High Percentage of IMP Supply Issues
| Type of indicator | Risk |
|---|---|
| Risk Category | IMP Supply Chain |
| Golden KRI | No |
| Therapeutic Area | General |
| IF Risk-Event | The investigational product (IMP) supply is impaired. |
| DUE TO Risk Causes | Warehouse, customs, or shipping company issues causing supply disruption. |
| THEN Risk Impact MAY RESULT | Interruption of the study or delays in study completion, potentially impacting participant treatment continuity. |
| Risk Indicator | High Percentage of IMP Supply Issues |
| Metric | Percent of Sites with IMP Supply Issues |
| Unit | % |
| What level should be measured | Study, Country |
| Purpose | Minimize the occurrence and impact of IMP supply issues on study timelines, data integrity, and subject safety by identifying delays early and taking corrective action. |
| Description | This KRI monitors the percentage of sites experiencing IMP supply issues within a defined time period, ensuring timely availability of investigational products and uninterrupted study conduct. |
| Formula | Identify sites that experienced IMP supply issues (non-availability within XXX days) during the last YYY days. The number of sites with IMP supply issues/The total number of sites X 100. |
| Suggested Thresholds - High | 4% |
| Suggested Thresholds - Medium | 2% |
| Associated Metric 1 | Number of Sites |
| Associated Metric 2 | Number of Sites with IMP Supply Issues |