alexa Base of a Research: Good Clinical Practice in Clinical Trials | OMICS International | Abstract
ISSN: 2167-0870

Journal of Clinical Trials
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Review Article

Base of a Research: Good Clinical Practice in Clinical Trials

Kapil Verma*
Amity Institute of Forensic Sciences (AIFS), Amity University, Uttar Pradesh, India
Corresponding Author : Kapil Verma
Amity Institute of Forensic Sciences (AIFS)
B-Block, Lower ground floor, Amity University
Uttar Pradesh Sec-125, Noida-201303, Uttar Pradesh, India
E-mail: [email protected]
Received December 21, 2012; Accepted January 24, 2013; Published January 27, 2013
Citation: Verma K (2013) Base of a Research: Good Clinical Practice in Clinical Trials. J Clin Trials 3:128. doi:10.4172/2167-0870.1000128
Copyright: © 2013 Verma K. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Abstract

This article illustrates the importance of Good Clinical Practice (GCP), defines and outlines the goals of GCP, presents a historical perspective on GCP and Outlines FDA regulations relating to GCP. Ongoing research shows that whether conducting research involving a new drug, a behavioral intervention, or an interview/survey, Good Clinical Practice (GCP) provides investigators and their study teams with the tools to protect human subjects and collect quality data. In this article, the author will define GCP, explain the benefits of following GCP for all types of human research and clinical trial studies, and provide some resources to assist investigators in implementing the tenets of GCP for their own research studies. This article reviews the impact of Good Clinical Practice (GCP) on clinical trials. GCP is likely to follow the International Conference on Harmonization of GCP guidelines in many aspects. GCP will enforce tighter guidelines on ethical aspects of a clinical study. Higher standards will be required in terms of comprehensive documentation for the clinical protocol, record keeping, training, and facilities including computers. Quality assurance and inspections will ensure that these standards are achieved. The additional requirements of GCP are discussed and any advantage to the study subject. GCP aims to ensure that the studies are scientifically authentic and that the clinical properties of the investigational product are properly documented. In this paper, we address the background history and the events that led up to the formation of these guidelines. Today, the GCP are used in clinical trials throughout the globe with the main aim of protecting and preserving human rights.

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