CATrialAuthorisation object

Regulatory and ethics bodies involved in approval process

Competent Authority/-ies (CA)/ For certain types of MDs
Ethics committee(s)
Agency for data protection

CA - Submission for authorisation mandatory for

All clinical investigations of MD

CA - Submission required to

National CA
CA(s) of EU&EFTA Member States concerned

Applicable national legal framework/ Reference

Art 13 GDR 2009 (fr)

Submission to CA and EC to be performed in the following order

In parallel

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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