Denmark CTIS Part II Guides

Which Denmark CTIS guide should you use?

Denmark CTIS Part II Document Checklist

Use this first to identify the Part II documents that normally belong in the Denmark dossier, which items are conditional, and which national forms or statements apply.

Read the Denmark CTIS Part II Document Checklist guide

Denmark Patient Information and Consent Requirements

Use this for the main Danish Participant Information Sheet and Informed Consent Form, including language, signature, record-access, data-protection and biological-sample content.

Read the Denmark Patient Information and Consent Requirements guide

Denmark Patient-Facing Document QC Checklist

Use this before submission to check protocol consistency, Danish consent logic, translations, privacy text, biological samples, version control and population coverage.

Read the Denmark Patient-Facing Document QC Checklist guide

Denmark Healthy Volunteer Consent Requirements

Use this when healthy volunteers are recruited and the information package needs to address the absence of therapeutic benefit, burden, compensation and other healthy-volunteer-specific points.

Read the Denmark Healthy Volunteer Consent Requirements guide

Denmark Minor Consent and Assent Requirements

Use this for children and adolescents, including parental-authority consent, age-adapted information, the 15 to 17 year pathway and re-consent when the participant becomes an adult.

Read the Denmark Minor Consent and Assent Requirements guide

Denmark Limited-Capacity Participant and Legal Representative Consent Requirements

Use this for adults who cannot provide valid informed consent, including the Danish roles of nearest relative, trial guardian and legal guardian.

Read the Denmark Limited-Capacity Participant and Legal Representative Consent Requirements guide

Denmark Emergency Enrollment Consent Requirements

Use this when Article 35 emergency enrollment without prior consent is proposed. Denmark has detailed national guidance for the eligibility conditions and subsequent consent process.

Read the Denmark Emergency Enrollment Consent Requirements guide

Denmark Impartial Witness Consent Requirements

Use this when a participant or legal representative can consent but is unable to write, so an alternative method of documenting consent with an impartial witness is needed.

Read the Denmark Impartial Witness Consent Requirements guide

Denmark Pregnancy Follow-Up Requirements

Use this when the protocol or safety plan involves pregnancy follow-up. The guide distinguishes follow-up of a pregnant trial participant from data collection about a pregnant partner.

Read the Denmark Pregnancy Follow-Up Requirements guide

Denmark Secondary Use Consent Requirements

Use this for research use of data or biological material outside the main protocol, optional substudies, surplus samples and unspecified future research.

Read the Denmark Secondary Use Consent Requirements guide

Main Denmark-specific differences

The Danish ethics review is handled by VMK together with the Danish Medicines Agency through CTIS. Denmark has not created a separate national CTR checklist that replaces Annex I. Sponsors therefore need to use the CTR dossier structure together with VMK's national Part II guidance. The Denmark Part II document checklist maps that combination into a practical submission set.

For consent, Denmark requires the oral information interview and receipt of informed consent to be performed by a duly qualified physician authorised in Denmark. If that physician is not the principal investigator, a written delegation agreement is required. The same physician must give the oral information and receive consent. The Denmark patient information and consent guide explains the document and signature implications.

VMK publishes dedicated CTR consent forms for competent adults, holders of parental authority, 15 to 17 year olds together with their parents, and nearest relatives together with a trial guardian. VMK encourages use of these forms and states that a form not following the standard may be harder to approve. These are recommended national forms, not a basis for turning every trial into the same consent pathway.

Denmark's Part II guidance is unusually specific about access to patient records and biological material. If records are used for screening or recruitment, the application needs to describe the data, purpose, number of records and time period. Contact based on record information also requires permission from the treating healthcare professional, or in the stated fallback situation, site management. Where samples are collected, the participant information needs to explain sample type and amount, purpose, analysis and storage locations, duration, destruction and relevant transfers.