Spørgsmål/svar om CTR og CTIS

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.

Please refer to our guidance (in Danish): Decentrale kliniske forsøg

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 our site on De Videnskabsetiske Medicinske Komiteer (VMK) (in Danish)

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.

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

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

For trials where both MDR/IVDR and CTR applications are submitted, the 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.

In cases where potential participants (or their legal representative(s)) do not speak the national language (Danish), participants (or their legal representative(s)) must receive the information in their native language or a language that the participant understands to the same degree.

There must be a validated1 written translation of the participant information sheet and the informed consent form. The conversation, where the participant is orally informed about the trial, must be aided by a certified interpreter or a person fluent in the participant’s (or their legal representative(s)’s) native language or a language that the participant understands to the same degree. It could for instance be the informing physician (principal/sub-investigator), or other trial staff, or relatives who provide the oral translation, as relevant and appropriate for the specific trial. The investigator is responsible for ensuring that participants understand all provided participant information whereas the responsibility for the translation lies with the sponsor.

The decision on the practice of the MREC (VMK) is derived from the requirements in CTR article 29, 2) that the information shall enable the participant (or their legal representative(s)) to understand the consequences of participating in the clinical trial and must be comprehensive, concise, clear, relevant, and understandable to a layperson, please also refer to article 29 3)-5). In addition, reference can also be made to the statement in the European Commission’s Questions and Answers Document - Regulation (EU) 536/2014 (Q&A) Annex IV on Eudralex Volume 10, Classification of changes to ongoing clinical trials, that the following requirement otherwise apply in connection with non-substantial modifications: “A validated translation of the local approved ICF in another language in order to be used for a potential subject who is not fluent in the local (country) language”.

1 Validated should be interpreted as confirming that the translation of the information and consent form is understood as intended.

Please refer to 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 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.

The MREC only requires CV for principal investigator at trial sites in Denmark. Documentation on any other investigators is not required.