Risk-Based Data Monitoring
Table 1
Table
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Table 1
Table
Table 1
| Risk | Impact | Indicator | Control |
|---|---|---|---|
| Missing primary outcome | High | Primary outcome missing rate | Weekly report and rapid query escalation |
| Under-reported adverse events | High | Site AE rate compared with similar sites | Central trend review and site retraining |
| Eligibility errors | High | Eligibility violations detected | Pre-enrollment checklist and source verification |
| Delayed data entry | Medium | Entry lag over 72 hours | Site performance report and coordinator follow-up |
| Duplicate participants | Medium | Duplicate ID or demographic match | Duplicate check and site confirmation |
| Inconsistent laboratory units | High | Outlier lab values by site | Validation ranges and lab reconciliation |