A risk threshold data set is used to 1) define the risk levels for individual
variables
for RBM analyses 2) specify the contribution of each variable to overall indicators of site risk. This process allows users to define a new risk threshold data set for RBM analyses.
Risk threshold data sets can be applied to future studies and can incorporate user-defined variables for analysis. However, the presence or absence of defined variables does not impede the RBM analysis. Variables that are available within a study but do not have defined risk levels are still presented, but they simple lack the
traffic-light
colors indicative of the risk level. Alternatively, variables with defined risk levels for the currently selected risk threshold data set that are not available for the current study are simple not used. Further, several risk threshold data sets can be defined to evaluate the
sensitivity
of the
Risk Based Monitoring
analysis to varying assumptions and risk thresholds. Finally, several overall indicators are defined, allowing for the straightforward combination of related
factors
.
Note
: When integrating with a SAS server, a single individual can be responsible for defining risk thresholds, making them available to the entire clinical team through a drop-down menu in the analysis
dialog
.
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
.