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Transitional trials

Clinical trials authorised under the Clinical Trials Directive 2001/20/EC and expected to be ongoing after 31 January 2025 must be transferred into the legal framework of the Regulation by 30 January 2025 using the Clinical Trials Information System (CTIS).

The sponsor is responsible for a timely transition to CTR. An expedited administrative procedure is foreseen up to 16 October 2024. For submission beyond this date, a prompt approval cannot be guaranteed.

It is the responsibility of the sponsor to decide whether the trial should be transitioned or not, based on the details of the trial:

  • Is the Last Patient Last Visit of your trial(s) foreseen to occur after 30 January 2025?

If there are going to be active sites for the trial after 30 January 2025, it is mandatory to transition it to the Clinical Trials Information System (CTIS), to comply with Regulation (EU) 536/2014. Refer to CTIS: how to get started and how to transition a trial

  • Is the Last Patient Last Visit of the above trial(s) foreseen to occur before 30 January 2025?

If there are not going to be active site for the trial after 30 January 2025, no transition is needed. Upon trials’ completion/premature end,  please submit the end of trial form(s) to the relevant EudraCT National Competent Authority(/ies) and submit results.

  • Should the trial(s) status be ‘completed’, ‘prematurely ended’ or ‘transitioned’ in EudraCT?

Please notify us to update the trial status on EudraCT in case it has ended. For completed/prematurely ended trials, results are expected within one year from their End of trial date (or within 6 months, if conducted on paediatric subjects).

Part II document requirements for transition trials

With the transition trial application, it is mandatory to submit the latest ICF versions.

The following Part II documents must be submitted with the first substantial modification:

  • CV(s) of the principal investigator(s);
  • Certificate of insurance;
  • Compensation for trial participants and Financial Arrangements;
  • Statement of compliance with Regulation (EU) 2016/679 (GDPR);
  • Compliance with Member State applicable rules for the collection, storage and future use of human biological samples (Article 7.1h) – applicable when handling biological samples;
  • Recruitment and Informed consent procedure template – to be provided in case of an active recruitment phase.

Retrospectively, the site suitability template does not need to be submitted. There is no need to update existing document templates, e.g. no need to redraft CVs.

  1. The European Commission Guidance for the transition of clinical trials as well as the Quick Guide on CTR .
  2. CTIS: how to get started and how to transition a trial --> collection of training and reference documents for new CTIS users.
  3. The CTCG best practice guide and accompanying annex for sponsors with multinational trials. The guide aims to support sponsors transitioning multinational trials with protocols, IMPD or Investigator’s Brochure that are not harmonised across Member States. The annex provides a template with information that should be provided in the cover letter of applications for transitioning a clinical trial authorised under the CTD to the CTR.
  4. Chapter 5 of the CTIS Sponsor Handbook it includes an overview of the transition period, general considerations for transitioning trials, the assessment timelines, and information on creating and managing trials transitioned to CTIS.
  5. Module 23 of the CTIS online training programme it includes instructions on how to submit a transitional trial, including submitting notifications and clinical trial results. An overview of the content is also available in the Quick Guide for Sponsors.
  1. The video recording and presentation of the CTIS Bitesize talk from 21 June 2023 on how to submit a transitional trial in CTIS, available on the event page
  2. The video recording of the CTIS webinar on 4 July 2023 on the Second year of transition, available on the event page
  3. The video recording and presentations of the Training from 9 February 2024 for non-commercial sponsors on transitioning trials to the CTR and CTIS, available on the event page. It also contains information on OMS and xEVMPD
  4. The video recording of the CTIS Bitesize talk from 29 February 2024, on how to submit a transitional trial in CTIS, available on the event page

Last updated: 07.05.2024