All clinical trials expected to continue beyond 30 January 2025 must be transitioned to the EU Clinical Trials Regulation (CTR) via the Clinical Trials Information System (CTIS). This date marks the end of a three-year transition period that began when the CTR became applicable.
Clinical trials conducted under the previous legislative framework of the Clinical Trials Directive (CTD) that have not transitioned by 30 January 2025 and remain ongoing in EudraCT will be considered non-compliant with the CTR, as highlighted in the European Commission’s guidance on transition.
We would therefore like to provide you with some key information to ensure a smooth transition to the CTR:
- If you have not done so, begin transitioning the relevant trials as soon as possible. Please consider the time required for the Member State(s) evaluation procedure, which can take up to 3 months.
- Important checkbox: When submitting your application in CTIS, ensure to tick the checkbox for ‘Transitional trial’.
- Access support resources: The CTIS website offers a range of resources (information, training, etc.) for sponsors transitioning trials.
Support sessions & resources:
- Latest bitesize talk on transitioning trials – 29 February 2024 on Transitioning of trials
- CTIS webinar – last year of transition – 25 March 2024
- CTIS walk in clinic dedicated to transition – 18 September 2024.
Additional tools to assist in transition:
- CTCG updated best practice guide and cover letter template for sponsors transitioning trials to the CTR
- Annex II: Fees for transitional trials in EU/EEA Member States
- CTIS Sponsor Handbook: Detailed information in Chapter 5.