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.

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

What do I need?

This process requires the Demographics (DM) and Disposition (DS) SDTM domain data sets. Required variables include USUBJID, SITEID, and COUNTRY from DM and USUBJID and DSDECOD from DS.

Output/Results

Running this process generates and surfaces a Study Risk data set in a tabbed output dashboard. All modifications to the data set are done in this dashboard. Refer to the Update Study Risk Data Set output documentation for detailed descriptions and instructions for updating the data set.