10/11 October 2023
In order to help sponsors using the CTIS, the EMA has published a sponsor handbook. The EMA is continuously updating the CTIS Sponsor Handbook with further priority topics and a revised Version 3.01 has now been published. Following the previous update on how to manage clinical trials transitioned to the CTR (Version 3.00), the EMA now clarifies the timelines for the transition period.
There is a 3-year transition period that started on the CTIS go-live date:
Only trials submitted under the CTD and likely to be ongoing beyond 30 January 2025 need to be transitioned if they meet certain criteria (see "How to manage clinical trials transitioned to the CTR"). In CTIS after submission of the dossier, the assessment workflow is triggered and the MSC (Member States Concerned) need to select the RMS (Reference Member State) in the event of multi-national trials. Transitioning a trial from the CTD to the CTR can take up to a period of 60 days. In case, the documentation submitted does not correspond with the documents approved under the CTD the timelines would be extended by 15 days in the validation or 31 days in the assessment phase.
More information can be found in the Clinical Trial Information System (CTIS) - Sponsor Handbook (v. 3.01) on the EMA CTIS website.