ECMultiCenterStudiesEthicalReview object

Ethical approval (favourable opinion) required from

Lead EC (authorised to issue a single opinion)

Submission of application required to

Any competent EC where PI or coordinator is located

Additional Information

40 Lead ECs in France, no local ECs.
France has been divided in seven regional areas and the clinical trial application authorisation can be submitted by the sponsor to any Comité de Protection des Personnes (CPP) in the region where the principal investigator (or coordinator in multicentre Clinical trials) is located. This CPP is responsible for the single opinion and has to evaluate i.a. the participant’s protection, the adequacy between objectives of the research and means used and the qualification of the investigators.