Update Study Risk Data Set

The Update Study Risk Data Set tab contains the following elements:

•	One Data Table : This data table contains site-level data merged into the data taken from the study database and used to define sets of risk indicators for analysis with the Risk-Based Monitoring Report . The values shown here were generated for the Nicardipine example.

Relevant columns are listed in the following table:

Column(s)	Description
Study Site Identifier	CDISC SITEID variable (taken from current database)
Country	CDISC COUNTRY variable (taken from current database). The values in this column are used to geolocate the sites.
City	User-entered field 1 representing the city of the site. The values in this column are used to geolocate the sites.
State or Province	User-entered field representing the state or province of the site. These values are required for international cities in order to distinguish between multiple cities with the same name. Use Map Geocoding Help for correct suggestions. U.S. states and territories must use 2-letter postal codes. The values in this column are used to geolocate the sites.
Five Digit Zip Code	User-entered field for sites in the United States. It is easiest and recommended to fill in five digit ZIP codes for sites in the U.S., and city, state or province designations for non-U.S. locations. The values in this column are used to geolocate the sites.
Latitude, Longitude	These values can be obtained automatically from other geographic information with Geocode Sites drill down. Alternatively, values can be entered directly
Site Active Date	User-entered date that the site is considered active for recruiting patients. This date allows metrics for target and expected number of randomized subjects to be calculated.
Monitor	User-entered names of the person with the primary oversight responsibility for the trial site. Values determine the number of exported tables that are generated using the Export Tables drill-down.
Total Queries, Overdue Queries, Missing Pages, Computed Deviations	User-entered pre-defined site-level variables that are used to define two risk indicators each: • one normalizing by number of randomized subjects, and • one normalizing by patient-weeks on study. Note : Leave these variables blank if they are not used.
Query Response Time, CRF Entry Response Time	User-entered pre-defined site-level variables that are used as risk indicators. Values typically represent the mean or median value of the site. Note : Leave these variables blank if they are not used.
Other variables	You can use the Add Variable drill-down to enter any number of fields for additional variables at the site-level in the Risk Based Monitoring (RBM) analysis. Variables added in this way are added to the Study Risk Data Sets of future studies by default (they can be left blank if not used). Each variable is summarized in the RBM analysis, along with one indicator normalized by the number of randomized subjects and one normalizing by patient-weeks on study. All three variables (the one variable added plus the two additional indicators) are added to future Risk Threshold Data Sets when updated using Define Risk Threshold Data Set . Note : These variables are not assessed against any thresholds until they are added to the Risk Threshold Data Sets.

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Values can be entered directly into the table in the Results window. To save any changes that you make, be sure to click the Save Study Risk Data Set drill-down button.

By default, an empty table (save for country and study site identifier) with one row per site is presented.