33  Safety Oversight Workflows

33.1 End-to-End Safety Oversight Workflow

flowchart LR
  A[Event Occurs] --> B[Investigator Assessment]
  B --> C[AE/SAE Documentation]
  C --> D[Sponsor Safety Review]
  D --> E[Follow-Up Information]
  E --> F[CRA Verification]
  F --> G[TMF / Site Binder Filing]

33.2 CRA Safety Workflow (Visit-Level)

• Review AE/SAE listings
• Cross-check against source documentation
• Identify missing or late reports
• Request follow-up documentation
• Document actions in visit report