CT01: How to Gain and Maintain Approval for Clinical Research Under the EU Clinical Trials Directive

Description

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 (i.e. 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.