Chapter

Quality assurance

Curtis L. Meinert and Susan Tonascia

in Clinical Trials

Published in print September 1986 | ISBN: 9780195035681
Published online September 2009 | e-ISBN: 9780199864478 | DOI: http://dx.doi.org/10.1093/acprof:oso/9780195035681.003.0016

Series: Monographs in Epidemiology and Biostatistics

Quality assurance

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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

Chapter.  6762 words.  Illustrated.

Subjects: Public Health and Epidemiology

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