2.4 Reviewing Risk Indicators
2.4.1 Site-Level Risk
2.4.1.1 Risk Indicator Data Table
Once supplemental data
and geographic information have been supplied for the clinical sites
through Update Study Risk Data Set (Section 2.2.1.2 Risk Indicators from Other Data Sources and Section 2.3 Geocoding Sites) and a set
of risk thresholds are defined through Define Risk Threshold
Data Set (upcoming in Section 3.2), the user is now ready
to perform an analysis of site performance using the Risk-Based
Monitoring report. In actuality, however, the analyst
is free to begin the analysis immediately, without adding any supplemental
data, by taking advantage of the Default Risk Threshold data set. In this scenario, the RBM analysis and review will be limited ...
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