Risk Based Monitoring

This process generates a dashboard for risk-based monitoring of clinical trials.

What do I need?

This process requires the subject level analysis data set ( ADSL ) included in the Analysis Data Model ( ADaM ) and domain data sets from the Study Data Tabulation Model ( SDTM , v3.1.1). SDTM domains include Adverse Events ( AE ), Demographics ( DM ), Disposition ( DS ), Exposure ( EX ), Subject Visits ( SV ), Protocol Deviations ( DV ), and Inclusion/Exclusion Criteria Not Met ( IE ).

Note : You should refer to How does JMP Clinical define various terms for risk-based monitoring? for information about how terms used in risk-based monitoring are defined.

Output/Results

The output generated by this process is summarized in a tabbed report. Refer to the Risk Based Monitoring output documentation for detailed descriptions and guides to interpreting your results.