A2 Healthcare Corporation Clinical Operations Promotion Department Central Monitoring Office Director Yu Fukumasu A2 Healthcare Corporation Clinical Operations Promotion Department Central Monitoring Office Yasuko Ishiguchi, Yuko Fujita
JMP Clinical is a tool that makes it easy to analyze clinical trial data. To use it, CDISC standard data must be prepared, but if CDISC standard data can be prepared during the clinical trial, the statistical analysis function, one of the features of JMP Clinical, makes it possible to identify medical institutions with different data trends. We prepared CDISC standard data during the clinical trial and were able to actually experience central monitoring (data review) using JMP Clinical. To conduct central monitoring, it is necessary to create a plan that describes the procedures for data review. Therefore, we considered what should be written in the central monitoring plan when using JMP Clinical. In this presentation, we will introduce the results of that consideration.
