Submit new trials under the Clinical Trials Regulation (CTR)

Clinical trials on medicinal products must undergo a scientific and ethical review and may only be initiated upon approval of a research ethics committee.

With the introduction of the new EU Clinical Trials Regulation (CTR), an application for all clinical trials on medicinal products in Denmark must be submitted to the Medical Research Ethics Committees (MREC) for review.

Following the implementation of CTR, the submission procedure for clinical drug trial applications was changed. Applications must now be submitted through the EU system CTIS (Clinical Trials Information System). During a transition period, it has been possible to continue to report a drug trial under the rules of the Directive, but as of January 31st 2023, all applications must be submitted under CTR.

From January 31st 2025, all ongoing trials originally approved under the Directive must be registered on CTIS and be administratively approved according to CTR. It is the responsibility of the sponsor to ensure that an ongoing trial is submitted as a transition trial to CTIS in due time before this deadline, read more under section 11.3 and 11.6 here. 

Clinical Trials Information System

CTIS  is a portal and database for clinical trials on medicinal products in the EU. All trials that are to be performed in one or more EU member states must be submitted in CTIS. Here, they will be processed by the authorities of all the member states concerned at the same time. In Denmark, applications are processed in a collaboration between MREC and the Danish Medicines Agency, who will also coordinate a joint decision on behalf of Denmark.

It is the European Medicines Agency (EMA) that creates and maintains CTIS in collaboration with member states and the European Commission.

All interactions between authorities and applicants must take place through the portal. Communication with MREC in CTIS can take place in English, but all trial material intended for research participants must be in Danish.

Submission in general

Applicants are themselves responsible for acquiring training in the use of CTIS. EMA has developed a sponsor’s handbook  to guide the use. Furthermore, we strongly recommend following the CTIS training program  developed by EMA. Finally, you can find answers to many of the questions you may have about CTR and its requirement in the Q&A  developed by the European Commission.

On the website of the Danish GCP Units, you can find regularly updated information and guidance. See, for instance, an overview  of the CTR application process. They have also prepared a CTIS guide  in English.

Using templates and checklists

No separate checklist has been developed for CTR trials, but Appendix 1  of the CTR presents a detailed overview of the content requirements of applications.

It is recommended, although not required, to use the templates listed in EUDRALEX volume 10, chapter 1. If the templates are not used, all the information indicated in the templates must appear in the relevant documents in some other way.

It is also possible to take a look at the reports that are uploaded for Parts I and II, respectively, for all completed clinical trial applications on the public CTIS website. This may be useful for observing where emphasis is placed in the report and in the assessment of the dossier. In addition to the completed reports, you can also see a blank report template for part II.

Last updated 01-02-2024

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