Which CFR parts govern IRB oversight and IND requirements for clinical trials?

• A. 21 CFR Part 50 and 56
• B. 21 CFR Part 11 and 54
• C. 21 CFR Part 801 and 803
• D. 21 CFR Part 56 and 312

Answer: (D)

The main idea is that clinical trial protection and regulation come from two parts of the CFR: one sets up the review and oversight by an institutional body, and the other governs the use of investigational drugs in humans. IRB oversight is provided by 21 CFR Part 56, which covers the responsibilities of Institutional Review Boards, including approving study protocols, safeguarding informed consent, and ongoing review of continuing risk to participants. IND requirements are in 21 CFR Part 312, which outlines when an Investigational New Drug can be studied in humans, the roles and duties of sponsors and investigators, and the reporting and compliance tasks needed to conduct an IND.

Together, these parts ensure that a clinical trial has ethical review and regulatory approval for the investigational product. Other options mix in areas like electronic records (Part 11), financial disclosures (Part 54), or device-specific provisions (Parts 801 and 803), which do not address both IRB oversight and IND requirements. Some combinations also pair informed consent rules (Part 50) with IRB oversight, but they still miss the IND regulatory framework found in Part 312.