Clinical Operation Promotion Dept. Aware Health Care Inc. Central Monitoring Office Yuichi Fukusuke
Atsu Healthcare Co., Ltd. Hatayama Chi Kei, Fujita Yuko, Shirahama Satoko
Risk-based monitoring (RBM), which efficiently manages the process of clinical trials, is becoming a standard as a testing implementation system in recent years.Among them, Central monitoring (CM) which intensively reviews the data grasps the state of the established process and plays an important role of detecting abnormality.Currently, CM is done using various software, but JMP Clinical is excellent both in visualization and analysis of data, and about 60 kinds of report functions are prepared, and data visualization and analysis can be done easily.However, not all reporting functions are intended for use in CM, but what kind of risks each reporting function is suitable for detecting, what is necessary to grasp the expertise necessary to read the report It is thought that experience of use is necessary.
Therefore, in this presentation, focusing on reports that are particularly effective for use in CM, identifying reporting functions, and summarizing the contents.We will also refer to the expertise necessary to read and understand various reports.
