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According to 21 CFR 312.32, what is the maximum timeframe within which a sponsor must report an unexpected fatal or life-threatening suspected adverse reaction to the FDA?

15 calendar days after the sponsor's initial receipt of the information. 10 working days after the site reports the event to the sponsor. 24 hours after becoming aware of the event. 7 calendar days after the sponsor's initial receipt of the information.

Correct Answer:

7 calendar days after the sponsor's initial receipt of the information.

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