Real-time RBQM requires proportionate analysis frequency matched to data arrival and issue criticality, not continuous reanalysis, because signal churn from over-frequent runs creates alert fatigue and operational noise that obscures meaningful deterioration.
Real-time data are increasingly presented as essential for clinical trial oversight. In risk-based quality management (RBQM), centralized analyses examine accumulating trial data to identify patterns that may represent potential quality or safety issues and require human review. In this context, real time can mean continuously rerunning analyses as data arrive, or ensuring that reviewers see the latest available data when assessing a potential issue. Confusing the two can create more activity without improving oversight.
