Sweden CTIS Part II Pregnancy Follow-Up Consent Requirements

Pregnant trial participant

Conditional. If pregnancy can occur during the trial, the main Swedish participant information should explain any relevant pregnancy risks, contraception requirements, pregnancy testing and what happens if pregnancy is identified.

When the pregnant person is already the trial participant, follow-up information collected under the approved protocol remains part of that participant's trial pathway. If follow-up goes beyond what the original participant information reasonably described, prepare the additional Swedish information or consent needed for that expanded activity.

If the protocol intentionally enrolls pregnant or breastfeeding women, ensure that the Article 33 conditions are addressed in the trial design and participant documents.

Pregnant partner of a trial participant

A pregnant partner is not automatically a trial participant simply because their partner is enrolled. If the sponsor wants to collect identifiable health information directly from the pregnant partner, obtain information and consent from that person through a separate Swedish document where the protocol requires direct pregnancy follow-up.

Do not ask the enrolled participant to provide consent on the pregnant partner's behalf.

No Swedish authority source reviewed for this guide sets a universal mandatory national pregnancy-partner consent template. The need for a separate document is study-specific and depends on the information being collected and how it is collected.

Maternal, pregnancy outcome and infant information

Where pregnancy follow-up is planned, the participant-facing documents should define the information actually needed by the protocol. This may include:

• pregnancy status and estimated dates
• relevant maternal medical information
• exposure timing
• pregnancy course
• outcome of the pregnancy
• newborn or infant information when scientifically justified
• duration and frequency of follow-up

Do not collect broad maternal or infant medical information simply because a pregnancy form exists. The scope should match the protocol and data-protection documentation.

Medical-record access

If pregnancy follow-up requires access to a pregnant partner's medical records, the partner should be told what access is requested and why. The study should not rely on the enrolled participant's ICF as authority for access to another person's records.

For a pregnant trial participant, medical-record access should remain within the information and permissions described for that participant.

Privacy and signatures

Any separate pregnancy follow-up information and consent form used for the pregnant partner should be in Swedish when used in Sweden. Use controlled versioning and clear signature roles.

The Swedish normal rule for obtaining informed consent applies when the person is being consented into a trial-related research activity that requires informed consent. Where a sponsor is collecting safety follow-up information outside formal trial participation, the sponsor should ensure that the process is consistent with the approved protocol, data-protection basis and Part II documents rather than automatically copying the main trial ICF.

Follow-up duration

The official Swedish sources reviewed do not set a single national pregnancy follow-up duration for all clinical trials. Use the protocol-defined period and explain it clearly to the person being followed.

Return to the Sweden CTIS Part II hub and run the patient-facing document QC checklist to keep pregnancy wording consistent with the protocol and privacy documents.