3.2 Defining Alternate Risk Thresholds and Actions
3.2.1 Thresholds for Individual and Overall Risk Indicators
JMP Clinical is shipped
with a predefined set of risk thresholds contained within the Default
Risk Threshold data set. This set of thresholds can
be applied or selected by choosing Default Risk Threshold in
either the Risk-Based Monitoring or Define
Risk Threshold Data Set reports. Default thresholds
were based partially on suggestions from Section 8.1.4 in the TransCelerate
BioPharma Position Paper, and are intended to illustrate some of the
flexibility in threshold definitions that are available to the user
[1]. The Default Risk Threshold data set serves two purposes. First, it gives users the opportunity to start analyzing their data ...
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