Norway CTIS Pregnancy Follow-Up Consent Requirements

First distinguish the two pathways

Pregnant trial participant

The pregnant person is already a trial participant. Check whether the approved main consent clearly covers pregnancy reporting, follow-up contacts, medical-record access, pregnancy outcome and infant information. If it does not, prepare an approved pregnancy follow-up consent or re-consent before collecting additional information, unless another lawful urgent safety route applies.

Stopping study treatment does not automatically end every agreed safety follow-up. Explain which activities are required for safety, which are optional and how withdrawal affects each one.

Pregnant partner of a trial participant

The pregnant partner is not automatically a trial participant and is not bound by the enrolled participant's consent. Give the partner a separate Norwegian information and consent form before collecting identifiable health information, accessing maternal records or contacting healthcare professionals.

The enrolled participant cannot consent on the partner's behalf. Minimize information first passed through the participant and contact the partner directly only through an approved process.

Information to include

Describe only the information justified by the safety plan, such as:

• estimated conception and delivery dates
• exposure timing and relevant investigational-product details
• maternal medical and obstetric history relevant to the assessment
• concomitant medicines and relevant risk factors
• pregnancy course, testing and complications
• outcome, including live birth, pregnancy loss or termination where relevant
• delivery information and congenital anomalies
• infant health and development for the justified follow-up period

State the contact schedule, who will collect information and whether the study team will access maternal, obstetric, neonatal or pediatric records. Identify any information expected from the participant, partner, healthcare professional or medical record.

Consent and privacy logic

Conditional. Obtain the pregnant person's signed and dated consent before accessing their medical records or collecting identifiable follow-up information not already covered by an approved consent. The person conducting the consent discussion also signs and dates the form. Provide a copy.

Explain the controller, recipients, coding, transfers, retention, withdrawal and limits on deletion. Keep pregnancy follow-up consent separate from agreement to participate in the main trial. For a partner, refusal must not affect the enrolled participant's treatment or trial participation.

If infant information will be collected after birth, define who may authorize that collection and how long it continues. Do not use an open-ended statement. Any direct procedures involving the infant require their own regulatory and consent assessment and cannot be treated as routine pregnancy follow-up.

Submission and document control

Submit a blank Norwegian pregnancy follow-up form in Part II when the process is planned and the document will be used in Norway. Keep participant and partner forms separate if their information, rights or signature roles differ.

Match follow-up scope and duration to the protocol, investigator's brochure and safety-reporting plan. EU guidance requires pregnancy exposures related to an investigational medicinal product to be recorded and notified through the applicable safety process. This reporting obligation does not remove privacy and consent requirements for collecting information from a pregnant partner.

Use the Norway patient-facing document QC checklist before submission. Return to the Norway CTIS hub for all guides.