Which statement best describes protocol compliance in clinical trials?

• A. The Institutional Review Board (IRB)
• B. The US Food and Drug Administration
• C. The designated state's board of nurse examiners
• D. Both A and B

Answer: (D)

Protocol compliance means following the approved trial plan and all regulatory requirements to protect participants and ensure reliable results. The IRB reviews and approves the protocol before the study starts and continues to monitor conduct to safeguard participants’ rights and safety. The FDA regulates clinical trials, enforcing federal rules and Good Clinical Practice to maintain protocol integrity and proper reporting. The designated state's board of nurse examiners focuses on nursing licensure and practice, not trial protocol compliance, so it does not describe how trials are conducted. Because both the IRB and the FDA are involved in ensuring protocol compliance, the best description includes both.