On 3 December 2021 EMA and ECRIN offered a joint training session to the ECRIN CTU community, Implementation of the Clinical Trial Regulation (EU) No 536/2014 for academia: Live demonstration of CTIS and Q&A session. Over 275 participants connected during the event and watched demonstrations on CTIS Access & User Management, Completion of an initial application, Modifications to an initial application – under evaluation via RFI (request for information) and Modifications to an authorised initial application via modifications & adding a new MSC.
The training, chaired by Ralf Herold, Scientific Officer in the Regulatory Science and Innovation Task Force – Research and Innovation, EMA and Sabine Klager, Head of Clinical Operations, ECRIN lead to many pertinent questions by the participants.
A few useful links shared in the training include the latest version of the Sponsor Handbook, module 19 ‘CTIS for SMEs and academia’, Module 10 ‘How to create an initial application’, and the subscription link for the EMA newsletter (write to CT.Communication@ema.europa.eu).
The event was a success thanks to the chairs, the informative panellists and the inquisitive participants that kept asking questions up until the close of the training.