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In accordance with the ICH E2A Guideline, the sponsor must report an adverse event that is life-threatening, unexpected, and associated with the investigational drug to the regulatory authority as soon as possible but no later than how many calendar days after first knowledge of the event?
Serious adverse events are subject to expedited reporting requirements.
ICH E2A 3.2.2: ''Fatal or life-threatening unexpected ADRs should be reported as soon as possible but no later than 7 calendar days after first knowledge.''
ICH E2A 3.2.3: Other serious unexpected events must be reported within 15 days.
Thus, the 7-day rule applies to life-threatening and unexpected events (as in this case).
Correct answer: B (7 days).
ICH E2A, 3.2.2.
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