Practical guidance on Part II of the transitioning application the first substantial modification to transition trials

The Medical Research Ethics Committees generally follow the guidance on Eudralex Volume 10 by the European Commission: Guidance for the transition of clinical trials 

Cover letter

The cover letter must must include details stating: 

  • the name of the research ethics committee that approved the initial clinical trial application under the Clinical Trials Directive (CTD). This may be a regional research ethics committee (name must be specified), the Medical Research Ethics Committees (VMK) or the National Committee on Health Research Ethics (NVK). 
  • that all the documents submitted to the CTIS portal under Part II for Denmark are the documents currently authorised by the research ethics committee in question. We recommend using the cover letter template provided by the CTCG, see link under further information. 

Part II documents 

The only mandatory documents for Part II of the application are the currently approved versions of the participant information sheet(s) and informed consent form(s). 

For the mandatory sections in the CTIS portal "Recruitment arrangements", "Financial arrangements" and "Proof of insurance", we recommend uploading a so-called placeholder document, which describes/confirms that the aspect in question has been assessed and approved by the research ethics committee having evaluated the trial CTD (and therefore is covered by the conclusion of the assessment under the CTD). 

In the case of multinational trials, we encourage applicants to upload the currently approved version of the Danish protocol addendum (for example under “Proof of insurance”). This document should include the Member State-specific information authorised under the CTD with respect to the sections “Recruitment arrangements”, “Financial arrangements” and “Proof of insurance”. 

As there are no requirements for submitting further documentation in Part II, the other fields in the CTIS portal may be left empty. Applicants wishing to submit additional documentation as part of the transitioning application are advised that only documents authorised under the CTD are accepted. We recommend that any additional documentation be clearly specified in the cover letter, see the template provided by the CTCG. 

The applicant must inform the initial committee having authorised the trial under the rules of the CTD that the clinical trial has been transferred to CTIS, thus being regulated by the rules of the CTR henceforth. 

Trials in emergency situations 

The rules under the CTR regulating clinical trials in emergency situations differ significantly from the rules of the CTD in Denmark. This includes the requirements for recruitment and obtaining informed consent. To comply with the provisions of article 35 of the CTR (clinical trials in emergency situations), a substantial modification must be applied for immediately after the transitioning application has been authorised. In the review of the transitioning application, the applicant will be asked to confirm that such a modification request is planned. 

Practical guidance on the first substantial modification to Part II of transition trials 

Sponsors should only submit substantial modifications to part II in Denmark for transition trials, if there are substantial modifications to part II according to the rules under the CTR.

For the first substantial modification to a transition trial involving Part II of the application, relevant documents of Part II must be updated pursuant to the rules of the CTR.  

For transition trials processed in Denmark, only the documents affected by the substantial modification must updated and submitted. If, for example, the modification concerns the addition of a new trial site in Denmark, only documents specific to this new trial site and its investigator must be submitted. If, for example, the modification concerns a new analysis of biological material, only an updated version of the document on biological material and the updated participant information sheet(s) must be submitted. 

Other documents should remain as submitted under the transitioning application, including "placeholder documents". Consequently, in Denmark there is no requirement for sponsors to complete the Part II dossier, including completing and submitting all CTR templates at the first SM after transition.  

Further information 

A number of guidance documents have been provided to facilitate applications for transition of clinical trials to the CTR:

Similarly, a number of guidance documents have been provided to facilitate applications for the first SM after the transition to CTR. Please note the special requirements for substantial modifications concerning the part II dossier for clinical trials in Denmark. 

Last updated 14-06-2024

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