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What does 21 CFR 54 pertain to?

  1. Drug Approval Process

  2. Biological Product Regulations

  3. Financial Disclosure by Clinical Investigators

  4. Clinical Study Safety Protocols

The correct answer is: Financial Disclosure by Clinical Investigators

21 CFR 54 pertains to the financial disclosure by clinical investigators. This regulation requires clinical investigators involved in research on FDA-regulated products to disclose certain financial interests that could potentially create a conflict of interest. Option A, the drug approval process, falls under title 21 CFR 314. Options B and D are also incorrect, as they fall under different sections of title 21 CFR - 21 CFR 601 pertains to biological product regulations, and 21 CFR 312 pertains to clinical study safety protocols. These options are not related to financial disclosure, which is the focus of 21 CFR 54.

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