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.
- Application for Trial Site registration (as per e-form) and printed form attached.
- 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).
- 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:
- 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).
- 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).
- 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