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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.“

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

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