ECMultiCenterStudiesEthicalReview object
Ethical approval (favourable opinion) required from
Central EC (authorised to issue a single opinion)- can be delegated to a Regional EC
Additional Information
TUKIJA gives national ethical opinions on international multi-centre clinical trials on medicinal products. This can also be delegated to regional ECs of hospital districts, where the person responsible for the research (National Coordinator) is based, which will then issue any necessary national opinion.