Risk Management
Study A Phase 3
| Risk | Mitigation | Risk Level | Logged Date |
|---|---|---|---|
| Site 101 temporarily closed due to COVID-19 | Resourced patient follow up capacity with Leapcure | Medium | 2024-03-23 |
| Belgium EC approval delay | Reallocate media | Low | 2024-09-10 |
| Screened patients (3) no longer comfortable due to COVID-19 risk | Resourced patient recruitment to targeted sites with Leapcure | High | 2024-06-09 |
Study B Phase 2
| Risk | Mitigation | Risk Level | Logged Date |
|---|---|---|---|
| COVID-19 caused four month delay average to SIV schedule | Increased resourcing of patient pre-registry | Medium | 2024-05-25 |
| Site 101 temporarily closed due to COVID-19 | Resourced patient follow up capacity with Leapcure | Medium | 2024-03-14 |
| Delayed LIRB approval from UCSF | None | Low | 2024-07-19 |
Study C Phase 2
| Risk | Mitigation | Risk Level | Logged Date |
|---|---|---|---|
| Site selection delayed due to travel restrictions | Increased site selection options and capabilities | Medium | 2024-04-30 |
| Possible manufacturing delays | Resourcing alternative source | Medium | 2024-05-22 |