Lithuania CTIS Pregnancy Follow-Up Consent Requirements

Pregnant trial participant

If an enrolled participant becomes pregnant, follow the protocol's safety and discontinuation rules.

The existing main ICF should already explain:

• pregnancy risks known or unknown
• required contraception and pregnancy testing
• what the participant should do if pregnancy occurs
• whether investigational treatment stops
• what pregnancy follow-up is requested
• what maternal, pregnancy outcome and infant information may be collected

Conditional. A separate pregnancy follow-up consent form may be appropriate when follow-up involves data collection or medical-record access not adequately covered by the approved main ICF.

Do not assume that pregnancy automatically ends all trial participation. Follow the protocol and approved participant information.

Pregnant partner of a trial participant

A pregnant partner is not automatically a clinical trial participant.

Conditional. If the sponsor wants to collect the partner's pregnancy, health, obstetric, outcome or infant information, give the partner information about that follow-up and obtain the necessary consent or authorisation before collecting identifiable information directly from the partner or accessing the partner's medical records.

The enrolled participant cannot provide informed consent on behalf of the pregnant partner simply because the participant is the partner or parent.

A separate partner information and consent form is usually the clearest structure.

What the pregnancy follow-up document should explain

Keep the document limited to the actual follow-up.

Explain:

• why pregnancy information is being collected
• what information will be collected
• whether maternal medical records will be accessed
• whether pregnancy outcome information will be collected
• whether infant information will be collected and for how long
• who will receive the data
• how the data will be coded and protected
• whether information may be transferred outside Lithuania or the EEA where applicable
• how long data will be retained
• the right to refuse the follow-up without affecting the trial participant's care or participation where applicable
• how withdrawal from follow-up will be handled

Do not add broad permission for unrelated future research unless that use is separately described and optional.

Scope and duration

The protocol should define the pregnancy follow-up period and the data needed for safety evaluation.

Avoid open-ended statements such as "we may collect any relevant health information." List the expected categories and time period.

If infant follow-up continues after birth, explain the duration and what information is collected from the infant's medical record or parent.

Medical-record access

Where the sponsor or site needs information from obstetricians, hospitals or other healthcare providers, the partner or participant document should clearly explain the requested access.

The consent should match the practical process. If the site plans to contact an external healthcare provider, the form should not imply that data are collected only from the participant.

Lithuania Part II handling

Lithuania requires the Part II documents covered by the national recommendations to be submitted in Lithuanian.

The national Part II list reviewed for this guide does not provide a separate mandatory pregnancy follow-up template. The sponsor should therefore use the standard Lithuania participant-information, privacy and consent principles and decide whether the pregnancy form is part of the initial consent package or another participant-facing document requiring Part II submission under the Clinical Trials Regulation and current Lithuanian Bioethics Committee guidance.

If a new or revised participant-facing consent document later changes the approved consent process, assess whether a Part II substantial modification is required before use.

Pregnant women enrolled as trial participants

Article 33 of the Clinical Trials Regulation adds specific safeguards for trials that intentionally include pregnant or breastfeeding women. These requirements concern whether the trial may include that population, not only how pregnancy follow-up is documented.

Do not confuse an incidental on-study pregnancy with a protocol designed to enroll pregnant women.

Signature logic

At CTIS submission, any pregnancy consent form included in the dossier is submitted blank.

When follow-up consent is obtained:

• the pregnant trial participant signs their own follow-up consent where separate consent is needed
• the pregnant partner signs their own partner follow-up consent
• the person conducting the consent discussion signs and dates the form when the applicable consent process requires it
• the participant cannot substitute for the partner's signature

If future research use of samples or coded data is also proposed, separate that choice using the Lithuania secondary-use consent guide.

Final pregnancy-document QC

Confirm that:

• participant and partner pathways are not mixed
• the protocol supports the exact follow-up period
• maternal and infant data categories are specific
• medical-record access is explained
• privacy and transfer wording matches actual data flows
• refusal consequences are accurate
• any separate pregnancy document is in Lithuanian for Lithuania Part II
• future-use choices remain separate

Use the Lithuania patient-facing QC checklist for final consistency review.