Richard C. Zink, Principal Research Statistician Developer, SAS richard.zink
Guidelines from the International Conference on Harmonisation (ICH) suggest that clinical trial data should be actively monitored to ensure data quality. Traditional interpretation of this guidance has often led to 100 percent source data verification (SDV) of respective case report forms through on-site monitoring. Such monitoring activities can also identify deficiencies in site training and uncover fraudulent behavior. However, such extensive on-site review is time-consuming, expensive and, as is true for any manual effort, limited in scope and prone to error. In contrast, risk-based monitoring (RBM) makes use of central computerized review of clinical trial data and site metrics to determine if sites should receive more extensive quality review through on-site monitoring visits. I will demonstrate the RBM dashboard and review capabilities available within JMP Clinical to assess clinical trial data quality. Further, I describe a suite of tools useful for identifying potentially fraudulent data at clinical sites. Data from a clinical trial of patients who experienced an neurysmal subarachnoid hemorrhage will provide illustration.