32  Causality, Severity & Expectedness

32.1 Key Concepts (CRA Lens)

32.1.1 Causality

Relationship between study intervention and event.

32.1.2 Severity

Intensity of the event (e.g., mild, moderate, severe).

32.1.3 Expectedness

Whether the event is described in protocol/IB/product label.

32.2 CRA Role

CRAs: - Do not determine medical causality - Verify that causality/severity fields are completed - Ensure consistency between source, SAE forms, and EDC

32.3 Common CRA Findings

• Missing severity grading
• Inconsistent causality across documents
• Expected events not documented because “they were expected”