What is required regarding follow-up information for expedited ADR reports?

• A. Follow-up information should be actively sought and submitted as it becomes available.
• B. Follow-up is only needed if the initial is inconclusive.
• C. No follow-up information is ever required.
• D. Follow-up should be submitted only after a year.

Answer: (A)

Follow-up information for expedited ADR reports must be actively sought and submitted as it becomes available. Initial expedited reports are often incomplete, so regulators rely on timely updates to accurately assess causality, seriousness, and the patient’s outcome. Clinicians and sponsors should have a process to collect additional details—such as diagnostic results, clinical course, treatment changes, and final outcomes—and file a follow-up promptly. This keeps the safety record current and improves the quality of regulatory decisions. Waiting for data to be perfectly complete, delaying follow-up until it’s inconclusive, or submitting follow-up only after a long time would weaken the safety signal and is not consistent with expedited reporting requirements.