ECAmendment object

Ethical review mandatory for

Any substantial amendments

Responsible for notification of SA

Sponsor

Timeline Ethical review of SA (max nr days)

30

Guidance on submission of SA

Notification of substantial amendments to the federal CA and all involved ECs is performed by use of the DIMDI platform.

Applicable national legal framework/ Reference

§ 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
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