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Risk-Based Approaches to Data Management and Data Quality: Double Standards or Is It Just Common Sense and Intelligence Taking Over?

April 26, 2017

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Data Management

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Article

At a recent Risk-based Monitoring (RBM) conference at University of Tokyo, the authors were asked “Do the various RBM approaches lead to double-standards in processes and quality?”. This report provides several examples when clinical data management (CDM) standard and a so-called best practices can, and perhaps should be deviated from – including such rarely questioned decisions involving database unlock, hard-coding or local laboratory ranges.

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Data Basics
V. Tantsyura, Target Health, Inc., J. Mitchel, Target Health, Inc., YJ Kim, Target Health, Inc., T. Mijaji, The University of Tokyo, Graduate School of Medicine, Department of Clinical Trial Data Management, T. Yamaguchi, The University of Tokyo, Graduate School of Medicine, Department of Clinical Trial Data Management, I. McCanless Dunn, vTv Therapeutics
April 26, 2017
http://scdm.org/

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