In the Guidance for the Transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation, question 6, is described the documents needed to transition a clinical trial approved under the Clinical Trial Directive (CTD). For the transition of a clinical trial, first only the latest versions of the following documents approved under the CTD should be placed in CTIS:
- Protocol (a consolidated or harmonized version in case of a multinational clinical trial)
- Investigator’s Brochure
- Good manufacturing Process (GMP) documents
- IMPD
- Documents related to non-investigational medicinal products (i.e. auxiliary medicinal products under the CTR, if applicable)
- Subject information sheet and informed consent form
In CTIS a blank document should be uploaded in the placeholders for the remaining documents (where document upload is required). The title of these documents must include the term “blank document”.
The cover letter should include:
- A declaration that the clinical trial is in line with the requirements for transition trial (as set out in question 11 of the Q&A CTR) and that the clinical trial is still in line with the authorisation given under the CTD.
- The name of the ethics committee who has given a positive opinion on the clinical trial under CTD.
There will be no assessment during the transition of a CTD clinical trial to CTIS. Therefore, the Netherlands does not want to receive any documents other than those mentioned above during the initial transition.
After the initial transition, the dossier must be completed at the first substantial modification (SM). If the SM only concerns Part I, then only Part I documents must be completed. For a SM relating solely to Part II, only the mandatory Part II documents must be supplied. Remarks:
- The site specific documents need to be supplemented only for those sites that are still active in the clinical trial. An active site in the context of transition trials means that the last visit of the last subject, or other trial-specific interventions with the subject specified in the protocol, will take place after 30 January 2025.
- Recruitment arrangements: This document may be omitted if the recruitment of new trial participants has stopped.
- CV (resume): The previous CV’s (used in the CTD application) can be provided. Please note that in CTIS a redacted version (without personal details and signature) should be submitted.
- Declaration Site Suitability [VGO]: If this is the previously used Research Declaration under the CTD, then this can be submitted, and it is not necessary to supply a new VGO. Please note that a redacted version should also be submitted (without personal details and signature).