(English follows Japanese)
Japanese title: Experience with central monitoring using JMP Clinical - To promote RBM (Risk-based monitoring)
Yuichi Fukumasu, Central Monitoring Department, Development Strategy Headquarters, A2 Healthcare Corporation
A2 Healthcare Corporation is promoting RBM (risk-based monitoring) to effectively and efficiently ensure the quality of clinical trials.
- This time, we will report on the experience of central monitoring using JMP Clinical, which is being carried out by the Central Monitoring Department of A2 Healthcare Corporation. After central monitoring is carried out, an RBM review meeting is held to confirm the status of KRIs (Key Risk Indicators). Since JMP Clinical was introduced, it has become possible to efficiently create materials to be used at the review meeting. The advantage of using JMP Clinical is that, if it is SDTM-ized, it can execute default functions such as CSM (Central Statistical Monitoring) and fraud detection to a certain extent.
- Because it can be operated through a GUI, even those who carry out central monitoring can do so without having to write programming languages such as SAS to visualize data.
- You can drill down from each chart to check KRIs and find information on cases of interest.
Central monitoring, unlike the past, requires a bird's-eye view of data, but by using JMP Clinical, you can easily create the charts and graphs you need. Here, we introduce a case study of central monitoring using JMP Clinical at A2 Healthcare Corporation.
Experiences of Centralized Monitoring Using JMP® Clinical: Promoting Risk-Based Monitoring
Yuichi Fukumasu, Centralized Monitoring Department, Development Strategy Division, A2 Healthcare Corp.
At A2 Healthcare, we promote risk-based monitoring (RBM) to effectively and efficiently ensure the quality of clinical testing. This presentation will be a report of our experiences with central monitoring using JMP Clinical, which is carried out by the Central Monitoring Department of A2 Healthcare. After central monitoring is conducted, an RBM review meeting is held to confirm the key risk indicators (KRIs). Since adopting JMP Clinical, it has become possible to efficiently create materials used at these meetings. The advantages of using JMP Clinical are as follows:
- STDM, the somewhat default function of central statistical monitoring (CSM), and fraud detection can be executed.
- GUI operation is possible, so the members carrying out central monitoring can do so without writing any programming code.
- By drilling down from charts to confirm the KRIs, interesting case information can be followed.
Central monitoring necessitates that data be viewed from a higher perspective, but by using JMP Clinical, individuals can easily create the charts they need. I will introduce case examples of central monitoring utilizing JMP Clinical, conducted by A2 Healthcare.
