Output Overview Descriptions | Clinical Reports | 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 sections. Each tab contains one or more plots, data panels, data filters, or other elements that facilitate your analysis.
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 Variables from Supplementary Data : Click 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. Note : Added variables must be numeric. 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.
Save risk threshold data set : Click to save the updated data set..
Check risk threshold data set : Click to check the validity of the variables in the risk threshold data set. A static report is generated showing the results of the check:
Delete this risk threshold data set : Click to delete the updated risk threshold data set.