All Contract Research Organizations should be registered a single time in the Peruvian Clinical Trials Registry – REPEC, in order to have an updated inventory of institutions administering clinical trials conducted in the trial sites of the country.

Requirements (according to Annex 16 of Procedure Manual in force).

1. Application for Contract Research Organization registration (as per e-form) and printed form attached.
2. Certified copy of notarially recorded deed.
3. Curriculum Vitae of Contract Research Organization (CRO) representative and monitors.
4. Institutional Brochure, containing the institutional goals and organization and function chart.
5. Selection procedures for trial sites and investigators who will conduct the clinical trials.
6. Personnel training plan in aspects related to clinical trials, good clinical practices and ethics in research.
7. Summary of studies in which your institution has participated.
8. Affidavit indicating your institution conducts clinical trials according to the Peruvian norms and good clinical practices.

NOTE: All the documents should be numbered, submitted to the National Institute of Health in a folder or binder and ordered pursuant to the stipulations set forth, indicating each document name by means of markers.

CRO registration application e-form

Enter your data in the following form. Once the form is filled, click Save; you will receive a temporary Contract Research Organization (CRO) registration number. Then, print the form, sign it and sent it to OGITT via Documentary Procedure Office of INS – Central Headquarters. 

List of Registered Contracted Research Organization (CRO).