To initiate a clinical trial, it is necessary to request the signature of the suitability of the facilities by sending an e-mail to the Clinical Trials Unit of INCLIVA (ensayosclinicos@incliva.es) with the basic study information (Code, EUDRACT, Principal Investigator and Performing Department) and the following documentation:
- Study protocol.
- Synopsis in Spanish.
- General financial report.
- Completed INCLIVA Template for Facility Suitability Annex IV AEMPS (Agencia Española de Medicamentos y Productos Sanitarios – Spanish Agency of Medicines and Medical Devices).
After receiving the request, the Clinical Trials Unit will contact the Principal Investigator and his/her team to confirm the participation of the other services involved and will proceed to process the signature of the document by the Medical Directorate of the Center (the only valid signature for the suitability of the facilities).
The Clinical Trials Unit will send the signed document to the sponsor or CRO (Clinical Research Organization) to the requesting e-mail address, and the management of the contract and the financial report may begin.
Management of the Suitability of the Facilities
Manu Erasun
ensayosclinicos@incliva.es
merasun@incliva.es
Telephone: 961 62 89 21