SOCRA CCRP Practice Exam

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What FDA regulations govern the contents of a clinical trial protocol?

  1. 21 CFR 50.25

  2. ICH GCP guideline

  3. 21 CFR 312.53(c)(3)

  4. 21 CFR 56.115

The correct answer is: 21 CFR 312.53(c)(3)

FDA regulations state that clinical trial protocols must comply with 21 CFR 312.53(c)(3), meaning they must include specific information on the purpose of the study, study design, subject eligibility, and study treatment plan. While the other options mentioned, such as 21 CFR 50.25 and 21 CFR 56.115, may also include regulations related to clinical trial protocols, they do not specifically govern their contents. Similarly, the ICH GCP guideline provides internationally accepted standards for designing, conducting, recording, and reporting trials, but it is not a FDA regulation. Therefore, option C is the most accurate and appropriate answer.

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