Submission of an application for transition of a clinical trial
Transition applications concern clinical trials (and combination trials) that have already been approved by an ethics committee and authorized by an NCA under the CTD. An application for transition of a clinical trial is submitted to CTIS.
A transition application must be submitted if the study continues after the 30th of January 2025. If the trial ends before this date in the EU/EEA (more specifically in all MSs within the EU/EEA), there is no need for a transition application
No fee is charged for processing transition applications.
More detailed guidance on transition applications can be found in Guidance for the Transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation. See also EudraLex volume 10 document, which is updated regularly.
Euroopan komission transitio-ohje
EudraLex - Volume 10 - Clinical trials guidelines
The cover letter should include a statement that the clinical trial is still in line with the authorization given under the CTD, and it meets the conditions for transfer to the EU portal and database.
The cover letter should also identify the ethics committee that has provided a positive opinion on the clinical trial.
In addition, the cover letter must state that the documents which need approval have been approved before the transitional application is made.
The latest approved versions of the following documents must be submitted:
- Protocol (for multinational studies, possibly a consolidated or harmonized protocol; harmonization requires a substantial amendment application under the Directive procedure)
- Investigator's brochure (IB)
- GMP relevant documents
- Investigational medicinal product documentation (IMPD)
- Documents related to non-investigational medicinal products (i.e. auxiliary medicinal products under the CTR)
In addition, other approved documentation under the Directive, may be submitted.
For Part II, the latest authorized versions of the subjects' information sheet and the informed consent form are the documents that are required as a minimum.
Other additional documentation that has been assessed and authorized under the CTD may also be submitted.
Only the latest approved versions of the documents will be sent. A separate document on biological samples is not needed, as this was not required under the Directive-based procedure.
Except for the Site Suitability Template, all other documents corresponding to the ones mentioned in Annex I of CTR must be submitted and updated to comply with the regulation in the first substantial modification (SM), depending on which part (I, II or I & II) of the application is concerned with.
A document on compliance with the rules for the collection, storage and future use of biological samples and declarations of interest (of principal investigators) must be provided at this point.