Slovakia CTIS Pregnancy Follow-Up Consent Requirements

Relationship to the main consent form

The main Slovakia patient information and consent guide explains how contraception, pregnancy testing and reproductive risks should appear in the ordinary Participant Information Sheet. A pregnancy follow-up form is an additional use-case document for information collected after a pregnancy occurs.

The protocol and safety plan should define what follow-up is required. Part II documents should explain it in participant language without expanding the collection beyond the approved plan.

Pregnant trial participant

Conditional. If the participant becomes pregnant, follow the protocol rule on investigational treatment and trial procedures. Give the participant the approved pregnancy follow-up information before collecting additional pregnancy, obstetric, outcome or infant data that is not already covered by the main trial information.

The form should explain continued safety follow-up, contact with obstetric providers, medical-record review, expected time points, pregnancy outcome and any infant follow-up. State whether participation in pregnancy follow-up is required for safety under the main trial or is a separate voluntary activity.

Do not use a pregnancy follow-up form to obtain broad consent for unrelated research or optional sample collection.

Pregnant partner of a trial participant

Conditional. Prepare a separate Slovak Participant Information Sheet and consent or authorization form addressed to the pregnant partner. The enrolled participant cannot consent on the partner's behalf and should not provide the partner's medical records without an appropriate legal basis.

Explain how the sponsor learned of the pregnancy, what information will be collected, who will contact the partner, whether her obstetric clinician will be contacted and what infant information is requested. The partner should decide independently whether to provide information and permit medical-record access.

The enrolled participant may still need to consent to disclosure of his own relevant exposure or treatment information where required, but that does not replace the partner's decision.

Information to describe

Limit collection to the approved safety purpose. Depending on the protocol, explain collection of:

• estimated conception and delivery dates
• relevant investigational-product exposure
• pregnancy course and complications
• prenatal test or imaging results
• pregnancy outcome
• delivery details
• congenital anomalies or neonatal outcomes
• infant follow-up for the defined period

State who obtains the data, the planned number of contacts, the end of follow-up and whether data will be transferred outside the European Economic Area.

Consent and signature logic

Submit blank Slovak forms in Part II when pregnancy follow-up is planned and participant-facing documents are required for the pathway. They are not signed at CTIS submission.

At follow-up enrollment, the pregnant participant or partner and the person conducting the discussion sign and personally date the approved form. Medical-record access should be stated clearly. If infant information is collected after birth, assess who has legal authority to provide that information and whether a separate parent or legal-representative permission is needed.

Withdrawal from pregnancy follow-up should not affect the enrolled participant's care or main-trial rights. Explain which safety data already collected may be retained.

Privacy and sensitive data

Pregnancy and infant information is sensitive health data. Identify the controller, recipients, international transfers, retention and rights. Keep the partner's records separate from the enrolled participant's trial record where practicable and limit access to authorized staff.

Do not treat the enrolled participant's main consent as permission to process the partner's data. Align the form with the CTIS GDPR compliance statement and Regulation (EU) 2016/679.

Submission checks

Confirm that the protocol, pharmacovigilance plan, main consent form and pregnancy forms agree on reporting triggers, required data, contacts and duration. Check Slovak language, medical-record permission, maternal and infant data, signature blocks and withdrawal handling.

Use the Slovakia patient-facing QC checklist and Part II checklist before submission. Return to the Slovakia CTIS hub for the complete country series.