Peru has a primary registry, Peruvian Clinical Trials Registry (REPEC) which has a provision to register a clinical trial. REPEC is a World Health Organization (WHO) recognized primary registry. It was developed in 2007 by the National Institute of Health (INS) and contains records of clinical trials since 1995. Information on all clinical trials submitted to the General Office for Research and Technology Transfer (OGITT) by the National Institute of Health (INS) and that has been authorized or not authorized to be executed in Peru is published on it.
Registries at a Glance | |||||
Registry | PHUSE Categorization | Information to be Entered By | Route of Data in Registry | Study Type | Language |
REPEC | Mandatory National Database (includes Ethics Requirement) | Competent authority | Clinical Trial Application |
Interventional (Phase 1-4);Observational |
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Registration and Results Requirements | |||
Registry | Activity | Legal Requirement | Timing |
REPEC | Registration |
Yes |
Prior to enrollment |
Results |
Yes |
Not yet specified |
Registry Updates
- March 2022: Peru Regulatory Update - Peruvian Registry of Clinical Trials (REPEC) published a notification (Press release No. 007-2022-OGITT/INS) on March 15, 2022. This details the measures established for the reception of documents by Documentary Procedure (TD) in a virtual and face-to-face manner. Submissions and Inquiries via Email: Submission of TD requests, related to all types of new or ongoing clinical … Continue reading "March 2022: Peru Regulatory Update"
- February 2022: Peru Update - The Peruvian Registry of Clinical Trials (REPEC) published a notification (PRESS RELEASE No. 006-2022-OGITT/INS) on February 03, 2022, stating that- The services of REPEC Version 2 (V2) have been restored. All the documentation entered through [email protected] during the month of January to date must be regularized in the REPEC V2 in order to have the … Continue reading "February 2022: Peru Update"
- January 2022: Peru Update - The Peruvian Registry of Clinical Trials (REPEC) published a notification (PRESS RELEASE No. 005-2022-OGITT/INS) on January 26, 2022, stating that- From January 06, 2022 (the date since which REPEC Version 2 [V2] is out of service), until the REPEC V2 system is enabled again, all documents must be directed to [email protected] and [email protected] emails. Once … Continue reading "January 2022: Peru Update"
References
- Regulation of Clinical Trials Approved with Supreme Decree N° 021-2017-SA. Regulation of Clinical Trials. https://ensayosclinicos-repec.ins.gob.pe/images/REC-021-2017-sa-1538902-2.pdf. Published June 30, 2017. Accessed February 1, 2019.