Processes | Clinical | Define Risk Threshold Data Set

Define Risk Threshold Data Set
A risk threshold data set is used to 1) define the risk levels for individual variables for RBM analyses 2) specify the contribution of each variable to overall indicators of site risk. This process allows users to define a new risk threshold data set for RBM analyses.
Risk threshold data sets can be applied to future studies and can incorporate user-defined variables for analysis. However, the presence or absence of defined variables does not impede the RBM analysis. Variables that are available within a study but do not have defined risk levels are still presented, but they simple lack the traffic-light colors indicative of the risk level. Alternatively, variables with defined risk levels for the currently selected risk threshold data set that are not available for the current study are simple not used. Further, several risk threshold data sets can be defined to evaluate the sensitivity of the Risk Based Monitoring analysis to varying assumptions and risk thresholds. Finally, several overall indicators are defined, allowing for the straightforward combination of related factors.
Note: When integrating with a SAS server, a single individual can be responsible for defining risk thresholds, making them available to the entire clinical team through a drop-down menu in the analysis dialog.
Note: JMP Clinical 5.1 supports English-, Chinese-, and Japanese-language versions of Risk Threshold Data Sets.
What do I need?
This process requires the Demographics (DM) and Disposition (DS) SDTM domain data sets. Required variables include USUBJID, SITEID, and COUNTRY from DM and USUBJID and DSDECOD from DS.
Running this process generates and surfaces a Study Risk data set in a tabbed output dashboard. All modifications to the data set are done in this dashboard. Refer to the Define Risk Threshold Data Set output documentation for detailed descriptions and instructions for updating the data set.