CASubmissionOfApplication object
Responsible for study submission
Sponsor
Legal representative
Guidance on submission of application
Documentation is specified in Annex of Executive Decree No 235/2009.
Documentation for non interventional studies is specified in Annex 4 of 23/2002 Decree of the Minister of Health
Additional Information
Sponsor can assign or transfer the responsibility for trial submission to another organization like CRO. So application for the approval can be submitted by the sponsor, the CRO or even the trial site in case of single site study. In the last two cases “Declaration of Authorization” is required.