Italy pregnancy follow-up requirements

Start with the protocol and risk plan

Define the reportable pregnancy event, contraceptive failure, exposure window and required follow-up. Identify who detects and reports the pregnancy, the pharmacovigilance timeline, contact attempts, medical-record access, maternal outcome, fetal outcome and any infant follow-up.

Collect only data needed for the approved safety purpose. Align the form with the protocol, investigator's brochure, safety-management plan, data-management plan and separate privacy information. An ethics-approved follow-up process is needed before identifiable health data are obtained from a person who is not already covered.

When the pregnant person is the trial participant

The main participant information should already explain reproductive risks, pregnancy testing, contraception, required reporting and what happens if pregnancy occurs. State whether investigational treatment stops, what clinical care is offered and what safety follow-up continues.

If the approved main consent and privacy documents clearly cover pregnancy and outcome follow-up, use them for the participant and document confirmation of the person's willingness to continue the relevant follow-up. If the follow-up adds new procedures, longer infant observation, new record access or another material use not covered by the approved documents, obtain an approved separate or revised consent before that additional collection.

Participation and medical care remain voluntary. Avoid language that makes consent to research follow-up a condition of receiving pregnancy care. Explain any safety data that must still be retained after withdrawal.

When the pregnant person is a participant's partner

The pregnant partner is not the trial participant. She is a separate person whose identifiable health, pregnancy and outcome data cannot be collected merely because her partner joined the trial. As a practical compliance conclusion from the CCNCE privacy-separation requirements and GDPR, provide her with separate Italian information and an appropriate privacy and consent process before direct data collection or medical-record access.

The participant may tell the site that a pregnancy occurred and may pass contact information only through an approved, privacy-respecting route. The site should not pressure the participant to obtain the partner's signature or disclose the partner's medical details.

Contact the partner only through the method described in the approved documents. Explain the research purpose, what information is requested, who receives it, whether records will be reviewed, transfers, retention, contacts, voluntariness and withdrawal limits. Her decision must not affect her care or her partner's trial participation.

Maternal, fetal and infant information

Specify the minimum dataset and time points. It may include exposure timing, relevant medicines and conditions, prenatal course, pregnancy outcome, gestational age, delivery, congenital anomaly or other medically important outcome. Infant data may include only the follow-up defined in the approved safety plan.

Do not describe the fetus as an independent consent giver. After birth, the infant's information is personal data and the legally valid parent or guardian route applies to any direct infant assessment or identifiable record collection beyond what the approved maternal process lawfully covers.

For extended infant procedures, provide age-appropriate paediatric arrangements and obtain parent or guardian permission before collection. Use the minor consent and assent guide when the activity is more than passive safety outcome collection or continues as the child matures.

Medical-record access and healthcare contacts

State whether the investigator will contact an obstetrician, general practitioner, paediatrician or hospital and what records are requested. Obtain the person's appropriate permission before that contact unless another clear legal basis and approved emergency route applies.

Use a provider letter that identifies the study and requested facts without disclosing unnecessary trial information. Verify provider contact details independently. Return source documents securely and record unsuccessful contact attempts without repeated pressure.

Privacy notice and consent wording

Use the separate Italian privacy information and data-processing consent model as the baseline. Identify controllers, purposes, legal bases, data categories, recipients, processors, transfers, retention and rights. Explain pseudonymisation accurately and do not call coded pregnancy data anonymous.

Where a partner's consent is the basis for direct follow-up contact or record access, provide an independent signature block. Keep clinical-trial participation consent separate from privacy information and separate again from optional sample or genetic research.

Explain that the person may stop new follow-up contact. Data already lawfully collected may need to remain for safety reporting, regulatory review and trial integrity. Avoid promising deletion that cannot be delivered.

Samples and genetics

Pregnancy follow-up does not by itself authorise placental, cord-blood, fetal, maternal or infant sample collection. Describe any such sample in the protocol and provide specific information and consent. Separate immediate safety analysis from optional future research.

Use the secondary-use consent guide for storage, genetics, biobanking and future use.

Document set and quality control

Prepare only the forms the pathway requires. A study may need a participant pregnancy follow-up sheet, a separate pregnant-partner information and privacy form, healthcare-provider release wording and an infant follow-up permission. Make roles obvious in the titles and signature blocks.

Match exposure windows, follow-up duration, record access, endpoints and contacts across every document. State clearly whether completion is optional, what happens after refusal and which safety reports still proceed using data already held.

Use the main patient information and consent guide and patient-facing QC checklist. Return to the Italy CTIS guide hub.