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Clinical TrialsDesign, Conduct and Analysis$
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Curtis L. Meinert

Print publication date: 1986

Print ISBN-13: 9780195035681

Published to Oxford Scholarship Online: September 2009

DOI: 10.1093/acprof:oso/9780195035681.001.0001

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PRINTED FROM OXFORD SCHOLARSHIP ONLINE (www.oxfordscholarship.com). (c) Copyright Oxford University Press, 2019. All Rights Reserved. An individual user may print out a PDF of a single chapter of a monograph in OSO for personal use. date: 15 December 2019

Quality assurance

Quality assurance

(p.166) 16 Quality assurance
Clinical Trials

Curtis L. Meinert (Contributor Webpage)

Susan Tonascia

Oxford University Press

Quality assurance, as applied to clinical trials, is any method or procedure for collecting, processing, or analyzing study data that is aimed at maintaining or enhancing their reliability or validity. This chapter details the general procedures needed to ensure the quality of the data generated in a trial. Topics covered include ongoing data intake, data editing, replication as a quality control measure, monitoring for secular trends, and data integrity and assurance procedures.

Keywords:   clinical trials, quality control, data quality, data editing, secular trends

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