Good clinical practice (GCP) is an international quality standard that is provided by ICH, an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects. These standards for clinical trials are referred to as ICH-GCP which is a recommendation in clinical guidelines. Good Clinical Practice is defined as a standard for the Design, Conduct, Performance monitoring, Auditing, Recording, analysis and Reporting of clinical trails that provides assurance that the data and the reported results are credible and accurate and that the rights integrity and confidentiality of the trail subjects are protected. GCP enforces tight guidelines on ethical aspects of a clinical study. GCP aims to ensure that the studies are scientifically authentic and that the clinical properties of the investigational product are properly documented. Ongoing research shows that whether conducting research involving a new drug, a behavioral intervention, or an interview or survey, GCP provides investigators and their study teams with the tools to protect human subjects and collect quality data.

This topic describes: Principles of ICH-GCP.

GCP Guidelines

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