CAAmendment object

Notification mandatory for

All clinical trials requiring authorisation by CA

Responsible for submission of SA

Sponsor

Standard notification form

EU Standard Amendment Notification form

Timeline for approval of SA (max nr days)

35

Applicable national legal framework/ Reference

Art 9 modified RGD 30 May 2005

Additional Information

Timelines of approval counted from the date of receipt of the proposed amendment.
Implicit approval if no reasoned objections raised by 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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