Published by SAS Institute (edition ), 2014
ISBN 10: 1612909914 ISBN 13: 9781612909912
Language: English
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Published by SAS Institute 2014-07, 2014
ISBN 10: 1612909914 ISBN 13: 9781612909912
Language: English
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Published by SAS Institute 7/1/2014, 2014
ISBN 10: 1612909914 ISBN 13: 9781612909912
Language: English
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Paperback or Softback. Condition: New. Risk-Based Monitoring and Fraud Detection in Clinical Trials Using JMP and SAS. Book.
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Kartoniert / Broschiert. Condition: New. Über den AutorrnrnRichard C. Zink is a Principal Research Statistician Developer in the JMP Life Sciences division at SAS Institute. He is a developer for JMP Clinical, an innovative software package designed to streamline the review of cl.
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Taschenbuch. Condition: Neu. nach der Bestellung gedruckt Neuware - Printed after ordering - International guidelines recommend that clinical trial data should be actively reviewed or monitored; the well-being of trial participants and the validity and integrity of the final analysis results are at stake. Risk-based monitoring (RBM) makes use of central computerized review of clinical trial data and site metrics to determine if and when clinical sites should receive more extensive quality review or intervention. Risk-Based Monitoring and Fraud Detection in Clinical Trials Using JMP and SAS describes analyses for RBM that incorporate and extend the recommendations of TransCelerate Biopharm Inc., methods to detect potential patient-or investigator misconduct, snapshot comparisons to more easily identify new or modified data, and other novel visual and analytical techniques to enhance safety and quality reviews. The analytical methods described enable the clinical trial team to take a proactive approach to data quality and safety to streamline clinical development activities and address shortcomings while the study is ongoing.