CATrialAuthorisation object

Regulatory and ethics bodies involved in approval process

Competent Authority/-ies (CA)
Ethics committee(s)

CA - Submission for authorisation mandatory for

Clinical IMP trials
Clinical ATMP trials

National trial registry - Registration mandatory

Yes

National trial registry

All clinical trials have to be registered and submitted to the National Clinical Trials Monitoring Centre Database (Osservatorio – OsSC), the database of the Agenzia Italiana del Farmaco (AIFA).

Additional Information

Since Oct 1st 2014, a new version of OsSC has been activated for new Clinical Trial Applications (CTA) fulfilling the condition that all ECs involved in the clinical study have been certified and are included in the EC national register. To access the OsSC, the sponsor/CRO must register via user ID/password. Instructions regarding registration and use of the database are accessible at AIFA website.
The complete list of certified ECs and the instructions for CRO self-certification are accessible at the same URL.
The registration of the trial data and documents within the OsSC complies with the Italian and European requirements (EudraCT DB) for Clinical Trial electronic data transmission to the CA.

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395