What is Good Clinical Practice (GCP) in the context of clinical trials?

• A. A marketing term with no regulatory basis.
• B. A software standard used in data management.
• C. A standard for ethical conduct and quality in clinical trials.
• D. A government tax regulation for research.

Answer: (C)

Good Clinical Practice is an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials that involve human participants. It ensures the rights, safety, and well-being of volunteers are protected and that the study data are credible and accurate. GCP is implemented through guidelines like ICH-GCP, which outline responsibilities for investigators, sponsors, and ethics committees, and cover elements such as informed consent, ethics approvals, protocol adherence, proper documentation, data handling, monitoring, and audits. Regulatory authorities in many regions require adherence to GCP, making it a regulatory framework rather than a marketing term, a software standard, or tax regulation.