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:

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Click Choose and then navigate to the location of the data set.

To View the Contents of the Specified Data Set:

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Click Open.