Appendixes | Report Option Descriptions | Supplemental SAS data set for RBM

Supplemental SAS data set for RBM
Specify the full path and name to the input SAS data set containing supplemental data for risk-based monitoring.
Note: This data set should be formatted using the CDISC-like standard for RB.
Risk-Based Monitoring (RBM) supports site-level variables in the supplemental data set. These are identified by having USUBJID missing. Study Site Identifier (SITEID) is now a required variable for this format. Because dates can be provided, site-level variables should be summarized in time trend analyses. Within the same analysis, subject and site-level variables cannot share the same values for VARIABLE and RBDECOD. Refer to Risk-Based Monitoring - External Standard - Version 2 for more information about supplemental data sets used for RBM.
To Specify the Supplemental Data Set:
Click Choose and then navigate to the location of the data set.
To View the Contents of the Specified Data Set:
Click Open.