In brief
On 30 January 2023, the European Commission published a document on the application of Regulation UE 536/2014 on clinical trials to provide sponsors and investigators with a quick guide on the rules and procedures established in the same Regulation with a view to facilitating its implementation (“Guide“).
Key takeaways
The Guide concisely covers the different phases of clinical trials, focusing on the obligations of investigators and sponsors, including those concerning the reporting and notification of adverse events.
In addition, the Guide describes the various steps to be followed when submitting a clinical trial application through the CTIS (“Clinical trial information system”) which, as of 30 January 2023, has become the single point of access for submission, authorization, and supervision of clinical trial applications in the EU.
