Which regulatory framework governs the conduct of clinical trials, including IRB oversight and informed consent?

• A. Good Laboratory Practice
• B. Good Manufacturing Practice
• C. Good Clinical Practice
• D. International Conference on Harmonisation guidelines

Answer: (C)

Good Clinical Practice sets the ethical and scientific standards for conducting clinical trials, defining how studies should be designed, conducted, recorded, and reported to protect participants and ensure data integrity. The hallmark elements are IRB/IEC review and informed consent, which are required under GCP to safeguard participants’ rights, safety, and well-being. IRB oversight ensures the study protocol, risk/benefit analysis, and consent documents are appropriate before a trial starts and that ongoing safety is monitored. Informed consent ensures participants understand the purpose, procedures, risks, benefits, and their right to withdraw, with voluntary participation documented appropriately.

Good Laboratory Practice focuses on nonclinical safety testing, not the conduct of trials in humans. Good Manufacturing Practice emphasizes manufacturing quality of the product. The International Conference on Harmonisation guidelines provide a harmonized framework that includes GCP, but the standards most directly governing how trials are run—including IRB oversight and informed consent—are encompassed by Good Clinical Practice.