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.
