High Percentage of Total Overdue Queries
| Type of indicator | Performance |
|---|---|
| Risk Category | Data Collection |
| Golden KRI | YES |
| Therapeutic Area | General |
| IF Risk-Event | Sites fail to respond to data queries within the expected timeframe |
| DUE TO Risk Causes | Lack of understanding of the query, insufficient site resources, competing priorities, or poor communication processes |
| THEN Risk Impact MAY RESULT | Delayed data cleaning, potential protocol or GCP compliance concerns, and risks to database lock and overall study timelines |
| Risk Indicator | High Percentage of Overdue Queries |
| Metric | Percent of Queries Remaining Unresolved Beyond XXX Days |
| Unit | % |
| What level should be measured | Study, Country, Site |
| Comment | Include only queries that are open at the time of assessment. |
| Purpose | Assess site responsiveness and data query management performance. A high rate of overdue queries may indicate resource constraints, training needs, or communication gaps at the site that could impact study quality or timelines. |
| Description | This KRI monitors the percentage of open queries that have not been responded to within the defined time window. It highlights potential site performance issues that require follow-up or support. |
| Formula | For all open queries, calculate the time difference between the query open date and the query response date.
Percent of Overdue Queries = (Number of Overdue Queries) / (Number of Open Queries) × 100. |
| Suggested Thresholds - High | 10% |
| Suggested Thresholds - Medium | 5% |
| Associated Metric 1 | Number of Manual Queries |
| Associated Metric 2 | Number of Automatic Queries |
| Associated Metric 3 | Days to Respond to Queries |