AI Documentation Standards for Regulatory Submission: Mastery of documentation requirements for AI-driven pharmacovigilance systems including model cards,...
Domain: D08 - Signal Detection & Management Type: Knowledge Proficiency Level: L4 (Proficient - Independent practice) Bloom Level: Evaluate
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.
When this skill is activated, Claude should:
Generated from PV KSB Framework v1.0 | 2025-12-31