Croatia pregnancy follow-up consent requirements

When pregnancy follow-up documents are needed

Conditional. Prepare pregnancy follow-up documents when the protocol or pharmacovigilance plan will collect information about a pregnancy arising during or after trial exposure. This may cover maternal health, pregnancy course, fetal development, pregnancy outcome, birth, and infant health for a defined period.

The main trial consent should explain reproductive risks, contraception, pregnancy reporting, and that a separate follow-up consent will be offered if pregnancy occurs. Do not present the later consent as automatic or mandatory.

Croatian national specifics expect both partners to use a reliable contraceptive method in trials where effects on reproductive cells, embryo, fetus, or unborn child are unknown or potentially harmful. Align the follow-up trigger with the approved contraception and reporting periods.

Pregnant trial participant

Mandatory when follow-up is planned. Prepare a separate Croatian informed consent for the pregnant participant. Explain why follow-up is requested, what information will be collected, how often she will be contacted, how long follow-up lasts, whether the child will be followed after birth, and what happens if she refuses or withdraws.

The document should distinguish trial treatment decisions from follow-up data collection. Explain whether the investigational medicine stops, which safety visits remain necessary, and which pregnancy contacts are optional. Do not imply that consent to join the main trial already covers every pregnancy and infant data use.

If the pregnant participant is a minor or lacks legal capacity, prepare a separate representative informed consent and an age-appropriate or capacity-appropriate assent statement for the pregnant participant.

Pregnant partner of a trial participant

Mandatory when partner follow-up is planned. Prepare a different Croatian informed consent addressed to the pregnant partner. Explain the trial exposure relevant to her pregnancy, the purpose of collecting her and the child's data, contact schedule, information requested, privacy, transfers, retention, withdrawal, and the defined end of follow-up.

Do not obtain the partner's medical information through the enrolled participant alone. The trial participant may pass an invitation or approved information to the partner, but the partner decides whether to contact or be contacted by the trial team under the approved process.

If the pregnant partner is under 18, prepare a representative informed consent and a separate age-appropriate assent statement for the partner. Apply the Croatian minor assent requirements to this follow-up context.

Maternal, pregnancy, outcome, and infant information

Describe the exact data to be collected. Depending on the approved protocol, this may include:

• estimated conception date and timing of trial exposure
• pregnancy confirmation and expected delivery date
• relevant maternal medical and obstetric history
• medicines, vaccines, substances, illnesses, and complications during pregnancy
• prenatal tests, imaging, and fetal findings
• miscarriage, termination, stillbirth, live birth, or other outcome
• gestational age, delivery details, birth weight, sex, and congenital findings
• neonatal course and infant health during a clearly defined follow-up period

Collect only information necessary for the approved safety purpose. Do not add open-ended access to unrelated medical records or indefinite infant follow-up.

Medical-record access and contact with healthcare professionals

Croatian national specifics state that health information about the pregnant participant, pregnant partner, and child must be obtained from the woman herself. It is not acceptable to contact her gynaecologist, obstetrician, paediatrician, or other healthcare professionals to obtain the information.

The consent may invite the woman to inform the clinician managing her pregnancy and the child's paediatrician that follow-up is taking place. The choice and communication remain with her. Remove global wording that asks for the clinicians' contact details or gives the sponsor blanket direct medical-record access.

If the protocol cannot meet its safety objective without direct source access, seek written clarification from the Central Ethics Committee before submission rather than assuming the global model is acceptable.

Privacy and consent choices

Identify the controller, trial team, sponsor safety recipients, processors, transfer countries, retention period, safeguards, participant rights, and AZOP route. Explain whether pregnancy information will be linked to the trial participant and how the partner's identity will be protected from unnecessary disclosure.

The pregnant woman signs and dates her paper consent, and the physician or dentist conducting the consent interview also signs and dates it. She receives a signed copy. For a minor, the legal representative and capable minor complete the approved representative and assent process.

State that declining or withdrawing pregnancy follow-up does not affect ordinary healthcare and does not penalise the enrolled participant. Explain what happens to information already collected and what legally required safety records may remain.

Scope and duration

State whether follow-up ends at pregnancy outcome, at hospital discharge, or after a defined infant period. If infant follow-up is planned, give the duration and contacts. Avoid phrases such as "until no longer needed" or "as required by the sponsor."

Align the period with the protocol, investigator's brochure, risk-management rationale, safety forms, and data-retention plan. The consent should not authorise broader future research with pregnancy or child data. Any optional secondary use needs a separate choice or document under the Croatia secondary use consent guide.

Croatia-specific final checks

• There is one document for the pregnant participant and another for the pregnant partner.
• Minor or limited-capacity variants include the correct representative and assent process.
• Infant follow-up is covered only when planned and has a defined duration.
• The woman is the source of maternal and child health information.
• The trial does not request contact details for her gynaecologist or the child's paediatrician.
• Data categories, contacts, transfer, retention, and withdrawal are specific.
• The document is professionally translated and proofread Croatian.
• The woman and physician or dentist interviewer sign and date in person on paper.

Return to the Croatia CTIS hub for all Croatia Part II guides.