High Percentage of Missing Outcomes/Endpoints
| Type of indicator | Performance |
|---|---|
| Risk Category | Study Endpoints |
| Golden KRI | YES |
| Therapeutic Area | General |
| IF Risk-Event | A high proportion of outcome/endpoint data is missing |
| DUE TO Risk Causes | Missed assessments, delayed data entry, data capture/system issues, or protocol non-adherence |
| THEN Risk Impact MAY RESULT | Inconclusive study outcomes and reduced ability to assess investigational product efficacy |
| Risk Indicator | High Percentage of Missing Outcomes/Endpoints |
| Metric | Percent of Missing Outcomes/Endpoints |
| Unit | % |
| What level should be measured | Study, Country, Site |
| Purpose | Primary (or key secondary) outcome data are essential to determine investigational product efficacy. If too much of this critical data is missing, it may be impossible to draw valid conclusions, wasting time and resources and needlessly exposing subjects to risk. This KRI highlights missing data but does not distinguish between unavailable and not-yet-entered data—follow-up is required. |
| Description | This KRI monitors the proportion of missing outcome/endpoint data and triggers an alert when the rate exceeds expected thresholds. |
| Comments | Consider only scheduled visits. Exclude AE, CM, ET and other irregular forms expectations OR consider specific expectations criterias. |
| Formula | (Number of Empty eCRF Outcome Fields) / (Number of Empty eCRF Outcome Fields + Number of Complete eCRF Outcome Fields) × 100. Include only outcome fields as defined in Study settings → Study Protocol (Study Outcomes file) or in Metadata files. |
| Suggested Thresholds - High | 5% |
| Suggested Thresholds - Medium | 3% |
| Associated Metric 1 | Number of Empty eCRF Fields (Mandatory, Outcome) |
| Associated Metric 2 | Number of Complete eCRF Fields (Mandatory, Outcome) |