AI in Pharmacovigilance: Systems, Agents & Governance
Module Assessment
6 questions covering the whole module, mixing recall with applied scenarios. Answer everything, then submit — you’ll see your score and every explanation at once. Pass threshold: 70%. Retake as many times as you like.
RecallQuestion 1
Why does it matter to distinguish rule-based automation from machine learning, beyond terminology precision?
ScenarioQuestion 2
What is the single most important distinction to make about agentic AI in production PV systems?
RecallQuestion 3
What is the status of the CIOMS WG XIV report, and why does that status matter?
CritiqueQuestion 4
A company’s vendor contract states the AI platform vendor is "responsible for all safety decisions made using its coding suggestions." Under CIOMS WG XIV’s Accountability principle, is this valid?
ScenarioQuestion 5
A workflow has AI process a case and take action automatically, with a human reviewing a summary report at the end of each week. What HITL level is this, and is it compliant for case processing?
RecallQuestion 6
Why does genuine HITL review require the source document and AI-extracted fields to be shown side by side, rather than the extraction alone?