France CTIS Part II Pregnancy Follow-Up Consent Requirements

Pregnant trial participant

When a trial participant becomes pregnant, follow the protocol's treatment-stopping, safety-reporting and medical-care process. The original trial consent may cover protocol-defined pregnancy tests, immediate safety reporting and limited follow-up if those activities, data sources, duration and disclosures were clearly described.

Prepare a French pregnancy follow-up addendum or separate information and consent form when the follow-up adds direct contacts, medical-record access, obstetric information, delivery data, infant information or a duration not adequately covered by the main consent. Do not treat a general safety-follow-up sentence as unlimited authorization.

The participant makes the decision for her own pregnancy and health data. If identifiable infant data or procedures continue after birth, identify the person legally entitled to authorize that collection and use the appropriate parent or guardian information. Confirm the protocol and privacy route before birth where possible.

Pregnant partner of a trial participant

A pregnant partner is a separate data subject who did not consent through the participant's trial form. The trial participant may provide contact details only through an approved and lawful contact route. The participant cannot consent to collection of the partner's medical or pregnancy information.

Give the partner a separate French information and consent document before direct interviews, questionnaires or access to identifiable medical records. Explain that the partner's choice does not affect the participant's treatment or trial participation and that she may decline without penalty.

If initial pregnancy information is received indirectly from the trial participant before the partner is contacted, address the GDPR Article 14 information route and minimize the data. Once the partner provides information directly, provide the Article 13 notice and document the applicable permissions.

Required document set

Conditional. A French pregnant-participant follow-up addendum or separate consent form where the original approved participant consent does not fully cover the planned follow-up.

Mandatory. When partner data are collected, a separate French pregnant-partner information and consent document with its own privacy notice and signature blocks.

Conditional. A French authorization for access to obstetric, delivery, neonatal or pediatric medical records where direct record access is planned. This may be included in the appropriate follow-up form when the records, holders, purpose and period are clear.

Conditional. Parent or guardian information and authorization for identifiable infant follow-up beyond data lawfully covered through maternal care records. Define who will be contacted after birth and under what authority.

Mandatory. The protocol, safety plan and recruitment and informed consent procedure should align on contact, data sources, follow-up endpoints, duration and later withdrawal.

Information to collect

Collect only data needed for the stated safety or scientific purpose. The justified set may include estimated conception and delivery dates, timing and extent of investigational-product exposure, relevant maternal history, concomitant medicines, prenatal testing, pregnancy complications, outcome, delivery details, fetal or neonatal findings and limited infant follow-up.

Do not copy an unrestricted medical-record request into the form. Identify the relevant records, healthcare professionals or institutions, time period and categories of information. Separate routine safety collection from optional long-term research.

If biological samples or genetic examinations are proposed for the pregnant person or infant, use the separate sample and genetics consent requirements. Pregnancy follow-up consent alone does not authorize genetic testing.

Consent and signature logic

The pregnant trial participant signs her addendum or follow-up form when a separate consent is needed. The pregnant partner signs her own form. The trial participant does not sign for the partner. The person conducting the consent interview signs and dates the record, and the signer receives a copy.

For infant follow-up, obtain authorization from the person or people with the applicable parental authority when identifiable infant information or procedures require it. A pregnant partner's prenatal consent to her own data should not be drafted as permanent consent for every future infant activity.

Make continued follow-up voluntary. Explain what happens after refusal or withdrawal, including the status of safety information already reported and lawful processing already performed.

Medical-record access

State whether data will be collected from the pregnant person, the trial site, an obstetrician, a maternity unit, a pediatrician or another holder. Obtain the person's explicit authorization for direct access where that is the approved route. Use the authorization only for the described records, purpose and period.

Where the site asks the pregnant person to request records personally, explain what is requested and how it will be transferred. Do not pressure the person to disclose records beyond the safety purpose.

Privacy, transfers and retention

Identify the controller, data categories, purposes, sources, recipients, retention, rights and privacy contacts. Match the information to MR-001 or the applicable CNIL authorization route. Explain which rights can be exercised and what happens to previously reported safety data.

For international transfer, list destination countries, recipients or recipient categories, transfer purposes and adequacy status as expected by the France Part II guidance. Do not assume that privacy text in the participant's main form covers the partner.

Use a study code where possible and keep the link to identity under controlled access. Restrict partner and infant information to staff who need it. Do not place the partner's full clinical history in the participant's ordinary source record when a separated record can meet safety needs.

Follow-up scope and duration

State the planned end point, such as pregnancy outcome, neonatal status at birth or a defined infant follow-up age. Explain the expected contacts and records at each point. If the sponsor may request longer follow-up after a finding, describe the trigger and seek any additional permission before extending beyond the approved scope.

Keep the participant document, partner document, case-report fields and protocol consistent. Remove fields that have no stated purpose and do not retain identifiable follow-up data indefinitely.

National template position

France has no mandatory national pregnancy follow-up consent template. Prepare the French documents under the Clinical Trials Regulation, the French information and consent rules, GDPR, MR-001 and the national Part II guidance.

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