Germany CTIS Pregnancy Follow-Up Consent Requirements

First identify the pregnancy pathway

Pregnant trial participant

The pregnant person is already a participant. The approved main information should explain pregnancy prevention, testing, reporting, treatment changes, immediate safety actions, and any routine trial pregnancy follow-up.

A separate or revised consent is needed when follow-up introduces new data sources, medical-record access, procedures, purposes, recipients, duration, or child follow-up not covered clearly by the original consent.

Pregnant partner of a trial participant

The pregnant partner is not a trial participant merely because their partner is enrolled. The pregnant partner must receive information addressed to them and consent to collection of their pregnancy, medical, and outcome data.

The enrolled participant cannot consent on behalf of the pregnant partner. The contact approach should protect both people's privacy and should not pressure the partner to participate in follow-up.

Required documents by scenario

Pregnant participant follow-up information and consent

Conditional. Prepare a German addendum or separate document when the main ICF does not already cover the proposed follow-up. Explain whether trial treatment stops, which pregnancy and outcome information is collected, medical-record access, contacts, follow-up duration, and what happens after withdrawal.

Pregnant partner information and consent

Mandatory when partner data will be collected. Provide a separate German document addressed to the pregnant partner. Explain why the sponsor requests the information, that participation is voluntary, what the enrolled participant may have told the site, and that refusal does not affect either person's care or the participant's trial involvement.

Child or infant follow-up information and consent

Conditional. If health information about the child will be collected after birth, identify the lawful representative or representatives who must authorize it under the planned follow-up and local process. Explain the child's data, records, tests, duration, recipients, and withdrawal separately from the mother's data.

Healthcare-provider or medical-record authorization

Conditional. If the site or sponsor will obtain information from an obstetrician, hospital, pediatrician, midwife, or other record holder, the relevant person must authorize that access where required. Name or describe the record sources and the information requested.

Content of the pregnancy follow-up document

Explain only the data and activities actually planned, including where relevant:

• pregnancy confirmation and estimated dates
• exposure timing, dose, and relevant concomitant medicines
• maternal medical and obstetric history
• pregnancy course and complications
• prenatal tests and imaging
• pregnancy outcome
• delivery details
• fetal, neonatal, and infant health information
• congenital anomalies or other medically relevant outcomes
• follow-up contacts and duration
• medical-record access
• coding, sponsor access, safety reporting, transfers, and retention

Do not describe clinical care as a research procedure if the study only collects records. Do not promise treatment, diagnosis, or benefit from a safety follow-up registry.

Consent and signature logic

Submit blank German documents in CTIS Part II when they form part of the proposed participant-facing package. At the time of follow-up:

• the pregnant trial participant signs for new processing or activities not covered by the main consent
• the pregnant partner signs for their own data and records
• the appropriate legal representative or representatives authorize collection of child data where required
• the physician or other person conducting the approved information process signs and dates according to the form

Use separate choices if maternal data, child data, additional samples, genetics, or long-term follow-up can be accepted independently.

Privacy and contact controls

The pregnant partner's contact details and medical data are personal data obtained for a new person. Explain how the site receives the contact details, who contacts the partner, and what happens if the partner declines.

Limit disclosure of the enrolled participant's treatment or health information to what is necessary and lawful. Similarly, do not disclose the partner's pregnancy information back to the enrolled participant without a valid basis.

The consent should explain safety reporting, pseudonymization, international transfers, retention, withdrawal, and any required continued processing. Match the data flow to the protocol, pharmacovigilance plan, and Part II GDPR statement.

Scope and duration

Define the end point of follow-up. It may be pregnancy outcome, neonatal follow-up, a stated infant age, or another protocol-defined point. Avoid open-ended wording unless the purpose and legal basis support it.

If longer future research is optional, separate it from the pregnancy safety follow-up and use the Germany secondary-use consent guide

German template

AKEK publishes a 2018 model text for information and consent to follow the pregnancy of a trial participant's partner and the child's health. It is useful as a Germany-specific drafting reference but predates current CTR implementation and is not a mandatory form. Update it against the current protocol, section 40b data requirements, GDPR, and the current CTIS submission.

AKEK does not list an equivalent current CTR model for every pregnant-participant scenario. Build that document from the approved main consent and the actual follow-up plan.

Use the Germany patient-facing document QC checklist before submission.

Return to the Germany CTIS hub

The Germany CTIS submission guide hub contains the full English guide series.

Other language versions

Read this guide in German.