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An Introduction to Clinical Governance and Patient Safety$
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Elizabeth Haxby, David Hunter, and Siân Jaggar

Print publication date: 2010

Print ISBN-13: 9780199558612

Published to Oxford Scholarship Online: January 2011

DOI: 10.1093/acprof:oso/9780199558612.001.0001

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Research governance

Research governance

Chapter:
(p.113) Chapter 13 Research governance
Source:
An Introduction to Clinical Governance and Patient Safety
Author(s):

Paul Farquhar-Smith

Publisher:
Oxford University Press
DOI:10.1093/acprof:oso/9780199558612.003.0013

This chapter discusses research governance, which aims to facilitate the conduct of high quality, ethical scientifically valid research, while protecting both subjects and investigators. Good research governance mandates meticulous record keeping and trial surveillance, and drives a quality research culture. The Research Governance Framework explicitly sets out national standards supported by legislation for research conducted within the NHS in the United Kingdom. This document defines the roles and responsibilities of all those involved in research, and the implementation of the framework using Good Clinical Practice (GCP) principles and standard operating procedures (SOPs). It also highlights the importance of meticulous documentation and monitoring (local and external) during any trial. These mechanisms ensure continual assessment of the quality of conduct of research and allow continuing trial development and improvement.

Keywords:   Research Governance Framework, good clinical practice, research quality, Good Clinical Practice, research

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