CAAmendment object

Authorisation mandatory for

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

Responsible for submission of SA

Sponsor
Principal Investigator (if no sponsor related to study)

Standard notification form available

Yes

Standard notification form

European Substantial Amendment Notification Form

Timeline for approval of SA (max nr days)

35
By silent (implicit) approval

National legal framework in place

Yes

Applicable national legal framework/ Reference

Art 15 & 31 Regulation no 433/2004

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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