Denmark CTIS Part II Pregnancy Follow-Up Consent Requirements

Pregnant trial participant

If a person already enrolled in the clinical trial becomes pregnant, follow the protocol-defined safety, treatment, withdrawal and follow-up rules. The main PIS should have explained foreseeable pregnancy risks, contraception or pregnancy restrictions, and what will happen if pregnancy occurs where these are relevant to participation.

Conditional. If pregnancy follow-up involves additional trial procedures, additional record access, new participant-facing information or a change in the participant's trial pathway, make sure the approved Part II materials cover those activities.

Information collected can include pregnancy status, maternal health information, pregnancy outcome, fetal information and information about the child after birth when the protocol or safety obligations require it. The exact scope and duration should match the protocol and pharmacovigilance plan rather than a generic global form.

Access to the participant's medical record must remain within the Danish record-access wording and the consented trial purpose. Any post-withdrawal record follow-up must be described and justified in the participant information and application.

Pregnant partner of a trial participant

Denmark's national rule is different when the pregnant person is the partner of a trial participant and is not otherwise enrolled in the trial.

VMK asks sponsors to distinguish two situations:

1. The sponsor only collects information from the pregnant partner, including information from medical records or related systems, about the pregnancy, fetus or child after birth.
2. The pregnant partner becomes a trial participant, for example because pregnancy outcome is a trial endpoint or because the partner undergoes trial procedures such as blood sampling.

Data collection only

Usually outside VMK Part II approval. VMK states that collection of information from a pregnant partner is generally not within VMK's approval competence and is not covered by the Part II approval in CTIS. VMK therefore recommends omitting the separate pregnant-partner information and consent material from Part II in that data-only situation, because an uploaded document could incorrectly appear to be ethically approved in CTIS.

If a sponsor nevertheless submits standalone information and consent material for pregnant-partner data collection, VMK requires the information to make three points clear: participation in the data collection is voluntary, the data will be collected and processed under the GDPR and the Danish Data Protection Act, and the material itself is not approved by VMK because it falls outside the committee's statutory competence.

Pregnant partner becomes a trial participant

Part II participant pathway applies. If the pregnant partner undergoes trial procedures or is included in the actual research purpose or endpoints, treat that person as a participant. The relevant participant information, consent, risk and data provisions then need Part II review.

Do not label an invasive research procedure as mere safety follow-up to avoid the participant-consent pathway.

Consent and signature logic

For a pregnant trial participant or a pregnant partner who becomes a participant, use the normal Denmark consent process for a competent adult unless another population-specific rule applies. Oral information and receipt of consent are handled by a duly qualified physician with Danish authorisation, and the same physician performs both steps.

For pregnant-partner data collection that is outside VMK Part II approval, the legal basis and consent or other data-processing mechanism must be designed under the applicable data-protection framework. Do not confuse that separate data arrangement with CTR consent to participate in the clinical trial.

Privacy and medical-record access

Pregnancy information, fetal information and infant information can be sensitive health data. The materials should identify what is collected, from whom, from which records where applicable, why it is needed, who receives it and how long follow-up is expected.

If data are transferred outside Denmark, explain the purpose. If transferred outside the EU or European Economic Area, address the destination countries and Chapter V GDPR requirements.

If the pregnant person is not a trial participant, do not rely on the enrolled participant's consent as authority to access the pregnant partner's medical record.

Practical document decision

Before uploading a pregnancy-related form to Denmark Part II, ask one question: Is the pregnant person a participant in the clinical trial, or is the sponsor only collecting follow-up data about a non-participant partner?

That classification determines whether the material belongs within VMK's Part II approval. Use the Denmark secondary use guide for the similar distinction between approved trial research and activity outside the defined protocol. Return to the Denmark CTIS hub for the full guide set.