Romania CTIS Part II Pregnancy Follow-Up Consent Requirements

Start with the main Romania consent requirements

Pregnancy follow-up should remain consistent with the Romania patient information and consent requirements.

The main ICF should explain pregnancy prevention and reporting obligations that apply to the participant during the study.

Pregnant trial participant

If a participant becomes pregnant during the trial, the protocol and participant information should explain what happens to investigational treatment, study procedures and follow-up.

If additional maternal, pregnancy-outcome or infant information will be collected beyond what the main consent already covers, use a dedicated Romanian-language follow-up information and consent document where the approved study process requires it.

Explain the follow-up period, information collected, contacts and whether medical-record access is requested.

Pregnant partner of a trial participant

A pregnant partner is not automatically a trial participant merely because their partner is enrolled.

If the sponsor asks the pregnant partner directly for health information, pregnancy outcome data, infant information or access to medical records, provide a dedicated Romanian-language information document for that person and document the agreed data-collection process.

Do not rely only on the trial participant's consent to explain collection of another person's medical information.

What the pregnancy follow-up document should cover

Describe:

• why pregnancy information is being collected
• what maternal and pregnancy-outcome information is requested
• whether infant information is collected and for how long
• whether the sponsor or investigator needs access to medical records
• who will receive the information
• how privacy is protected
• what happens if the person declines further follow-up

Keep the description consistent with the protocol and data-protection documentation.

Medical-record access

Conditional. If pregnancy follow-up requires access to records held by another healthcare professional or institution, the participant-facing document should explain the access requested and the process used.

Do not use broad language suggesting unlimited access if the protocol only needs defined pregnancy or infant information.

Compensation

For pregnant or breastfeeding trial participants, EU rules prohibit financial inducements beyond compensation for expenses and loss of earnings directly related to participation.

Romania's national compensation form should match participant-facing information if reimbursement or compensation is provided.

A pregnant partner who is only providing follow-up information should not be described as receiving trial treatment or expected benefit.

Withdrawal and stopping follow-up

Explain how a person can decline additional pregnancy follow-up and whom to contact.

Avoid promising deletion of data already lawfully collected if the sponsor must retain it for trial integrity or legal obligations.

Submission package

If the protocol includes pregnancy follow-up, ensure the Romanian package contains the relevant main ICF wording and any separate participant or partner follow-up document actually used by the trial.

Check that the pregnancy pathway matches the protocol, safety plan, privacy information and compensation documents.

Use the Romania patient-facing QC guide before submission and the Romania Part II checklist for the full dossier. Return to the Romania CTIS hub for related guides.