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Adverse Event Reporting

Adverse event identification, documentation, and regulatory reporting

Complexity: Complex | Duration: 30m+ | Category: Industry/Healthcare

Tags: adverse-event safety pharmacovigilance healthcare

Workflow Diagram​

Steps​

Step 1: Identify event​

Agent: clinical

specialist - Recognize adverse event

Step 2: Document details​

Agent: safety

officer - Record event specifics

Step 3: Assess severity​

Agent: safety

officer - Grade event severity

Step 4: Determine causality​

Agent: clinical

specialist - Evaluate relationship

Step 5: Notify stakeholders​

Agent: safety

officer - Alert leadership and sponsors

Step 6: Submit reports​

Agent: compliance

auditor - File with FDA/IRB as required

Step 7: Implement corrective action​

Agent: safety

officer - Address root cause

Step 8: Follow​

Agent: up

safety-officer - Monitor patient and process

Usage​

To execute this workflow:

/workflow industry/healthcare/adverse-event-reporting.workflow

See other workflows in this category for related automation patterns.