New courses on clinical research under the EU Clinical Trials Regulation released
grapl ltd, owner of the Zenosis library of eLearning for the medicines and healthcare products industries, is delighted to announce the release of two new courses on clinical research under the European Union’s recently implemented Clinical Trials Regulation:
- CT11: How to Gain Authorisation for Clinical Research Under the EU Clinical Trials Regulation
- CT12: How to Conduct Clinical Research Under the EU Clinical Trials Regulation
The long-awaited implementation of the Regulation ushers in a simplified and harmonised process of authorisation and supervision of clinical trials in the European Economic Area. 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. It 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.
The CT11 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.
The existing course CT01, which deals with clinical research under the Clinical Trials Directive – the law repealed by the Clinical Trials Regulation – has been updated. During the first year of transition to the Regulation, sponsors have the option of applying for approval under the Directive, and they can continue trials under that regime until 31 January 2025.