CASubmissionOfApplication object

Responsible for study submission

Sponsor

Guidance on submission of application

Detailed guidance for Clinical Trial submission is provided on the FAMHP site ( section: Human medicines > Medicines > Medicines > Research & Development > Clinical trials) in the following documents:
1) Detailed Guidance CT1: Detailed guidance for the request for authorisation of a CT on a medicinal product for human use
2) Circular 575 + annexes: Application for clinical trials and submissions of substantial amendments.

Applicable national legal framework/ Reference

Chapter IX Art 12 (1) Law 7 May 2004

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
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