ECMultiCenterStudiesEthicalReview object

Lead EC (authorised to issue a single opinion)

Lead EC + All concerned local ECs for site-specific assessment

In multi-centre studies, the coordinating investigator or the sponsor submits the study dossier to the lead ethics committee (responsible ethics committee of the canton at the site of activity of the project coordinator (HRA Art. 47). The lead EC checks formal completeness and informs applicant. Applicant submits clinical trial dossier to all local Cantonal ECs responsible at other trial sites. The cantonal ECs evaluate local items only (e.g. adequate qualification of the investigator, infrastructural requirements, acceptance by the local community) and inform the lead EC on their decision.
The lead ECs review the complete documentation, issues its final reasoned opinion on the clinical trial application and communicates its decision to the applicant, the local ECs concerned and to the CA (in case of Cat B and C trials).
The local ECs can accept or refuse this decision or eventually add locally determined minor supplements.

Additional trial sites must be submitted to the local EC(s). (Art. 27 KlinV/ClinO).