What is the primary purpose of protection of clinical trial subjects under GCP?

• A. Protect the rights, safety and well-being of trial subjects
• B. Ensure sponsor profits
• C. Accelerate regulatory approval
• D. Minimize regulatory oversight

Answer: (A)

Under GCP, the protection of clinical trial subjects centers on safeguarding their rights, safety, and well-being. This means participants must be treated with respect, receive clear information about the study, its risks and potential benefits, and give voluntary consent that they can withdraw from at any time. The protocol is designed to minimize risks and maximize benefits, with ongoing safety monitoring and prompt reporting of any adverse events. An independent ethics committee or IRB reviews and oversees the study to protect subjects, and privacy and confidentiality of participant data are maintained. These protections ensure that participants are not exposed to unnecessary risks and that the data collected are credible and ethically obtained. Goals like increasing sponsor profits, accelerating approvals, or reducing oversight are not the purpose of GCP protections.