ECAmendment object

Ethical review mandatory for

Any substantial amendments (except related to quality of investigational medicine)

Responsible for notification of SA

Sponsor

Applicable national legal framework/ Reference

Art 20-22 Rulebook Application 2011

Additional Information

A positive vote of the relevant EC(s) is a prerequisite for approval by the CA.

NB! Assessment by the EC(s) is not required if the substantial amendments are related to the quality of the IMP or changes to the bearer of the authorization for the implementation of clinical trials.

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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