CAAmendment object
Authorisation mandatory for
All clinical trials requiring notification to CA (without approval process)
All clinical investigations requiring authorisation by CA
Responsible for submission of SA
Sponsor
Standard notification form available
Yes
Standard notification form
Submission online via DIMDI platform
Timeline for approval of SA (max nr days)
30
Applicable national legal framework/ Reference
§ 22c MPG
Additional Information
Implicit approval of substantial amendments.