By name: "KSB-D08-K0045" description: "Human-in-the-Loop (HITL) Requirements: Comprehensive understanding of human-in-the-loop requirements for AI-driven pharmacovigilance includ..." version: "1.0.0" domain: "D08" domain_name: "Signal Detection & Management" type: "Knowledge" proficiency_level: "L3" bloom_level: "apply" triggers: - "explain human-in-the-loop (hitl) requirements" - "what is human-in-the-loop (hitl) requirements" - "apply human-in-the-loop (hitl) requirements" epa_mapping: "EPA-04, EPA-05" cpa_mapping: "CPA-02" regulatory_refs: ""
KSB-D08-K0045: Human-in-the-Loop (HITL) Requirements
Overview
Domain: D08 - Signal Detection & Management Type: Knowledge Proficiency Level: L3 (Competent - Minimal supervision) Bloom Level: Apply
Description
Comprehensive understanding of human-in-the-loop requirements for AI-driven pharmacovigilance including CIOMS WG XIV oversight principles, levels of automation requiring human review, critical decision points mandating human judgment, and regulatory expectations for maintaining human control over safety-critical AI outputs. Includes knowledge of HITL design patterns: human-on-the-loop (monitoring), human-in-the-loop (approval), and human-in-command (override) configurations.
Context
- Major Section: AI Integration and Advanced Analytics
- Section: Human Oversight in AI-Driven Signal Detection
EPA Mapping
- EPA-04:3009-3010
- EPA-05:3011-3012
CPA Pathway
- CPA-02
Regulatory References
- General PV competency
Instructions
When this skill is activated, Claude should:
- Demonstrate L3 proficiency in human-in-the-loop (hitl) requirements
- Apply apply level cognitive skills to apply the topic
- Reference relevant regulatory guidance (general PV standards)
- Connect to related EPAs: EPA-04, EPA-05
Key Competencies
- Comprehensive understanding of human-in-the-loop requirements for AI-driven pharmacovigilance including CIOMS WG XIV oversight principles, levels of automation requiring human review, critical decision points mandating human judgment, and regulatory expectations for maintaining human control over safety-critical AI outputs. Includes knowledge of HITL design patterns: human-on-the-loop (monitoring), human-in-the-loop (approval), and human-in-command (override) configurations.
Assessment Criteria
- Can apply core concepts independently
- Demonstrates understanding of regulatory context
- Applies knowledge appropriately to PV scenarios
Related Skills
- Other D08 skills in Human Oversight in AI-Driven Signal Detection
- Cross-domain integrations per DAG architecture
Generated from PV KSB Framework v1.0 | 2025-12-31