CTIS - New FAQ Document Released

9th April 2026

The FAQ is based on questions raised by sponsors during CTIS events and via the CTIS Service Desk. It complements the CTIS Sponsor Handbook and provides additional guidance on specific topics, including:

• IMPD-Q only applications
• content requirements for clinical study reports (CSRs) to be submitted in CTIS

The new FAQ replaces previous CTIS Q&A documents, as listed under section 7.
 
We encourage sponsors to refer to the Sponsor Handbook when preparing and managing clinical trial applications in CTIS. In case of specific questions, sponsors can now consult the FAQ.

View FAQ

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