These clinical studies will be jointly reviewed by the FAMHP and an independent ethics committee, accredited through the law of 07/05/2017. Only one submission is required through the national contact (FAMHP) and only one joint opinion will be delivered. The complete file must be submitted, via the CESP, to the FAMHP.
These studies can therefore not be submitted directly to EC Research.
The following types of studies should be submitted according to this pathway:
Performance studies:
o with surgically invasive sample-taking only for the purpose of the performance study
o which are interventional clinical performance studies
o with additional invasive procedures or other risks for the subjects
o involving companion diagnostics (not on left-over samples)