Latvia Pregnancy Follow-Up Consent Requirements

Pregnant trial participant

If a trial participant becomes pregnant, follow the protocol's treatment, unblinding, discontinuation, safety, and follow-up rules. The main consent may already cover pregnancy reporting and defined follow-up. Use a separate or renewed consent when the planned collection, medical-record access, long-term follow-up, or infant data is not adequately covered.

Explain:

• whether trial treatment stops or may continue and who decides
• maternal examinations and pregnancy monitoring
• information collected from obstetric and other medical records
• pregnancy outcome, delivery, fetal, neonatal, and infant information
• the follow-up period and contact schedule
• recipients, coding, retention, transfers, and safety reporting
• what is optional and what safety information is sought after trial treatment stops

Participation in pregnancy follow-up should not obscure the participant's right to withdraw from trial activities. Explain any lawful retention and pharmacovigilance use of information already collected.

Pregnant partner of a trial participant

The pregnant partner is a separate person and data subject. The trial participant cannot consent to collection of the partner's health information or authorise access to her medical records.

Mandatory when partner data will be collected. Obtain the pregnant partner's own informed consent before collecting identifiable pregnancy, medical-record, outcome, or infant information from her or her healthcare professionals. Provide a Latvian information and consent document even if the enrolled participant first reports the pregnancy.

Limit the partner form to the follow-up activities that apply to her. Do not describe her as a trial participant unless she is independently enrolled. Make clear that declining partner follow-up does not affect the enrolled participant's care or trial participation, subject to any protocol safety actions concerning the enrolled participant.

Infant information and medical records

Explain whether the follow-up covers live birth, congenital anomalies, neonatal status, development, or later infant health. Identify the duration and data sources. Where identifiable infant medical information will be obtained, plan the authority and consent of the child's legal representative under Latvian law.

Consent for direct medical-record access should identify the records, purpose, authorised recipients, and safeguards. Latvia's clinical-trial regulation recognises direct access based on informed consent and related data-processing permission for quality control and monitoring, but the permission must come from the person whose records are accessed or another person legally able to authorise it.

Document and signature logic

Prepare separate Latvian documents or clearly separated pathways for:

• the pregnant trial participant
• the pregnant partner of a trial participant
• infant follow-up when separate authority or information is needed
• optional sample collection or future research

The blank forms are not signed at CTIS submission. At consent, the pregnant participant or partner and the person conducting the interview sign and date the applicable record. Add the legal representative signature for infant data or procedures when required. Give the signer a copy.

Align the follow-up scope with the protocol, safety-management plan, data-protection statement, case-report forms, and sample plan. Use the Latvia secondary-use consent guide if samples or data may be retained for research beyond the pregnancy follow-up purpose.

Complete the Latvia patient-facing document QC checklist and return to the Latvia CTIS guide hub for related population requirements.