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

1.6 Organization of This Book

While this chapter has served as an introduction and brief literature review, the remaining chapters of this book describe analyses in more specific detail using the Nicardipine study to illustrate the various methodologies. Chapters 2 and 3 discuss an implementation of RBM based on the recommendations of TransCelerate BioPharma [1]. Here, an artificial example is created for Nicardipine using simulated data for several site metrics typically not found within the clinical trial database. Locations of trial sites were modified to include countries in Europe and Asia, and random cities were selected to represent site locations. Chapters 4 and 5 present analyses to identify potentially fraudulent data in your clinical ...