SOCRA CCRP Practice Exam

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How many days does an IRB have to inform the FDA that it is reviewing different types of FDA-regulated products?

15 days
30 days
45 days
60 days

The correct answer is: 30 days

An IRB (Institutional Review Board) is a committee that is responsible for reviewing and approving research involving human subjects. In this case, the question is asking how many days an IRB has to inform the FDA (Food and Drug Administration) when they are reviewing different types of FDA-regulated products. The answer is 30 days. This is the required timeframe according to the federal regulations for IRBs (45 CFR 56.108) which state that IRBs must notify the FDA within 30 days of reviewing a product for the first time. Option A (15 days) is incorrect because it does not align with the federal regulations. Option C and D (45 and 60 days) are also incorrect as they are outside of the required 30 day timeframe.