SOCRA CCRP Practice Exam

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How many days does a sponsor have to report an emergency use of an investigational product (IP) to the FDA?

3 working days
5 working days
7 working days
10 working days

The correct answer is: 5 working days

A 3 working days is not the correct answer because it would not provide enough time for the sponsor to gather and report all necessary information to the FDA. C: 7 working days is not the correct answer because it could be considered too long to report an emergency use of an IP, which may delay the FDA's ability to take appropriate action. D: 10 working days is not the correct answer because it is even longer than 7 working days and could also result in delays in the FDA's response. By process of elimination, B: 5 working days is the most suitable option as it provides enough time for the sponsor to report the emergency use of an IP to the FDA without overly delaying the process. It allows for the necessary information to be gathered and reported in a timely manner, allowing the FDA to take action as soon as possible.