Output Overview Descriptions | Clinical | Risk Based Monitoring

Risk Based Monitoring
Running this process for the Nicardipine study generates the tabbed Results window shown below. Refer to the Risk Based Monitoring process description for more information. Output from the process is organized into tabs. Each tab contains one or more plots, data panels, data filters, or other elements that facilitate your analysis.
The Results window contains the following panes:
Tab Viewer
This pane provides you with a space to view individual tabs within the Results window. Use the tabs to access and view the output plots and associated data sets.
The following tabs are generated by this process:
Site-Level Data: This tab consists of a data table displaying risk indicators derived using the study database as well as data entered using Update Study Risk Data Set. Risk indicators with defined thresholds are colored in green, yellow, or red.
Site-Level Distributions: This tab contains a series of Histograms for risk indicators from the site-level risk indicators data table.
Site-Level Maps: This tab contains global and, depending on the countries present in the data, country maps detailing the location of the clinical sites based on geocoding performed in Update Study Risk Data Set. Site colors are based on the selected risk indicator from the Drill Down drop down menu. Note; This tab is present only with geocoded sites.
Country-Level Data: This tab consists of a data table displaying risk indicators summarized at the country level. Risk indicators with defined thresholds are colored in green, yellow, or red.
Country-Level Distributions: This tab contains a series of Histograms for risk indicators from the country-level risk indicators data table.
Country-Level Map: This tab contains global map coloring countries based on the selected risk indicator from the Drill Down drop down menu.
Drill Down Buttons
Drill down buttons provide you with an easy way to drill down into your data. The following drill down buttons are generated by this process:
Risk Indicators: Click to highlight risk-indicator colors on data table row markers, histogram outliers, and map points. Note: This option is for use with indicators having defined thresholds,
Show Subjects: Click to open a data table of subjects from the sites selected from the site-level data table for review.
Report Actions: Click to open a set of distributions for selected rows listing recommended actions for selected study sites.
Open Edit Checks: Click to open a document of consistency checks performed on the risk indicators. The findings might suggest queries to one or more sites.
Select Rows Using Risk Indicators: Click this button to select rows based on the color of the selected Risk Indicator for both the site- and country-level risk indicator data tables.
Select Sites Using Country Selection: Click this button to select rows in the site-level data table for sites within the countries selected in the country-level data table.
General
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 tabs.
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.