ECSingleCenterStudiesEthicalReview object
Ethical approval (favourable opinion) to be obtained from
Local EC
Additional Information
According to the law every hospital needs to have a (research) ethics committee that has to review applications for clinical trials with medical devices. Additionally the province authorities have to establish (research) ethics committees for clinical trials in institutions outside of hospitals (outpatients).
It is possible that one Ethics Committee is the competent committee for several hospitals.