Organizing information for using JMP Clinical - Aiming for use in central monitoring -
Yuichi Fukumasu, Central Monitoring Department, Development Strategy Headquarters, A2 Healthcare Corporation
The role of central monitoring in RBM is to detect risks in trial operation early during the trial by centrally reviewing data. JMP Clinical excels at visualizing data and can run about 60 types of reports, but information such as which report can be used to detect what risks and which members should review each report is not organized, which is an obstacle to using JMP Clinical effectively. In addition, many reports can be run by converting CRF data to SDTM format, but in order to run RBM reports that detect risks at medical institutions from operational data (number of days of EDC input, number of queries issued, number of deviations, etc.), it is necessary to prepare these operational data as RB domain format dedicated to JMP Clinical. A2 Healthcare identified the JMP Clinical reports required for central monitoring and considered how to review each report and how to create RB domains. This presentation will introduce the efforts.
