Spain CTIS Part II Pregnancy Follow-Up Consent Requirements

Start with the main Spanish PIS/ICF

The main PIS should explain known fetal risks or state that they are unknown, describe required contraception, address breastfeeding and tell participants to report pregnancy promptly. The Spain main patient information and consent guide covers the baseline document.

Submit all pregnancy information and consent forms in Spanish as blank Part II documents. Signatures are obtained only if a pregnancy occurs and the applicable consent process is used.

Pregnant trial participant

Mandatory information in the main PIS. Tell a participant who can become pregnant what study treatment or procedures may stop, what medical care and safety follow-up are planned and what pregnancy and infant information will be requested. State the follow-up period, such as through delivery or a defined period after birth.

Conditional separate consent. A separate pregnancy follow-up form may not be needed when the approved main PIS/ICF clearly covers the participant's own pregnancy follow-up, purpose, data, record access and duration. Use a separate form when the planned collection is optional, extends beyond the approved main consent, adds new medical-record access or involves a distinct infant-data decision.

Pregnancy does not automatically mean withdrawal from all study follow-up. The protocol and PIS should distinguish stopping investigational treatment, remaining in safety follow-up and withdrawing consent.

Pregnant partner of a trial participant

Mandatory specific consent. AEMPS states that information about the pregnancy of a male participant's partner must be requested through a specific consent. The trial participant cannot consent on the partner's behalf.

Prepare a separate Spanish Partner Pregnancy Information Sheet and Consent Form. Explain why she is being contacted, that she is not a trial participant unless separately enrolled, what information will be collected, where it will come from, how long follow-up lasts and that refusal will not affect her care or her partner's care.

Do not obtain direct medical-record information from the partner based only on the trial participant's report or main study consent. A safety report received from the participant may still need to be documented, but direct follow-up and record access require the partner's own approved pathway.

Documents to prepare

Mandatory in relevant trials. Main PIS pregnancy section. Include fetal-risk information, contraception, reporting, pregnancy and infant follow-up, duration and data-protection reference.

Conditional. Participant pregnancy follow-up PIS/ICF. Use this when separate or expanded consent is needed for the enrolled participant.

Mandatory when partner follow-up is planned. Partner pregnancy PIS/ICF. Keep it independent from the male participant's ICF and include the pregnant partner's own privacy rights and contacts.

Conditional. Infant follow-up authorisation. If identifiable information will be collected directly from the child's medical record or healthcare team after birth, confirm the appropriate parent or guardian authorisation and signature route. State which infant information is collected and for how long.

Spain publishes no dedicated national pregnancy-follow-up template. Adapt AEMPS Annex VIIIA, including its data-protection appendix principles, to the person whose data are collected.

Information to include

Describe the pregnancy start and estimated due date, relevant exposure dates, maternal health, pregnancy course, prenatal testing, complications and outcome. For a live birth, limit infant information to the approved safety purpose, such as gestational age, birth outcome, congenital anomalies and defined follow-up milestones.

Do not use an open-ended statement allowing collection of any maternal or infant record. Identify the categories, source, purpose, coding, recipients and retention. State whether the investigator will contact the obstetrician, general practitioner, hospital, paediatrician or another healthcare professional.

Explain whether additional tests or visits are requested and whether costs are reimbursed. Follow-up should not impose protocol activities that the person did not consent to.

Privacy and data processing

Identify the sponsor and site roles, explain coding and state who can access identifiable information. Provide sponsor and site data-protection contacts. Explain sharing, transfers outside the European Economic Area and retention when applicable.

Keep the pregnant partner's information separate from the trial participant's coded study record where possible. Explain any link needed for safety analysis. Do not disclose the partner's medical details to the trial participant without a lawful and disclosed basis.

For infant data, identify whose rights apply and who may exercise them. Use only the minimum data needed for the approved pharmacovigilance and research purpose.

Consent, signatures and withdrawal

At CTIS submission, pregnancy forms are blank. When a separate pregnancy follow-up consent is obtained, the pregnant participant or partner and the investigator or authorised person obtaining consent sign and date it. Give the signer a signed and dated copy.

The pregnant person may refuse or later withdraw optional follow-up. Explain what happens to information already collected and what safety reporting may still be legally required. Withdrawal by the partner should not alter the male participant's trial participation.

Follow-up scope and duration

Use a defined endpoint from the protocol, such as pregnancy outcome, delivery plus a stated period or a defined infant milestone. Do not write “until no longer needed.”

If longer follow-up becomes scientifically necessary, update the approved documents and obtain new consent where required before expanding collection.

Final Spain review

Compare the main PIS, partner form, participant form, protocol, Investigator's Brochure and safety plan. Confirm that every route uses the same exposure window, data set and duration.

Use the Spain patient-facing document QC checklist before submission and the Spain CTIS guide hub for the wider national package.