Output Tab Descriptions | Clinical | Define Risk Threshold Data Set

Define Risk Threshold Data Set
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.
Table columns include:
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 .
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.
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.
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.
The table is interactive and you can add, delete, or change values.