CTR and CTIS: Frequently Asked Questions
We have compiled a list of questions and answers that can support applicants working with the new Clinical Trial Regulation (CTR) and the CTIS system. If your question is not included in the list below, do not hesitate to contact us at email@example.com
No, all new applications must be submitted through the Clinical Trials Information System (CTIS). Please see further information on CTIS here.
Substantial Modifications to studies approved under the Clinical Trials Directive will still be submitted to the National Office by email in the usual way, until 30 January 2025, by which time all studies must transition to the CTR. Please see below for further information on transitioning to the CTR.
For studies approved under, or transitioned to the CTR, reporting will take place through CTIS. For studies approved under the CTD, or not yet transitioned, reporting will continue in the usual way.
All applicants must register on the Organisation Management System (OMS) in the first instance. Further information on CTIS can be found here.
All trials approved under the CTD must transition to the CTR by 30 January 2025. However, the National Office encourages sponsors to transition sooner if suitable. The process is outlined in the question below.
Create an account on the in the sponsor workspace. Follow the steps as outlined in the EMA guidance document, and upload the required documents for Part I and Part II dossiers. Please see the guidance from the EMA for further detail on the steps required.
A very high volume of substantial modifications (SMs) are submitted on a monthly basis to the National Office. SMs must be reviewed sequentially, and the National Office cannot prioritise applications based on chosen CTR transition date. The National Office team advise submission of SM applications for assessment at least three (3) months ahead of the Sponsor’s intended timeframe to transition under CTR.
All documents that were applicable under CTD and that are also applicable to CTR, can be uploaded to CTIS in their most recently approved versions. As a minimum, the most recently approved versions of all PISCF documents must be submitted to transition a trial to CTR. For document categories that are applicable only to CTR, a statement can be uploaded that confirms that the relevant information has been approved under CTD, in another document. E.g., Recruitment Arrangements. The full Part II Dossier should be brought in line with the CTR only at the time of the first Substantial Modification after the transition has been completed. Further information on Part II Requirements is available here.
In addition to submission of any documents that are part of the SM, the rest of the Part II Dossier should also be added. This includes documents that were not applicable under CTD, including Recruitment Arrangements, Declaration of Interest, Financial Arrangements, Compliance statements for Data Protection legislation and Compliance for use of Biological Samples. These documents should only be added at the first SM, and not as part of the transition to the CTR.
There will be no approval letters sent under the CTR. A Final Assessment Report (FAR) will be uploaded to CTIS for the Part II dossier. The complete list of reviewed documents and their version numbers will not be stated on the FAR. This information will be accessible through CTIS in the Sponsor Workspace.