ECMultiCenterStudiesEthicalReview object
Ethical approval (favourable opinion) required from
Lead EC (authorised to issue a single opinion)
Submission of application required to
Multicentric Ethics Committees (MECs) + All concerned local ECs of participating sites
Additional Information
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.
(Section 54 of Act No 378/2007 Coll. on Amendment to the Act on Pharmaceuticals)
