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What does the 21 CFR 56 regulation pertain to?

  1. GCP guidelines

  2. Manufacturing controls

  3. IRBs

  4. Drug labeling

The correct answer is: IRBs

21 CFR 56 refers to the regulations for Institutional Review Boards (IRBs). These boards are responsible for reviewing and approving research studies involving human subjects. Option A, GCP guidelines, is regulated under 21 CFR 312 and 314. Option B, manufacturing controls, is regulated under 21 CFR 211. Option D, drug labeling, is regulated under 21 CFR 201. Therefore, these options are incorrect in relation to the specific regulation mentioned in the question.