Processes | Clinical | Risk Based Monitoring

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.