High Percentage of Incorrect Subject Randomization
| Type of indicator | Risk |
|---|---|
| Risk Category | Technology |
| Golden KRI | No |
| Therapeutic Area | General |
| IF Risk-Event | Improper randomization of subjects occurs through the IWRS/IXRS/IRT system. |
| DUE TO Risk Causes | User error during data entry, system malfunction, or configuration issue in the system. |
| THEN Risk Impact MAY RESULT | Potential rejection of study results by health authorities or compromised study validity. |
| Risk Indicator | High Percentage of Incorrect Subject Randomization |
| Metric | Percent of incorrectly randomized subjects |
| Unit | % |
| What level should be measured | Study, Country, Site |
| Comments | This KRI requires detailed data from randomization logs or protocol deviation records to confirm incorrect randomization. Detection may be limited to post-database lock review in blinded trials. |
| Purpose | Ensure the accuracy and reliability of subject randomization processes, safeguarding the integrity of trial data and compliance with regulatory expectations. |
| Description | This KRI monitors the frequency of incorrect subject randomization events, identifying potential errors in system configuration or user input that could affect trial validity. |
| Formula | Identify all subjects with randomization errors (via protocol deviations, randomization cross-checks, or the system logs). The number of incorrectly randomized subjects/The total number of randomized subjects X 100. |
| Suggested Thresholds - High | 2% |
| Suggested Thresholds - Medium | 0% |
| Associated Metric 1 | Number of Randomized Subjects |
| Associated Metric 2 | Number of Subjects with Randomization Errors |