Define Risk Threshold Data Set

Running this process for the Nicardipine study with Default Threshold Weight specified generates the tabbed Results window shown below. Refer to the Define Risk Threshold Data Set process description for more information. Output from the process is organized into sections. Each tab contains one or more plots, data panels, data filters, or other elements that facilitate your analysis.

Note : Any available risk threshold data set can be used as a starting place for defining a new data set

The Results window contains the following panes:

•	Define Risk Threshold Data Set : This interactive table lists risk factors in rows and the conditions where those risk factors can adversely impact the study in columns.

Drill Down Buttons

The following drill down buttons are generated by this process:

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Save Risk Threshold Data Set : Click this button to save your risk threshold data set. You are prompted to specify a unique name for the data set. The saved data set is surfaced as a selection in the Risk Threshold Data Set drop-down menu the next time you open Risk Based Monitoring . Note : The Default Risk Threshold data set cannot be edited or overwritten.

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Check Risk Threshold Data Set : Click this button to run a series of data checks on the values entered into the data set. This feature helps ensure that the entered values are specified correctly, so that the analysis is performed as expected. If values are entered incorrectly, guidance is provided for correction and/or the user is notified as to the assumptions made within an RBM analysis should the values be left as is. For example, for the Nicardipine study, the checks state that missing weights are assumed to be 0 (not contributing to overall indicators) and that missing center flags are assumed to be median .

General

•	Click View Data to view the associated data table. Refer to View Data for more information.

•	Click Reopen Dialog to reopen the completed process dialog used to generate this output.

•	Click Create Report to generate a standardized pdf - or rtf -formatted report containing the plots and charts of selected sections.

•	Click Add Notes to take notes, and store them in a central location. Refer to Add Notes for more information.

•	Click View Notes to read user-generated notes. Refer to View Notes for more information.

•	Click Close All to close all graphics windows and underlying data sets associated with the output.