Regulation 17C Ethical review of performance studiesF1

In Regulation (EU) 2017/746 a reference to an ethics committee is a reference to an ethics committee within the meaning of regulation 3(1).

In relation to a performance study to which Article 58(5)(b) applies, the sponsor must submit to the Secretary of State a copy of the opinion of the ethics committee as soon as it becomes available and before the performance study starts.