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

5.5 Final Thoughts

In this chapter, we focused on identifying patients that enrolled at two or more clinical sites within the same study, and described how the analysis could be extended to identify those individuals that enrolled within multiple studies within the same clinical development program. These analyses suggest the usefulness of collecting height and weight for all trials, not just those studies where such physical characteristics affect the dose of study drug or play an important role in the disease. There are numerous other checks that could be performed to assess the quality of data provided by study participants. Currently, the Constant Findings report summarizes any tests within Findings domains with no variability, while the ...