CAAmendment object

Authorisation mandatory for

Substantial amendments (changes of study plan or participating sites)

Responsible for submission of SA

Sponsor

Standard notification form available

Yes

Standard notification form

The submission can be performed online via "E-service for notification" (can be accessed on MPA website in section Medical Devices > Clinical Investigations > Notification and Forms)

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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