ECMultiCenterStudiesEthicalReview object
Ethical approval (favourable opinion) required from
Multicentric Ethics Committee (MEC) + all local ECs of involved trial sites
Submission of application required to
Multicentric Ethics Committee (MEC) + all local ECs of involved trial sites
Additional Information
Applications for opinions on multicentric clinical trials have to be submitted to one of the11 established Multicentric Ethics Committees (MECs) and, concurrently, to all local ECs at the planned trial sites. The applicant needs to inform all relevant ECs on the involvement of other ECs (multicentric about local and vice versa).
The multisite clinical trial ethical review is done by an ethics committee for multi-site studies (MEC) and also by each of the relevant local EC.
