Lead EC (authorised to issue a single opinion)
Lead EC + All concerned local ECs for site-specific assessment
The lead EC can be chosen freely, but should be locally competent for one of the participating sites. The trial application needs to be submitted to the lead EC and in parallel to the local ethics committees of the trial sites (Art 41b AMG). This is mandatory for initial submission and submission of any amendments. Local ethics committees assess the appropriateness of the investigators and the sites. For multicentre trials a pharmacologist has to be member of the EC.