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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