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The importance of Good Clinical Practice guidelines and its role in clinical trials

By A Vijayananthan and O Nawawi

Abstract

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. It also serves to protect the rights, integrity and confidentiality of trial subjects. It is very important to understand the background of the formation of the ICH-GCP guidelines as this, in itself, explains the reasons and the need for doing so. In this paper, we address the historical background and the events that led up to the formation of these guidelines. Today, the ICH-GCP guidelines are used in clinical trials throughout the globe with the main aim of protecting and preserving human rights

Topics: Review Article
Publisher: Department of Biomedical Imaging, Faculty of Medicine, University of Malaya, Malaysia
OAI identifier: oai:pubmedcentral.nih.gov:3097692
Provided by: PubMed Central

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