Output Overview Descriptions | Clinical | Update Study Risk Data Set

Update Study Risk Data Set
Running this process for the Nicardipine study generates the tabbed Results window shown below. Refer to the Update Study Risk Data Set 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 tab is generated by this process:
Update Study Risk Data Set: This data table contains site-level data that is merged into the data taken from the study database to define sets of risk indicators for analysis with the Risk-Based Monitoring Report. This table can be manually updated to include additional relevant information.
Drill Down Buttons
The following drill down buttons are generated by this process:
Save Study Risk 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 .
Add Variable: This option enables you to add additional variables to the data table. By default, Total Queries, Overdue Queries, Query Response Time, CRF Entry Response Time, Missing Pages, and Computed Deviations are pre-defined. Each new variable added generates two additional risk indicators, one normalized by number of randomized subjects and the second by patient-weeks on study. Note: Any pre-defined variables that are not used should be ignored.
Geocode Sites: Using information from City, State or Province, Five Digit ZIP code (U.S. only), and Country generates and populates the latitude and longitude of each center. Alternatively, latitude and longitude can be entered directly. Map Geocoding Help can assist with acceptable spellings.
Show Map: Click to view geocoded sites on a geographic map
Import Tables: Imports all updated JMP tables (from a previous export) from a selected directory and updates the values in the primary table.
Export Tables: Click this button to subset the Study Risk Data Set based on distinct values in the Monitor column and export each subset into a new data table. Missing values for Monitor go to an unassigned JMP table. These tables include the pre-defined variables and any user-defined variables so that monitors can update information and the study risk data set can be updated in a single step from multiple tables with Import Tables.
Export Blank Tables: Click this button to subset the Study Risk Data Set based on distinct values in the Monitor column and export each subset into a blank data table. One table is generated for each data monitor and includes a row for each study site assigned to that monitor. Columns from the original table are carried over but the data in those columns are excluded from the tables.
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 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.