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New Publication on Risk-based Monitoring – Bravo to Vadim Tantsyura


Our esteemed data management expert and prolific writer, Vadim Tantsyura has done it again. The publication entitled “Risk-Based Approaches to Data Management and Data Quality: Double Standards or Is It Just Common Sense and Intelligence Taking Over?“ was recently published in Data Basics and co-authored with an international team from the US and Japan.


From the introduction: “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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Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor



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