CAAmendment object

Authorisation mandatory for

Any substantial amendments

Responsible for submission of SA

Sponsor

Standard notification form available

Yes

Standard notification form

"Substantial Amendment form” of Annex 2 of guideline ENTR/CT 1

Timeline for approval of SA (max nr days)

20
By silent (implicit) approval

Guidance on submission of SA

GCP-V (Section 10) provides definitions of substantial amendments as well as procedures and legal consequences

National legal framework in place

Yes

Applicable national legal framework/ Reference

Section 10 GCP-V

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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