Planned system interruptions
Users are advised to avoid using CTIS or this website during the regular maintenance windows:
- Tuesdays and Thursdays, from 18:00 to 21:00 Amsterdam time
- Every first Saturday of the month, from 10:00 to 14:00 Amsterdam time
The time zone used in CTIS is Central European Time (CET). All due dates and deadlines are displayed in CET despite the daylight-saving time change taking place in Europe on 26 March 2023.
Unplanned system interruptions
If CTIS is unexpectedly down outside of the above downtime windows, users can consult EMA's User support Service landing page for further information.
Release notes
These documents outline the latest updates to the CTIS system, including the secure Sponsor and Authority workspaces, and to the Clinical Trials website. Updates may include improvements to existing features and functionality, the addition of new features and functionality and technical improvements.
CTIS Release Notes v1.0.50.0.pdf (PDF, in English), March 2025
CTIS Release Notes public portal v2.2.0.pdf (PDF, in English), March 2025
Lists of known issues and proposed workarounds
These documents outline the issues that sponsor and authority users may encounter when using the CTIS secure workspaces, with possible workarounds.
The Clinical Trials Information System (CTIS) is the online system for the regulatory submission, authorisation and supervision of clinical trials in the European Union and the European Economic Area.
- for CTIS sponsor workspace users v1.0.47.0 (PDF, in English), November 2024
- for CTIS authority workspace users v1.0.47.0 (PDF, in English), November 2024
- for CTIS sponsor workspace users v1.0.44.0 (PDF, in English), September 2024
- for CTIS authority workspace users v1.0.44.0 (PDF, in English), September 2024
- for CTIS sponsor workspace users v1.0.42.0 (PDF, in English), July 2024
- for CTIS sponsor workspace users v1.0.38.0 (PDF, in English), May 2024
- for CTIS authority workspace users v1.0.38.0 (PDF, in English), May 2024
- for CTIS sponsor workspace users v1.0.27.0 (PDF, in English), September 2023
- for CTIS authority workspace users v1.0.27.0 (PDF, in English), September 2023
- for CTIS sponsor workspace users v1.0.28.0 (PDF, in English), September 2023
- for CTIS authority workspace users v1.0.28.0 (PDF, in English), September 2023
- for CTIS sponsor workspace users v1.0.21.0 (PDF, in English), May 2023
- for CTIS authority workspace users v1.0.21.0 (PDF, in English), May 2023
- for CTIS sponsor workspace users v1.0.22.0 (PDF, in English), May 2023
- for CTIS authority workspace users v1.0.22.0 (PDF, in English), May 2023
- for CTIS sponsor workspace users v1.0.16.0 (PDF, in English), March 2023
- for CTIS authority workspace users v1.0.16.0 (PDF, in English), March 2023
- for CTIS sponsor workspace users v1.0.18.0 (PDF, in English), March 2023
- for CTIS authority workspace users v1.0.18.0 (PDF, in English), March 2023
- for CTIS sponsor workspace users v1.0.20.0 (PDF, in English), March 2023
- for CTIS authority workspace users v1.0.20.0 (PDF, in English), March 2023
- for CTIS sponsor workspace users v1.0.13.0 (PDF, in English), January 2023
- for CTIS authority workspace users v1.0.13.0 (PDF, in English), January 2023
- for CTIS sponsor workspace users v1.0.14.0 (PDF, in English), January 2023
- for CTIS authority workspace users v1.0.14.0 (PDF, in English), January 2023
- for CTIS sponsor workspace users v1.0.12.0 (PDF, in English), December 2022
- for CTIS authority workspace users v1.0.12.0 (PDF, in English), December 2022
- for CTIS sponsor workspace users v1.0.6.0 (PDF, in English), October 2022
- for CTIS authority workspace users v1.0.6.0 (PDF, in English), October 2022
- for CTIS sponsor workspace users v1.0.4.0_Update (PDF, in English), September 2022
- for CTIS sponsor workspace users v1.0.5.0_Update (PDF, in English), September 2022
- for CTIS authority workspace users v1.0.4.0 (PDF, in English), September 2022
- for CTIS authority workspace users v1.0.5.0 (PDF, in English), September 2022
- for CTIS sponsor workspace users v1.0.3.2_Update (PDF, in English), July 2022
- for CTIS authority workspace users v1.0.3.2 (PDF, in English), July 2022
- for CTIS sponsor workspace users v1.0.2.0 (PDF, in English), May 2022
- for CTIS authority workspace users v1.0.2.0 (PDF, in English), May 2022
- for CTIS sponsor workspace users v.1.0.0.5 (PDF, in English), January 2022
- for CTIS authority workspace users v.1.0.0.5 (PDF, in English), January 2022
Support and training
