Discrepancy b/w Locals and Central Labs Data
| Type of indicator | Risk |
|---|---|
| Risk Category | Operational Complexity |
| Golden KRI | NO |
| Therapeutic Area | General |
| IF Risk-Event | Discrepancies are observed between local and central laboratory test results. |
| DUE TO Risk Causes | Parallel use of local and central laboratories for identical measurements, differences in testing methods, equipment calibration, or sample handling procedures. |
| THEN Risk Impact MAY RESULT | Inconsistent laboratory data leading to difficulties in interpreting results, potential misclassification of findings, and risks to subject safety or reliability of study conclusions. |
| Risk Indicator | Discrepancy Between Local and Central Labs Data |
| Metric | Percent of Discrepancies Between Local and Central Lab Data |
| Unit | % |
| What level should be measured | Study, Country, Site |
| Purpose | Ensure consistency, accuracy, and reliability of laboratory results by monitoring and analyzing discrepancies between local and central lab data. Supports data integrity and reliable clinical interpretations. |
| Description | This KRI monitors discrepancies between values obtained from local and central laboratories for identical parameters. It helps identify potential issues in data consistency, analytical methods, or sample handling across labs. |
| Formula | Identify all data points analyzed by both local and central laboratories. Determine the number of data points where the comparison between the two results failed (discrepant results). Percent Discrepancy = (Number of Discrepant Data Points / Total Number of Data Points Compared) × 100. |
| Suggested Thresholds - High | 10% |
| Suggested Thresholds - Medium | 5% |
| Associated Metric 1 | Number of Data Points Compared |
| Associated Metric 2 | Number of Data Points with Discrepancies Between Local and Central Labs |