ECAmendment object

Ethical review mandatory for

Substantial amendments (SA) relating to aspects applicable to EC

Timeline Ethical review of SA (max nr days)

20 resp. 35 (ATMP) - from receipt of the application

Applicable national legal framework/ Reference

Section 10 GCP-V

Additional Information

In case of multi-centre trials, the leading EC issues the opinion in cooperation with all other local ECs.
The EC's opinion has to be provided within the given timeframe to the sponsor and the CA.

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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