Greece Pregnancy Follow-Up Consent Requirements

Pregnant trial participant

The main Greek trial form should explain contraception, pregnancy testing, reproductive risks, reporting duties and what happens if pregnancy occurs. If the protocol requests pregnancy-specific follow-up beyond the main trial information, prepare a focused Greek pregnancy follow-up form or a clearly separated section.

Explain whether trial treatment stops, what safety follow-up continues, which pregnancy, maternal, fetal, delivery and outcome information will be collected, and whether medical records or treating clinicians will be contacted. Participation in follow-up must be voluntary unless a specific safety activity has another lawful basis that is explained accurately.

Pregnant partner of a trial participant

The pregnant partner is not automatically a trial participant and has not signed the participant's main ICF. Obtain her own Greek information and consent before collecting identifiable pregnancy, medical or outcome information from her or her healthcare records.

The form should identify the sponsor, purpose of follow-up, categories of information, source records, recipients, international transfers, retention, privacy rights, withdrawal and contacts. Do not ask the enrolled participant to authorize access to the partner's medical information.

Greek National Ethics Committee guidance requires the pregnant-partner signature page always to include fields for a legally designated representative and two impartial witnesses. These are contingency fields and are used only if the applicable legal conditions arise. The ordinary signature remains the pregnant partner's own signature with the investigator or authorized study-team member.

Infant and newborn information

Conditional. If the sponsor will collect information about a newborn or infant whose biological parent participated in the trial, obtain a separate consent from both parents or guardians of the child. This applies whether the pregnancy form relates to a pregnant participant or a participant's pregnant partner.

The infant permission is distinct from the pregnant person's permission for pregnancy and fetal information. Greek guidance allows it to be a separate, dated signature page at the end of the form, signed by both parents or guardians and the investigator, provided the information clearly explains the infant data collection.

Describe the infant information to be collected, such as birth date, gestational age, delivery, sex, weight, congenital conditions, neonatal complications, development or other protocol-defined outcomes. State the follow-up duration and contact schedule. Do not collect broader pediatric information than the approved purpose requires.

Medical-record access and privacy

Obtain explicit permission to contact the obstetrician, hospital, pediatrician or other treating clinician and to review relevant records. Identify who may access source records and how confidentiality is protected.

Keep the Greek privacy section consistent with the sponsor's GDPR compliance statement. Explain controller contacts, the Data Protection Officer, purposes and legal bases, recipients, third-country transfers, retention, applicable rights and the Hellenic Data Protection Authority complaint route.

Insurance and compensation

The Greek insurance certificate submitted in Part II must contain the required pregnancy clause. Check that the participant and pregnancy forms describe injury compensation consistently with the certificate and do not promise coverage beyond the actual policy.

Explain whether follow-up visits or record retrieval create any cost, and who pays reasonable expenses. Trial-specific follow-up should not shift costs to the pregnant person, child or their public or private insurer contrary to the approved arrangement.

Signatures and withdrawal

At CTIS submission, upload blank Greek forms with all applicable future signature and full-date fields. During conduct, follow the Greek in-person paper-consent process and give the signer a signed copy.

Explain that refusal of pregnancy or infant follow-up does not remove the enrolled participant from unrelated trial care unless the protocol and safety rules require a separate clinical action. If consent is withdrawn, stop new optional collection and explain what happens to information already obtained.

If a witness route is used, apply the Greece impartial witness guide. For a child born during follow-up, keep the two-parent permission consistent with the Greece minor consent guide.

Return to the Greece CTIS guide hub and use the Greece patient-facing QC checklist before submission.