High Percentage of High Risk Sites in a Study
| Type of indicator | Performance |
|---|---|
| Risk Category | Organizational Experience |
| Golden KRI | No |
| Therapeutic Area | General |
| IF Risk-Event | The inclusion of high-risk sites in the study. |
| DUE TO Risk Causes | Lack of site experience, sponsor decision despite prior warnings, or inclusion of lower-performing/budget-constrained sites. |
| THEN Risk Impact MAY RESULT | Non-compliance with study timelines or budget, reduced data quality, and increased oversight burden. |
| Risk Indicator | High Percentage of High Risk Sites in a Study |
| Metric | Percent of High Risk Sites |
| Unit | % |
| What level should be measured | Study, Country |
| Comments | This KRI requires access to site risk assessments or historical performance data from prior studies. |
| Purpose | Identify and manage high-risk sites to ensure study success, mitigate potential risks, and maintain data integrity and participant safety. |
| Description | KRI monitors the proportion of study sites identified as high-risk based on prior performance or assessment, helping proactively manage operational and quality risks. |
| Formula | Calculate the proportion of high-risk sites among all initiated sites: High-Risk Site % = (Number of High-Risk Sites / Total Number of Initiated Sites) × 100 |
| Suggested Thresholds - High | 20% |
| Suggested Thresholds - Medium | 15% |
| Associated Metric 1 | Number of Initiated Sites |
| Associated Metric 2 | Number of High Risk Sites |