Denmark CTIS Part II Patient Information and Consent Requirements

Language and translation requirements

Mandatory. Danish is the national language for the normal Danish participant-facing pathway. The participant must receive information that is understandable to them.

If a potential participant or legally designated representative does not understand Danish, VMK requires a validated written translation of both the Participant Information Sheet and the Informed Consent Form into the person's native language or another language understood to the same degree. VMK defines validation as confirmation that the translation is understood as intended.

The oral information conversation must also be linguistically effective. It may be supported by a certified interpreter or another person fluent in the relevant language where appropriate. VMK gives examples that can include the informing physician, other trial staff or a relative, depending on the case. The investigator remains responsible for ensuring that the participant understands the information. The sponsor is responsible for the translation.

What the Danish participant information should cover

The Participant Information Sheet should explain the trial in concise, clear language suitable for a lay reader. The exact content follows the trial, but the normal package should cover:

• the purpose and nature of the trial
• what participation involves and how long it lasts
• trial procedures and additional procedures compared with ordinary care
• foreseeable risks, adverse effects, discomforts and burdens
• expected benefits, including a clear statement when direct benefit is not expected
• available treatment alternatives where relevant
• voluntary participation and the right to refuse or withdraw without detriment
• what happens if participation or trial treatment stops
• pregnancy, contraception and reproductive restrictions where relevant
• compensation, reimbursement and the applicable damage-compensation or insurance arrangement
• who to contact about the trial and participant rights
• data processing, record access and confidentiality
• collection, analysis, transfer, storage and destruction of biological samples where relevant
• handling of significant health findings where such findings are reasonably likely
• availability of trial results as required by the CTR

The information should not merely copy protocol language. It needs to explain what the protocol means for a Danish participant.

Danish patient-record access wording

Mandatory. when records are accessed during the trial. Denmark requires the participant information to explain that the sponsor, sponsor representatives and investigator may obtain and process necessary health information from the participant's medical record and systems supplementing the record when this is needed to conduct the trial and perform required quality control and monitoring.

The information must also state that Danish Medicines Agency inspectors may access necessary health information in medical records for inspection of the clinical trial. If relevant, explain that foreign medicines authorities may obtain health information from records where necessary for quality control connected with a marketing-authorisation process.

Conditional. If the protocol plans record-based follow-up after a participant withdraws from the trial, the participant information must explain the extent and conditions under which sponsor representatives and investigators will continue to obtain health information. The application also needs to justify the purpose of that follow-up.

If patient records are used before consent to screen and identify potential participants, the recruitment document needs separate Danish detail. The Denmark Part II document checklist explains that pathway.

Data-protection content

Mandatory. The dossier must state that trial data will be collected and processed in accordance with the General Data Protection Regulation and the Danish Data Protection Act. VMK provides a standard sponsor declaration for this purpose.

The Participant Information Sheet must present the relevant privacy information and data-subject rights in a way the participant can understand. The controller is responsible for the GDPR information obligations and the underlying legal basis. The ethics consent to trial participation is not the same as GDPR consent for data processing.

Conditional. If data are processed or transferred outside Denmark, explain the purpose of each relevant transfer or processing activity. If data go to countries outside the EU or European Economic Area, identify the countries and state that the transfer and processing will comply with Chapter V of the GDPR.

VMK does not accept using the main trial consent form to regulate ordinary data-law matters. If a controller nevertheless uses a distinct GDPR consent in a situation where that is legally appropriate, it must be clearly separated from the CTR trial consent.

Biological samples and significant health findings

Conditional. If biological material is collected, the participant information should state:

• what types of material are collected
• how many samples or how much material is collected per participant
• why each type is collected
• where it will be analysed
• where it will be stored and for how long
• the purpose of storage
• whether it will be destroyed after analysis or at trial end
• relevant transfers outside Denmark and, for third countries, the applicable data-transfer information

If already archived biological material is used as part of the approved trial, the participant must be informed that it is used. VMK states that a separate consent solely for the use of already collected or archived material is not required on that basis when the use is part of the trial.

Conditional. Where new significant health findings are reasonably likely, explain the possibility of such findings and the Danish feedback approach. A participant who does not want to receive qualifying significant findings must be informed about the consequences and use the separate right-not-to-know form. VMK recommends its CTR standard consent forms and the right-not-to-know addendum for this situation.

Optional substudies and future research are not treated identically. The Denmark secondary use consent guide explains when a separate substudy PIS and ICF belongs in Part II and when future-use material falls outside VMK's Part II approval.

Consent form, signatures and dating

Mandatory. at consent, not at CTIS submission. The blank ICF is submitted in Part II. It is not participant-signed at application time.

When consent is obtained, CTR Article 29 requires the consent to be written, dated and signed by the participant, or the legally designated representative when applicable, and by the person performing the information interview. In Denmark, the national rule means that interviewer is the duly qualified Danish-authorised physician who also receives the consent.

The participant or representative must receive a copy of the document or record by which consent was given. Adequate time must be provided for the decision, and understanding should be verified during the information interview.

VMK publishes dedicated CTR consent forms and encourages their use. Use the form that matches the participant category. Do not use the competent-adult form for a legal-representative pathway simply because it is easier to adapt.

Population-specific variations

The standard competent-adult PIS and ICF is not enough for every population.

For children and adolescents, use the Denmark minor consent and assent guide. It explains parental-authority consent, age-adapted information and the additional own consent required from capable 15 to 17 year olds.

For an adult who cannot consent, use the Denmark limited-capacity and legal representative guide. Denmark may require both the nearest relative and a trial guardian, or a legal guardian where the guardianship covers research consent.

For inclusion without prior consent in a genuine medical emergency, use the Denmark emergency enrollment guide. Article 35 is a narrow exception with a detailed Danish subsequent-consent process.

If a participant can consent but cannot write, use the Denmark impartial witness guide.

For pregnancy and partner follow-up, use the Denmark pregnancy follow-up guide, because VMK draws a specific line between a pregnant partner who only provides follow-up data and a pregnant partner who becomes a trial participant.