Organizing information for using JMP Clinical - Aiming at utilization in central monitoring -
Atsu Healthcare Corporation Development Strategy Headquarters Central Monitoring Department Yuichi Fukusuke
The role of central monitoring in the RBM is to detect pilot risks early from the stage of the trial implementation through a centralized review of the data.JMP Clinical is excellent in data visualization and can execute about 60 kinds of reports, but which reports can use to detect what risks can be detected, and what kind of members should review each report Information is not organized, it is an obstacle to effectively using JMP Clinical.Although many reports can be executed by converting the CRF data to the SDTM format, an RBM report for detecting the risk of the medical institution is executed from the operational data (the number of EDC input days, the number of issues issued, the number of deviations, etc.) In order to do this, it is necessary to prepare these operational data as RB domain format dedicated to JMP Clinical.In AG Healthcare, we identified JMP Clinical's reports that are required for central monitoring, and examined how to review each report and how to create an RB domain.In this presentation, we will introduce our efforts.
