CT11: How to Gain Authorisation for Clinical Research Under the EU Clinical Trials Regulation

Description

To conduct a clinical trial in one or more member states (MSs) of the European Economic Area (EEA) a sponsor must first gain the approval of each relevant national regulator and the favourable opinion of research ethics committees relevant to the investigational sites. The European Union (EU) Clinical Trials Regulation ensures that the rules for assessing clinical trial applications and for conducting clinical trials are identical throughout the EEA. It establishes a harmonised procedure for gaining and maintaining authorisation for trials in up to 30 countries on the basis of a single electronic application per trial, and subsequent interactions, via a single EU online information system. MSs concerned in a trial collaborate on, and coordinate, its evaluation and supervision, and each MS returns a single decision on authorisation. The Regulation also mandates greater transparency of information on trials. The Regulation applies from 31 January 2022 and, after a grace period of one year, sponsors of all new clinical trials in the EEA must comply with it.

This course sets out the procedures that sponsors need to follow to gain authorisation to conduct clinical trials under the Regulation, and it summarises and links to the extensive guidance available from the European Commission and the European Medicines Agency. Its companion course CT12 sets out the procedures that sponsors need to follow to conduct authorised clinical trials in compliance with the Regulation. The two courses therefore provide an ideal foundation for understanding and complying with the new law.