ECSubmissionFormat object
Format option(s)
Online portal
Preferred format
Online portal
Online portal
OsSC:
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).
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 the AIFA website.
Standard application form available
No
Standard application form
Use of Online Portal (OsSC)
