How to Gain and Maintain Approval for Clinical Research Under the EU Clinical Trials Directive

To conduct a clinical trial in the European Economic Area under the Clinical Trials Directive the sponsor must apply for authorisation from the national competent authority (medicines regulator); and favourable opinion must be obtained from a research ethics committee; in each member state in which the trial is to take place. This module sets out the requirements for successful compilation; submission and maintenance of the applications. During the first year of transition to the Clinical Trials Regulation; sponsors have the option of applying for approval under the Directive; and they can continue trials under that regime until 31 January 2025.