Update Study Risk Data Set

Not all of the data needed to assess the performance of a study site are contained within the study database. Missing items can include the total number of queries, overdue queries, site responsiveness to query resolution or CRF entry, the number of missing CRF pages or deviations identified on-site or computed using other analysis programs. These data must be assembled before risk analysis can be performed.

Update Study Risk Data Set allows users to manually enter site-specific descriptive information as well as risk indicator information.

Running this report for the Nicardipine study generates the tabbed Results window shown below. Output from the report is organized into sections. Each tab contains one or more plots, data panels, data filters, or other elements that facilitate your analysis.

Note: This report is accessed using an option on the Studies main page.

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.

Down Buttons

The following down buttons are generated by this report:

•	Save Study Risk Data Set: Click 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.

•	Geocode Sites: Click to update the study risk data set with longitude and latitude values for the study sites.

•	Show Map: Click to display a geographical map showing the boundaries of physical entities, landmarks, and other features on a latitude (y-axis) and longitude (x-axis) scale

General

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

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

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

•	Click the Options arrow to reopen the completed report dialog used to generate this output.