High Percentage of Screen Failures
| Type of indicator | Risk |
|---|---|
| Risk Category | Subject Population |
| Golden KRI | YES |
| Therapeutic Area | General |
| IF Risk-Event | Higher than expected screen failure rate |
| DUE TO Risk Causes | Complex inclusion/exclusion criteria, incorrect application of screening criteria, or poor pre-screening practices |
| THEN Risk Impact MAY RESULT | Inability to enroll the required number of participants, extended study duration, or the need for additional sites and increased costs |
| Risk Indicator | High Percentage of Screen Failures |
| Metric | Percent of Screen Failures |
| Unit | % |
| What level should be measured | Study, Country, Site |
| Purpose | This KRI helps detect potential site-level screening issues, such as selection of ineligible participants or incorrect application of screening criteria. At the study level, it highlights a risk of higher-than-expected screen failure rates, which could lead to extended enrollment timelines or the need for additional sites. |
| Description | This KRI monitors the rate of screen failures in a study and triggers an alert when the percentage exceeds expected thresholds. |
| Formula | (Number of Screen Failures) / (Number of Screened Subjects) × 100. Use values from the same date and exclude subjects who have started but not yet completed screening (screening process had been started but had not been finished). |
| Suggested Thresholds - High | 20% |
| Suggested Thresholds - Medium | 10% |
| Associated Metric 1 | Number of Screen Failures |
| Associated Metric 2 | Number of Screened Subjects |