Good clinical practice appraisal and its significance in proper conductance of clinical trials, global adoption scenario

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Authors: Nikita Paliya, Sunil Chaudhry, Rakesh Pandit
Cited by: 0

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.

Fields of Study & Subjects

Ethics in Clinical Research Biomedical Ethics and Regulation Pharmaceutical industry and healthcare

Publication details

Journal / source
Indian Journal of Pharmacy and Pharmacology
Volume
12
Issue
4
Pages
212–223
Publication date
2 February 2026