High Percentage of Overdue Monitoring eCRF Pages
| Type of indicator | Performance |
|---|---|
| Risk Category | Data Collection |
| Golden KRI | YES |
| Therapeutic Area | General |
| IF Risk-Event | eCRFs are not monitored regularly according to plan |
| DUE TO Risk Causes | Insufficient monitoring resources, competing priorities, or process inefficiencies |
| THEN Risk Impact MAY RESULT | Delays in database lock and overall study timelines due to unmonitored eCRF pages |
| Risk Indicator | High Percentage of eCRF Pages Overdue for Monitoring |
| Metric | Percent of eCRF Pages Unmonitored Within XXX Days |
| Unit | % |
| What level should be measured | Study, Country, Site |
| Purpose | Identify studies, countries, or sites where eCRF pages remain unmonitored beyond the defined timeframe. This enables proactive action to ensure timely monitoring, prompt query resolution, and data consistency. |
| Description | This KRI monitors the proportion of eCRF pages that remain unmonitored beyond the expected monitoring window (XXX days) after the last data entry or query resolution. It highlights potential bottlenecks in data review and monitoring processes. |
| Formula | Identify each CRF form (page) that exceeds the monitoring threshold:
If the number of days exceeds XXX (study specific parameter), mark the form as overdue. Percent of overdue CRFs = (Number of Overdue CRF Pages) / (Total Number of CRF Pages) × 100. |
| Suggested Thresholds - High | 15% |
| Suggested Thresholds - Medium | 10% |
| Associated Metric 1 | Number of Overdue CRF Pages |
| Associated Metric 2 | Total Number of CRF Pages |