Clinical Trials Information System (CTIS): New FAQ document available for clinical trial sponsors

The EMA has published a new Frequently Asked Questions (FAQ) document to help clinical trial sponsors using the Clinical Trials Information System (CTIS) more effectively. 

The FAQ document addresses common questions raised by sponsors during CTIS live events and through the CTIS Service Desk. It will be updated regularly as new issues arise. 

It is intended to complement the CTIS Sponsor Handbook, which has been updated to reference the new FAQ document. 

Sponsors are advised to:

• Use the CTIS Sponsor Handbook when managing clinical trial applications in CTIS
• Check the FAQ when additional clarification or practical guidance is needed 

Further information on CTIS and compliance with the Clinical Trials Regulation are available on our guidance for clinical trials sponsors webpage. 

Sponsors can also subscribe to the EMA Clinical Trials Highlights Newsletter keep up to date on clinical trial regulatory news, updates, and events.