How should SAEs be reported?

• A. Annually, in the safety report.
• B. Only at the end of the trial.
• C. Through the primary care physician only.
• D. Immediately to the sponsor, including an assessment of causality.

Answer: (D)

Prompt safety reporting is essential. When a Serious Adverse Event occurs, it must be reported to the sponsor without delay, with an assessment of causality. This allows the sponsor to rapidly evaluate risk, take appropriate safety actions, and fulfill regulatory and ethics requirements for ongoing oversight. Delaying reporting until the end of the trial or routing the information only through a primary care physician would prevent timely safety evaluation and action. The initial investigator report to the sponsor, including causality assessment, is the trigger for the sponsor to notify regulatory authorities and ethics committees as required and to manage ongoing safety monitoring.