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.