Risk-Based Monitoring and Fraud Detection in Clinical Trials Using JMP and SAS

Download or read book Risk-Based Monitoring and Fraud Detection in Clinical Trials Using JMP and SAS written by Richard C. Zink and published by SAS Institute. This book was released on 2014-07 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.