Detailed Explanation
Good Clinical Practice represents the foundational ethical and scientific quality standard that governs the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials involving human participants. Developed through the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, GCP provides assurance that the rights, safety, and well-being of trial subjects are protected in accordance with principles rooted in the Declaration of Helsinki. The standard simultaneously ensures that clinical trial data is credible, accurate, and suitable for supporting regulatory decisions about new therapies.