We kindly advise sponsors/investigators that the deadline for transitioning clinical trials from the CTD to the CTR is approaching. Transition must be completed by 30 January 2025. Sponsors/investigators are therefore encouraged to peruse the information below and to plan and prioritise ahead with respect to ongoing trials authorised under the CTD that need to be transitioned to the CTR.
Which clinical trials must be transitioned to the CTR?
Ongoing trials that have not ended on or before 30 January 2025 need to be transitioned to the CTR. If the transition has not been authorised by 30 January 2025, the clinical trial must be discontinued as its conduct would otherwise be unlawful.
Clinical trials with active sites need to be transitioned to the CTR. An active site means that Last Patient/Last Visit (LPLV) has not taken place yet, and that trial-specific activities involving the trial participants at the trial site are still ongoing. Multinational trials with no active sites in Denmark, as described above, which still have active sites in other Member States must transition to the CTR in those Member States only. Mono-national trials in which the Danish Medicines Agency has been notified of the end of trial (LPLV) are not to transition to the CTR.
Prior to transition to the CTR
All applications for substantial amendments for trials under the CTD must be completed before transition to the CTR. Remember to take into account the assessment times of the Danish Medicines Agency and the Medical Research Ethics Committees. If the submission is clearly marked with the words “Preparation for transitioning”, both authorities will endeavour to prioritise expedited review.
For multinational trials, it is necessary to make sure that all Part I documents of the application are harmonised or consolidated. In other words, the protocol must be identical in all Member States, or the protocol must specify any national differences (in a consolidated document). The Investigator's Brochure and the Investigational Medicinal Product Dossier may also have to be harmonised or consolidated prior to transition. See the CTCG’s best practice guide below.
Should harmonisation or consolidation result in substantial amendments to the documentation, these must be authorised as substantial amendments prior to transition. Remember to take into account the assessment times of the Danish Medicines Agency and the Medical Research Ethics Committees. If the submission is clearly marked with the words “Preparation for transitioning”, both authorities will endeavour to prioritise expedited review.
If the amendments are not substantial, this must be clearly indicated in the cover letter submitted with the transitioning application. The cover letter must also specify which versions of the documents were previously authorised under the CTD, stating the dates of their authorisation and the research ethics committee having authorised the trial under the CTD. Please also see the cover letter template below.
Application for transfer to the EU Regulation
It has been agreed between the EU Member States that the review of “transitioning applications” should be shortened to one week following the receipt of a valid application – usually about 32 days from submission as the application must first be validated. However, a longer timeline for review may be anticipated if the submitted material in Part II has major deficiencies. Note that the application must be authorised no later than 30 January 2025, not just submitted.
A number of guidance documents have been provided to facilitate applications for transition of clinical trials to the CTR:
Updating the application in accordance with the requirements under the CTR:
When submitting the first Substantial Modification (SM) after the transition to CTR:
Part I: All documents of the application must be updated to comply with the requirements under the CTR.
Part II in Denmark: Only documents that are changed as a result of the submitted SM need to be updated. Other documents should remain as submitted under the transitioning application, including "placeholder documents". In Denmark, there is no requirement to complete the Part II dossier, including completing and submitting CTR templates at the first SM after transition. Further guidance is available here.
The sponsor may delay submitting the first SM until there are planned changes to the dossier. However, all Part I documents must be updated before applying for the addition of a new member state to the trial.
A number of guidance documents have been provided to facilitate applications for the first SM after the transition to CTR:
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