Abstract :
Good Clinical Practice (GCP) guidelines serves as the cornerstone for ethical and scientifically sound clinical research, providing a globally recognized framework to ensure the safety, rights, and well-being of trial participants while maintaining the credibility of collected data. This review comprehensively examines the historical evolution of GCP, beginning from unethical research practices in the early 20th century to the establishment of internationally harmonized ICH-GCP standards. The article outlines the core principles of GCP, including informed consent, risk-benefit assessment, scientific rigor, and proper documentation, and illustrates how these principles integrative function across all phases of clinical trials—from protocol design to trial closure and post-study reporting. Furthermore, it explores the critical regulatory and legal implications of GCP adherence and how it facilitates ethical oversight, regulatory approvals, and international norms related to trials.
Keyword :
Good Clinical Practice (GCP), Clinical Trials, Ethical Guidelines, Informed Consent, Regulatory Compliance, ICH-GCP, Patient Safety, Data Integrity, Trial Phases, Research Ethics.