Denmark CTIS Part II Document Checklist

Core Part II documents for Denmark

Recruitment arrangements and informed consent procedure

Mandatory. when the information is not fully contained in the protocol. Annex I requires a detailed description of subject inclusion and recruitment. For Denmark, use the current European Commission recruitment and informed consent procedure template or provide the same required information in an accepted location. VMK's June 2026 guidance explains the Danish additions.

If patient records are used to identify potential participants, describe the specific record data, purpose, approximate number of records and relevant time period. State the Danish legal basis used for disclosure. Contact with a potential participant based on record information may occur only when the treating healthcare professional permits it. If that person cannot be contacted, site management may give the permission described in the national guidance.

The document must also explain who gives oral information and receives consent. In Denmark this must be a duly qualified medical doctor with Danish authorisation. The same physician gives the oral information and receives consent. If that person is not the principal investigator, a written agreement with the principal investigator must be in place.

Language: Danish or English may be used for the application description. Participant-facing documents are prepared in Danish for Danish-speaking participants, with validated translations for people who do not understand Danish.

Signed at CTIS submission: No participant signature is expected at submission. The procedure document itself is normally an application document rather than a participant-signed form.

CTIS category: Recruitment arrangements and informed consent procedure.

Template: European Commission Part II recruitment and informed consent procedure template. Version 2.0 is highly recommended as of the review date and is scheduled for full implementation on 1 September 2026.

For the detailed consent pathway, use the Denmark patient information and consent guide.

Recruitment advertisements and invitation materials

Conditional. Submit advertisements and other recruitment communications when they are used. Annex I requires copies of advertising material and a description of how responses will be handled. Danish patient-record rules still apply if recruitment begins from records rather than public advertising.

Language: The version actually used with Danish participants should be understandable to that population. If a non-Danish language version is used for a participant who does not understand Danish, the same translation-quality principle applies.

Signed at CTIS submission: No.

CTIS category: Recruitment arrangements.

Participant Information Sheet

Mandatory. for the applicable consent pathway. Submit all information given to participants or legally designated representatives before the decision to participate. The Danish Participant Information Sheet should cover the trial, procedures, risks and burdens, alternatives where relevant, voluntary participation, withdrawal, compensation and insurance, contacts, data processing, record access, sample handling and other trial-specific points.

Denmark adds specific wording needs for direct access to patient records, Danish Medicines Agency inspection access, international data transfers where relevant and biological material. If there is a likelihood of significant health findings, describe the feedback pathway and the participant's right not to know.

Language: Danish for Danish-speaking participants. For a participant or legal representative who does not understand Danish, provide a validated written translation into the person's native language or another language understood to the same degree.

Signed at CTIS submission: No. The information sheet is reviewed as a blank, version-controlled document.

CTIS category: Subject information, informed consent form and informed consent procedure.

Informed Consent Form

Mandatory. for the applicable population. Submit the blank consent form together with the participant information. At consent, the form is written, dated and signed by the participant or legally designated representative and by the physician who performed the information interview, subject to the special alternative-signature rule for a person unable to write.

VMK publishes CTR-specific standard forms for competent persons, holders of parental authority, minors aged 15 to 17 together with parents, and nearest relatives together with a trial guardian. VMK encourages their use. They may be edited for trial-specific information, date and version. If the standard text fields are not changed and the sponsor confirms that, VMK states that the form will be accepted without comments on those fields.

Language: Danish for the normal Danish pathway, with validated translations where required for non-Danish-speaking participants or representatives.

Signed at CTIS submission: No. Signatures are obtained when consent is given during trial conduct.

CTIS category: Subject information and informed consent form.

Population variations are explained in the minor consent guide, limited-capacity consent guide, emergency enrollment guide and impartial witness guide.

Principal investigator curriculum vitae

Mandatory. Annex I requires evidence of investigator qualifications. VMK states that Denmark requires a curriculum vitae for the principal investigator at each Danish trial site and does not require CVs for sub-investigators for Part II.

The CV should demonstrate relevant qualification, clinical-trial experience, Good Clinical Practice knowledge and patient-care experience as applicable.

Language: Danish or English can be used in CTIS unless VMK requests otherwise for a specific case.

Signed at CTIS submission: Follow the current EU template and CTIS requirements. Do not add a signature requirement that is not present in the current template.

CTIS category: Suitability of the investigator.

Template: European Commission Investigator Curriculum Vitae template is available in EudraLex Volume 10.

Investigator declaration of interests

Mandatory. where needed to satisfy Annex I investigator-suitability information. Any economic interests or institutional affiliations that could influence impartiality must be presented. The European Commission provides a declaration of interest template for Part II.

Signed at CTIS submission: Follow the current template requirements.

CTIS category: Suitability of the investigator.

Site suitability statement

Mandatory. Annex I requires a justified written statement confirming that each trial site has suitable facilities, equipment, human resources and expertise for the trial. The statement is issued by the head of the clinic or institution, or another responsible person under the national system.

Signed at CTIS submission: The suitability statement is an institutional application document. Use the current European Commission site suitability form and its signature requirements.

CTIS category: Suitability of the facilities.

Template: European Commission Site Suitability Form.

Insurance or indemnification information

Mandatory. as a coverage arrangement, with the supporting document conditional on the Danish coverage route. The sponsor is responsible for insurance coverage at all Danish trial sites. Sites may be covered by Patienterstatningen, the Danish Patient Compensation system, or by independent insurance.

If Patienterstatningen covers the Danish sites, VMK does not require a stand-alone insurance policy to be uploaded. The application material must state that the Danish sites are covered by Patienterstatningen. If a site is not covered by that system, document the independent arrangement needed to meet the CTR compensation requirement.

Signed at CTIS submission: Depends on the insurance or guarantee document used.

CTIS category: Proof of insurance cover or indemnification.

Financial arrangements and participant compensation

Mandatory. Annex I requires a brief description of trial financing, payments or compensation to participants and investigators or sites, and other agreements between sponsor and site. VMK accepts either a draft or final trial budget in Part II. If a draft is used, approval is conditional on the final budget not differing substantially from the submitted version.

A draft Clinical Trial Agreement can likewise be submitted under the Danish Q&A approach, subject to the final agreement not differing substantially where VMK has accepted that route.

For healthy volunteers, the Danish ethics guidance allows inconvenience compensation based on the actual burden, but compensation must not be structured so that it improperly drives the decision to participate. The healthy volunteer consent guide explains the participant-facing implications.

Signed at CTIS submission: Follow the relevant agreement or form. A participant does not sign the compensation description merely because it is submitted in Part II.

CTIS category: Financial and other arrangements.

Proof of fee payment

Conditional. under Annex I, but normally not an initial Denmark upload before invoicing. Denmark charges one combined fee for the Danish Medicines Agency and VMK. The Danish ethics authority states that the fee is paid to the Danish Medicines Agency no later than one month after receipt of the invoice. This timing means the Danish process should not be treated as a pre-submission payment requirement unless the authority's current invoice process for the particular application says otherwise.

CTIS category: Proof of payment of fee, if applicable.

Data-protection compliance statement

Mandatory. Denmark requires a sponsor statement that trial data will be collected and processed in accordance with the General Data Protection Regulation and the Danish Data Protection Act. VMK publishes a standard English sentence for this purpose.

The participant information also needs understandable privacy information. If data are processed or transferred outside Denmark, describe the purpose. For transfers outside the EU or European Economic Area, identify the relevant third countries and explain that the transfer and processing will comply with Chapter V of the GDPR.

Signed at CTIS submission: The requirement is a sponsor declaration in the dossier. Use the current Commission or VMK format rather than inventing a participant signature.

CTIS category: Proof that data will be processed in compliance with Union law on data protection.

Biological-sample compliance information

Conditional. Use when the trial collects, stores, transfers or uses biological material. State the type and amount of each sample per participant, purpose, analysis location, storage location and duration, and whether material is destroyed after analysis or at trial end.

For material transferred or stored outside the EU or European Economic Area, the participant information must identify relevant countries and address GDPR requirements where the material generates or is linked to personal data. If significant health findings are reasonably likely, include the Danish feedback process and the right-not-to-know documentation.

The European Commission provides a Part II template for compliance with applicable rules for biological samples. Denmark's national Part II guidance adds the country-specific content.

Signed at CTIS submission: No participant signature on the compliance description itself. Any optional substudy or separate secondary-use consent is handled through its own consent pathway.

CTIS category: Compliance with applicable rules for biological samples, with related participant-facing documents under the consent section.

For future-use distinctions, use the Denmark secondary use consent guide.

Denmark pre-submission check

Before filing, confirm that:

• the participant information and consent forms are in Danish for the normal Danish-speaking population
• validated translations are prepared if a participant or representative will not understand Danish
• the recruitment and consent procedure identifies a Danish-authorised physician as the person giving oral information and receiving consent
• any delegated consent physician has a written agreement with the principal investigator
• patient-record screening and contact logic match the Danish requirements
• only principal investigator CVs are included unless another document is specifically requested
• insurance coverage is described correctly for Patienterstatningen or independent insurance
• data-protection text uses the Danish GDPR statement and explains relevant foreign transfers
• biological material is described with type, amount, purpose, location, duration and disposition
• every population-specific consent document needed by the protocol is included
• no document is duplicated across CTIS sections without a clear reason

The Denmark patient-facing QC checklist provides a final content-level review after the dossier list is complete.