Watch Now 15:29
JMP Clinical: Centralized Statistical Monitoring of Clinical Trials
Presenter: Chris Kirchberg
Overview of Risk-Based Clinical Trials Monitoring
The presenter introduces the characteristics of risk-based monitoring, explains how it relates to FDA recommendations for monitoring clinical trials and describes how JMP Clinical implements a central, computerized review of clinical trials data and site metrics. He describes the Nicardipine ydrochloride clinical trials data used in his demonstration.
Examining Risk-Based Indicators
The presenter examines the Nicardipine hydrochloride clinical trials data using JMP Clinical tabular and graphical tools. He describes site-level time trends and site-, country- and subject-level indicators; shows how to identify possible risks; and examines related adverse events and other indicators that could contribute to the risk score. He explains that it is the responsibility of the therapeutic team to set the thresholds and weight the risks that contribute to the risk score. He concludes by showing how to update study risk data sets from ADAM or STDM data.
Uncovering Data Integrity Issues
The presenter examines the Nicardipine hydrochloride clinical trials data using JMP Clinical to uncover any possible modified, fabricated or duplicate patient records; failure to follow protocols; or data entry errors. He shows the variety of data integrity reports available, how to link to the report descriptions and options from JMP Clinical, and how to add reports to your analysis. He demonstrates how to view and drill into tabular and graphical data for a variety of reports including Correlated Findings to compare lab data across sites, Digit Preferences to identify possible instrument or data rounding issues, and Duplicate Records to find participants participating in more than one study.