Delay in IP availability for Subject treatment
| Type of indicator | Risk |
|---|---|
| Risk Category | IMP Supply Chain |
| Golden KRI | NO |
| Therapeutic Area | General |
| IF Risk-Event | The Investigational Product (IP) is not available on time for subject treatment or resupply. |
| DUE TO Risk Causes | Manufacturing delays, customs clearance issues, product expiry, late ordering, or other supply chain disruptions. |
| THEN Risk Impact MAY RESULT | Delays in enrollment, interruptions to subject treatment, protocol deviations, and increased subject dropouts due to lack of IP availability. |
| Risk Indicator | Delay in IP Availability for Subject Treatment |
| Metric | Number of days between planned and actual IP availability for subject resupply. |
| Unit | Days |
| What level should be measured | Subject, Site, Country |
| Purpose | Ensure continuous IP availability to maintain subject treatment schedules and prevent protocol deviations or subject withdrawal due to treatment interruptions. |
| Description | This KRI monitors delays in providing Investigational Product (IP) for scheduled subject treatments. It triggers an alert when the actual IP delivery date significantly exceeds the planned availability date, potentially impacting study continuity and subject safety. |
| Formula | Calculate the number of days between the planned IP availability date and the actual date the IP is received at the site. Delay (Days) = Actual IP Availability Date − Planned IP Availability Date |
| Suggested Thresholds - High | 5 days |
| Suggested Thresholds - Medium | 2 days |
| Associated Metric 1 | Planned IP Availability Date |
| Associated Metric 2 | Actual IP Availability Date |