Poland Pregnancy Follow-Up Consent Requirements

First decide whose pregnancy is being followed

The document logic starts with the person whose information will be collected.

Pregnant trial participant

A trial participant is already within the main informed-consent framework. If pregnancy testing, pregnancy reporting and follow-up are foreseeable trial procedures, the main Polish PIS and ICF should explain them at a level that allows an informed decision before enrollment.

A separate pregnancy follow-up information and consent document may still be useful when pregnancy triggers additional contacts, medical-record access, obstetric information, outcome collection or infant follow-up beyond what is clearly described in the main ICF.

Pregnant partner of a trial participant

The pregnant partner is a separate person. The trial participant's informed consent does not by itself provide the partner with information or authorise the study team to obtain the partner's identifiable medical information.

If the sponsor intends to contact the pregnant partner, request health information directly, access obstetric records or collect identifiable pregnancy and infant data, provide the partner with a separate Polish information document and an appropriate record of permission for that follow-up process.

Do not copy the participant's main-study ICF and simply replace the name. A partner is generally not receiving the investigational treatment and is not agreeing to the participant's study procedures.

When a separate pregnancy follow-up document is useful

Conditional. Use a separate document when the follow-up request is distinct enough that it cannot be understood from the main ICF alone.

Triggers can include:

• collection of pregnancy outcome after the trial participant stops study treatment
• direct contact with an obstetrician or other health care professional
• access to maternal medical records
• collection of information about delivery, congenital anomalies or neonatal outcomes
• follow-up of an infant after birth
• collection from a pregnant partner who is not a trial participant

The form should identify the exact follow-up rather than asking for an unlimited permission to collect any future health information.

Information to include for a pregnant trial participant

Where additional participant pregnancy follow-up is planned, explain:

• why the study collects pregnancy information
• what information is collected about the pregnancy and maternal health
• pregnancy outcome information to be collected
• whether infant information will be collected after birth
• how long follow-up will continue
• whether the study team may contact other treating professionals
• whether medical-record access is requested
• what happens to study treatment and trial visits after pregnancy is reported
• how withdrawal from pregnancy follow-up is handled
• the privacy information relevant to the additional data

Keep the document consistent with the protocol's contraception, pregnancy testing and treatment-discontinuation rules. A pregnancy form should not introduce new mandatory safety procedures that do not exist in the approved protocol.

Information to include for a pregnant partner

The pregnant partner document should be written from the partner's perspective. Explain that the partner is being asked for information because of exposure connected with the participant's trial treatment or another protocol-defined reason.

Describe:

• what information is requested from the partner
• whether information is also requested about the fetus or infant
• who may be contacted for records
• whether the partner can decline without affecting the participant's medical care or trial participation, except where the protocol must respond to missing safety information in a defined way
• how long follow-up lasts
• how to withdraw from further partner follow-up
• how previously collected information is handled
• sponsor and privacy contacts

Do not imply that the pregnant partner is a clinical-trial participant unless the person is independently enrolled in the trial.

Medical-record access

Conditional. If the sponsor or study team intends to obtain information from the pregnant person's medical records, say so explicitly. Identify the type of records, the purpose of access and the parties that may review the information.

A general sentence that the sponsor may review "relevant records" is weak when the pregnancy follow-up actually requires obstetric, delivery or neonatal information. Define the scope well enough for the person to understand the request.

The site should also confirm the local operational authority needed to obtain records from a health care provider that is not the trial site. The patient-facing form should not promise access the site cannot lawfully obtain.

Privacy and data-protection wording

Health, pregnancy and infant information is sensitive personal data. The pregnancy document should therefore align with the sponsor's data-protection framework and the Poland privacy wording used elsewhere in the trial.

Do not confuse informed consent to the clinical-trial or pregnancy follow-up procedure with the legal basis for processing personal data under the General Data Protection Regulation (GDPR). European Commission guidance on the CTR and GDPR treats these as separate legal questions.

For a pregnant partner, provide the required privacy information to that partner as a separate data subject. The trial participant's privacy notice does not substitute for information owed to another person whose identifiable health data are being collected.

Poland applies the GDPR together with the Polish Data Protection Act. Keep controller, purpose, recipients, transfers, retention and rights wording consistent with the sponsor's approved data-protection statement and actual data flow.

Follow-up of the infant

Conditional. If the protocol collects identifiable health information about the child after birth, define what is collected and for how long. The document should distinguish information about the pregnancy outcome from ongoing infant follow-up.

Determine who is legally able to permit the requested collection for the child and reflect that in the form. Do not assume that consent obtained from a pregnant person before birth automatically covers every later use of the child's identifiable health information.

If a child becomes the subject of research procedures rather than only a source of safety follow-up information, reassess whether the pediatric clinical-trial requirements apply. The Poland minor consent and assent guide explains the trial-participation pathway for minors.

Pregnant or breastfeeding women enrolled in the trial

Article 33 of the Clinical Trials Regulation contains additional conditions for clinical trials involving pregnant or breastfeeding women. It is not simply a pregnancy-reporting rule.

If the protocol intentionally enrolls pregnant or breastfeeding participants, the scientific and ethical justification must satisfy Article 33. The informed-consent information should describe the trial-specific risks and potential benefits to the woman, fetus, embryo or child as relevant.

Article 33 also prohibits incentives or financial inducements beyond compensation for expenses and loss of earnings directly related to participation.

Do not use a pregnancy follow-up form to solve a protocol-level Article 33 eligibility issue. Planned enrollment of pregnant participants must be addressed in the protocol and trial assessment itself.

Compensation wording in partner forms

The Poland main participant ICF should explain the Clinical Trials Compensation Fund and mandatory sponsor and investigator civil liability insurance as described by the Patient Rights Ombudsman.

A pregnant partner who is only providing follow-up information is not automatically a trial participant. Do not copy participant compensation language into the partner form in a way that falsely creates the impression that the partner has the same status under the clinical-trial compensation scheme.

Explain any compensation or reimbursement that genuinely applies to the partner follow-up and keep it separate from the participant's statutory trial protections.

Signatures and timing

At CTIS submission, submit blank controlled Polish versions of any pregnancy follow-up documents that are part of the planned participant-facing package. They are not signed at submission.

At the site, obtain the applicable signature or documented permission before collecting the additional information or accessing records that depend on that permission. Date the form and identify the person conducting the discussion where the form functions as an informed-consent document.

For a pregnant partner, do not wait until after identifiable medical records have already been obtained to present the follow-up information.

QC against the protocol and safety plan

Check the pregnancy documents against:

• pregnancy testing and contraception requirements
• rules for investigational product interruption or discontinuation
• safety reporting instructions
• pregnancy outcome data fields
• infant follow-up period
• medical-record access plan
• international transfers and central safety databases
• withdrawal language

The Poland patient-facing document QC checklist helps with the broader patient-document review. Return to the Poland CTIS Part II guide hub for the full set of Poland guides.