Which regulation governs Good Clinical Practice in the United States?

Which regulation governs Good Clinical Practice in the United States?

• A. FDA 21 CFR Part 812
• B. 21 CFR Part 312
• C. ISO 14155
• D. ICH E6

Answer: (B)

The regulation that governs Good Clinical Practice (GCP) in the United States is specifically outlined in 21 CFR Part 312. This part of the Code of Federal Regulations pertains to the Investigational New Drug Application (IND) process and outlines the requirements and guidelines for the conduct of clinical trials involving drugs. Part 312 establishes the criteria under which clinical studies must be planned and executed, ensuring the safety and efficacy of investigational drugs. It encompasses the responsibilities of sponsors, investigators, and institutional review boards (IRBs), thereby safeguarding the rights and welfare of trial participants. This regulatory framework plays a crucial role in maintaining high levels of clinical trial integrity and ethical standards. While other options may relate to clinical research, they do not specifically govern GCP in the same comprehensive way as 21 CFR Part 312. For instance, FDA 21 CFR Part 812 covers Investigational Device Exemptions and is focused on medical devices rather than drug trials. ISO 14155 pertains to the conduct of clinical trials for medical devices and is an international standard rather than a U.S. regulation. Similarly, ICH E6 provides guidelines for GCP and is recognized globally but does not serve as a regulation per se within the U.S. legal framework.

The regulation that governs Good Clinical Practice (GCP) in the United States is specifically outlined in 21 CFR Part 312. This part of the Code of Federal Regulations pertains to the Investigational New Drug Application (IND) process and outlines the requirements and guidelines for the conduct of clinical trials involving drugs.

Part 312 establishes the criteria under which clinical studies must be planned and executed, ensuring the safety and efficacy of investigational drugs. It encompasses the responsibilities of sponsors, investigators, and institutional review boards (IRBs), thereby safeguarding the rights and welfare of trial participants. This regulatory framework plays a crucial role in maintaining high levels of clinical trial integrity and ethical standards.

While other options may relate to clinical research, they do not specifically govern GCP in the same comprehensive way as 21 CFR Part 312. For instance, FDA 21 CFR Part 812 covers Investigational Device Exemptions and is focused on medical devices rather than drug trials. ISO 14155 pertains to the conduct of clinical trials for medical devices and is an international standard rather than a U.S. regulation. Similarly, ICH E6 provides guidelines for GCP and is recognized globally but does not serve as a regulation per se within the U.S. legal framework.