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

A Work in Progress

In this book, I summarized several methodologies to enable the centralized monitoring of clinical trials, using an example cardiovascular study to illustrate concepts. Methods include the risk-based monitoring (RBM) approaches as outlined by TransCelerate BioPharma Inc., numerous statistical and graphical techniques to identify quality issues or fraud, and comparisons between data snapshots to easily identify new or modified data as the trial progresses. Further, I describe the implementation of these tools in terms of the CDISC domains and variables that are required in order to perform the various analyses. This last point is particularly important. Though the terms “CDISC” or “data standards” do not appear anywhere ...