Yuichi Fukumasu, Central Monitoring Office, Clinical Operations Promotion Department, A2 Healthcare Corporation
A2 Healthcare Corporation Tomoyoshi Hatayama, Yuko Fujita, Satoko Shirahama
Risk-based monitoring (RBM), which efficiently manages the clinical trial process, has become the standard in clinical trial implementation systems in recent years. Central monitoring (CM), which centrally reviews data, plays an important role in understanding the status of established processes and detecting abnormalities. Currently, CM is performed using a variety of software, but JMP Clinical excels in both data visualization and analysis, and has approximately 60 report functions that make it easy to visualize and analyze data. However, not all report functions are designed for use in CM, and sufficient experience is required to understand what types of risks each report function is suitable for and the expertise required to interpret the reports.
Therefore, in this presentation, we will focus on reports that are particularly effective for use in CM, identify report functions, and summarize their contents. We will also mention the expertise required to interpret each type of report.