SOCRA CCRP Practice Exam

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Which FDA regulation outlines the roles and responsibilities of a sponsor?

  1. 21 CFR 312.50

  2. 21 CFR 312.30

  3. 21 CFR 812.40

  4. 21 CFR 314.50

The correct answer is: 21 CFR 812.40

The FDA regulation that outlines the roles and responsibilities of a sponsor is 21 CFR 812.40. Option A, 21 CFR 312.50, pertains to the contents of an investigational new drug application (IND). Option B, 21 CFR 312.30, covers the general responsibilities of an IND sponsor. Option D, 21 CFR 314.50, outlines the requirements for drug marketing applications. Therefore, these options are not relevant to the roles and responsibilities of a sponsor as stated in the question.

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