Finland Pregnancy Follow-Up Consent Requirements

This is a specific use case of the main consent document

Use the Finland Patient Information and Consent Requirements guide for common language, privacy, insurance and signature rules. The pregnancy documents should match the protocol, investigator brochure and pharmacovigilance plan.

This guide addresses safety follow-up after a pregnancy occurs. A trial intentionally enrolling pregnant or breastfeeding women must also meet Article 33 of Regulation (EU) No 536/2014 and describe the pregnancy-specific benefit, risk and burden in the primary trial consent.

Pregnant trial participant

Conditional. The main Participant Information Sheet should explain the protocol's contraception requirements, pregnancy reporting, treatment changes and safety follow-up. State whether information will be collected about the pregnancy, pregnant participant, foetus, birth outcome and infant, and give the planned duration.

If the approved main consent clearly covers that collection and lawful medical-record access, a separate pregnancy form may not be needed merely because pregnancy occurs. Use a separate document when the follow-up adds information, contacts, record access or duration that the participant could not reasonably understand from the main consent.

Do not assume the participant must continue trial treatment. Explain treatment interruption, withdrawal, medical care and continued safety follow-up separately.

Pregnant partner of a trial participant

Mandatory when partner data are collected. Tukija's template states that a separate Participant Information Sheet and Informed Consent Form must be issued if data will be collected about a trial participant's partner during pregnancy. The trial participant's consent does not authorise collection of the partner's health information.

Address the partner directly. Explain that participation in follow-up is voluntary and separate from the trial participant's continued participation. Obtain the partner's signature and date and the signature and date of the person receiving consent before collecting identifiable partner information or accessing records.

Content of the pregnancy follow-up document

Describe only the data needed for the safety purpose, such as:

• estimated conception and pregnancy dates
• exposure timing and relevant trial treatment
• maternal medical and obstetric history needed for assessment
• pregnancy course and complications
• prenatal test and imaging information
• pregnancy outcome, including live birth, loss or termination where relevant
• neonatal or infant health information and follow-up period
• concomitant medicines and other relevant exposures

Explain contact frequency, who supplies the data, medical-record sources and whether the partner's healthcare professional will be contacted. Avoid open-ended access to the full record.

Privacy, records and international reporting

Identify the controller, purposes, legal basis, recipients, retention and data-subject rights for the person whose data are collected. Explain pseudonymisation and any disclosure to the sponsor, safety database, authorities or recipients outside the EU or EEA.

Medical-record access needs an explicit and understandable explanation of the records, healthcare providers, information sought and access method. The partner should know how to withdraw from new follow-up contacts and what happens to data already used in safety reporting.

If infant data will be collected after birth, identify the legal basis and representative-consent pathway. Do not imply that the pregnant partner's signature automatically covers unlimited future child data.

Follow-up scope and duration

Match the duration to the protocol and product risk. State whether follow-up ends at pregnancy outcome or continues through a defined infant age. Describe any additional calls, examinations or record checks and whether they create costs or burden.

If new information changes the follow-up materially, assess whether a revised document and re-consent are needed. Keep pregnancy follow-up consent separate from optional future research involving samples or unrelated data.

Apply the Finland patient-facing document QC checklist before filing and return to the Finland CTIS hub for the complete consent series.