In the European legislative framework, the approval of clinical trial applications is the responsibility of the member states. The national competent authorities and the ethics committees are responsible for authorising a clinical trial taking place in the member state. Also, the national competent authorities are responsible for entering protocol related information that has been submitted to their member state into the EudraCT database. The authorities also add to this information the authorisation of the clinical trial and the opinion from the relevant ethics committee. Once entered, a sub-set of this information is displayed through the EU clinical trials register website.
EU Clinical Trials Register version 2.2