SOCRA CCRP Practice Exam

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What FDA regulation governs financial disclosure?

  1. 21 CFR 312.53

  2. 21 CFR 54

  3. 21 CFR 50

  4. 21 CFR 56

The correct answer is: 21 CFR 54

The correct regulation is 21 CFR 54. The other options, 21 CFR 312.53, 21 CFR 50, and 21 CFR 56, all relate to different regulations within the FDA's Title 21 of the Code of Federal Regulations. 21 CFR 312.53 relates to investigator disqualification and 21 CFR 50 and 56 relate to the protection of human subjects in clinical trials. Therefore, these options are incorrect as they do not specifically govern financial disclosure.

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