SOCRA CCRP Practice Exam

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Within what timeline must a sponsor notify the FDA of a fatal or life-threatening SUSAR for drug studies?

Up to 7 calendar days
Within 15 calendar days
Immediately without undue delay
Within 30 calendar days

The correct answer is: Up to 7 calendar days

A sponsor must notify the FDA of any fatal or life-threatening SUSAR (Suspected Unexpected Serious Adverse Reaction) within 7 calendar days. This is an important timeline to adhere to because it allows the FDA to closely monitor and assess any potential risks to human subjects in the drug study. Option B, within 15 calendar days, may not provide enough time for the FDA to take prompt action. Option C, immediately without undue delay, is not a specific timeline and may cause confusion or delays in reporting. Option D, within 30 calendar days, is too long of a timeframe and may result in the FDA not being able to take necessary actions to protect human subjects in a timely manner. Therefore, option A is the most appropriate and time-sensitive option for notifying the FDA of fatal or life-threatening SUSARs.