SOCRA CCRP Practice Exam

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Which FDA regulation discusses audits?

  1. 21 CFR 50.25

  2. 21 CFR 312.68

  3. 21 CFR 56.108

  4. 21 CFR 312.57

The correct answer is: 21 CFR 312.68

The other options A, C, and D are incorrect because 21 CFR 50.25 pertains to "Protection of human subjects", 21 CFR 56.108 pertains to "Institutional review boards", and 21 CFR 312.57 pertains to "Investigational new drug applications". These regulations may not specifically mention audits. In contrast, option B, 21 CFR 312.68, specifically discusses audits in the context of clinical investigations. Therefore, it is the most appropriate choice for the question.

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