What must be included about the reporting source in expedited ADR reports?

• A. The source should always be specified and causality assessment required.
• B. Source identity is optional.
• C. Only the patient's physician needs to be identified.
• D. Source should be a regulatory authority.

Answer: (A)

In expedited adverse event reporting, the reporting source must be documented and a causality assessment must be included. Documenting the source ensures clear traceability and accountability—regulators need to know who provided the information so they can follow up if needed and verify the report. A causality assessment provides an initial judgment about whether the suspected drug could have caused the event, which helps regulators assess urgency, prioritize review, and determine next steps. The source can be a clinician, pharmacist, patient, sponsor, or other qualified reporter—not just a physician, and not limited to a regulatory authority. This combination—identifying the reporter and including a causality assessment—is essential for timely and meaningful signal evaluation in expedited reports.