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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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Quality assurance

Quality assurance

Chapter:
(p.166) 16 Quality assurance
Source:
Clinical Trials
Author(s):

Curtis L. Meinert (Contributor Webpage)

Susan Tonascia

Publisher:
Oxford University Press
DOI:10.1093/acprof:oso/9780195035681.003.0016

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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