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

6.1 Introduction

Data from a clinical trial should be examined by as many eyes as possible. Each individual brings a unique skill set important for understanding patient safety, protocol adherence or data insufficiencies that can affect the final analysis. Clinical data review is extremely time-consuming; a major reason for this prolonged effort involves the data collection process. To perform the final analysis as early as possible after the clinical trial ends, data are collected and cleaned as they become available. This review may necessitate queries to the clinical site to correct erroneous values or request additional data if the currently available information is unclear or insufficient. So not only are new data reviewed, the responses ...