SOCRA CCRP Practice Exam

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Master the SOCRA CCRP Exam with our comprehensive practice quiz. Tailored feedback, detailed explanations, and real-world scenarios to boost your confidence and success.

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What is the deadline for an investigator to report UADEs to the sponsor and IRB according to 21 CFR 812?

5 working days
10 working days
15 working days
20 working days

The correct answer is: 10 working days

The other options are incorrect because they do not align with the FDA regulations outlined in 21 CFR 812, which states that an investigator must report Unanticipated Adverse Device Effects (UADEs) to the sponsor and IRB within 10 working days. Option A, 5 working days, is too short of a time frame and may not allow for proper investigation and reporting. Option C, 15 working days, and option D, 20 working days, are both longer than the 10-day requirement and may delay important safety information from being reported. Therefore, option B is the most accurate and timely choice for reporting UADEs.