ksb-d08-k0050

name: "KSB-D08-K0050" description: "AI Documentation Standards for Regulatory Submission: Mastery of documentation requirements for AI-driven pharmacovigilance systems including model cards,..." version: "1.0.0" domain: "D08" domain_name: "Signal Detection & Management" type: "Knowledge" proficiency_level: "L4" bloom_level: "evaluate" triggers: - "explain ai documentation standards for regulatory submission" - "what is ai documentation standards for regulatory submission" - "evaluate ai documentation standards for regulatory submission" epa_mapping: "EPA-04, EPA-05" cpa_mapping: "CPA-02" regulatory_refs: ""

KSB-D08-K0050: AI Documentation Standards for Regulatory Submission

Overview

Domain: D08 - Signal Detection & Management Type: Knowledge Proficiency Level: L4 (Proficient - Independent practice) Bloom Level: Evaluate

Description

Mastery of documentation requirements for AI-driven pharmacovigilance systems including model cards, datasheets for datasets, algorithm description standards, validation documentation, performance monitoring reports, and change control records. Understanding of CIOMS WG XIV documentation expectations and alignment with FDA/EMA submission requirements for AI-enabled processes.

Context

• Major Section: AI Integration and Advanced Analytics
• Section: AI Transparency and Explainability

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:

1. Demonstrate L4 proficiency in ai documentation standards for regulatory submission
2. Apply evaluate level cognitive skills to evaluate the topic
3. Reference relevant regulatory guidance (general PV standards)
4. Connect to related EPAs: EPA-04, EPA-05

Key Competencies

• Mastery of documentation requirements for AI-driven pharmacovigilance systems including model cards, datasheets for datasets, algorithm description standards, validation documentation, performance monitoring reports, and change control records. Understanding of CIOMS WG XIV documentation expectations and alignment with FDA/EMA submission requirements for AI-enabled processes.

Assessment Criteria

• Can evaluate core concepts independently
• Demonstrates understanding of regulatory context
• Applies knowledge appropriately to PV scenarios

Related Skills

• Other D08 skills in AI Transparency and Explainability
• Cross-domain integrations per DAG architecture

Generated from PV KSB Framework v1.0 | 2025-12-31