Target Health Resources

Impact on Data Management of the New Definitions of Data Quality

December 1, 2016

Data Services



Risk-based approaches to monitoring (RBM) in clinical research1, 2, characterized by more cerebral operations with focus on critical processes and data components, are growing in popularity. Concurrently, these approaches are being accompanied by a dramatic reduction in manual data review and an increased reliance on sophisticated centralized procedures including data validation, data surveillance, and medical/clinical review. These new paradigms are radically decreasing the need for source document verification (SDV), especially for larger studies3. As a result, there is a requirement for more intelligent and sophisticated approaches to Data Management (DM) operations. How these evolutionary risk-based changes will impact daily DM operations is the topic of this report. Furthermore, this report focuses solely on aspects of DM operations that are undergoing changes, disregarding other components such as case report form designs, even if they have a noticeable impact on quality.

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