ECMultiCenterStudiesEthicalReview object
Ethical approval (favourable opinion) required from
Lead EC + All concerned local ECs for site-specific assessment
Regional EC (authorised to issue a single opinion)
Additional Information
The EC reviewing the study must be recognised by the Federal Agency for Medicines and Health products (list of EC on their website). In case of multicentre studies, a leading EC has to be indicated and the other EC will be non –leading. There are specific criteria to be leading EC to be found on FAMHP website.
