Portugal Pregnancy Follow-Up Consent Requirements

Pregnant trial participant

The main trial PIS and ICF should already explain reproductive risks, pregnancy testing, contraception, what to do if pregnancy occurs and whether trial treatment will stop. If pregnancy follow-up remains within the approved study activities and consent, a separate form may not be necessary.

Conditional. Use a pregnancy follow-up addendum or separate PIS and ICF when follow-up extends beyond the main consent, includes new record access, collects additional samples, continues after withdrawal from treatment or introduces a new purpose.

Explain which trial activities stop, which safety follow-up continues, what information is collected and whether infant follow-up is planned. Do not imply that pregnancy automatically ends all study participation if the protocol allows safe follow-up.

Pregnant partner of a trial participant

Mandatory when her data are collected. Provide the pregnant partner with her own Portuguese PIS and ICF. She is a separate data subject and may also be a research participant for the follow-up activity. The enrolled trial participant cannot consent for her.

Do not disclose the trial participant's confidential information beyond what is necessary and authorized. Design the contact pathway so the partner can decide freely and can contact the study team directly.

If infant data or records will be collected after birth, explain who will provide authorization for that collection and how parental authority will be verified. Do not assume that consent for maternal data automatically covers every infant follow-up activity.

Information to include

Describe the purpose and limits of follow-up. Identify the medicine or exposure in understandable terms and explain what is known and unknown about reproductive risk.

List the information that may be collected, such as:

• estimated conception and exposure dates
• pregnancy tests and gestational information
• relevant medicines, illnesses and risk factors
• pregnancy course and complications
• prenatal testing and relevant medical records
• live birth, miscarriage, termination, stillbirth or other outcome
• delivery information and congenital anomalies
• infant health and development during the protocol-defined follow-up

Collect only what the approved safety purpose requires. Do not use a pregnancy form as broad permission to access unrelated medical history.

Medical-record access

Conditional. If the study team or sponsor needs information from an obstetrician, maternity hospital, pediatrician or other provider, explain the specific records and purpose. Obtain the pregnant person's authorization and any further authorization required for infant records.

State who may access source records, how coded data are transferred and how providers may be contacted. Give the person a practical method to withdraw permission for future collection.

Privacy and data processing

Identify the controller, purposes, health and pregnancy data, recipients, transfers, retention and privacy contacts. Pregnancy and infant information are sensitive health data. The follow-up wording must align with the GDPR statement and Portuguese Law No 58/2019.

Explain which safety data may need to be retained after withdrawal. Do not say that all previously collected information will automatically be deleted.

Follow-up duration

State the actual protocol-defined duration and number of contacts. Portugal does not impose one universal follow-up period for every pregnancy. The period must be scientifically justified by the medicine, exposure and safety plan.

If infant follow-up extends beyond birth, explain its duration, procedures and separate data subject implications. Avoid an open-ended statement unless a separate optional future-research consent supports it.

Consent and signatures

The pregnant participant or pregnant partner and the person conducting the consent interview sign and date the relevant ICF. Give the person a signed copy. The model uploaded in CTIS is blank.

Participation in partner follow-up is voluntary. Refusal must not affect the trial participant's care or participation. Withdrawal stops future optional collection, subject to justified safety and legal record retention.

If the pregnant person is a minor or cannot consent, apply the correct Portuguese population pathway rather than asking the trial participant to sign. Use the Portugal minor guide or Portugal limited-capacity guide as applicable.

Final review

Confirm that:

• the pregnant participant and pregnant partner pathways are separate
• the person whose data are collected receives Portuguese information
• the purpose, data fields and follow-up duration match the protocol
• maternal and infant permissions are distinguished
• medical-record access is specific
• contact does not reveal unnecessary trial-participant information
• participation is voluntary and withdrawal is explained accurately
• privacy wording matches actual transfers and retention
• optional future use is not hidden in pregnancy safety follow-up
• signature blocks identify the correct data subject and interviewer

Use the Portugal patient-facing document QC checklist before submission. Return to the Portugal CTIS hub for the complete guide series.