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

2.5 Final Thoughts

This chapter served as a thorough overview of the basic RBM capabilities available in JMP Clinical. From my perspective, RBM is a topic with which the entire clinical development team should be familiar. Everyone is (and should be) responsible for the quality of the data, particularly those data important to the well-being of the study participants and the integrity and validity of the study conclusions. By proactively identifying important data, implementing regular review of these data, and defining appropriate risk management, important safety and quality issues can be identified and corrected while the trial is ongoing. This ongoing review should minimize any last-minute surprises for the study team, including discovering ...