Long Mean Time for Response to Queries
| Type of indicator | Performance |
|---|---|
| Risk Category | Data Collection |
| Golden KRI | NO |
| Therapeutic Area | General |
| IF Risk-Event | The site takes longer than expected to respond to data queries. |
| DUE TO Risk Causes | Lack of understanding of the queries, excessive query volume, inadequate site staffing, or competing priorities. |
| THEN Risk Impact MAY RESULT | Delays to database lock, study timelines, and potential impact on data quality. |
| Risk Indicator | Long Mean Time for Response to Queries |
| Metric | Mean number of days between query issuance and site response. |
| Unit | Days |
| What level should be measured | Study, Country, Site |
| Purpose | To assess site responsiveness to both manual and automatic queries and ensure timely resolution of data issues, preventing delays to study milestones and database lock. |
| Description | This KRI measures the mean time (in days) taken by a site to respond to data queries issued through the EDC system, whether automatically or manually generated. Prolonged response times may indicate site-level inefficiencies or resource constraints. |
| Formula | For all queries with a known open date, select those that were replied to within the past XXX days. For each selected query, calculate the number of days between the query open date and the response date (KKK days). Exclude queries open longer than YYY days if appropriate. Calculate the mean value of KKK across all included queries. |
| Suggested Thresholds - High | 15 days |
| Suggested Thresholds - Medium | 10 days |
| Associated Metric 1 | Number of Queries with Known Open and Response Dates |
| Associated Metric 2 | Number of Days Between Query Open and Response (per Query) |
| Associated Metric 3 | Mean Response Time for Queries (Days) |