EU Clinical Trial Regulation (CTR)
On 31 January 2022, the EU Clinical Trial Regulation (CTR) will be applicable. On this page information is given on how to get ready for this change. Please take note of all the information, follow training and watch webinars. CCMO will soon publish specific information for investigators on the procedures for a clinical trial application under the CTR.
Brochure: The CTR in a nutshell
A brochure published by the Dutch Clinical Research Foundation (DCRF) describes the changes in a nutshell.
A transition period of three years will apply once the CTR has come into force. During the first year, sponsors may choose to submit a clinical trial application according to the current legislation, or according to the CTR via CTIS.
Clinical Trials Information System (CTIS)
The Clinical Trials Information System (CTIS) will contain the centralised EU portal and database for clinical trials foreseen by the CTR. CTIS will be the single entry point for submitting the clinical trial application in the EU. The system will support the day-to-day business processes of Member States and sponsors throughout the life-cycle of a clinical trial. The European Medicines Agency (EMA) sets up and maintains CTIS, in collaboration with the Member States and the European Commission.
CTIS sponsor handbook
EMA provides a handbook on CTIS for sponsors of clinical trials.
CTIS training programme
A training programme on CTIS is also available on EMA’s website.
CTIS information events
EMA organises information events on CTIS.
EMA regularly publishes 'CTIS highlights' with news on the development of CTIS:
- CTIS highlights August 2021
- CTIS highlights June 2021
- CTIS highlights December 2020
- CTIS highlights June 2020
Would you like to subscribe to CTIS highlights? Please send an e-mail to firstname.lastname@example.org.
Q&A document: Answers to frequently asked questions
A Q&A document from the European Commission provides answers to frequently asked questions about the CTR.