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