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A pregnancy notification needs a sensitive, predefined response. Site teams should know how to obtain the relevant information, involve the investigator and preserve confidentiality without making unsupported assumptions about reportability or treatment.
Separate intake from medical decisions
Use the protocol, product information and current TİTCK safety guidance to establish the assessment pathway. Pregnancy and an associated serious event are not interchangeable categories. The appropriate medical and safety functions should assess the circumstances and applicable reporting obligations using verified information.
Create a confidential follow-up plan
We recommend a coded intake record with awareness date, exposure context, consent or lawful basis for follow-up, investigator contact and receiving safety function. Keep identifying details in the authorized clinical record. A participant's partner may require a different information and permission pathway; do not assume trial consent covers every person's records.
Check handoffs and reporting assessment
- Confirm immediate investigator review and the protocol-specific clinical management pathway.
- Record known facts, missing information and the medical assessment owner separately.
- Route relevant information to the safety function for documented reporting assessment.
- Agree authorized follow-up contacts and record attempts without coercing participation.
Keep follow-up proportionate
Reconcile outcome information with the safety database while preserving source attribution. Record when follow-up cannot be obtained and why. Avoid promising outcomes or giving individualized treatment instructions through an operational checklist; those decisions belong with the responsible clinical team.
Frequently asked questions
- Is every pregnancy automatically a serious adverse event?
- No. Assess pregnancy information and any associated event under the protocol and applicable safety guidance.
- Can the sponsor contact family members directly?
- Only through an authorized, appropriate information and permission pathway; preserve confidentiality and documented roles.