New Safety Module in the Clinical Trials Information System (CTIS)
23 September 2026
A new Safety Module in the Clinical Trials Information System (CTIS) will go live on 28 September 2026, followed by a two-month transition period ending on 30 November 2026.
The new Safety Module introduces updated processes for the submission and management of Annual Safety Reports (ASRs).It is expected to reduce the administrative burden and provide sponsors with greater flexibility, while supporting more harmonised procedures
across EU Member States.
What does this mean for you as a Sponsor/Investigator?
- Ongoing ASRs will continue to be processed and completed within the current system.
-
From the go-live date, all new ASRs must be submitted and managed through the new Safety Module. Submission through the current system will no longer be
possible.
- Access to completed ASRs in the current system will no longer be available once the transition period has ended.
- The new Safety Module will appear as a separate tab within CTIS, just like the current module, provided that the appropriate CTIS role (ASR Submitter) has been assigned. If you do not have this role, either you or another individual within your organisation must hold the Sponsor Safety Admin role in order to assign the ASR Submitter role.