Revised CTIS Sponsor Handbook release

The revised Sponsor Handbook for the Clinical Trials Information System (CTIS) will be published on the EMA website on Wednesday 9 July 2025. On the same day, a dedicated CTIS bite-size talk takes place at 15:30 CEST.

This updated version of the Sponsor handbook will replace all the previous sponsors’ training modules and will serve as the definitive reference for sponsor users of CTIS.

The redesign of the sponsors’ training materials was undertaken in response to stakeholder feedback, with the aim of improving usability and navigation. A stakeholder focus group, created under the ACT EU Multi-Stakeholder Platform, reviewed and validated the new materials to ensure they meet the needs of the sponsor community.

As announced above, EMA is hosting a dedicated CTIS bite-size talk on Wednesday 9 July 2025 at 15:30 CEST, to support the transition to the new format. This session will introduce the structure and key features of the handbook and provide an opportunity for questions.