Peru Profile Updated in ClinRegs

The Peru profile in ClinRegs has been reviewed and updated with the following information:

New National Institute of Health (Instituto Nacional de Salud (INS)) regulation and corresponding guidance issued on the application of sanctions during clinical trials (See Trial Authorization and Quality, Data & Records Management)

Revised or new forms related to clinical trial application, ethics committee accreditation and renewal, clinical trial products and supplies, and request for virtual supervision of a clinical trial (See Forms)

New INS communication issued on the updated Peruvian Clinical Trials Registry (Registro Peruano de Ensayos Clínicos (REPEC)) virtual platform, which allows applicants to register new clinical trial procedures, track application authorization status, and monitor active trials (See the Regulatory Authority topic, Clinical Trial Lifecycle topic, and Trial Authorization)

REPEC preliminary evaluation checklist to assist research centers applying for registration (See Site/Investigator Selection)

New INS communication notifying applicants of the new electronic and in-person procedures to submit clinical trial documentation to the agency’s Document Processing System (See Regulatory Authority and Submission Process)

New INS communication regarding trial extension request documentation requirements for sponsors/contract research organizations (See Scope of Assessment and Timeline of Review)

New INS communications updating research protocol and informed consent form requirements (See Scope of Assessment, Submission Content, Trial Authorization, Documentation Requirements, and Required Elements)

Updated REPEC Forms, Guides, and Annexes webpage, which now includes instructional videos on registering with the new REPEC platform (See the Regulatory Authority topic, Clinical Trial Lifecycle topic, Trial Authorization, and Site/Investigator Selection)

Sources Added During this Update:

(Regulation) Headquarters Resolution No. 064-2021-J-OPE/INS - Approves Procedure for the Application of Sanctions in the Regulatory Framework of Clinical Trials (Res064-2021 - Spanish) (March 23, 2021)
National Institute of Health, Ministry of Health

(Guidance) Procedure for the Application of Sanctions in the Regulatory Framework of Clinical Trials (G-CTSanction - Spanish) (Edition No. 1) (March 23, 2021)
National Institute of Health, Ministry of Health

(Document) Communique No. 001-2021-OGITT/INS - Communication of a New Version of the Peruvian Clinical Trials Registry (REPEC) (PER-88 - Spanish) (January 6, 2021)
General Office for Research and Technology Transfer, National Institute of Health

(Document) Communique No. 003-2021-OGITT/INS - INS Measures for the Receipt of Documents via Virtual and In-Person Delivery Methods (PER-92 - Spanish) (June 2, 2021)
General Office for Research and Technology Transfer, National Institute of Health

(Document) Communique No. 004-2021-OGITT/INS - Sponsor Notification re: Trial Extension Requirements (PER-93 - Spanish) (July 23, 2021)
General Office for Research and Technology Transfer, National Institute of Health

(Document) Multiple Office No. 007-2021-OGITT/INS - General Guidelines for the Approval of Protocols and Informed Consents (PER-82 - Spanish) (May 7, 2021)
General Office for Research and Technology Transfer, National Institute of Health

(Document) Multiple Office No. 014-2021-OGITT/INS - General Guidelines for the Approval of Protocols and Informed Consents - Update (PER-83 - Spanish) (July 9, 2021)
General Office for Research and Technology Transfer, National Institute of Health

(Document) Multiple Office No. 020-2021-OGITT/INS - Endorsement of Research Documents by the Research Ethics Committee - CEI (PER-96 - Spanish) (August 23, 2021)
General Office for Research and Technology Transfer, National Institute of Health

(Document) Preliminary Evaluation Checklist for the Registration of Research Centers (PER-90 - Spanish) (Version 1.0) (March 10, 2011)
REPEC, National Institute of Health, Ministry of Health

(Document) Single Text of Administrative Procedures (TUPA) - Executing Public Agency of the Ministry of Health: National Institute of Health in Compliance with the Supreme Decree No. 062-2009-PCM (PER-97 - Spanish) (Date Unavailable)
National Institute of Health, Ministry of Health

(Form) Virtual Supervision of Clinical Trials (FOR-OGITT-066) (PER-87 - Spanish) (Edition No. 01) (July 26, 2021)
National Institute of Health, Ministry of Health

(Webpage) By Means of a Simple Letter Addressed to the Director General of the General Office for Research and Technology Transfer (OGITT) of the National Institute of Health (PER-95 - Spanish) (Current as of November 22, 2021)
National Institute of Health, Ministry of Health

(Webpage) Peruvian Clinical Trials Registry (REPEC) - Old Registration Platform (PER-91 - Spanish) (Current as of November 22, 2021)
REPEC, National Institute of Health, Ministry of Health

(Webpage) Institutional Research Ethics Committee of the National Institute of Health (CIEI-INS) (PER-94 - Spanish) (Current as of November 22, 2021)
National Institute of Health, Ministry of Health

(Webpage) Peruvian Clinical Trials Registry (REPEC) - Registration Platform (PER-89 - Spanish) (Current as of November 22, 2021)
REPEC, National Institute of Health, Ministry of Health

(Webpage) WHO Trial Registration Data Set (PER-86) (Version 1.3.1) (Current as of November 22, 2021)
International Clinical Trials Registry Platform (ICTRP), World Health Organization (WHO)

Sources Revised During this Update:

(Form) Application for Clinical Trial Authorization (FOR-OGITT-028) (PER-24 - Spanish) (Edition No. 03) (July 23, 2021)
National Institute of Health, Ministry of Health

(Form) List of Products and Supplies to Import in the Clinical Trial (FOR-OGITT-033) (PER-42 - Spanish) (Edition No. 03) (July 26, 2021)
National Institute of Health, Ministry of Health

(Form) Request for Accreditation from the Institutional Ethics Committees (CIEIs) (FOR-OGITT-025) (PER-85 - Spanish) (Edition No. 03) (August 26, 2021)
National Institute of Health, Ministry of Health

(Webpage) Forms, Guides and Annexes (PER-81 - Spanish) (Current as of November 22, 2021)
National Institute of Health, Ministry of Health