46 Classification & Impact Assessment
46.1 Deviation Severity Levels (Typical)
| Level | Description |
|---|---|
| Minor | No impact on safety or data integrity |
| Major | Potential impact on safety or data |
| Critical | Significant risk to subject safety or data validity |
46.2 CRA Role
CRAs: - Do not determine regulatory classification alone - Verify site assessment - Escalate major/critical deviations - Document rationale
46.3 Impact Dimensions
- Subject safety
- Data integrity
- Regulatory compliance
- Study credibility