If the study falls under the Act on experiments on human beings (7 May 2004), proof of simultaneous submission to the ECs of all participating centres is required in the case of a multicentric study (see article 11, §7 of this act). If EC Research acts as the central EC in the study, this proof needs to be submitted to EC Research. This confirmation can be described in a Word document, which is sufficient as proof.
In addition to this proof, we also request the following information on the ECs of the participating centres (= "local EC"):
- CV (including GCP certificate) of the principal investigators at the local participating centres, including indication of the ethics committee to which each principal investigator is affiliated.
- Draft contract (if analogous to the contract with UZ Leuven, please specify).
In the case of a multicentric study in which EC Research UZ/KU Leuven acts as central committee, the EC Research's opinion will be delivered after consultation of the ethics committees of all other participating Belgian centres.