Slovenia CTIS Pregnancy Follow-Up Consent Requirements

Pregnancy-risk information before enrollment

Mandatory when risk applies. The main PIS and ICF should explain:

• known and unknown embryo-fetal, reproductive, and breastfeeding risks
• required pregnancy tests and their timing
• contraception methods and duration
• restrictions on sperm or egg donation
• what to do if pregnancy occurs
• whether trial treatment stops and what safety follow-up continues
• who to contact urgently
• what maternal, pregnancy-outcome, and infant information will be requested

KME RS guidance specifically asks for written pregnancy and fetal-risk information and contraception instructions where teratogenic risk exists. Women of childbearing potential should sign an acknowledgment that they understood the information and will avoid pregnancy for the risk period. The guidance asks for the same warning to be signed by healthy female partners of male patients participating in the research when relevant.

Do not replace informed consent with a bare contraception declaration. The risk, follow-up, privacy, and withdrawal information must remain understandable.

Pregnant trial participant

A trial participant's main consent may cover protocol-defined pregnancy testing and safety reporting, but pregnancy follow-up should be described specifically. Provide a dedicated Slovenian information and consent form or a clearly separate approved section when follow-up goes beyond the main trial information.

Explain:

• effect of pregnancy on trial treatment and procedures
• maternal safety monitoring
• pregnancy progress and outcome data
• fetal or neonatal assessments
• infant follow-up and duration
• access to obstetric, hospital, and paediatric records
• contact with healthcare professionals
• handling of miscarriage, termination, stillbirth, congenital anomaly, and other sensitive outcomes
• data retention, safety reporting, and withdrawal limits

Article 33 of the Clinical Trials Regulation imposes additional conditions when pregnant or breastfeeding women are intentionally included as trial participants. Do not treat an incidental pregnancy follow-up form as authorisation to continue investigational treatment contrary to the protocol.

Pregnant partner of a trial participant

The pregnant partner is a separate person and data subject. The trial participant cannot consent on her behalf. Obtain her direct Slovenian information and consent before collecting identifiable medical records, contacting her clinician, or conducting pregnancy or infant follow-up, unless a specific legal safety-reporting obligation permits a narrower collection without consent.

The partner form should explain:

• why the sponsor is requesting follow-up
• how exposure may have occurred
• what information will be collected from the partner, pregnancy, fetus, and infant
• which healthcare professionals and records may be contacted
• how long follow-up will continue
• recipients and international transfers
• whether any samples or genetic tests are requested
• voluntary participation and the effect of refusal
• data already collected and legally required safety records after withdrawal

Do not disclose the trial participant's confidential medical details beyond what is necessary and lawful. Also explain to the participant that the partner decides independently.

Required documents

Depending on the protocol, prepare:

• Slovenian pregnancy-risk and contraception text in the main PIS and ICF.
• A signed reproductive-risk acknowledgment when KME RS guidance applies.
• A Slovenian pregnant-participant follow-up information and consent form.
• A separate Slovenian pregnant-partner information and consent form.
• A separate medical-record release or clinician-contact authorisation if needed.
• Infant or child follow-up information and representative permission when follow-up continues after birth.
• Optional sample or genetic-research consent if those activities are not necessary safety follow-up.

Submit blank, versioned forms in CTIS Part II when the pathway is foreseeable. The participant or partner signs later when the relevant information and consent process occurs.

Data to define before drafting

Limit collection to the protocol and pharmacovigilance purpose. Common fields include exposure dates, estimated conception, pregnancy tests, maternal history relevant to outcome, concomitant medicines, prenatal tests, complications, outcome, gestational age, delivery, congenital anomalies, neonatal status, and defined infant milestones.

State the follow-up duration. Avoid an open-ended promise to collect any future information. If long-term infant follow-up is scientifically necessary, explain each period and how representative permission and later child involvement will be handled.

Privacy and medical-record access

Trial participation consent and GDPR legal basis are separate questions. Identify the controller, purposes, legal basis, recipients, transfers, retention, and rights for the pregnant participant or partner. Use a direct authorisation when the study needs access to obstetric, delivery, neonatal, or paediatric records and the legal framework requires it.

For a partner, avoid sending identifiable pregnancy information through the trial participant. Contact her directly using the approved method after she agrees to be contacted.

If infant data are collected, explain whose data are processed, who provides permission, and how the child's interests are protected. Do not treat maternal consent as unlimited permission for future research involving the child.

Consent, signatures, and withdrawal

At CTIS submission, all forms are blank.

During conduct, the pregnant participant or partner and the person conducting the interview sign and date the applicable approved form. Provide a signed and dated copy. Obtain any legal-representative permission needed for infant follow-up.

If consent is refused or withdrawn, stop optional contact and collection. Explain which safety data already collected must remain and whether limited reporting of serious outcomes is required. Separate withdrawal from pregnancy follow-up from withdrawal of the original trial participant where they are different decisions.

No dedicated national pregnancy follow-up template

No current Slovenia-specific CTIS pregnancy or partner follow-up form was identified on the JAZMP or KME RS pages. Use the protocol, CTR, Slovenian language rule, KME RS reproductive-risk guidance, and data-protection requirements. The national guidance provides a specific risk-warning expectation but not a complete follow-up template.

Return to the Slovenia CTIS hub for the full guide set.