Which guideline governs GCP?

• A. FDA Guidance.
• B. CIOMS Guidelines.
• C. Nuremberg Code.
• D. ICH E6.

Answer: (D)

The guideline that governs Good Clinical Practice is ICH E6. This International Conference on Harmonisation standard lays out the ethical and scientific quality requirements for designing, conducting, recording, and reporting clinical trials involving human subjects. It defines who is responsible for what—sponsors, investigators, and ethics committees—along with essential practices like informed consent, proper trial documentation, data integrity, safety monitoring, and regulatory compliance. Because ICH E6 provides a harmonized framework used by regulatory authorities around the world, it serves as the governing baseline for GCP in most regions (with the FDA recognizing it for trials submitted in the U.S.).

Other options aren’t the governing GCP standard. FDA Guidance documents offer agency-specific recommendations rather than universal requirements. CIOMS Guidelines provide ethics guidance but do not constitute the formal GCP standard. The Nuremberg Code is a foundational historical document that influenced modern ethics but is not a current regulatory standard for GCP.