Risk-Based Quality Management
ICH E6(R2) compliant centralized monitoring and KRI tracking
Overall Risk
57/100
KRI Breaches (Red)
6
KRI Warnings (Yellow)
17
Studies Monitored
4
Study Risk Overview
| Study | Risk Score | KRI Red | KRI Yellow | Signals | Issues | Trend |
|---|---|---|---|---|---|---|
BEACON-CRC Phase III ONCO-301 | 72 | 2 | 5 | 3 | 1 | ↔ stable |
SHIELD-NSCLC Phase II IMMUNO-205 | 45 | - | 3 | 1 | - | ↓ improving |
CLARITY-AD Phase III NEURO-401 | 81 | 4 | 8 | 6 | 3 | ↑ worsening |
PULSE-HF Phase II CARDIO-102 | 28 | - | 1 | - | - | ↓ improving |
Key Risk Indicators (KRI) Monitor
| KRI | Study | Threshold | Current | Status |
|---|---|---|---|---|
| Enrollment Rate | NEURO-401 | < 80% | 62% | |
| Protocol Deviations | ONCO-301 | > 5% | 7.2% | |
| Query Resolution Time | NEURO-401 | > 14 days | 18 days | |
| Data Entry Lag | ONCO-301 | > 7 days | 9 days | |
| SAE Reporting | NEURO-401 | > 24h | 28h | |
| Screen Failure Rate | IMMUNO-205 | > 30% | 25% |