SOCRA CCRP Practice Exam

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Which regulation contains FDA guidelines for IRB related topics?

  1. 21 CFR 50

  2. 21 CFR 56

  3. 21 CFR 312

  4. 21 CFR 58

The correct answer is: 21 CFR 56

FDA regulations are broken down into different sections based on specific topics. In this case, the question is asking about the regulations for Institutional Review Boards (IRBs). While option A and C may contain regulations related to clinical research, they do not pertain specifically to IRBs. Option D pertains to good laboratory practices, which is not directly related to IRBs. Therefore, option B, 21 CFR 56, is the most appropriate regulation as it specifically contains FDA guidelines for IRB related topics.

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