CTR and CTIS Q&A

Yes. A draft of a Clinical Trial Agreement between sponsor and trial site(s) is fine upon submission. Approval is thus given on condition that the final agreement does not differ substantially from the preliminary submission.

Awaiting guidance from Clinical Trials Coordination Group (CTCG)

No. Applicants can download Part I Final assessment report and Part II final assessment report respectively in CTIS. In addition, the overall decision on the trial is available from CTIS.

MREC requires a separate document describing which data protection rules apply in Denmark. I.e. a declaration of compliance with GDPR and the Data Protection Act, which is applicable to trials in DK.

Please refer to Guidelines on Decentralized Clinical Trials

From guidance document Experimental programme on new informed consent processes in decentralised clinical trials (DCT) (p. 6):

If there is application material (e.g. video material) that cannot be submitted via CTIS, the MREC assessor and applicant will agree on how this material can be submitted directly to MREC and linked to the same case number.

Please contact the MREC Secretariat if you wish to make use of the experimental scheme.

All written documents/screenshots can be submitted in CTIS. Video files must be submitted to the MREC Secretariat by other means outside the system, e.g. by e-mail. This will be agreed between the applicant and the MREC Secretariat.

The Part II final assessment report will state which committee has assessed the application with a link to the NCE website where committee members can be found.

Due to GDPR, we cannot provide names in the Part II assessment report, but all committee members will be listed on our website. Please refer to About the Medical Research Ethics Committees (MREC).

Yes. A draft or final clinical trial budget can be submitted under Part II in CTIS. If a draft budget is submitted, approval is given on condition that the final budget does not differ substantially from the preliminary submission.

CTR:
Regulation No. 536/2014 on clinical trials on medicinal products (CTR) implements the principles of the ICH-GCP Good Clinical Practice guidelines. The regulation has been applicable legislation since 31 January 2022.

Directive:
Please note that clinical trials may be notified under Directive 2001/20/EC of 4 April 2001 on the implementation of good clinical practice in the conduct of clinical trials of medicinal products for human use (GCP Directive). The directive is based on the principles of ICH-GCP. With regards to the Danish committee system on health research ethics the majority of the directive has been implemented in Danish legislation through Consolidation Act no. 1338 of 1 September 2020 on research ethics review of health research projects and health data research projects, as amended.

Please note that ongoing clinical trials prior to 30 January 2025 must be transferred to the CTR to remain authorized.

The sponsor is responsible for insurance coverage at all study sites in Denmark. Trial sites may be covered either by the Patienterstatningen or by independent insurance policies for trial sites not covered by the Patienterstatningen.

No. The VMK does not require the submission of stand-alone insurance policies if the trial sites in Denmark are covered by the Patienterstatningen. In this case, the application material must state that the trial sites in Denmark are covered by the Patienterstatningen.

For trials where both MDR/IVDR and CTR applications are submitted, MREC aims to process applications simultaneously, so that the same assessor and ethics committee process the two/multiple applications that form part of the overall trial. This presumes that the sponsor submits the applications at the same time.

Please refer to EMA’s Quick Guide for Sponsors: EMA’s Quick Guide for Sponsors

VMK generally assess Part I and Part II simultaneously, and we try, to the extent that CTIS deadlines allow us, to send out RFIs on Part I and Part II at the same time, so that changes to documents can be made across Part I and Part II at once. If changes are made to Part I documents as a result of an RFI on Part II, but that Part I is already approved, then this needs to be resolved by a future substantial modification (SM) or non-substantial modification (NSM) immediately. It is therefore important that no information appears from Part I documents that belongs in Part II.

VMK only requires CV for principal investigator at trial sites in Denmark. Documentation on any other investigators are not required.