Czechia CTIS Part II Pregnancy Follow-Up Consent Requirements

Pregnant trial participant

A participant who becomes pregnant remains covered by the main trial participation framework unless the protocol requires treatment discontinuation, withdrawal or a specific follow-up procedure.

The main PIS/ICF should explain pregnancy and fetal risks, contraception requirements and what the participant should do if pregnancy occurs. If the protocol requires collection of pregnancy, delivery or infant outcomes, explain that follow-up prospectively and at an appropriate level.

If additional optional data or medical-record access goes beyond the main study consent, use a separate consent choice where necessary rather than assuming that every pregnancy-related activity is automatically covered.

Pregnant partner of a trial participant

A pregnant partner is not the enrolled trial participant. The male participant cannot consent on the partner's behalf to access the partner's medical information.

SÚKL's KLH-22 lists documents such as permission to contact a pregnant partner, pregnant-partner information and consent and consent for collection of pregnancy data among documents for which the ethics committee provides the opinion rather than documents SÚKL itself approves under that guideline.

That national distinction matters when building the CTIS package. The partner should receive information directed to her own data and pregnancy follow-up, not a copy of the trial participant's PIS/ICF presented as if she were enrolled.

Information to include

The pregnancy follow-up document should explain the actual data collection required by the protocol. Depending on the study, that may include:

• pregnancy start and estimated dates
• relevant maternal medical and medication history
• pregnancy course and complications
• prenatal investigations relevant to the follow-up
• pregnancy outcome
• delivery information
• fetal or neonatal outcomes
• infant follow-up for the period specified in the protocol

Do not collect a broader dataset simply because pregnancy has occurred. The scope should match the protocol and approved safety follow-up plan.

Consent and signature logic

For a pregnant trial participant, the main trial consent remains the starting point. Where a separate pregnancy follow-up consent is used, the participant signs that document when the additional follow-up is agreed.

For a pregnant partner, obtain the partner's own consent before collecting information directly from her or accessing her medical records, unless a different lawful and approved pathway specifically applies. The enrolled participant's consent is not a substitute for the partner's consent.

Submit blank forms in CTIS. Actual signatures are obtained during trial conduct.

Medical-record access

If pregnancy follow-up requires information from an obstetrician, maternity hospital, pediatrician or other healthcare provider, explain the intended access and disclosure to the pregnant person.

The document should identify what information may be requested, for what purpose and for how long. Avoid a broad medical-record authorisation unrelated to the pregnancy follow-up.

Privacy and data processing

Explain how pregnancy, maternal and infant data will be coded, transferred, stored and used in a way consistent with the study's data-protection documentation.

For a partner, make clear that the partner is providing her own personal data even though the trial participant is someone else. If infant data are collected after birth, ensure the approved information and representative-consent pathway covers that collection.

The sponsor's separate SÚKL Template No. 5 data-protection declaration remains part of the Part II dossier.

Follow-up duration

State the duration required by the protocol. Some programs follow only the pregnancy outcome. Others include neonatal or infant follow-up for a specified period.

Do not use open-ended wording if the protocol defines a fixed period. If long-term follow-up is planned, say what information is collected and when.

Czech language and document status

Participant-facing pregnancy documents intended for use in Czechia should be prepared in Czech in line with the national approach to participant materials. If a foreign national requires another language, apply SÚKL's certified-translation pathway based on the approved Czech version where that rule is relevant.

No dedicated SÚKL pregnancy-follow-up template is listed in KLH-CTIS-01 Version 3. Use protocol-specific documents and ensure the ethics pathway is clear rather than inventing a national form.

The Czechia patient-facing QC checklist is useful for checking consistency across pregnancy risk wording, contraception, data access and partner documentation.