Capture and report adverse events
How capture and report adverse events are reshaped as AGI capability advances.
Business-as-Code
Read as an executable program — the work decomposed into Code, Generative, Agentic, and Human.
Capture and report adverse events sits inside a larger value-flow — 1 parent structure it composes into. The hierarchy is grounding, not the story: it tells you which aggregate exposure Capture and report adverse events inherits.
Where Capture and report adverse events sits
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How the work flows
Trigger: A patient, healthcare provider, or clinical site reports a negative side effect or health issue associated with a specific product.
- Receive and log the initial adverse event report
- Triage the event to determine severity and reporting timelines
- Enter case data and apply standard medical coding
- Request follow-up information to complete the clinical picture
- Perform medical review and causality assessment
- Submit the safety report to regulatory health authorities
- Archive the case and update aggregate safety databases
Outcome: The adverse event is medically evaluated, codified, and submitted to the relevant regulatory authorities within mandated legal timeframes.