Belgium Pregnancy Follow-Up Consent Requirements

Pregnant trial participant

Follow-up of a pregnant participant is subject to pharmacovigilance requirements. The sponsor must monitor and report relevant adverse events and should collect information on drug effects and outcomes for the pregnant participant and fetus.

Where collection and processing are necessary to meet a legal safety-reporting obligation, separate consent for data processing is not required. The legal basis is the controller's legal obligation under Article 6(1)(c) GDPR and public interest in public health under Article 9(2)(i). The participant must still receive the privacy information required by Articles 13 and 14 GDPR.

The CT-College prefers this information in the main ICF, using the pregnancy section of the Belgian template. A separate information letter or pregnancy follow-up ICF may also be used. Do not claim that consent is the GDPR basis when processing is mandatory for pharmacovigilance.

Follow-up of the child after birth

Mandatory when planned. An ICF or specific authorisation is required to follow the born child's health for drug-safety purposes. Information alone is not enough. The child is a separate person whose follow-up needs parental authorisation.

Belgium prefers two parental signatures for continued follow-up of the child. This can be a specific infant-authorisation ICF or an option in the main participant ICF, provided the potential other parent also has an appropriate information and signature route. Apply the two-parent exceptions described in the Belgium minor consent guide.

Pregnant partner of a trial participant

The pregnant partner is not automatically a trial participant merely because the other partner joined the trial. Following the pregnant partner's health and pregnancy is voluntary and must be described in the protocol, including the duration and any child follow-up.

Mandatory. Obtain the pregnant partner's written consent unless the activity is purely product-safety registration subject to a legal adverse-event reporting obligation. Provide a thorough partner ICF with privacy information and a compliant insurance clause. BAREC considers the partner follow-up to fall under the Belgian Law of 7 May 2004 on experiments on the human person, including its liability and insurance rule, while the same ethics committee should review it as part of the CTR study.

A pregnant-partner ICF may be submitted through a substantial modification when the exceptional situation arises. Planning it in the initial dossier is preferable when pregnancy is foreseeable.

If the partner completes questionnaires, joins calls or undergoes other research activities, the follow-up may be interventional. A separate ICF is then required for those activities. Do not rely only on permission from the original trial participant.

Information to collect and explain

The protocol and participant documents should identify only justified data, such as:

• exposure dates, dose and timing relative to conception and pregnancy
• maternal health and relevant medicines or risk factors
• pregnancy course and clinically relevant complications
• fetal assessments and pregnancy outcome
• delivery information and congenital anomalies
• infant health and development for the defined follow-up period
• medical-record access and contact with healthcare professionals where needed

State who provides data, who accesses medical records and whether direct contact, questionnaires or examinations occur. Obtain the pregnant person's permission for medical-record access unless a specific legal obligation allows the processing.

Follow-up duration

Define pregnancy and child follow-up in time, for example until a stated number of months after birth. Justify the duration using preclinical and clinical exposure data, known class effects, fetal-development risks and the investigational product's pharmacokinetics.

A short half-life may support shorter follow-up when no long-lasting effect is expected. It is not enough where the product or metabolites bind covalently or pharmacodynamic effects outlast measurable concentrations. Put the rationale in the protocol rather than leaving the duration open-ended.

Consent and withdrawal logic

Use separate decisions for the pregnant person and child follow-up. The trial participant cannot consent on behalf of a pregnant partner. Parental authorisation for the child should identify both parents where applicable.

Explain voluntary withdrawal from observational follow-up, what contact will stop and which safety data must still be processed under law. Do not condition the original participant's continued trial care on the partner's agreement to follow-up.

Final pregnancy-follow-up checks

• Distinguish pregnant participant, pregnant partner and born child.
• Put pharmacovigilance privacy information in the main ICF or a separate approved document.
• Obtain written partner consent when the follow-up is not limited to legally required safety reporting.
• Include the partner insurance clause required by the 2026 Belgian Q&A.
• Obtain specific infant authorisation and plan two parental signatures.
• Define activities, medical-record access and follow-up duration in the protocol.
• Provide every form in the correct Belgian regional language.

Use the Belgium patient-facing QC checklist before submission. Return to the Belgium CTIS hub for the full guide set.