicate information to research participants
  • Investigators agree to discontinue using individual participants when the community does not have the capacity to understand the implications of the participants’ involvement in the trial, despite the use of a translator or interpreter
  • In the case of including biological storage samples, it must have the authorization of the corresponding regional and local government, and of the respective community authorities, who must consider the interest of the community involved

The G-EC-CTReview further notes that the EC should ensure it has adopted all the appropriate measures when running a clinical trial in a community to minimize the potentially negative effects on the group and to ensure the community’s active involvement in the trial. The G-EC-CTReview also references DecreeNo021-2017’s provision pertaining to indigenous communities, which requires approval by the community’s authorities to conduct the study prior to obtaining individual informed consent. However, approval by the community authorities may not replace the consent of each individual research participant within the group.

Research Involving Participants with Physical Disabilities

Per DecreeNo021-2017 and DecreeNo021-2017-Corrections, in clinical trials involving participants with physical disabilities that prevent them from signing the informed consent form (ICF), but with the mental capacity to provide their consent, their legal representative(s) may grant his/her written consent by printing his/her fingerprint. This consent must be provided in the presence of at least one (1) witness designated by the participant and does not belong to the research team, and who in turn will sign the ICF. If the participant is unable to sign or provide a fingerprint, another means may be used that the participant approves. In this case, his/her legal representative(s) are required to sign the ICF with a witness present who is not a member of the research team. The participant and/or his/her legal representative(s) may withdraw his/her consent at any time without negative consequences as long as the withdrawal does not jeopardize the participant’s health.

Additionally, in the case of participants who, due to disabilities, are unable to give their informed consent and have not given consent prior to the onset of their disability, the following provisions must be met:

  • The informed consent must comply with the requirements delineated in the Informed Consent topic, Required Elements subtopic
  • The protocol must be approved by an EC that has experts in the disease under study, or, has consulted on the clinical, ethical and psycho-social aspects in the area of the disease and the group of patients affected

The G-EC-CTReview also notes that, per LawNo1384 which amends LawNo295, persons with disabilities have an equal capacity to exercise their rights in all aspects of life, including the right to choose to be a participant in a research study with the support of a legal representative(s), if applicable. In addition, LawNo1384 states that any person with a disability that requires reasonable adjustments or support to exercise his/her legal rights may request or designate a legal representative(s) of his/her choice for assistance. Persons with disabilities who cannot communicate their own wishes will receive support and safeguards from judicially designated entities.

Additional Resources
No additional resources
Informed Consent > Children/Minors
Last content review/update: November 19, 2020
Requirements
(1) (Legislation) Law No. 27337 – Law that Approves the New Code of Children and Adolescents (LawNo27337 - Spanish) (Effective August 2, 2000)
Ministry of Women and Vulnerable Populations
Relevant Sections: Preliminary Title (Article 1)
(2) (Legislation) Legislative Decree No. 1384 - Recognizing and Regulating the Legal Capacity of Persons with Disabilities in Equal Conditions (LawNo1384 - Spanish) (September 3, 2018)
Congress of the Republic
Relevant Sections: Article 1
(3) (Legislation) Legislative Decree No. 295 – Civil Code (LawNo295 - Spanish) (Effective November 14, 1984)
Congress of the Republic
Relevant Sections: Title V (Articles 42-46)
(4) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo021-2017 - Spanish) (GoogleTranslate-DecreeNo021-2017) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 2, 18, 33, and 36
(5) (Guidance) Guide for the Ethical Review of Clinical Trials by Institutional Research Ethics Committees (G-EC-CTReview - Spanish) (Edition No. 1) (January 8, 2020)
Executive Office of Research, General Office for Research and Technology Transfer, National Institute of Health, Ministry of Health
Relevant Sections: Ethical Criterion 4
Summary

Overview

Pursuant to LawNo27337, LawNo295, LawNo1384, and the G-EC-CTReview, the age of majority is 18 years of age. Per LawNo295 and the G-EC-CTReview, children under 16 are considered to be absolutely incapable of providing consent, except for those acts determined by law. Individuals who are over 16 and under 18 are considered to be relatively incapable of providing consent. However, individuals older than 16, who are married or have obtained an official title authorizing them to practice a profession or trade, are exempt from this regulation. Per LawNo295 and LawNo1384, females over 14 who are married are also exempt from this regulation. If a marriage is terminated, individuals who acquire this capacity by marriage do not lose this right. LawNo1384 further clarifies that individuals over 14 and under 18 who marry, or who become parents are considered fully capable of providing consent.

Per DecreeNo021-2017 and the G-EC-CTReview, assent should also be obtained from a child or adolescent under 18 years of age. DecreeNo021-2017 and the G-EC-CTReview note that children aged eight (8) to adolescents under 18 years of age are generally considered to be capable of understanding the explanation of the research as a research participant and can give their assent.

In addition to a minor providing his/her assent, DecreeNo021-2017 and the G-EC-CTReview state that the consent of both parents or his/her legal representative(s) or guardian(s) is required. Per DecreeNo021-2017, the consent of the legal representative(s) or guardian(s) may only be dismissed in the case of death, loss of rights according to Decree requirements, or, proven impossibility to obtain consent has been documented appropriately. In the event that one parent is a minor, the consent of the direct ascendant relative is also required unless the parent is a minor of 16 years of age or more, the participant has gotten married, or, has obtained an official professional or trade title as earlier noted per LawNo295. The assent of a pediatric participant from the age of 8 and under 18 years of age must be obtained to participate in an investigation.

DecreeNo021-2017 further explains that all pediatric participants should be fully informed about the trial and its risks and benefits in language and terms that they are easily able to understand. The investigator(s) must also accept the withdrawal of informed consent at the request of the child’s legal representative(s) or guardian(s) at any time, provided that the child’s health will not be jeopardized. A minor who is a teenager must also be excluded from a trial when a conflict of views exists between the legal representative(s) or guardian(s) and the teenager. A minor who reaches the age of majority during a trial must provide consent before he/she can continue to participate in the study.

In addition, an ethics committee (EC) that has a specialist in pediatrics, or has obtained advice on the clinical, ethical, and psycho-social aspects of the trial from a pediatric expert, if applicable, must approve the protocol.

Additional Resources
No additional resources
Informed Consent > Pregnant Women, Fetuses & Neonates
Last content review/update: November 19, 2020
Requirements
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo021-2017 - Spanish) (GoogleTranslate-DecreeNo021-2017) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 20-23 and Annex 4
Summary

Overview

As per DecreeNo021-2017, studies involving women of childbearing age or who are pregnant require additional safeguards to ensure that the research assesses the risks and benefits as well as any potential impact on fertility, pregnancy, the embryo or fetus, labor, lactation, and the newborn.

Clinical trials may only be conducted under the following conditions:

  • The informed consent of the woman and her spouse or partner is obtained, and they are given information about any potential risks to the embryo, fetus, or newborn prior to the trial
  • The spouse’s or partner’s consent may only be dismissed in the case of death; their inability to provide reliable consent; loss of rights; or, when there is imminent risk to the health or life of the woman or the embryo, fetus, or newborn
  • Informed consent may be withdrawn by the woman or spouse’s or partner’s request at any time, without detriment to them, provided the woman or fetus is not endangered
  • The research must be preceded by trials in non-pregnant women to demonstrate their safety, except for specific tests that require pregnant participants
  • The research must be aimed at improving the health of pregnant women and represent only a minimal risk to the embryo or fetus and the participant
  • During the study, investigators will not have the authority to decide on the timing, method, or procedure used to terminate the pregnancy, or to participate in decisions about the viability of the fetus
  • Informed consent for pregnant teenagers complies with the requirements stated in the Informed Consent topic, Children/Minors subtopic

Clinical trials may only be carried out in women in labor, postpartum, or breastfeeding when the following conditions are met:

  • Consent must be obtained before labor starts
  • Research will be authorized in postpartum women and breastfeeding only when there is minimal risk to the infant
  • Informed consent may be withdrawn at the participant’s or spouse’s or partner’s request at any time, without detriment to them, provided they do not affect or endanger the mother or the fetus or infant
  • The clinical trial has the potential to generate direct benefits greater than the risks to the nursing woman or child after birth

See Title III, Chapter II (Article 23) of DecreeNo021-2017, for additional details on embryos, fetuses, and newborns.

Research Involving Men and Women with Reproductive Capacity

Clinical trials involving men and women with reproductive capacity are only permitted under the following conditions:

  • For women, the principal investigator (PI) must conduct a pregnancy test to rule out any pregnancies, and to secure commitment from the women to use effective contraceptive methods. The sponsor will provide free access and a list of contraceptive methods to the participant(s) to be selected by the participant(s) and consistent with the trial
  • In the event of pregnancy during the study, the protocol should establish the exclusion of the mother; the application of procedures to monitor and control the pregnancy as well as monitoring and control of the newborn until at least six (6) months of age to identify any effects related to the investigational product
  • For men, the PI must secure a commitment from the men to prevent conception, and to use effective contraceptive methods to be provided free of charge to the participant(s) by the PI/sponsor, as specified in the protocol and the informed consent form
Additional Resources
No additional resources
Informed Consent > Prisoners
Last content review/update: November 19, 2020
Requirements
No applicable regulatory requirements
Summary

No relevant provisions.

Additional Resources
No additional resources
Informed Consent > Mentally Impaired
Last content review/update: November 19, 2020
Requirements
(1) (Legislation) Law No. 30947 – Mental Health Law (LawNo30947 - Spanish) (Effective May 23, 2019)
Congress of the Republic
Relevant Sections: Articles 1, 3-4, 6, 9, and 32
(2) (Legislation) Legislative Decree No. 1384 - Recognizing and Regulating the Legal Capacity of Persons with Disabilities in Equal Conditions (LawNo1384 - Spanish) (September 3, 2018)
Congress of the Republic
Relevant Sections: Article 3
(3) (Legislation) Legislative Decree No. 295 – Civil Code (LawNo295 - Spanish) (Effective November 14, 1984)
Congress of the Republic
Relevant Sections: Title V (Articles 43-44 and 46-47)
(4) (Regulation) Regulation of Law No. 29414 – Law that Establishes the Rights of the Users of Health Services – (Issued by Supreme Decree No. 027-2015-SA) (RegLawNo29414 - Spanish) (August 13, 2015)
Ministry of Health, Ministry of Labor and Employment Promotion, Ministry of Defense, and Ministry of Interior
Relevant Sections: Article 5
(5) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo021-2017 - Spanish) (GoogleTranslate-DecreeNo021-2017) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Article 37
(6) (Guidance) Guide for the Ethical Review of Clinical Trials by Institutional Research Ethics Committees (G-EC-CTReview - Spanish) (Edition No. 1) (January 8, 2020)
Executive Office of Research, General Office for Research and Technology Transfer, National Institute of Health, Ministry of Health
Relevant Sections: Ethical Criterion 4
Summary

Overview

The Peruvian government recently passed LawNo30947 to establish a legal framework that guarantees access to services, promotion, prevention, treatment and rehabilitation in mental health as conditions for the full exercise of the right to health and well-being of the person, the family, and the community. The law states that mental health care takes into account the model of community care as well as respect for human rights and the dignity of the individual, without discrimination and using the intercultural approach, which eliminates the stigmatization of people with mental health problems. Some of the principles addressed in LawNo30947 specifically applicable to ensuring consent in this vulnerable population include:

  • Confidentiality – Mental health care guarantees the confidentiality of information obtained in the clinical context. The disclosure, examination, or release of medical records without the express consent of the individuals involved, or, if applicable, the consent of their legal representative(s), is prohibited
  • Dignity – Care and treatment of an individual with mental health issues is based on protecting and promoting the dignity of an individual through the recognition of his/her fundamental rights
  • Human rights – The therapeutic, prophylactic, and promotional strategies, actions, and interventions in mental health matters must comply with the Convention on the Rights of Persons with Disabilities (CRPD) (PER-54) and other international and regional human rights instruments to which Peru is a party

LawNo30947 defines a representative as a person who, according to law, gives consent for the treatment of the mental health problems of children and adolescents. In the treatment of psychiatric disorders, mental health services also consider the special needs of the population in vulnerable situations, and prioritizes mental health care in vulnerable populations including early childhood, adolescence, women, and older adults.

Per LawNo30947, some, but not all of the rights, of users of mental health services related to consent are listed below:

  • To receive complete, timely, and ongoing information about their mental health status, in understandable terms, including diagnosis, prognosis, and treatment alternatives; as well as the risks, contraindications, precautions, and warnings of the interventions, treatments, and medications that are prescribed and administered
  • To be informed of their right to refuse to receive or to continue treatment, and to explain the consequences of that refusal
  • To authorize or not the presence of people who are not directly related to medical care, at the time of the evaluations
  • To allow their consent to be in writing when they are the subject of investigation for the application of medications or treatments
  • To choose not to receive contraception method without prior informed consent, and to be obtained by the individual when he/she is not in a crisis situation due to the diagnosed mental health problem
  • To not be discriminated against or be stigmatized for having or for suffering from, permanently or temporarily, a mental health problem
  • To be treated with respect to their dignity, autonomy and needs, in accordance with the provisions of the CRPD

In addition, LawNo295 further states that individuals who, for any reason, are deprived of discernment are considered to be absolutely incapable of giving consent. Individuals who suffer from mental deterioration that prevents them from expressing their free will are considered to be relatively incapable of giving consent.

The G-EC-CTReview specifies that persons who are temporarily mentally incapacitated may participate in a research study if their designated legal representative(s) or guardian(s) decides on their behalf to allow them to participate per the requirements specified in LawNo1384, which amends LawNo295. The legal representative(s) or guardian(s) should be over 18 years of age. When no support has been designated and there is no representation for a mentally incapacitated person, the decision regarding his/her participation in a clinical trial will be made by his/her legal representative(s) or guardian(s) in accordance with the consanguinity or affinity ties delineated in RegLawNo29414. See LawNo1384 and RegLawNo29414 for requirements related to the roles and responsibilities of legal representative(s) or guardian(s).

DecreeNo021-2017, in turn, indicates that the following conditions must be met for clinical trials involving participants who are mentally incapable of giving consent:

  • Informed consent must be obtained from the legal representative(s) or guardian(s) who have been informed of the possible risks, discomforts, and benefits of the trial
  • Informed consent may be obtained from the participant when he/she has been fully informed about the trial in easily understandable language
  • Consent may be withdrawn at any time without harm to the participant and/or his/her legal representative(s) or guardian(s)
Additional Resources
(1) (International Guidance) Convention on the Rights of Persons with Disabilities (CRPD) (PER-54) (Spanish) (Effective May 3, 2008)
UN General Assembly
(2) (Webpage) Government Enacts Mental Health Law (PER-68 - Spanish) (May 23, 2019)
Ministry of Health
Investigational Products > Definition of Investigational Product
Last content review/update: November 19, 2020
Requirements
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo021-2017 - Spanish) (GoogleTranslate-DecreeNo021-2017) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Article 2
(2) (Guidance) External User’s Guide for Safety Reporting in Clinical Trials (G-SafetyRpting - Spanish) (Edition No. 01) (March 22, 2019)
General Office of Research and of Health Technology Transfer, National Institute of Health, Ministry of Health
Relevant Sections: V
(3) (Guidance) Guideline for the Procedure for Requesting Authorization of the Clinical Trial (G-CTApplicProc - Spanish) (Edition No. 02) (November 15, 2019)
National Institute of Health, Ministry of Health
Relevant Sections: 2
Summary

Overview

As delineated in DecreeNo021-2017, the G-CTApplicProc, and the G-SafetyRpting, an investigational product (IP) is defined as a pharmaceutical form of an active substance or placebo, being tested or used as an active comparator in a clinical trial. This includes a product with a marketing authorization when it is used or assembled (formulated or packaged) in a different way from the approved form, when used for an unapproved indication, or when used to gain further information about an approved use.

DecreeNo021-2017 also defines a placebo as a product with a pharmaceutical form, with no active ingredient, and therefore devoid of specific pharmacological action, which may be used as a control in the clinical trial or for maintaining blinding.

Additional Resources
No additional resources
Investigational Products > Manufacturing & Import
Last content review/update: November 19, 2020
Requirements
(1) (Regulation) Supreme Decree No. 016-2011-SA: Regulatory Approval for the Registration, Control and Sanitary Surveillance of Pharmaceutical Products, Medical Devices and Health Products (DecreeNo016-2011 - Spanish) (July 27, 2011)
Ministry of Health
Relevant Sections: Title II (Chapter I and V) and Title III (Chapter I)
(2) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo021-2017 - Spanish) (GoogleTranslate-DecreeNo021-2017) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 8, 69, 70, 90, 94, 97, and 115-118
(3) (Guidance) Guideline for the Procedure for Requesting Authorization of the Clinical Trial (G-CTApplicProc - Spanish) (Edition No. 02) (November 15, 2019)
National Institute of Health, Ministry of Health
Relevant Sections: 4-5
(4) (Guidance) Procedures Manual of Clinical Trials (MAN-INS-001) (INS-CTManual - Spanish) (3rd Edition) (November 17, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Chapters VI (6.4) and VII (7.5), and Flow Charts No. 04
Summary

Overview

According to DecreeNo021-2017, DecreeNo016-2011, the INS-CTManual, and the G-CTApplicProc, the sponsor or his/her contract research organization (CRO) must obtain approval from the National Authority for Pharmaceutical Products, Medical Devices and Medical Products (la Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (ANM)) to manufacture or import investigational products (IPs) in Peru. (Note: The ANM is also referred to as the General Directorate of Medicines, Supplies and Drugs (La Dirección General de Medicamentos Insumos y Drogas (DIGEMID))). As per DecreeNo021-2017, Peru’s National Institute of Health (Instituto Nacional de Salud (INS)) must approve the clinical trial application prior to ANM’s approval of an IP. However, as specified in DecreeNo021-2017 and the G-CTApplicProc, the INS does request ANM to assess the safety profile of the IP to be used in a clinical trial as part of its application review and approval process.

DecreeNo021-2017 and DecreeNo016-2011 specify that ANM will authorize the import of IPs exclusively for research involving humans when the applicant can provide information to support the product’s safety and quality according to the stage and type of research being conducted. Documentation requirements for ANM’s approval are as follows:

  • Application for authorization to import the product(s) under investigation and complementary products
  • Copy of INS clinical trial authorization approval
  • List of INS-approved research products, complementary products and supplies to be used in the trial
  • Proof of payment for processing fee

The ANM will grant this authorization within three (3) business days of filing the application.

Per the INS-CTManual, to obtain INS approval for an amended supplies list, the sponsor or his/her CRO must submit the following documents:

  • Form FOR-OGITT-033 (PER-42)
  • Analysis certificate
  • IP labeling
  • Certificate of Good Manufacturing Practices

The ANM is also responsible for authorizing post-study access to the IP by study participants when it is demonstrated to be beneficial.

See Clinical Trial Lifecycle topic, Timeline of Review subtopic for additional information on ANM’s role in the clinical trial application approval process.

Please note: Peru is party to the Nagoya Protocol on Access and Benefit-sharing (PER-11), which may have implications for studies of IPs developed using certain non-human genetic resources (e.g., plants, animals, and microbes). For more information, see PER-57.

Additional Resources
(1) (Document) Communique No. 002-2019-OGITT/INS – Research Products Requirements for Clinical Trial Authorization (PER-5 - Spanish) (May 08, 2019)
General Office of Research and of Health Technology Transfer, National Institute of Health, Ministry of Health
(2) (Document) Nagoya Protocol on Access and Benefit-sharing (PER-11) (2011)
Convention on Biological Diversity, United Nations
(3) (Form) List of Products and Supplies to be Used in the Clinical Trial (FOR-OGITT-033) (PER-42 - Spanish) (Edition No. 02) (April 9, 2018)
National Institute of Health, Ministry of Health
(4) (Webpage) Country Profile: Peru (PER-57) (Current as of November 19, 2020)
Access and Benefit-sharing Clearing-house, Convention on Biological Diversity, United Nations
(5) (Webpage) General Directorate of Medicines, Supplies and Drugs (DIGEMID) (PER-56 - Spanish) (Current as of November 19, 2020)
Ministry of Health
Investigational Products > IMP/IND Quality Requirements
Last content review/update: November 19, 2020
Requirements
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo021-2017 - Spanish) (GoogleTranslate-DecreeNo021-2017) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 8, 40, 68, 69, 70, 108, and Annexes 2 and 5
(2) (Guidance) External User’s Guide for Safety Reporting in Clinical Trials (G-SafetyRpting - Spanish) (Edition No. 01) (March 22, 2019)
General Office of Research and of Health Technology Transfer, National Institute of Health, Ministry of Health
Relevant Sections: VII
(3) (Guidance) Guideline for the Procedure for Requesting Authorization of the Clinical Trial (G-CTApplicProc - Spanish) (Edition No. 02) (November 15, 2019)
National Institute of Health, Ministry of Health
Relevant Sections: 4-6
(4) (Guidance) Procedures Manual of Clinical Trials (MAN-INS-001) (INS-CTManual - Spanish) (3rd Edition) (November 17, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Chapter VI (6.4), VII (7.5, 7.6.3, 7.7.2, and 7.8.4), Chapter IX, and Flow Charts No. 04, No. 08, No. 11, and No. 15
Summary

Overview

In accordance with DecreeNo021-2017 and the G-CTApplicProc, the sponsor or his/her contract research organization (CRO) is responsible for providing the investigators with an Investigator’s Brochure (IB). The IB must contain all of the relevant information on the investigational product(s) (IPs) obtained through the earlier research phases, including preclinical, toxicological, safety, efficacy, and adverse events data. As noted in DecreeNo021-2017, the IB must be validated and updated on a regular basis by the sponsor and at least once a year by the responsible team member (if not the sponsor), when new information on the IP—not yet included in the manual—becomes available. DecreeNo021-2017 and the INS-CTManual indicate that the updated IB should be sent to the National Institute of Health (Instituto Nacional de Salud (INS))’s General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnológica (OGITT)), the EC(s), and the PIs. The INS-CTManual further specifies that the sponsor or his/her CRO is required to submit a signed notification form to inform the INS’s OGITT of any IB updates (see PER-41). The form must be accompanied by an update report of the applicable IP(s).

IB Content Requirements

As specified in DecreeNo021-2017, the IB must provide coverage of the following areas:

  • Physical, chemical, and pharmaceutical properties and formulation parameters
  • Non-clinical studies (pharmacology, pharmacokinetics, toxicology, and metabolism profiles)
  • Clinical studies (pharmacokinetics, metabolism, pharmacodynamics, dose response safety, efficacy, and other pharmacological activities; safety and efficiency
  • Post-marketing experience (e.g., countries where the IP has been marketed or approved or did not receive approval/registration, was withdrawn, or registration was suspended; any significant information arising from marketed use; potential risks and adverse reactions)
  • Publication and report references

See Annex 2 of DecreeNo021-2017 for detailed content guidelines.

In addition, per the G-SafetyRpting, the sponsor or his/her CRO must ensure that the IB specifies and lists the adverse events (AEs) observed with the IP and for which there is a confirmed or suspected causal relationship. Refer to the G-SafetyRpting for detailed information to include in the IB.

As specified in DecreeNo021-2017, the INS-CTManual, and the G-CTApplicProc, Peru’s INS requires the National Authority for Pharmaceutical Products, Medical Devices and Medical Products (la Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (ANM) to assess the safety and quality of the IP to be used in a clinical trial as part of its application review and approval process. Per DecreeNo021-2017, the ANM’s assessment must be completed within 30 days. (Note: The ANM is also referred to as the General Directorate of Medicines, Supplies and Drugs (La Dirección General de Medicamentos Insumos y Drogas (DIGEMID))).

DecreeNo021-2017 states that the IP must also meet at least one (1) of the following conditions to be authorized for use in clinical trials in Peru:

  • Must be approved for use in humans by drug regulatory authorities of countries with high health surveillance
  • Is produced in Peru, is used in preclinical research, and complies with Ministry of Health of Peru (Ministerio de Salud del Perú (MINSA))’s political and/or research priorities
  • Will serve to establish pharmaceutical therapeutic equivalence
  • Is considered a priority for the country’s public health or is within the scope of MINSA policies and/or research priorities
  • At the request of the ANM require a clinical trial to support its efficacy and safety for the health registry

Additionally, per DecreeNo021-2017, to obtain trial authorization, the following documents relating to the IP must be submitted:

  • Labeling info
  • Certificate of batch release analysis or documents that include technical specifications of the batch/series result of the finished product
  • Accelerated or long-term stability studies as appropriate
  • Current certificate of the good manufacturing practices of the IP manufacturer, issued by the competent authority of the country of origin or document that guarantees its compliance

For detailed information on submission requirements for comparator IPs and complementary products, refer to Annex 5 of DecreeNo021-2017.

Drug Manufacturing Certificate Requirements

As stated in DecreeNo021-2017 and the G-CTApplicProc, ANM must approve the manufacture of IPs for their use in a clinical trial. DecreeNo021-2017 also specifies that the sponsor or his/her CRO must ensure the products are manufactured in accordance with the current codes of Good Manufacturing Practice (GMP).

According to PER-42, the sponsor or his/her CRO must also supply the investigator(s)/institution(s) with the IP(s), including the comparator(s) and placebo, if applicable.

Per the INS-CTManual, the sponsor or his/her CRO must complete the List of Products and Supplies to be Used in the Clinical Trial (refer to PER-42). As indicated in PER-42, the form requires the sponsor or his/her CRO to provide the following data:

  • Name of product
  • Active ingredient(s)
  • Route of administration
  • Pharmaceutical form and concentration
  • Manufacturer name
  • Country of origin
  • Quantity
  • Lot number or coding system

In addition, per DecreeNo021-2017 and the INS-CTManual, if the sponsor or his/her CRO plans to modify or expand the IP list to be imported, he/she must apply to the INS within 30 calendar days prior to the trial’s expiration. According to the INS-CTManual, the following documents must be submitted:

  • Request for expansion or modification of the list of supplies
  • Report justifying the reasons for the expansion or modification of the list of supplies
  • Additional or modified detailed list of supplies necessary for the trial’s execution

See PER-42 for the form and the INS-CTManual for additional instructions on completing this form. Per the INS-CTManual, the INS approval process will be completed within a maximum of 10 days.

(See Investigational Products topic, Product Management subtopic for additional information on sponsor requirements).

Additional Resources
(1) (Document) Communique No. 002-2018-OGITT/INS - List of Products and Supplies to be Used in the Clinical Trial (PER-13 - Spanish) (March 18, 2018)
General Office of Research and of Health Technology Transfer, National Institute of Health, Ministry of Health
(2) (Form) List of Products and Supplies to be Used in the Clinical Trial (FOR-OGITT-033) (PER-42 - Spanish) (Edition No. 02) (April 9, 2018)
National Institute of Health, Ministry of Health
(3) (Form) Other Relevant Notifications (FOR-OGITT-059) (PER-41 - Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
(4) (Webpage) General Directorate of Medicines, Supplies and Drugs (DIGEMID) (PER-56 - Spanish) (Current as of November 19, 2020)
Ministry of Health
Investigational Products > Labeling & Packaging
Last content review/update: November 19, 2020
Requirements
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo021-2017 - Spanish) (GoogleTranslate-DecreeNo021-2017) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Article 91
Summary

Overview

Investigational product (IP) labeling in Peru must comply with the requirements set forth in DecreeNo021-2017. Labels for IPs used in a clinical trial must written in Spanish or English language and printed in indelible ink.

In addition, the following information must be included as a minimum on the product label:

  • Name, address and telephone number of the sponsor or contract research organization (CRO)
  • Trial number and/or trial title
  • IP name or unique code
  • Date of IP’s expiration or reanalysis
  • Manufacturing lot number
  • Number of units and pharmaceutical form
  • Route of administration
  • Special storage and conservation requirements
  • “For research use only”, “no sale”, or similar wording indicating the IP is clinical trial material

The inner labeling of the IP should contain:

  • IP name
  • Active ingredient concentration
  • Route of administration
  • Manufacturer's name or logo
  • Batch number and expiration date

In double-blind trials where the IP character, lot number, and manufacturer’s name are not included on the label, the package must include a document that links to information that identifies possible blinded treatments. Furthermore, the labeling must indicate the most restrictive storage requirements on both products.

(See Investigational Products topic, Product Management subtopic for additional information on investigational medicinal product (IMP) supply, storage, and handling requirements).

Additional Resources
No additional resources
Investigational Products > Product Management
Last content review/update: November 19, 2020
Requirements
(1) (Regulation) Supreme Decree No. 016-2011-SA: Regulatory Approval for the Registration, Control and Sanitary Surveillance of Pharmaceutical Products, Medical Devices and Health Products (DecreeNo016-2011 - Spanish) (July 27, 2011)
Ministry of Health
Relevant Sections: Title II (Chapter I and II) and Title III (Chapter I)
(2) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo021-2017 - Spanish) (GoogleTranslate-DecreeNo021-2017) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 8, 89, 90, 92-94, 97, 108, 115-118, and Annex 2
(3) (Guidance) Guideline for the Procedure for Requesting Authorization of the Clinical Trial (G-CTApplicProc - Spanish) (Edition No. 02) (November 15, 2019)
National Institute of Health, Ministry of Health
Relevant Sections: 4 and 6
(4) (Guidance) Procedures Manual of Clinical Trials (MAN-INS-001) (INS-CTManual - Spanish) (3rd Edition) (November 17, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Chapter VI (6.4), VII (7.5, 7.6.3, and 7.8.4), Chapter IX, and Flow Charts No. 04, No. 08, and No. 15
Summary

Overview

In accordance with DecreeNo021-2017, the INS-CTManual, and the G-CTApplicProc, the sponsor or his/her contract research organization (CRO) is responsible for providing the investigators with an Investigator’s Brochure (IB). The IB must contain all of the relevant information on the investigational product(s) (IPs) obtained through the earlier research phases, including preclinical, toxicological, safety, efficacy, and adverse events data. The sponsor should also update the IB as significant new information becomes available.

Investigational Product Supply, Storage, and Handling Requirements

According to PER-42, the sponsor or his/her CRO must supply the investigator(s)/institution(s) with the IP(s), including the comparator(s) and placebo, if applicable. In addition, if the sponsor or his/her CRO plans to modify or expand the IP list to be imported, he/she must apply to the National Institute of Health (Instituto Nacional de Salud (INS))’s General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnológica (OGITT)) and attach a report justifying the reasons for the application submission. See the INS-CTManual for detailed instructions on completing this form. The duration of the approval process for the extended or modified list is 10 days. In addition, according to DecreeNo021-2017, DecreeNo016-2011, and the G-CTApplicProc, the sponsor or his/her CRO must obtain approval from the National Authority for Pharmaceutical Products, Medical Devices and Medical Products (la Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (ANM)) to manufacture or import IPs in Peru. (Note: The ANM is also referred to as the General Directorate of Medicines, Supplies and Drugs (La Dirección General de Medicamentos Insumos y Drogas (DIGEMID))).

In addition, per the INS-CTManual, the sponsor or his/her CRO must complete the List of Products and Supplies to be Used in the Clinical Trial (refer to PER-42). This form requires the sponsor or his/her CRO to provide the following data:

  • Name of product
  • Active ingredient(s)
  • Route of administration
  • Pharmaceutical form and concentration
  • Manufacturer name
  • Country of origin
  • Quantity
  • Lot number or coding system

Per DecreeNo021-2017, IPs will be dispensed through a Dispensation Unit for Clinical Trials under the Service or Pharmacy Department of the research institution where the trial will be conducted. The dispensation process must comply with the Ministry of Health of Peru (Ministerio de Salud del Perú (MINSA))’s Good Practices of Storage and Good Dispensation Practices and study specifications agreed to by the sponsor. The Clinical Trial Dispensing unit is responsible for:

  • Maintaining a record of dates in which IP quantities are received/dispensed
  • Inventorying IPs
  • Controlling overused, used, and unused IPs for final disposal as established in the protocol

Additionally, per DecreeNo021-2017, the sponsor must fund IPs for use in trials and provide them free of charge to research participants.

As per DecreeNo021-2017, the IP must also meet at least one (1) of the following conditions to be authorized for use in clinical trials in Peru:

  • Must be approved for use in humans by drug regulatory authorities of countries with high health surveillance
  • Is produced in Peru, is used in preclinical research, and complies with MINSA’s political and/or research priorities
  • Will serve to establish pharmaceutical therapeutic equivalence
  • Is considered a priority for the country’s public health or is within the scope of MINSA policies and/or research priorities
  • At the ANM’s request, require a clinical trial to support its efficacy and safety for the health registry

DecreeNo021-2017 further notes that the sponsor or his/her CRO is responsible for the following IP surveillance activities:

  • Continuously evaluate IP safety and implement an IP security monitoring system
  • Notify the OGITT of all serious adverse events (SAEs), serious adverse drug reactions (SADRs), suspected and unexpected serious adverse reactions (SUSARs)
  • Submit SAE/SADR and SUSAR reports on international incidents to the OGITT using the Council for International Organizations of Medical Sciences (CIOMS) form
  • Submit IB updates to the OGITT, ethics committees (ECs) and principal investigators (PIs)
  • Submit annual IP safety reports to the OGITT and ANM
  • Notify the OGITT, EC, and PIs of any findings that could adversely affect the research participant safety, affect the conduct of the study, or alter the benefit/risk balance. A report must be prepared for the INS and corresponding EC within a maximum period of seven (7) calendar days
  • Maintain detailed records of all adverse events communicated by the PIs

As delineated in DecreeNo021-2017, the ANM is also responsible for authorizing post-study access to the IP by study participants when it is demonstrated to be beneficial. ANM authorization is granted on a case by case basis through the following procedures:

  • Authorization of a clinical trial corresponding to an OGITT approved extension study
  • ANM authorization for an IP which must have proved to be beneficial to a participant, at the PI’s discretion, and its use will be maintained as soon as there is benefit
  • The PI should communicate to the sponsor the IP’s benefit to the participant, and the sponsor must, in turn, request ANM authorization (See Title X of DecreeNo021-2017 for documentation submission requirements)
Additional Resources
(1) (Document) Communique No. 002-2019-OGITT/INS – Research Products Requirements for Clinical Trial Authorization (PER-5 - Spanish) (May 08, 2019)
General Office of Research and of Health Technology Transfer, National Institute of Health, Ministry of Health
(2) (Form) List of Products and Supplies to be Used in the Clinical Trial (FOR-OGITT-033) (PER-42 - Spanish) (Edition No. 02) (April 9, 2018)
National Institute of Health, Ministry of Health
(3) (Form) Other Relevant Notifications (FOR-OGITT-059) (PER-41 - Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
(4) (Webpage) General Directorate of Medicines, Supplies and Drugs (DIGEMID) (PER-56 - Spanish) (Current as of November 19, 2020)
Ministry of Health
Specimens > Definition of Specimen
Last content review/update: November 19, 2020
Requirements
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo021-2017 - Spanish) (GoogleTranslate-DecreeNo021-2017) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Complementary Provisions Final
Summary

No relevant provisions are currently available that define specimens.

However, as noted in DecreeNo021-2017, standards relating to biological samples to be used in clinical trials will be approved in a forthcoming National Institute of Health (Instituto Nacional de Salud (INS)) resolution.

Additional Resources
No additional resources
Specimens > Specimen Import & Export
Last content review/update: November 19, 2020
Requirements
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo021-2017 - Spanish) (GoogleTranslate-DecreeNo021-2017) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Complementary Provisions Final
Summary

No relevant provisions are currently available regarding the import or export of specimens.

However, as noted in DecreeNo021-2017, standards relating to biological samples to be used in clinical trials will be approved in a forthcoming National Institute of Health (Instituto Nacional de Salud (INS)) resolution.

Additional Resources
No additional resources
Specimens > Consent for Specimen
Last content review/update: November 19, 2020
Requirements
(1) (Legislation) Law No. 27337 – Law that Approves the New Code of Children and Adolescents (LawNo27337 - Spanish) (Effective August 2, 2000)
Ministry of Women and Vulnerable Populations
Relevant Sections: Civil Rights (Articles 1 and 4)
(2) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo021-2017 - Spanish) (GoogleTranslate-DecreeNo021-2017) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 25, 34, Annex 4, and Complementary Provisions Final
(3) (Guidance) Guide for the Ethical Review of Clinical Trials by Institutional Research Ethics Committees (G-EC-CTReview - Spanish) (Edition No. 1) (January 8, 2020)
Executive Office of Research, General Office for Research and Technology Transfer, National Institute of Health, Ministry of Health
Relevant Sections: Ethical Criterion 4 and Annex 2
Summary

Overview

In accordance with DecreeNo021-2017, if a clinical trial team is considering the collection and storage of biological samples for future use, this point should be delineated explicitly in a separate informed consent form (ICF).

Annex 4 of DecreeNo021-2017 and the G-EC-CTReview also state that the ICF must list the following biological sample study procedures:

  • Sample collection details: type, quantity and number of times to be extracted; explaining how many times and how much is needed, in measures that the research participant understands
  • Final destination of remaining samples: stating explicitly that the samples obtained will be used only for ongoing research, and will be destroyed when the trial is completed, unless storage is contemplated for future use
  • Sample storage or their remainders for future studies: if stock samples are to be stored beyond the end of the trial and/or biological samples are to be taken for storage and future studies, it should be incorporated into a specific ICF for that end

Per the G-EC-CTReview, donors of biological samples and related data must give their consent (either specific or broad) to authorize the future use of their samples. The ethics committee (EC) responsible for reviewing the associated research protocol must verify that the proposed uses of the donor samples are within the scope of authorization that the donor agreed to in the informed consent form.

In addition, Annex 4 of DecreeNo021-2017 and the G-EC-CTReview specify that in the event a research participant withdraws his/her informed consent, the ICF must explain how the participant’s rights to privacy and confidentiality in the handling of his/her biological data and samples will be upheld.

Further, as set forth in DecreeNo021-2017, when a clinical trial is to be conducted in indigenous peoples in Peru and the storage of biological samples is being considered, authorization must be obtained from the corresponding regional and local government, and of the respective community authorities, who must consider the interest of the community involved.

Per LawNo27337, children and adolescents are also guaranteed protection from experiments or genetic manipulations contrary to their integrity and their physical or mental development.

As noted in DecreeNo021-2017, standards relating to biological samples to be used in clinical trials will be approved in a forthcoming National Institute of Health (Instituto Nacional de Salud (INS)) resolution.

Additional Resources
No additional resources
Sections Country Announcement
Country Announcement
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COVID-19 Guidance

On June 26, 2020, Peru’s National Institute of Health (Instituto Nacional de Salud (INS)) issued Guidelines for the Conduct of Clinical Trials during the Health Emergency Due to COVID-19. The guidelines aim to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practices, and minimizing risks to trial integrity. (Google translation of guidelines)

The INS has also issued the following communications related to COVID-19:

On April 14, 2020, the Ministry of Health of Peru (Ministerio de Salud del Perú (MINSA)) issued Supreme Decree No. 014-2020 SA, which provides measures to ensure the proper conduct of clinical trials related to COVID-19. (Google translation of Supreme Decree No. 014-2020 SA)

A list of current resolutions related to COVID-19 is available here.

This message was reviewed on January 20, 2021
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