CAAmendment object

Notification mandatory for

All changes with respect to the clinical trial

Authorisation mandatory for

All substantial amendments to the study protocol (+ related information)

Responsible for submission of SA

Sponsor

Standard notification form available

Yes

Standard notification form

Submission of substantial amendments to federal CA and EC via DIMDI platform

Timeline for approval of SA (max nr days)

30
By silent (implicit) approval

National legal framework in place

Yes

Applicable national legal framework/ Reference

Art 22c MPG

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
Feedback