Denmark CTIS Part II Patient-Facing Document QC Checklist

Trial content checks

Confirm that the patient-facing documents accurately describe:

• trial purpose and treatment groups
• investigational and comparator treatments in terms a participant can understand
• visit schedule and participant duration
• randomisation and blinding where relevant
• invasive procedures, imaging, biopsies, blood draws and other burdens
• optional procedures and substudies as optional rather than part of the mandatory main trial
• expected risks, common important adverse effects and material uncertainties
• expected benefit without implying benefit that the protocol does not support
• alternatives to participation or standard treatment where relevant
• pregnancy prevention and follow-up procedures where relevant
• compensation, reimbursement and insurance arrangements

Protocol-to-patient-document consistency

Check every participant-facing statement against the approved protocol and Part I package. Focus on details that commonly drift during localization:

• visit number and timing
• treatment duration and follow-up period
• sample volumes and sample frequency
• optional versus mandatory biopsies or samples
• contraception periods
• record-based follow-up after treatment or withdrawal
• countries and laboratories receiving data or material
• retention periods
• endpoints or analyses that generate potentially significant findings

If a participant-facing document changes a scientific or operational fact rather than simply explaining it, resolve the inconsistency before submission rather than relying on an RFI.

Danish consent logic checks

Confirm that the consent procedure states that oral information is provided by a duly qualified physician with Danish authorisation. The physician should have appropriate clinical-trial experience, Good Clinical Practice knowledge and knowledge of the specific trial.

Confirm that the same physician is described as the person who receives the informed consent. If a physician other than the principal investigator performs the process, confirm that a written delegation agreement will be in place.

Check that the blank ICF submitted in CTIS is not pre-signed. Signatures and dates belong to the actual consent event. At consent, the participant or legally designated representative and the interviewing physician sign and date, subject to the alternative-means and witness pathway where the person cannot write.

For the main requirements, use the Denmark patient information and consent guide.

Population and document coverage checks

Match every protocol population to a specific information and consent pathway.

• Healthy volunteers: confirm that absence of therapeutic benefit, burdens and compensation are clear. Use the healthy volunteer guide.
• Minors: confirm age-adapted information, parental-authority consent and the additional pathway for 15 to 17 year olds. Use the minor consent and assent guide.
• Adults without capacity: confirm whether consent is from nearest relative plus trial guardian, or from a legal guardian whose mandate includes research. Use the limited-capacity guide.
• Emergency inclusion: confirm the Article 35 conditions and subsequent consent process. Use the emergency enrollment guide.
• Unable to write: confirm the alternative documentation method and impartial-witness procedure. Use the impartial witness guide.
• Pregnancy follow-up: distinguish a pregnant participant from a pregnant partner whose data are collected. Use the pregnancy follow-up guide.
• Secondary or future use: separate optional substudy consent, secondary data use and unspecified future sample use correctly. Use the secondary use guide.

Do not create a separate form simply because a global master package contains one. The Danish question is whether the document belongs to the Danish Part II approval and which consent pathway it supports.

Language and readability checks

Confirm that the normal participant package is in Danish and written for a lay reader.

If a participant or legal representative does not understand Danish, confirm that both the PIS and ICF have a validated written translation into the person's native language or another language understood to the same degree. Confirm that the consent procedure also explains how the oral conversation will be supported in that language.

Check that headings, sentence length, terminology and risk descriptions are understandable without medical training. Define unavoidable clinical terms when first used.

Patient-record checks

If records are used for screening before consent, confirm that the recruitment procedure identifies:

• the concrete information to be disclosed or accessed
• the purpose of the access
• the approximate number of records
• the time period covered
• the Danish legal basis used in the application
• the rule that contact based on record information requires permission from the treating healthcare professional, with the national fallback to site management where the treating professional cannot be contacted

For post-consent record access, check that the participant information explains access by sponsor, sponsor representatives and investigator for trial conduct, quality control and monitoring. It should also explain Danish Medicines Agency inspection access.

If record-based follow-up continues after withdrawal, make sure the PIS and protocol explain the scope, purpose and conditions consistently.

Data privacy checks

Confirm that the sponsor declaration states compliance with the GDPR and the Danish Data Protection Act.

Check that participant privacy text is understandable and that it does not present trial consent under the CTR as the legal basis for all personal-data processing.

For processing or transfers outside Denmark, confirm that the purpose is explained. For transfers outside the EU or European Economic Area, identify the relevant countries and explain the Chapter V GDPR safeguards at the level required by the current Danish guidance.

If a separate consent is sought for secondary use of data outside the protocol for research, confirm that the participant is told it can be withdrawn and that the consent is kept separate from the main trial ICF.

Biological-sample and secondary-use checks

For each sample type, confirm type, number or volume, purpose, analysis site, storage site, storage period and destruction or other disposition.

If a sample leaves Denmark, make sure the participant information identifies where it goes. If it is transferred to a third country, address the data-protection implications.

If significant health findings are reasonably likely, confirm that the PIS explains the possible findings and feedback process. Confirm that a participant who chooses not to receive qualifying findings uses the separate right-not-to-know form.

Distinguish three Danish pathways:

1. An optional substudy that is an integrated, defined part of the trial. It belongs within VMK's Part II assessment and should have a separate PIS and ICF.
2. Surplus material from trial samples retained for unspecified future research. The main PIS must explain the future storage and the Danish rules. VMK permits a specific opt-out checkbox for storage of surplus material.
3. Extra material collected specifically for unspecified future research outside the defined trial. VMK states that this is outside its Part II approval and recommends omitting that future-research information and consent material from Part II.

Signature, version and administrative checks

Before upload, confirm:

• document title matches the actual population and use case
• version number and date are consistent across PIS and ICF
• no participant or representative signature appears on blank submission documents
• the correct VMK CTR standard form is used where the sponsor has chosen to follow the national standard
• no legacy non-CTR consent form has been substituted for the CTR form
• optional checkboxes do not create consent logic that VMK does not accept
• all internal references to protocol sections, appendices and contact details are correct
• the CTIS filename is clear and does not rely on date or version information that conflicts with CTIS structured fields

Final Denmark release check

A patient-facing package is ready when the Danish reader can understand what will happen, the consent pathway matches Danish law, every protocol burden is represented, translations are controlled, record and privacy wording is complete, and every optional or population-specific pathway has the correct document set.

Use the Denmark CTIS hub to return to the full country guide set.