Estonia CTIS Pregnancy Follow-Up Consent Requirements

Start from the main Estonia consent requirements

Use the Estonia Patient Information and Consent Requirements guide for the common language, signature, data-protection and withdrawal principles.

Any pregnancy follow-up material given to a trial participant in Estonia must follow the national participant-language rules and include the EU CT number.

Estonia's official clinical-trial materials reviewed do not publish a separate national pregnancy follow-up consent template. Use the national ICF framework and protocol-specific content.

Pregnant trial participant

Conditional. If an enrolled participant becomes pregnant and the protocol requires pregnancy follow-up, the participant should receive clear information on what additional pregnancy and outcome information will be collected and for how long.

The document should distinguish safety follow-up from continued dosing or continued participation in trial interventions. If the protocol requires treatment discontinuation but permits follow-up, make that distinction explicit.

Potential data may include:

• pregnancy dates and exposure timing
• maternal medical information relevant to the pregnancy
• pregnancy complications
• delivery and pregnancy outcome
• fetal or neonatal outcome
• infant follow-up when required by the protocol

Only request information needed for the approved follow-up.

Pregnant partner of a trial participant

Conditional. If the sponsor plans to collect identifiable health information about a participant's pregnant partner, treat the partner as a separate person whose information and permissions must be addressed directly.

Do not rely on the enrolled participant's main ICF as if it were the partner's consent to collect the partner's medical information.

Prepare a partner-facing information and consent or authorisation document that explains:

• why the partner is being contacted
• what pregnancy and outcome data will be collected
• whether medical records or healthcare professionals may be contacted
• how data will be coded and shared
• how long follow-up will continue
• whether infant information will be collected
• the voluntary nature of providing follow-up information
• the effect of refusal or withdrawal

Use an Estonian version when the material is intended for use with an Estonian-speaking partner, and provide any other language actually intended for use.

Medical-record access

If follow-up requires information from obstetric, maternity, neonatal or other healthcare records, explain the planned access and the parties involved.

Do not promise direct sponsor access to Estonia's national Health Information System. Ravimiamet states that access to the Health Information System is limited by law and that trial-site systems must determine what access can technically and legally be provided to sponsor representatives.

The consent wording should match the actual operational pathway at the site.

Data protection

Pregnancy and infant data are health data and need clear data-protection information.

Explain the data categories, coding, recipients, transfers, retention and participant or partner rights. The sponsor's trial-participation consent and the General Data Protection Regulation legal basis for processing should not be conflated.

Where the follow-up extends beyond the main protocol or includes future scientific use, separate the optional future-use choice. See the Estonia secondary use consent guide.

Compensation and reimbursement

For a pregnant trial participant, Estonia's ethics guidance states that pregnant women and breastfeeding women may not receive participation compensation beyond reimbursement of direct costs.

Do not generalise this rule to a pregnant partner who is not a trial participant without assessing the specific legal and ethics position. Any proposed reimbursement for a partner follow-up procedure should be described transparently in the application and document set.

Signatures and withdrawal

When a separate pregnancy follow-up consent is required, use a signed and dated process appropriate to the person whose data are collected.

Estonia permits legally valid digital signatures. If remote consent is used, follow the national video-call, e-identification and ethics-approval requirements.

Explain what happens if the pregnant participant or partner later declines further follow-up. Keep safety reporting and legally required processing separate from optional future collection.

QC before submission

Check that:

• participant and partner scenarios use different document logic
• only necessary pregnancy and infant data are requested
• medical-record access wording matches the real Estonia pathway
• follow-up duration is defined
• privacy and data transfers are clear
• direct-cost reimbursement is distinguished from prohibited participant compensation
• Estonian language and EU CT number requirements are met where applicable

Use the Estonia patient-facing QC checklist for the final review.

Return to the Estonia CTIS hub for all Estonia guides.