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.
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