All the Institutional Research Ethics Committee should be registered in the Peruvian Clinical Trials Registry in order to create an inventory of Institutional Ethics Committees which review and approve clinical trials conducted in the trial sites of the country.

Requirements

1. Application for the Registration of Institutional Research Ethics Committee (as per e-form) and printed form attached.
2. Resolution issued by the higher authority of the Research Institution which authorizes the operation of the Institutional Research Ethics Committee.
3. Institutional Research Ethics Committee Procedure Manual, including:
   • Administrative requirements for the submission of files.
   • Follow-up procedures for the authorized research protocols included in the files.
   • Procedures for the preparation of meeting minutes.
   • Filing procedures for related documents.
4. Copy of the Ethics Committee Regulations approved by the institution.
5. Short descriptive Curriculum Vitae signed by each member of the Institutional Research Ethics Committee.

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.

WARNING: Useful information for the lining-up of Institutional Research Ethics Committees, published by INS, is available here.

Institutional Research Ethics Committee registration e-form

Enter your data in the Institutional Research Ethics Committee registration e-form (including Annex 17 of Procedure Manual in force). After filling the form, click Save, a temporary registration number for the Committee will appear. Then, print the form, sign it and attach it to the documents to be submitted via INS’ Documentary Procedure Office – Headquarters.

Listado de Comités Institucionales de Ética en Investigación Registrados.

The registration of a Trial Site is one of the most important requirements that should be performed before requesting the authorization for clinical trial conduction in Peru.

Before conducting any type of procedure, minutely review if the information entered in the form is correct, and if the procedure to be started complies with the requirements indicated in Article 66° of the Clinical Trials Regulation in Peru. This will prevent delays and annulments, and will allow offering a prompt and efficient service.

This procedure will be requested when a hospital, clinic, public and/or private institutes, polyclinics or doctor’s offices apply for the registration of a trial site for the conduction of clinical trials. Private doctor’s offices will only be able to perform as trial sites pursuant to the conditions set forth by Article 56° of Clinical Trials Regulations.

Requirements

1. Application for Trial Site registration (as per e-form) and printed form attached.
2. Enter the information required in the Checklist before Inspection, with the annex detailing documents, resources and infrastructure required to authorize the registration; attach printed form.
   CHECKLIST: This guideline is a Checklist to verify the Trial Site conditions in situ, which will allow to authorize the Trial Site registration for the conduction of Clinical Trials; this procedure is aimed at safeguarding the respect to dignity, protection of rights, physical and mental integrity, as well as the protection of research subject personal information.

          CHECKLIST INSTRUCTIONS (Optional).

Warning:

• The documents requested should be signed by the legal representative of the research institution, where the trial site is located.
• Submit the documents through INS’ Documentary Procedure Office – Headquarters, within 7 working days from the entering of data in the application.
• Once the documents are received by OGITT, it will schedule and notify the inspection date to the institution.

Trial Site Registration Application Form

To submit a Trial Site Registration application, follow these steps:

1. Search for the Research Institution (EESS) the trial site to be registered belongs to. It should have a Single Code from the National Registry of Health Care Providers Institutions (RENIPRESS, former RENAES) (Indispensable requirement).
2. Once the research institution is found, fill the Trial Site Registration application form with information of the research institution and site to be registered (included pursuant to Annex 14 of the Procedure Manual in force).
3. After filling the form, click Save, a temporary registration number for the trial site will appear: Application (Temporary RCI). Then, print the form, sign it and attach it to the documents to be submitted via INS’ Documentary Procedure Office.

Listado de Centros de Investigación Registrados por Institución de Investigación

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).