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
Parallel regulatory and ethical review permitted 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 30, 2018
Requirements
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 6, 7, 70, and 119-128
(2) (Guidance) Guideline for the Procedure for Requesting Authorization of the Clinical Trial (G-CTApplicProc - Spanish) (Edition No. 01) (November 28, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: 2
(3) (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
(4) (Regulation) Supreme Decree No. 001-2003-SA: Approves the Regulation of Organization and Functions of the National Institute of Health (DecreeNo 001-2003-SA - 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)
Summary

Overview

As per DecreeNo 021-2017-SA, the G-CTApplicProc, and Additional Resource (A), 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 DecreeNo 021-2017-SA, the G-CTApplicProc, the INS CTManual, and Additional Resource (B).

As indicated in DecreeNo 001-2003-SA and Additional Resources (C), (D), and (E), the INS is an 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 DecreeNo 021-2017-SA.

According to Additional Resource (E), 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 on the national level, institutional ethics committees (ECs), research sites, and contract research organizations (CROs). (See Additional Resource (G) for detailed information on REPEC.)

For information on OGITT’s role in clinical trial oversight, see Articles 119 through 128 of DecreeNo 021-2017-SA.

INS Contact Information
Instituto Nacional de Salud
Cápac Yupanqui 1400
Jesus María
Lima 11
Perú
Phone: 511 748 1111
Fax: Not Available

or

Av. Defensores del Morro 2268 (Former Huaylas)
Chorrillos
Lima 9
Peru
Phone: (511) 748 0000
Fax: Not Available
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
Email: webmaster@ins.gob.pe
Clinical Trial Phone: 511 748 1111 (Ext. 2191)
Fax: Not Available
Clinical Trial Email: consultaensayos@ins.gob.pe

Additional Resources
(A) (Website) History of the Processes Involved in the Legislation of Clinical Trials in Peru (Spanish) (Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
(B) (Website) About the Regulatory Authority (Spanish) (Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
(C) (Website) INS - About Us (Spanish) (Current as of November 28, 2018)
National Institute of Health, Ministry of Health
(D) (Website) About the Executive Research Office (OGITT) (Spanish) (Current as of November 28, 2018)
National Institute of Health, Ministry of Health
(E) (Website) Presentation (OGITT) (Spanish) (Current as of November 28, 2018)
National Institute of Health, Ministry of Health
(F) (Website) INS - Contact Us (Spanish) (Current as of November 28, 2018)
National Institute of Health, Ministry of Health
(G) (Website) Peruvian Clinical Trials Registry (REPEC) (Spanish) (English(Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
Regulatory Authority > Scope of Assessment
Last content review/update: November 30, 2018
Requirements
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 2, 6, 7, 8, 10, 40, 74, 52, 59, 63, 67-74, 94, 119-121, Complementary Provisions - Final (Eighth), and Annexes 1-5
(2) (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
(3) (Guidance) Guideline for the Procedure for Requesting Authorization of the Clinical Trial (G-CTApplicProc - Spanish) (Edition No. 01) (November 28, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: 2, 4, and 6
(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: 1, 2, 4, and 5
(5) (Regulation) Supreme Decree No. 016-2011-SA: Regulatory Approval for the Registration, Control and Sanitary Surveillance of Pharmaceutical Products, Medical Devices and Health Products (DecreeNo 016-2011-SA - Spanish) (July 27, 2011)
Ministry of Health
Relevant Sections: Title I (Article 2) and Title II (Chapters I and V)
Summary

Overview

In accordance with DecreeNo 021-2017-SA, the INS CTManual, the G-CTApplicProc, the G-CTSubmissionProcs, and Additional Resource (A), Peru’s National Institute of Health (Instituto Nacional de Salud (INS)) is responsible for reviewing, evaluating, and approving applications for clinical trials using registered or unregistered investigational products (IPs). As per DecreeNo 021-2017-SA, and DecreeNo 016-2011-SA, 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.

As specified in DecreeNo 021-2017-SA, the INS CTManual, and the G-CTApplicProc, the INS’s review and approval of a clinical trial application is dependent upon obtaining proof of ethics committee (EC) approval. 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, and Additional Resources (B) and (C) for the clinical trial application and detailed instructions on completing the form.

Further, according to DecreeNo 021-2017-SA, the G-CTApplicProc, and Additional Resources (D) and (E), the EC must be registered with the Peruvian Clinical Trials Registry (Registro Peruano de Ensayos Clínicos (REPEC)) (see Additional Resource (E) for EC registration form). Per the INS CTManual, the G-CTApplicProc, and Additional Resources (F) and (G), the sponsor and his/her contract research organization (CRO) must also register with the REPEC prior to submitting an application for clinical trial authorization. Refer to the INS CTManual, the G-CTApplicProc, and Additional Resources (F) and (G) for detailed registration instructions, and Additional Resources (H) and (I) 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 DecreeNo 021-2017-SA and the G-CTApplicProc, the sponsor must also ensure authorization by the research institution where the clinical trial will be carried out.

DecreeNo 021-2017-SA states that the 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), require 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 Additional Resource (A), 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 DecreeNo 021-2017-SA, DecreeNo 016-2011-SA, 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 DecreeNo 021-2017-SA, 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 profile of the IP to be used in a clinical trial as part of its application review and approval process.

As per DecreeNo 021-2017-SA, the INS CTManual, and Additional Resource (A), the INS review and approval process for a clinical trial application takes a maximum of 40 working days (including the 30 days for the ANM per DecreeNo 021-2017-SA). However, when biological products are used, or, in controversial situations that involve convening a technical commission in clinical research, the maximum period for clinical trial authorization is 60 working days (including the 45 days for the ANM’s safety profile evaluation).

DecreeNo 021-2017-SA also notes that the INS will be able to convene a technical commission of experts when controversial situations arise during the authorization process. Also, the sponsor has the right to appeal when the INS does not grant authorization.

DecreeNo 021-2017-SA 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 DecreeNo 021-2017-SA, 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 Additional Resource (J), for any clinical trial lasting longer than 12 months, the sponsor or his/her CRO must request a trial authorization renewal and submit the following documents to the INS within 30 calendar days prior to the trial’s expiration:

  • Authorization renewal request (use the REPEC e-form (Additional Resource (B))
  • EC-approved research protocol and valid informed consent
  • Additional supply list
  • INS-issued payment receipt

Per Additional Resource (J), a trial renewal is a separate procedure from a trial extension. The application to be used depends on the total duration of the trial registered in the trial authorization form via REPEC, and the time elapsed from the study’s commencement. The fee for requesting a renewal is 839.50 Peruvian Soles and the INS procedure will be completed within 10 days.

DecreeNo 021-2017-SA and Additional Resource (J) 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 (using the REPEC e-form (Additional Resource (B) per Additional Resource (J))
  • 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-registered EC
  • List of additional supplies required (if applicable) to implement the trial per the INS CTManual
  • Proof of payment of processing fees
  • Current insurance policy (Additional Resource (J))

The authorized trial extension will be valid for a maximum of 12 months from the date of issue. Additional Resource (J) also notes that the fee for requesting an extension is 839.50 Peruvian Soles and the INS procedure will be completed within 10 days.

Additional Resources
(A) (Website) Registration of a Clinical Trial - Authorization (Spanish) (Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
(B) (Form) Application for Clinical Trial Authorization (FOR-OGITT-028) (Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
National Institute of Health, Ministry of Health
(D) (Website) Registration of Institutional Research Ethics Committee (Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
(E) (Website) National Registry of Institutional Ethics Committees in Accredited Research (Spanish) (Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
(F) (Website) Registration of a Sponsor (Spanish) (Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
(G) (Website) Registration of Contract Research Organization (CRO) (Spanish) (Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
(H) (Form) Application for Contract Research Organization Registration (FOR-OGITT-021) (Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
(I) (Form) Application for Sponsor Registration (FOR-OGITT-020) (Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
(J) (Website) List of Procedures (Spanish) (Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
(K) (Website) Peruvian Clinical Trials Registry (REPEC) (Spanish) (English(Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
(L) (Website) General Directorate of Medicines, Supplies and Drugs (DIGEMID) (Spanish) (Current as of November 28, 2018)
Ministry of Health
Regulatory Authority > Regulatory Fees
Last content review/update: November 30, 2018
Requirements
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 67, 76, 78-80, 87, and 88
(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: 5
(3) (Guidance) Guideline for the Procedure for Requesting Authorization of the Clinical Trial (G-CTApplicProc - Spanish) (Edition No. 01) (November 28, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: 6
Summary

Overview

As per DecreeNo 021-2017-SA, the G-CTSubmissionProcs, and Additional Resource (A), the sponsor or his/her contract research organization (CRO) is responsible for paying a fee, as applicable, to the National Institute of Health of Peru (Instituto Nacional de Salud (INS)) to submit a clinical trial application for authorization. Additionally, per DecreeNo 021-2017-SA, 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. The G-CTSubmissionProcs also indicates that the INS reimburses processing fees when an application is cancelled.

Per DecreeNo 021-2017-SA and the G-CTApplicProc, in the case of multicenter clinical trials, payment must be made by each of the participating research centers in Peru.

According to Additional Resource (A), the INS processing fee for a clinical trial authorization is 1775.00 Peruvian Soles. In addition, Additional Resource (B) provides the following INS processing fees information:

  • Trial authorization renewal: 839.50 Peruvian Soles
  • Trial extension: 839.50 Peruvian Soles
  • Research center extension: Trial evaluation by additional center (Lima): 401.50 Peruvian Soles; Trial evaluation by additional center (Provinces): 730.00 Peruvian Soles

See DecreeNo 021-2017-SA and Additional Resources (A) and (B) for detailed information on INS clinical trial-related costs.

Additional Resources
(A) (Website) Registration of a Clinical Trial - Authorization (Spanish) (Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
(B) (Website) List of Procedures (Spanish) (Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
Relevant Sections: Clinical Trial Authorization Renewal, Extension for a Clinical Trial, Addition of New Research Sites
Ethics Committee > Ethics Committee
Last content review/update: November 30, 2018
Requirements
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 40, 59, 61-66, 71, 102, and Complementary Provisions - Final (Eighth)
(2) (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
(3) (Guidance) Guideline for the Procedure for Requesting Authorization of the Clinical Trial (G-CTApplicProc - Spanish) (Edition No. 01) (November 28, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: 4 and 6
(4) (Guidance) Model Manual of Procedures for Institutional Ethics Committees on Research in Peru (INS ECManual - Spanish) (January 2013)
National Institute of Health, Ministry of Health
Relevant Sections: Objectives, Operating Definitions, Chapter I, Chapter II, Annex A, and Annex B
Summary

Overview

As set forth in DecreeNo 021-2017-SA, the INS CTManual, the G-CTApplicProc, and Additional Resources (A), (B), and (C), Peru requires clinical trial approval from an institutional level ethics committee (EC) that is registered with the National Institute of Health (Instituto Nacional de Salud (INS))’s Peruvian Clinical Trials Registry (Registro Peruano de Ensayos Clínicos (REPEC)). There are no stated requirements regarding which EC the sponsor should choose to conduct the clinical protocol review. As noted in DecreeNo 021-2017-SA, those research institutions that do not have an EC may select another INS-accredited EC, preferably located in the same region. Refer to Additional Resources (B) and (C) for additional EC registration instructions, and Additional Resource (C) for the application form required to register an institutional EC.

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 DecreeNo 021-2017-SA, institutional ECs should consist of at least five (5) members represented by a multidisciplinary group of health professionals and community members, including:

  • Persons 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 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 list of all members must be publically accessible. Also, the EC should seek the assistance of expert consultants on different topics when it lacks the knowledge and experience necessary to evaluate the protocol.

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

DecreeNo 021-2017-SA and the INS ECManual state that infrastructure requirements for the operation of institutional ECs must be met including insuring work environments that guarantee confidentiality and computer equipment with sufficient capacity, and providing administrative staff.

ECs must also have stated rules and prepare a procedures manual that is approved by the research institution; seek specialist(s) advice on diseases or methodologies outside the EC’s expertise; and ensure that alternate committee members have been selected. The rules should establish composition and requirements to be fulfilled by its members; meeting frequency; and specific quorum requirements. The procedures manual should provide filing dossier administrative requirements, and procedures for monitoring authorized research protocols, for the preparation and approval of meeting minutes, and for filing related documentation. Further, when an EC member has a conflict of interest, he/she must be replaced by an alternate member for the review and this must be documented in the meeting minutes. See Title IV, Chapter 7 of DecreeNo 021-2017-SA for detailed EC requirements.

Additional Resources
(A) (Website) Registration of a Clinical Trial - Authorization (Spanish) (Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
(B) (Website) Registration of Institutional Research Ethics Committee (Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
(C) (Website) National Registry of Institutional Ethics Committees in Accredited Research (Spanish) (Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
(D) (Website) Peruvian Clinical Trials Registry (REPEC) (Spanish) (English(Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
(E) (Website) Schedule and Members (CIEI-INS) (Spanish) (Current as of November 28, 2018)
National Institute of Health, Ministry of Health
Ethics Committee > Scope of Review
Last content review/update: November 30, 2018
Requirements
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 24, 58, 60, 67 and 70
(2) (Guidance) Model Manual of Procedures for Institutional Ethics Committees on Research in Peru (INS ECManual - Spanish) (January 2013)
National Institute of Health, Ministry of Health
Relevant Sections: Objectives, Operating Definitions, Chapter I, Chapter II, Annex A, and Annex B
(3) (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
(4) (Guidance) Guideline for the Procedure for Requesting Authorization of the Clinical Trial (G-CTApplicProc - Spanish) (Edition No. 01) (November 28, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: 4, 6, and Annexes 1 and 3
Summary

Overview

According to DecreeNo 021-2017-SA and the INS ECManual, the primary scope of information assessed by institutional ethics committees (ECs) relates to maintaining and protecting the dignity and rights of research participants and ensuring their safety throughout their participation in a clinical trial.

As per DecreeNo 021-2017-SA and the INS ECManual, ECs must also pay special attention to reviewing informed consent and to protecting the welfare of certain classes of participants deemed to be vulnerable. 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 Institutional Research Ethics Committee of the National Institute of Health (El Comité Institucional de Ética en Investigación (CIEI) 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).

DecreeNo 021-2017-SA and the INS ECManual also state that the National Institute of Health (Instituto Nacional de Salud (INS))-registered 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. They 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. See DecreeNo 021-2017-SA and the INS ECManual for detailed ethical review guidelines.

Role in Clinical Trial Approval Process

As per DecreeNo 021-2017-SA, the INS CTManual, and the G-CTApplicProc, an INS-registered 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.

As per the INS ECManual, the EC typically reviews and approves submitted applications between 20 and 40 days depending on the project’s complexity. The INS ECManual also specifies that the approval of a new application is valid for one (1) year. All approved studies running for more than one (1) year are subject to continuing annual review by the respective EC. An application for continuing EC review must be made one (1) month prior to the expiration of the previous approval. (See the Clinical Trial Lifecycle topic, Submission Process and Timeline of Review subtopics for detailed submission process and timeline details.)

Additional Resources
No additional resources
Ethics Committee > Ethics Committee Fees
Last content review/update: November 30, 2018
Requirements
No applicable regulatory requirements
Summary

No relevant provisions.

Additional Resources
No additional resources
Ethics Committee > Authorizing Body
Last content review/update: November 30, 2018
Requirements
(1) (Regulation) Supreme Decree No. 001-2003-SA: Approves the Regulation of Organization and Functions of the National Institute of Health (DecreeNo 001-2003-SA - Spanish) (January 9, 2003)
Ministry of Health
Relevant Sections: Title I, Title II (Chapters I and III)
(2) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Article 63 and Complementary Provisions - Final (Eighth)
(3) (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
(4) (Guidance) Guideline for the Procedure for Requesting Authorization of the Clinical Trial (G-CTApplicProc - Spanish) (Edition No. 01) (November 28, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: 4 and 6
Summary

Overview

As set forth in DecreeNo 001-2003-SA, 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 DecreeNo 021-2017-SA, the INS CTManual, the G-CTApplicProc, and Additional Resource (A), the INS’s General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnológica (OGITT)) is responsible for accrediting institutional ethics committees (ECs) registered 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 accreditation standards established in the INS CTManual. DecreeNo 021-2017-SA created the National Registry of Institutional Ethics Committees in Accredited Research under this regulation in 2017.

Refer to Additional Resource (A) for the application form required to register an institutional EC and Additional Resource (B) for EC registration instructions.

DecreeNo 021-2017-SA and the INS CTManual, state that accreditation is temporary and must be renewed every three (3) years. Per DecreeNo 021-2017-SA, the INS CTManual, and Additional Resource (E), accreditation requirements to be completed include the following:

  • Application for accreditation/renewal of EC accreditation sent to INS (Additional Resource (C))
  • Resolution/decision obtained from the highest authority within the institution that empowers EC operation
  • Copy of institutionally approved EC regulations and its Manual of Procedures
  • Affidavit of compliance with accreditation standards in the INS CTManual (Additional Resource (D))
  • Curriculum vitaes signed by each EC member

The INS CTManual further recommends that applications for EC accreditation renewals be submitted 30 calendar days before the end of term. DecreeNo 021-2017-SA 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 Additional Resource (A) for detailed submission instructions, and Additional Resources (C) and (D) for the EC accreditation application form and EC affidavit of compliance form.

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

Additional Resources
(A) (Website) National Registry of Institutional Ethics Committees in Accredited Research (Spanish) (Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
(B) (Website) Registration of Institutional Research Ethics Committee (Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
National Institute of Health, Ministry of Health
(D) (Form) Affidavit of Compliance with the Accreditation Standards of the CIEI (FOR-OGITT-026) (Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
General Office of Research and of Health Technology Transfer, National Institute of Health, Ministry of Health
(F) (Website) Peruvian Clinical Trials Registry (REPEC) (Spanish) (English(Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
Clinical Trial Lifecycle > Submission Process
Last content review/update: November 30, 2018
Requirements
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 34, 40, 59, 61, 63, 67, 70, 71, 88, 91, Annex 1, and Complementary Provisions Final
(2) (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
(3) (Guidance) Guideline for the Procedure for Requesting Authorization of the Clinical Trial (G-CTApplicProc - Spanish) (Edition No. 01) (November 28, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: 4, 5, and 6
(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: 1, 2, 4, 5, and Key Points
(5) (Guideline) Notice No. 001-2017-OGITT/INS Notification of Deviations to the INS OGITT (Notice No001-2017-OGITT/INS - Spanish) (July 19, 2017)
General Office of Research and of Health Technology Transfer, National Institute of Health, Ministry of Health
Summary

Overview

In accordance with DecreeNo 021-2017-SA, 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-registered EC.

DecreeNo 021-2017-SA 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 Additional Resources (A), (B), and (C) for detailed information on clinical trial authorization and EC registration with the INS’s Peruvian Clinical Trials Registry (Registro Peruano de Ensayos Clínicos (REPEC)). See also the INS CTManual, the G-CTApplicProc, and Additional Resources (D) and (E), for sponsor and contract research organization (CRO) registration instructions, and Additional Resources (F) and (G) for sponsor and CRO registration forms.

According to DecreeNo 021-2017-SA, the INS CTManual, and the G-CTApplicProc, the INS and EC reviews may not be conducted in parallel. The INS-registered 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.

For details on submitting protocol amendments, refer to Notice No001-2017-OGITT/INS and Additional Resource (H). (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 DecreeNo 021-2017-SA, the INS CTManual, the G-CTApplicProc, the G-CTSubmissionProcs, and Additional Resource (A), the sponsor or his/her CRO must submit a request for clinical trial authorization electronically using the 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 DecreeNo 021-2017-SA. Per the G-CTSubmissionProcs, the application should be completed using the OGITT approved forms that are available on the REPEC website. 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 DecreeNo 021-2017-SA 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 (Additional Resource (L))
  • Information related to the quality of the investigational product (IP) according to Annex 5 of DecreeNo 021-2017-SA (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, the electronic version should be accompanied by a printed page listing all of the attached digital media included in the application. 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 DecreeNo 021-2017-SA. If any corrections 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.

Refer to the INS CTManual, the G-CTApplicProc, the G-CTSubmissionProcs, and Additional Resource (A) for additional submission information, and Additional Resources (H) and (I) for the clinical trial application and detailed instructions on completing the form.

Clinical Trial Application Language Requirements

As delineated in DecreeNo 021-2017-SA, 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 (Additional Resource (F)) should 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 DecreeNo 021-2017-SA and the G-CTApplicProc, the research protocol and updated IB must be written in Spanish, and in the original language if different from Spanish, in both printed and electronic media. DecreeNo 021-2017-SA 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
(A) (Website) Registration of a Clinical Trial - Authorization (Spanish) (Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
(B) (Website) Registration of Institutional Research Ethics Committee (Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
(C) (Website) National Registry of Institutional Ethics Committees in Accredited Research (Spanish) (Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
(D) (Website) Registration of a Sponsor (Spanish) (Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
(E) (Website) Registration of Contract Research Organization (CRO) (Spanish) (Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
(F) (Form) Application for Sponsor Registration (FOR-OGITT-020) (Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
(G) (Form) Application for Contract Research Organization Registration (FOR-OGITT-021) (Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
(H) (Form) Application for Clinical Trial Authorization (FOR-OGITT-028) (Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
National Institute of Health, Ministry of Health
(J) (Website) INS - Contact Us (Spanish) (Current as of November 28, 2018)
National Institute of Health, Ministry of Health
(K) (Website) Peruvian Clinical Trials Registry (REPEC) (Spanish) (English(Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
(L) (Form) List of Products and Supplies to be Used in the Clinical Trial (FOR-OGITT-033) (Spanish) (Edition No. 02) (April 9, 2018)
National Institute of Health, Ministry of Health
(M) (Website) General Directorate of Medicines, Supplies and Drugs (DIGEMID) (Spanish) (Current as of November 28, 2018)
Ministry of Health
Clinical Trial Lifecycle > Submission Content
Last content review/update: November 30, 2018
Requirements
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (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
(2) (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
(3) (Guidance) Guideline for the Procedure for Requesting Authorization of the Clinical Trial (G-CTApplicProc - Spanish) (Edition No. 01) (November 28, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: 4 and 6
(4) (Guidance) Model Manual of Procedures for Institutional Ethics Committees on Research in Peru (INS ECManual - Spanish) (January 2013)
National Institute of Health, Ministry of Health
Relevant Sections: Chapter I, Annex A, Annex B, Annex C, and Annex D
Summary

Overview

As set forth in DecreeNo 021-2017-SA, 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-registered ethics committee (EC) to conduct a clinical trial. Please refer to Additional Resources (A), (B), and (C) for detailed information on clinical trial authorization and EC registration with the INS’s Peruvian Clinical Trials Registry (Registro Peruano de Ensayos Clínicos (REPEC)). See also the INS CTManual, the G-CTApplicProc, and Additional Resources (D) and (E), for sponsor and contract research organization (CRO) registration instructions, and Additional Resources (F) and (G) for sponsor and CRO registration forms.

INS Requirements

As specified in DecreeNo 021-2017-SA, the INS CTManual, the G-CTApplicProc, and Additional Resource (A), a clinical trial application submission must include the following documents:

  • Application for clinical trial authorization (Additional Resource (H))
  • Proof of current registration of the research center(s) authorized research to conduct the clinical trial
  • 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 (see Annex 1 in DecreeNo 021-2017-SA)
  • ICF (see Annex 4 in DecreeNo 021-2017-SA)
  • Investigator’s Brochure (IB) in Spanish, and in the original language, if different from Spanish (See Annex 2 in DecreeNo 021-2017-SA)
  • Sponsor affidavit indicating fulfillment of responsibilities
  • Affidavit stating no conflict of financial interest signed by the sponsor or his/her CRO and the PI
  • Affidavit signed by PI and sponsor on preparation of research institution for trial
  • In the case of foreign sponsor: copy of proof of delegation of functions to the sponsor representative authenticated with The Hague Apostille
  • Affidavit signed by PI that indicates compliance with the regulatory obligations and requirements
  • Affidavit on compensation for participants signed by the sponsor or his/her CRO and PI (covers budget and expenses for any trial-related injuries)
  • Copy of current insurance policy purchased by the sponsor
  • List of clinical trial supplies
  • Information related to the investigational product (IP) quality (see Annex 5 in DecreeNo 021-2017-SA)
  • Copy of curriculum vitaes (CVs) for the PI, co-investigator(s), and rest of research team
  • 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
  • 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 DecreeNo 021-2017-SA, the INS CTManual, the G-CTApplicProc, and Additional Resource (A) for detailed submission information, and Additional Resources (H) and (I) for the clinical trial application and detailed instructions on completing the form. Also see the Submission Process subtopic for additional submission requirements.

Institutional EC Requirements

As per the INS ECManual and Additional Resource (J), institutional ECs generally require PIs to submit the following documentation for ethics approval:

  • Letter from the PI to the EC Chairman
  • Two (2) copies of the Basic Format Application (see Annex A in the INS ECManual)
  • Two (2) copies of the research protocol (in printed and electronic format with date and version number)
  • Two (2) copies of the ICF (in printed and electronic format with date and version number)
  • One (1) copy of PI and co-investigator(s) CV(s)
  • One (1) copy of the PI statement
  • One (1) copy of the Declaration of the PI and research center director/research institution head
  • One (1) copy of the Declaration of the PI and co-investigators
  • One (1) copy of the Declaration of financial details and potential conflicts of interest
  • One (1) copy of the Certificate of Approval of the Protocol, by an institutional research committee to ensure scientific validity
  • One (1) copy of signed Commitments of the Investigator Form
  • List of requirements for submission of projects
  • One (1) copy of the Form for the Use of Cryopreserved Biological Samples in the INS bank or other institutions, if applicable
  • Payment receipt for evaluation of research project
  • Two (2) copies of the IB
  • One (1) copy of sponsor’s insurance policy (original and, if applicable, a version with a certified Spanish translation)
  • One (1) copy documenting the PI’s training in good clinical research ethics

Additional Resource (J) further notes that all documentation must be paginated, presented with a table of contents in a lever file, and organized according to the requirements listed above with separators between each section. An electronic version (CD) of this information should also be provided.

Clinical Protocol

According to DecreeNo 021-2017-SA, 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 DecreeNo 021-2017-SA.

Additional Resources
(A) (Website) Registration of a Clinical Trial - Authorization (Spanish) (Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
(B) (Website) Registration of Institutional Research Ethics Committee (Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
(C) (Website) National Registry of Institutional Ethics Committees in Accredited Research (Spanish) (Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
(D) (Website) Registration of a Sponsor (Spanish) (Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
(E) (Website) Registration of Contract Research Organization (CRO) (Spanish) (Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
(F) (Form) Application for Sponsor Registration (FOR-OGITT-020) (Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
(G) (Form) Application for Contract Research Organization Registration (FOR-OGITT-021) (Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
(H) (Form) Application for Clinical Trial Authorization (FOR-OGITT-028) (Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
National Institute of Health, Ministry of Health
(J) (Website) Requirements for Project Evaluation (Spanish) (Current as of November 28, 2018)
National Institute of Health, Ministry of Health
General Office of Research and of Health Technology Transfer, National Institute of Health, Ministry of Health
Clinical Trial Lifecycle > Timeline of Review
Last content review/update: November 30, 2018
Requirements
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 8, 40, 59, 63, 69, 70, 71, and Complementary Provisions Final
(2) (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
(3) (Guidance) Guideline for the Procedure for Requesting Authorization of the Clinical Trial (G-CTApplicProc - Spanish) (Edition No. 01) (November 28, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: 5 and 6
(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
Summary

Overview

Based on DecreeNo 021-2017-SA, 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-registered EC. Therefore, the INS and EC reviews may not be conducted in parallel.

INS Approval

Clinical Trial Application Submission

As per DecreeNo 021-2017-SA, the INS CTManual, and Additional Resource (A), the INS review and approval process for a clinical trial application takes a maximum of 40 working days (including 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) to conduct its safety profile and the investigational product (IP) quality evaluations per DecreeNo 021-2017-SA). (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)). However, per DecreeNo 021-2017-SA and the INS CTManual, when biological products are used, or, in controversial situations that involve convening a technical commission in clinical research, the maximum period for clinical trial authorization is 60 working days (including 45 days for the ANM’s safety profile evaluation). For specific information on pre-submission registration requirements, see Clinical Trial Lifecycle topic, Submission Process subtopic.

DecreeNo 021-2017-SA 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 and it is recorded as “Total duration of the trial” as indicated in the Application for Clinical Trial Authorization (Additional Resource (B)).

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 Additional Resource (D), for any clinical trial lasting longer than 12 months, the sponsor or his/her CRO must request a trial authorization renewal and submit the following documents to the INS within 30 calendar days prior to the trial’s expiration:

  • Authorization renewal request (use the REPEC e-form (Additional Resource (B))
  • EC approved research protocol and valid informed consent
  • Additional supply list
  • INS issued payment receipt

Per Additional Resource (D), a trial renewal is a separate procedure from a trial extension. The application to be used depends on the total duration of the trial registered in the trial authorization form via REPEC, and the time elapsed from the study’s commencement. The fee for requesting a renewal is 839.50 Peruvian Soles and the INS procedure will be completed within 10 days.

DecreeNo 021-2017-SA and Additional Resource (D) also provide information on how the sponsor or his/her CRO should request a trial extension. The following documents must be submitted must submit within 30 calendar days prior to the trial’s expiration:

  • Application for extension of time (using the REPEC e-form (Additional Resource (B)) per Additional Resource (D)
  • 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-registered EC
  • List of additional supplies required (if applicable) to implement the trial per the INS CTManual
  • Proof of payment of processing fees
  • Current insurance policy (Additional Resource (D))

The authorized trial extension will be valid for a maximum of 12 months from the date of issue. Additional Resource (D) also notes that the fee for requesting an extension is 839.50 Peruvian Soles and the INS procedure will be completed within 10 days.

As indicated in DecreeNo 021-2017-SA 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. DecreeNo 021-2017-SA 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
(A) (Website) Registration of a Clinical Trial - Authorization (Spanish) (Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
(B) (Form) Application for Clinical Trial Authorization (FOR-OGITT-028) (Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
National Institute of Health, Ministry of Health
(D) (Website) List of Procedures (Spanish) (Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
Relevant Sections: Clinical Trial Authorization and Renewal and Extension for a Clinical Trial (English website); Clinical Trial Time Extension (Spanish website)
Clinical Trial Lifecycle > Trial Initiation
Last content review/update: November 30, 2018
Requirements
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (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
(2) (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
(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 (DecreeNo 016-2011-SA - Spanish) (July 27, 2011)
Ministry of Health
Relevant Sections: Title II (Chapter I and II) and Title III (Chapter I)
(4) (Guidance) Guideline for the Procedure for Requesting Authorization of the Clinical Trial (G-CTApplicProc - Spanish) (Edition No. 01) (November 28, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: 4 and 6
(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, and 5
Summary

Overview

In accordance with DecreeNo 021-2017-SA, 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-registered 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 DecreeNo 021-2017-SA and DecreeNo 016-2011-SA, 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 DecreeNo 021-2017-SA, all investigators must possess appropriate qualifications, training, and experience. 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) (ICH-GCPs-Addendum).

Clinical Trial Agreement

According to DecreeNo 021-2017-SA, the INS CTManual, and the G-CTApplicProc, and Additional Resource (A), 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. Further, per the G-CTApplicProc, and Additional Resource (A), the sponsor must sign an affidavit indicating that he/she will fulfill the responsibilities delineated in DecreeNo 021-2017-SA; the PI must also sign an affidavit indicating his/her compliance with obligations and requirements in this regulation; and, both the sponsor and the PI must sign an affidavit establishing that there is no conflict of financial interest in executing the trial. See Additional Resources (J), (K), (L), and (M) for referenced affidavit forms.

EC Confirmation of Review and Approval

DecreeNo 021-2017-SA, the INS CTManual, and the G-CTApplicProc, mandate that the sponsor or his/her CRO obtain written confirmation of EC review and approval from an INS-registered 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 DecreeNo 021-2017-SA, the INS CTManual, the G-CTApplicProc, the G-CTSubmissionProcs, and Additional Resource (A), 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 Additional Resources (N), (P), and (Q).

Per the INS CTManual, the G-CTApplicProc, and Additional Resources (F) and (G), 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 Additional Resource (A), (B), and (C) for detailed submission instructions, Additional Resources (D) and (E) for the clinical trial application and detailed instructions on completing the form. See also Additional Resources (F) and (G) for sponsor and CRO registration instructions, and Additional Resources (H) and (I) for the sponsor and CRO registration forms.

According to Additional Resource (R), REPEC was accredited by the Pan American Health Organization (PAHO)/World Health Organization (WHO) in 2016 as an official member of the WHO registry on May 6, 2016.

Data Safety Monitoring Board

DecreeNo 021-2017-SA 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
(A) (Website) Registration of a Clinical Trial - Authorization (Spanish) (Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
(B) (Website) Registration of Institutional Research Ethics Committee (Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
(C) (Website) National Registry of Institutional Ethics Committees in Accredited Research (Spanish) (Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
(D) (Form) Application for Clinical Trial Authorization (FOR-OGITT-028) (Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
National Institute of Health, Ministry of Health
(F) (Website) Registration of a Sponsor (Spanish) (Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
(G) (Website) Registration of Contract Research Organization (CRO) (Spanish) (Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
(H) (Form) Application for Sponsor Registration (FOR-OGITT-020) (Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
(I) (Form) Application for Contract Research Organization Registration (FOR-OGITT-021) (Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
(J) (Form) Affidavit of Compliance with Minimum Research Center Requirements (FOR-OGITT-023) (Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
National Institute of Health, Ministry of Health
(L) (Form) Affidavit by Sponsor and Principal Investigator (FOR-OGITT-030) (Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
National Institute of Health, Ministry of Health
General Office of Research and of Health Technology Transfer, National Institute of Health, Ministry of Health
General Office of Research and of Health Technology Transfer, National Institute of Health, Ministry of Health
(P) (Form) Notification of Deviations to the Protocol (FOR-OGITT-053) (Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
General Office of Research and of Health Technology Transfer, National Institute of Health, Ministry of Health
(R) (Document) REPEC - Accreditation Letter from PAHO/WHO (WHO Charter) (Spanish) (May 6, 2016)
National Institute of Health, Ministry of Health
(S) (Website) General Directorate of Medicines, Supplies and Drugs (DIGEMID) (Spanish) (Current as of November 28, 2018)
Ministry of Health
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 4
(U) (Website) Peruvian Clinical Trials Registry (REPEC) (Spanish) (English(Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
Clinical Trial Lifecycle > Safety Reporting
Last content review/update: November 30, 2018
Requirements
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Article 2, 40, 52, and 108-111
(2) (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 DecreeNo 021-2017-SA, 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) or Unexpected ADR – Any AE, ADR, or unexpected ADR that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is 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 DecreeNo 021-2017-SA and the INS CTManual, 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 DecreeNo 021-2017-SA, 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. The PI must also follow up with a detailed written report.

Furthermore, 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

Lastly, per DecreeNo 021-2017-SA, 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 DecreeNo 021-2017-SA, the INS CTManual, and Additional Resource (A), 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 DecreeNo 021-2017-SA, the INS CTManual, and Additional Resources (A), (B), and (C), the sponsor or his/her CRO and the PI are required to submit all expected and unexpected SAE/SADR (related or not per Additional Resource (A)) and SUSAR reports electronically through the Serious Adverse Events Virtual Reporting System (Sistema de Reporte de Eventos Adversos Serios) (REAS-NET) to the OGITT within seven (7) business days from the occurrence of the incident, or, as soon as the sponsor is aware of the incident. Per the INS CTManual, the electronic form (Additional Resource (C)) submitted via REAS-NET should be printed and signed by the sponsor or his/her CRO. The submitted information above must be updated with any additional relevant information in a follow-up tracking report within eight (8) business days. 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 DecreeNo 021-2017-SA and Additional Resource (A), 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.

As delineated in DecreeNo 021-2017-SA and Additional Resource (A), 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. Additional Resource (A) further indicates that the sponsor should send the SUSAR reports for events that have occurred abroad as soon as possible to the investigator using the CIOMS form. 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. Refer to Additional Resource (D) for the CIOMS form. (See the Investigational Products topic for additional information on IPs.)

Further, per DecreeNo 021-2017-SA, 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, 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 Additional Resource (E) for the form). Prenatal monitoring reports must also be prepared during pregnancy, childbirth, and for one (1) year 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, the sponsor or his/her CRO must also submit an annual IP safety report to the OGITT. The translation of the annual report summary must be presented in English and Spanish. Refer to Additional Resource (F) for the safety report form to be used.

See DecreeNo 021-2017-SA, the INS CTManual, and Additional Resources (B) and (C) for detailed sponsor/CRO reporting requirements.

Form Completion & Delivery Requirements

As per DecreeNo 021-2017-SA, the INS CTManual, and Additional Resource (A), all AEs/ADRs, SAEs/SADRs, and SUSARs must be reported electronically by the sponsor or his/her CRO using REAS-NET. Refer to Additional Resource (C) for OGITT SAE/SADR form. All SAEs/SADRs and SUSARs must also be reported on the CIOMS Form I (Additional Resource (D)).

Data Safety Monitoring Board

DecreeNo 021-2017-SA 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
(A) (Website) List of Procedures (Spanish) (Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
Relevant Sections: Serious Adverse Events Report
(B) (Website) Serious Adverse Event Reporting - REAS NET (Spanish) (Current as of November 28, 2018)
National Institute of Health, Ministry of Health
(C) (Form) Serious Adverse Event Report (FOR-OGITT-046) (Spanish) (Edition No. 02) (June 4, 2018)
National Institute of Health, Ministry of Health
(D) (Form) CIOMS Form I (Date Unavailable)
Council for International Organizations of Medical Sciences
(E) (Form) Notification of Pregnant Woman and Newborn in Clinical Trials (FOR-OGITT-047) (Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
(F) (Form) Summary of the Annual Security Report of the Research Product (FOR-OGITT-048) (Spanish) (Edition No. 01) (April 10, 2017)
National Institute of Health, Ministry of Health
General Office of Research and of Health Technology Transfer, National Institute of Health, Ministry of Health
(H) (Website) Serious Adverse Events Virtual Reporting System (REAS-NET) (Spanish) (Current as of November 28, 2018)
National Institute of Health, Ministry of Health
Clinical Trial Lifecycle > Progress Reporting
Last content review/update: November 30, 2018
Requirements
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 2, 40, 52, and 104-107
(2) (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 DecreeNo 021-2017-SA, the INS CTManual, and Additional Resource (A), 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 DecreeNo 021-2017-SA, the principal investigator (PI) is responsible for submitting clinical trial progress and final reports to the research institution and the institutional ethics committee (EC).

Interim/Progress Reports

As delineated in DecreeNo 021-2017-SA, the INS CTManual, and Additional Resources (A), (B), and (C), 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 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 Additional Resources (B) and (C) for the progress report form and detailed submission instructions.

In addition, DecreeNo 021-2017-SA and Additional Resource (A) 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) (DecreeNo 021-2017-SA)
  • 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 (DecreeNo 021-2017-SA)
  • Number of patients who failed the screening (Additional Resource (A))
  • Number of patients with clinical failure (Additional Resource (A))
  • SAEs
  • Non-SAEs

According to Additional Resource (A), 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 DecreeNo 021-2017-SA, the INS CTManual, and Additional Resources (A), (D), and (E), 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 Additional Resources (D) and (E) for the final report form and detailed submission instructions.

DecreeNo 021-2017-SA 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 DecreeNo 021-2017-SA, the INS, in coordination with the sponsor, must publish the results of authorized and performed clinical trials through REPEC. 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. The published article must also be sent to the INS and the research institution in print and electronic media.

National Final Report

Per DecreeNo 021-2017-SA, the INS CTManual, and Additional Resource (A), national final reports should be submitted to REPEC within 60 calendar days following the date of the final report submission of the last research center. 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. 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 Additional Resources (F) and (G) for the national final report form and detailed submission instructions.

DecreeNo 021-2017-SA also states 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 DecreeNo 021-2017-SA, the INS CTManual, and Additional Resource (A), 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 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. In addition, a report of the study results and conclusions should be attached as established in the INS CTManual. Additional Resource (A) also notes that the report should include the results and the study conclusions before publication. Refer to the INS CTManual for additional information, and Additional Resources (H) and (I) for the international final report form and detailed submission instructions.

Additional Resources
(A) (Website) List of Procedures (Spanish) (Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
Relevant Sections: Clinical Trial Progress Report and Final Reports
(B) (Form) Clinical Trial Progress Report (FOR-OGITT-054) (Spanish) (Edition No. 01) (Published May 7, 2018) (Effective May 7, 2018)
National Institute of Health, Ministry of Health
(C) (Document) Instructions for Filling Out Form FOR-OGITT-054 Edition No. 01 – Clinical Trial Progress Report  (Spanish) (Edition No. 01) (Published May 7, 2018) (Effective July 7, 2018)
National Institute of Health, Ministry of Health
(D) (Form) Final Report of the Research Center (FOR-OGITT-055) (Spanish) (Edition No. 01) (Published May 7, 2018) (Effective July 5, 2018)
National Institute of Health, Ministry of Health
(E) (Document) Instructions for Filling Out Form FOR-OGITT-055 Edition No. 01 - Final Report of the Research Center (Spanish) (Edition No. 01) (Published May 7, 2018) (Effective July 5, 2018)
National Institute of Health, Ministry of Health
(F) (Form) Final National Report (FOR-OGITT-056) (Spanish) (Edition No. 01) (Published May 7, 2018) (Effective July 5, 2018)
National Institute of Health, Ministry of Health
(G) (Document) Instruction for Filling Out Form FOR-OGITT-056 Edition No. 01 - Final National Report (Spanish) (Edition No. 01) (Published May 7, 2018) (Effective July 5, 2018)
National Institute of Health, Ministry of Health
(H) (Form) International Final Report (FOR-OGITT-057) (Spanish) (Edition No. 01) (Published May 7, 2018) (Effective July 5, 2018)
National Institute of Health, Ministry of Health
(I) (Document) Instructions for Filling Out Form FOR-OGITT-057 Edition No. 01 – International Final Report (Spanish) (Edition No. 01) (Published May 7, 2018) (Effective July 5, 2018)
National Institute of Health, Ministry of Health
General Office of Research and of Health Technology Transfer, National Institute of Health, Ministry of Health
(K) (Website) Peruvian Clinical Trials Registry (REPEC) (Spanish) (English(Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
Sponsorship > Definition of Sponsor
Last content review/update: November 30, 2018
Requirements
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 41 - 45
(2) (Guidance) Guideline for the Procedure for Requesting Authorization of the Clinical Trial (G-CTApplicProc - Spanish) (Edition No. 01) (November 28, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: 6
Summary

Overview

DecreeNo 021-2017-SA 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.

DecreeNo 021-2017-SA 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.

DecreeNo 021-2017-SA 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.

Additional Resources
No additional resources
Sponsorship > Trial Authorization
Last content review/update: November 30, 2018
Requirements
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 40 and 67
(2) (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
(3) (Guidance) Guideline for the Procedure for Requesting Authorization of the Clinical Trial (G-CTApplicProc - Spanish) (Edition No. 01) (November 28, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: 4, 5, and 6
(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: 1, 2, 4, 5, and Key Points
Summary

Overview

In accordance with DecreeNo 021-2017-SA, the INS CTManual, and the G-CTApplicProc, 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))-registered 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, and Additional Resources (A) and (B), 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 Additional Resources (C) and (D) for the sponsor and CRO registration forms.

As delineated in the INS CTManual, the G-CTApplicProc, the G-CTSubmissionProcs, and Additional Resource (E), 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-CTApplicProc and 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 DecreeNo 021-2017-SA. 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, DecreeNo 021-2017-SA 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
(A) (Website) Registration of a Sponsor (Spanish) (Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
(B) (Website) Registration of Contract Research Organization (CRO) (Spanish) (Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
(C) (Form) Sponsor Registration (FOR-OGITT-020) (Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
(D) (Form) Registration of Contract Research Organization (FOR-OGITT-021) (Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
(E) (Website) Registration of a Clinical Trial - Authorization (Spanish) (Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
(F) (Form) Application for Clinical Trial Authorization (FOR-OGITT-028) (Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
National Institute of Health, Ministry of Health
(H) (Website) Peruvian Clinical Trials Registry (REPEC) (Spanish) (English(Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
Sponsorship > Insurance
Last content review/update: November 30, 2018
Requirements
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 2 and 28
(2) (Guidance) Guideline for the Procedure for Requesting Authorization of the Clinical Trial (G-CTApplicProc - Spanish) (Edition No. 01) (November 28, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: 6
(3) (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 DecreeNo 021-2017-SA, the G-CTApplicProc, and Additional Resource (A), 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 Additional Resource (A), the sponsor or his/her CRO should sign an affidavit guaranteeing an active insurance policy is in place according to requirements in the INS CTManual. (See Additional Resource (B) for the affidavit form).

DecreeNo 021-2017-SA 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.

Additional Resources
(A) (Website) Registration of a Clinical Trial - Authorization (Spanish) (Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
National Institute of Health, Ministry of Health
Sponsorship > Compensation
Last content review/update: November 30, 2018
Requirements
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (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. 01) (November 28, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: 2 and 6
Summary

Overview

As specified in DecreeNo 021-2017-SA 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.

DecreeNo 021-2017-SA 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. DecreeNo 021-2017-SA, the G-CTApplicProc, and Additional Resource (A) further state that the sponsor or his/her CRO must also submit an affidavit guaranteeing a financial fund is immediately and conveniently available that guarantees free medical treatment to participants who suffer any trial-related injuries, as long as the insurance policy is activated, and he/she must sign a statement to that effect. (See Additional Resource (B) for the affidavit form).

DecreeNo 021-2017-SA 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 DecreeNo 021-2017-SA, 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
(A) (Website) Registration of a Clinical Trial - Authorization (Spanish) (Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
National Institute of Health, Ministry of Health
General Office of Research and of Health Technology Transfer, National Institute of Health, Ministry of Health
Sponsorship > Quality, Data & Records Management
Last content review/update: November 30, 2018
Requirements
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 2, 40, 83, and Annex 1
(2) (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 DecreeNo 021-2017-SA, 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, as well as the requirements established in DecreeNo 021-2017-SA.

DecreeNo 021-2017-SA 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)).

Electronic Data Processing System

No relevant regulatory provisions

Record Management

As set forth in DecreeNo 021-2017-SA, 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, DecreeNo 021-2017-SA 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 INS CTManual indicates 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

DecreeNo 021-2017-SA, 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. The request must include a report providing the reasons for the suspension, including all of the data up to the time of the suspension, measures to protect the research participants, and a copy of the letter from the EC that approved the study acknowledging notification.

Multicenter Studies

Per DecreeNo 021-2017-SA, multicenter clinical trials require an appointed coordinator responsible for processing all of the data and analyzing the results.

Additional Resources
No additional resources
Sponsorship > Site/Investigator Selection
Last content review/update: November 30, 2018
Requirements
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 2, 40-42, 53-57, 108, and Annexes 3 and 4
(2) (Guidance) Guideline for the Procedure for Requesting Authorization of the Clinical Trial (G-CTApplicProc - Spanish) (Edition No. 01) (November 28, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: 6
Summary

Overview

As set forth in DecreeNo 021-2017-SA, 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 DecreeNo 021-2017-SA, 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 DecreeNo 021-2017-SA, research centers must register with the Peruvian Clinical Trials Registry (Registro Peruano de Ensayos Clínicos (REPEC)) and uphold the following minimum requirements:

  • Research centers without hospitalization are not required to have a hospitalization area, however, there must be an agreement in place with a health institution nearby that can admit patients
  • The clinical laboratory must comply with duly certified or accredited quality standards and good laboratory practices. Research institutions that do not have a clinical laboratory within their facilities should work with an external laboratory to comply with this requirement. If a clinical laboratory provides services on a national level, it must also be registered in the IPRESS National Registry (Registro Nacional de IPRESS) (RENIPRESS)), a national registry of institutions that provide health services.

According to Additional Resource (A), research centers should apply using the application form provided in Additional Resource (B) and complete the affidavit form in Additional Resource (C). Research center registration is valid for three (3) years. Refer to Additional Resource (A) for detailed registration instructions. Per DecreeNo 021-2017-SA, multicenter clinical trials require an appointed coordinator responsible for processing all of the data and analyzing the results.

Foreign Sponsor Responsibilities

DecreeNo 021-2017-SA 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 DecreeNo 021-2017-SA, 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)

DecreeNo 021-2017-SA 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
(A) (Website) Registration of a Research Center (Spanish) (Current as of November 28, 2018)
REPEC, National Institute of Health, Ministry of Health
National Institute of Health, Ministry of Health
(C) (Form) Affidavit of Compliance with Minimum Research Center Requirements (FOR-OGITT-023) (Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
National Institute of Health, Ministry of Health
(E) (Form) Affidavit by Sponsor and Principal Investigator (FOR-OGITT-030) (Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
(F) (Form) Curriculum Vitae of the Research Team (FOR-OGITT-031) (Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
(G) (Form) Application for Clinical Trial Authorization (FOR-OGITT-028) (Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
National Institute of Health, Ministry of Health
Informed Consent > Documentation Requirements
Last content review/update: November 30, 2018
Requirements
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 2, 11, 32, 33, 34, and Annex 4
Summary

Overview

In all Peruvian clinical trials, a freely given informed consent must be obtained from each participant in accordance with the requirements set forth in DecreeNo 021-2017-SA. 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 DecreeNo 021-2017-SA, 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 briefly and clearly presented 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. When drafting and presenting the ICF, special consideration must be taken with regard to the participant’s culture, traditional values, intelligence, and education. The participant and his/her legal representative(s) or guardian(s) should also be given adequate time to consider whether to participate.

Re-Consent

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

The ICF must be written in Spanish and in the language of the research participant.

Documentation Copies

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.

Additional Resources
No additional resources
Informed Consent > Required Elements
Last content review/update: November 30, 2018
Requirements
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 32, 34, 40, 67, 115-118, and Annex 4
Summary

Overview

As delineated in DecreeNo 021-2017-SA, 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 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

DecreeNo 021-2017-SA states 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 DecreeNo 021-2017-SA, the ICF should include the following statements or descriptions, as applicable:

  • Trial title
  • 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
  • Contact information for the principal investigator, the EC president, and the INS's General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnológica (OGITT)) in the event of trial-related injuries
  • 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))

If biological sample storage and collection is being considered for future use, then this point should be made explicit in an additional ICF.

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

Additional Resources
No additional resources
Informed Consent > Compensation Disclosure
Last content review/update: November 30, 2018
Requirements
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 34, 35, 40, 115-118, and Annex 4
Summary

Overview

In accordance with DecreeNo 021-2017-SA, 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.

Annex 4 of the DecreeNo 021-2017-SA provides informed consent format guidelines that require the following points be included on the form:

  • A statement that free treatment and procedures are part of the trial
  • Economic compensation for additional expenses (transport, accommodation, communication, and food) should be provided with a specific amount listed

Compensation for Participation in Research

Trial participants should be compensated for the specific amounts expended on travel, accommodations, communication, food, supplies purchased, free medical treatment, and other expenses incurred while participating in the trial. The ICF must also explicitly state what expenses will be covered and the amount of compensation as a result of participation.

DecreeNo 021-2017-SA also states that participants must be ensured free access to the investigational product 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.

Compensation for Injury

The ICF should include a statement advising the participant that compensation and medical treatment is available in the event of any trial-related injury. (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 30, 2018
Requirements
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 4, 9, 34, and 40, and Annex 4
Summary

Overview

In accordance with DecreeNo 021-2017-SA, Peru’s ethical standards promote respect for all human beings and safeguard the rights of research participants. 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

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

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

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

The Right of Inquiry/Appeal

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

The research participant’s dignity, safety, and welfare must be guaranteed while ensuring the quality of the research process in developing new products.

See the Informed Consent topic, and the subtopics of Required Elements and Vulnerable Populations for additional information regarding requirements for participant rights.

Additional Resources
No additional resources
Informed Consent > Special Circumstances/Emergencies
Last content review/update: November 30, 2018
Requirements
No applicable regulatory requirements
Summary

No relevant provisions.

Additional Resources
No additional resources
Informed Consent > Vulnerable Populations
Last content review/update: November 30, 2018
Requirements
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 2, 19, 24, 25, 33 and 38
Summary

Overview

As per DecreeNo 021-2017-SA, 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. 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.

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 DecreeNo 021-2017-SA 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

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 individuals who are included in the trial
  • 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

Research Involving Participants with Physical Disabilities

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, in the presence of at least one witness, designated by the participant and who does not belong to the research team, 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. Consent may also be withdrawn by the participant and/or his/her legal representative(s) 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 ethics committee 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
Additional Resources
No additional resources
Informed Consent > Children/Minors
Last content review/update: November 30, 2018
Requirements
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 2, 18, 33 and 36
Summary

Overview

Although DecreeNo 021-2017-SA does not specifically state that 18 years of age is the age of majority, this point may be inferred from the definition of assent provided in the regulation. Specifically, “assent” is defined as the process by which the authorization or permission to participate in the study is obtained in documented form from the child or adolescent under 18 years. Further, DecreeNo 021-2017-SA notes that it is generally considered that children aged 8 to adolescents under 18 years of age are capable of understanding the explanation of the research and can give their assent.

DecreeNo 021-2017-SA states that a minor must give his/her assent, when capable of understanding the explanation of the research,  as a research participant in addition to the consent of both parents or his/her legal representative(s) and/or guardian(s). 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 appropriately documented. 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 established in the Civil Code. 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.

All pediatric participants should be fully informed about the trial and its risks and benefits in a 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, the protocol must also be approved by 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.

Additional Resources
No additional resources
Informed Consent > Pregnant Women, Fetuses & Neonates
Last content review/update: November 30, 2018
Requirements
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 20-23 and Annex 4
Summary

Overview

As per DecreeNo 021-2017-SA, 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

See Title III, Chapter II (Article 23) of DecreeNo 021-2017-SA, 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 30, 2018
Requirements
No applicable regulatory requirements
Summary

No relevant provisions.

Additional Resources
No additional resources
Informed Consent > Mentally Impaired
Last content review/update: November 30, 2018
Requirements
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Article 37
Summary

Overview

According to DecreeNo 021-2017-SA, 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
  • Obtain informed consent 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
No additional resources
Investigational Products > Definition of Investigational Product
Last content review/update: November 30, 2018
Requirements
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Article 2
(2) (Guidance) Guideline for the Procedure for Requesting Authorization of the Clinical Trial (G-CTApplicProc - Spanish) (Edition No. 01) (November 28, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: 2
Summary

Overview

As delineated in DecreeNo 021-2017-SA and the G-CTApplicProc, 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.

DecreeNo 021-2017-SA 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 the purpose of maintaining blinding.

Additional Resources
No additional resources
Investigational Products > Manufacturing & Import
Last content review/update: November 30, 2018
Requirements
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 8, 69, 70, 90, 94, 97, and 115-118
(2) (Regulation) Supreme Decree No. 016-2011-SA: Regulatory Approval for the Registration, Control and Sanitary Surveillance of Pharmaceutical Products, Medical Devices and Health Products (DecreeNo 016-2011-SA - Spanish) (July 27, 2011)
Ministry of Health
Relevant Sections: Title II (Chapter I and V) and Title III (Chapter I)
(3) (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
(4) (Guidance) Guideline for the Procedure for Requesting Authorization of the Clinical Trial (G-CTApplicProc - Spanish) (Edition No. 01) (November 28, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: 4
Summary

Overview

According to DecreeNo 021-2017-SA, DecreeNo 016-2011-SA, 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 DecreeNo 021-2017-SA, 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 DecreeNo 021-2017-SA 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.

DecreeNo 021-2017-SA and DecreeNo 016-2011-SA 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 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.

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.

Additional Resources
(A) (Website) General Directorate of Medicines, Supplies and Drugs (DIGEMID) (Spanish) (Current as of November 28, 2018)
Ministry of Health
World Health Organization
Relevant Sections: Annex 3 (b): Certificate of Pharmaceutical Product(s)
Investigational Products > IMP/IND Quality Requirements
Last content review/update: November 30, 2018
Requirements
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (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) Guideline for the Procedure for Requesting Authorization of the Clinical Trial (G-CTApplicProc - Spanish) (Edition No. 01) (November 28, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: 4, 5, and 6
(3) (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 DecreeNo 021-2017-SA 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 DecreeNo 021-2017-SA, 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. DecreeNo 021-2017-SA 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 (Additional Resource (A)). The form must be accompanied by an update report of the applicable IP(s).

IB Content Requirements

As specified in DecreeNo 021-2017-SA, 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 DecreeNo 021-2017-SA for detailed content guidelines.

As specified in DecreeNo 021-2017-SA, 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 profile of the IP to be used in a clinical trial as part of its application review and approval process. Per DecreeNo 021-2017-SA, 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)).

DecreeNo 021-2017-SA 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 DecreeNo 021-2017-SA, 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 documents required to be submitted for comparator IPs and complementary products, refer to Annex 5 of DecreeNo 021-2017-SA.

Drug Manufacturing Certificate Requirements

As stated in DecreeNo 021-2017-SA and the G-CTApplicProc, the manufacture of IPs for their use in a clinical trial must be approved by ANM. DecreeNo 021-2017-SA 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 Additional Resource (B), 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 form in Additional Resource (B)). As indicated in Additional Resource (B), the form requires the sponsor or his/her CRO to provide the following data:

  • Name of product
  • Active ingredient(s)
  • Pharmaceutical form and concentration
  • Manufacturer name
  • Country of origin
  • Quantity
  • Coding system

In addition, per DecreeNo 021-2017-SA 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 Additional Resource (B) for the form to be submitted 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 Product topic, Product Management subtopic for additional information on sponsor requirements).

Additional Resources
(A) (Form) Other Relevant Notifications (FOR-OGITT-059) (Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
(B) (Form) List of Products and Supplies to be Used in the Clinical Trial (FOR-OGITT-033) (Spanish) (Edition No. 02) (April 9, 2018)
National Institute of Health, Ministry of Health
General Office of Research and of Health Technology Transfer, National Institute of Health, Ministry of Health
(D) (Website) General Directorate of Medicines, Supplies and Drugs (DIGEMID) (Spanish) (Current as of November 28, 2018)
Ministry of Health
Investigational Products > Labeling & Packaging
Last content review/update: November 30, 2018
Requirements
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (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 DecreeNo 021-2017-SA. IPs to be used in a clinical trial must be properly labeled in the Spanish 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 is 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 Product 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 30, 2018
Requirements
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (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
(2) (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
(3) (Guidance) Guideline for the Procedure for Requesting Authorization of the Clinical Trial (G-CTApplicProc - Spanish) (Edition No. 01) (November 28, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: 4 and 6
(4) (Regulation) Supreme Decree No. 016-2011-SA: Regulatory Approval for the Registration, Control and Sanitary Surveillance of Pharmaceutical Products, Medical Devices and Health Products (DecreeNo 016-2011-SA - Spanish) (July 27, 2011)
Ministry of Health
Relevant Sections: Title II (Chapter I and II) and Title III (Chapter I)
Summary

Overview

In accordance with DecreeNo 021-2017-SA, 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 Additional Resource (B), 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. 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)) (Additional Resource (B)) and attach a report justifying the reasons for the application submission. See the INS CTManual for detailed instructions on completing this form. The sponsor or his/her CRO will have a maximum of 10 business days to submit the modified or expanded IP list. In addition, according to DecreeNo 021-2017-SA, DecreeNo 016-2011-SA, 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 form in Additional Resource (B)). As indicated in Additional Resource (B). This form requires the sponsor or his/her CRO to provide the following data:

  • Name of product
  • Active ingredient(s)
  • Pharmaceutical form and concentration
  • Manufacturer name
  • Country of origin
  • Quantity
  • Coding system

Per DecreeNo 021-2017-SA, 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 Ministerio de Salud del Perú (Ministry of Health of Peru) (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 DecreeNo 021-2017-SA, IPs for use in trials must be funded by the sponsor and provided free of charge to research participants.

As per DecreeNo 021-2017-SA, 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

DecreeNo 021-2017-SA 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, impact 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 DecreeNo 021-2017-SA, 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 DecreeNo 021-2017-SA for documentation submission requirements)
Additional Resources
(A) (Form) Other Relevant Notifications (FOR-OGITT-059) (Spanish) (Edition No. 01) (October 4, 2017)
National Institute of Health, Ministry of Health
(B) (Form) List of Products and Supplies to be Used in the Clinical Trial (FOR-OGITT-033) (Spanish) (Edition No. 02) (April 9, 2018)
National Institute of Health, Ministry of Health
General Office of Research and of Health Technology Transfer, National Institute of Health, Ministry of Health
(D) (Website) General Directorate of Medicines, Supplies and Drugs (DIGEMID) (Spanish) (Current as of November 28, 2018)
Ministry of Health
Specimens > Definition of Specimen
Last content review/update: November 30, 2018
Requirements
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (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 DecreeNo 021-2017-SA, 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 30, 2018
Requirements
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (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 DecreeNo 021-2017-SA, 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 30, 2018
Requirements
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
Relevant Sections: Articles 25, 34, Annex 4, and Complementary Provisions Final
Summary

Overview

In accordance with DecreeNo 021-2017-SA, if a clinical trial team is considering the collection and storage of biological samples for future use, this point should be explicitly delineated in a separate informed consent form (ICF).

Annex 4 of DecreeNo 021-2017-SA also states 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

In addition, Annex 4 of DecreeNo 021-2017-SA also states 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 DecreeNo 021-2017-SA, 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.

As noted in DecreeNo 021-2017-SA, 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
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