Hungary CTIS Pregnancy Follow-Up Consent Requirements

Pregnant trial participant

Conditional. If a participant becomes pregnant during the trial and the protocol requires pregnancy follow-up, explain the follow-up in the main ICF or in a dedicated pregnancy follow-up document.

The participant's existing trial consent does not automatically authorise any new collection that falls outside what was explained. Check whether maternal, obstetric, outcome and infant data were described sufficiently in the approved consent.

If the pregnancy changes treatment, dosing, contraception requirements or study participation, explain those consequences in the participant-facing documents.

Hungarian Health Act Section 161 also imposes protections on research involving pregnant or breastfeeding women when they are themselves research subjects. That rule is relevant when the protocol proposes research procedures on the pregnant participant, not merely passive safety follow-up.

Pregnant partner of a trial participant

Conditional. Use a separate pregnant-partner information and consent form when the sponsor wants to collect identifiable pregnancy or medical information from the partner of a trial participant.

The participant cannot consent on behalf of the partner for her health data.

ETT-KFEB's GDPR recommendation specifically names a pregnant partner as an example of a separately affected person who should receive privacy information in her own information document.

What the pregnancy follow-up document should cover

Describe only the data actually needed by the protocol or safety plan. Depending on the study, this can include:

• estimated date of conception and pregnancy timing
• relevant maternal medical and medication history
• prenatal and obstetric information
• pregnancy complications
• pregnancy outcome
• delivery information
• fetal or neonatal outcome
• infant follow-up where scientifically and ethically justified

Do not include an open-ended promise to collect any medical information the sponsor later wants. State the scope.

Medical-record access

If the sponsor or investigator will obtain information from the pregnant person's treating clinician or medical record, describe the access and obtain the pregnant person's consent before that access where required.

State who may access the information, what is collected, how it is coded or transferred and how long it is retained.

If infant medical records will be accessed after birth, define the lawful consent pathway for the infant's data separately rather than assuming the mother's consent covers every future use.

Privacy

The pregnancy follow-up form should identify the pregnant person as the data subject for her own information.

Include the Hungary-required privacy elements relevant to the document, including data categories, recipients, access, coding, storage, international transfers and safeguards, rights and NAIH contact information.

If the partner form refers to the main participant ICF for general sponsor information, the partner document should still contain the privacy information that is specific to the partner.

Consent and signatures

The pregnant trial participant signs her own follow-up consent where a separate consent decision is required.

A pregnant partner signs her own partner follow-up consent. The trial participant's signature is not a substitute.

Use the Hungarian ICF signature and date logic. If the person cannot read or write, the Hungary impartial witness guide applies.

Follow-up duration

No fixed Hungary-specific pregnancy follow-up duration was identified in the official national guidance reviewed for this guide. Use the duration justified by the protocol, safety plan and product risk, and state it clearly in the participant document.

Do not copy a global duration that conflicts with the Hungarian version of the approved protocol.

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