SOCRA CCRP Practice Exam

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What FDA regulations govern IRB documentation requirements?

  1. 21 CFR 56.115

  2. 21 CFR 312.53(c)(3)

  3. ICH GCP guideline

  4. 21 CFR 50.25

The correct answer is: 21 CFR 56.115

The other options are incorrect because they refer to specific regulations or guidelines that pertain to different aspects of clinical trials and research, such as drug development (B), good clinical practice (C), and informed consent (D). Option A, however, specifically addresses FDA regulations related to documentation requirements for Institutional Review Boards (IRBs), which oversee and approve research involving human subjects. Therefore, A is the most accurate and appropriate answer for this question.

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