30  Safety Framework & Roles

30.1 What “Safety Oversight” Means for a CRA

CRAs do not perform medical assessment, but they: - Verify safety processes are followed - Confirm documentation supports reported events - Escalate incomplete, late, or inconsistent reporting

30.2 Roles (Simplified)

Role	Primary Responsibility
Investigator	Medical assessment and reporting of AEs/SAEs
Sponsor/CRO Safety	Regulatory reporting and aggregate analysis
CRA	Oversight, verification, and follow-up documentation

30.3 Inspection Reality

Inspectors will not ask CRAs to judge medical causality, but will ask whether safety processes were followed and documented.