ECSubmissionOfApplication object
Responsible for study submission
Sponsor
Guidance on study submission
Detailed guidance on the format and documentation of a clinical trial application to be submitted to by the sponsor to the concerned EC(s) is published in Decreto Ministeriale 21 Dec 2007/ Ministerial Decree 21 December 2007 and is accessible in the OsSC.
Additional Information
The application has to be submitted in parallel to the lead EC and all involved local ECs.
