ECMultiCenterStudiesEthicalReview object

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

Lead EC (authorised to issue a single opinion)

The sponsor shall appoint a coordinator of clinical investigation from among all the clinical investigators involved in a multi-centre clinical investigation (Art 42 Medical Device Act 2010).

The sponsor or the designated coordinator shall submit the application to the EC (“Bioethics Committee”) where the coordinating investigator has his/her registered office.
This EC, acting as “lead” EC, shall inform all other ECs of the involved trial sites on the envisaged participation. They have 14 days to perform a site-specific assessment and submit reservations concerning the participation of the investigator or site in the clinical investigation.
The designated “lead” EC is authorized to issue a binding “single opinion” on the clinical investigation on behalf of the other involved ECs.
(Art 49 Medical Device Act 2010)