The
Define Risk Threshold Data Set
tab displays the Risk Threshold Data Set. This interactive table lists risk indicators in rows and the conditions where those risk factors can adversely impact the study in columns.
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Variables
and label that specify the individual risk indicators that are used for analysis. This table is complete whether individual studies contain variables or not. This includes any variables defined in
Update Study Risk Data Set
, as well as version of the variable normalized by the number of randomized subjects and
PatientWeeks
.
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Risk threshold specifications for color-coding of columns in output of the
Risk Based Monitoring
report. Values where
Yellow Percent of Center
<
Values
<=
Red Percent of Center
of at least
Yellow Magnitude
are color-coded yellow. Values >
Red Percent of Center
of at least
Red Magnitude
are color-coded red. Otherwise, values are coded green.
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Specifications for defining the center of the response range. Values can either be
Mean
,
Median, or
Fixed
. For example, when either
Mean
or
Median
is selected, the
Center
specified above in Risk threshold specifications compares to the
mean
or
median
of the variables for all centers, respectively. Selecting
Fixed
value enables you to specify a meaningful threshold in
Center Value
. For example, to start applying risk once 5% of subjects at a site die (regardless of actual mean or median), you should specify
Fixed
and
5
for
PCTDEATH
variable.
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Specification for determining whether the risk is greater above (
U
), below (
L
), or both above and below (
B
) the specified threshold. Consider
PCTDEATH
, for example. A yellow flag is generated only if the deaths percent for a site is 5% to 10% above the median of all site death percents. For
AVGAE
, a yellow flag is generated only if the average number of
AE
s per randomized subject for a site is 5% to 15% above or below the median of all site average
AE
s per randomized subjects. This determination is important for whether certain events or safety concerns are being under-reported.
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