ECSingleCenterStudiesEthicalReview object
Ethical approval (favourable opinion) to be obtained from
Central EC (appointed as co-authority)
Additional Information
Single-site clinical investigations with medical devices fall in the nationwide competence of TUKEB (acting as co-authority for ethical approval).
Every clinical investigation with medical devices (even Non-Interventional Trials) conducted within the territory of Hungary falls in the competence of HRTC, and has to be approved by CA!
NB! Submission only via CA (HRTC); there is no possibility of direct submisson to the EC (TUKEB)!
