ksb-d09-k0031

name	KSB-D09-K0031
description	Post-Authorization Safety Study Protocols: EU PASS requirements, FDA post-marketing study commitments, regulatory submission standards, protoco...
version	1.0.0
domain	D09
domain_name	Post-Authorization Studies
type	Knowledge
proficiency_level	L1
bloom_level	understand
triggers	["explain post-authorization safety study protocols","what is post-authorization safety study protocols","explain post-authorization safety study protocols"]
epa_mapping	EPA-02, EPA-04, EPA-05
cpa_mapping	CPA-02, CPA-07
regulatory_refs	FDA-STAT-001, FDA-CFR-006, EMA-GVP-009

KSB-D09-K0031: Post-Authorization Safety Study Protocols

Overview

Domain: D09 - Post-Authorization Studies Type: Knowledge Proficiency Level: L1 (Novice - Direct supervision required) Bloom Level: Understand

Description

EU PASS requirements, FDA post-marketing study commitments, regulatory submission standards, protocol approval processes

Context

• Major Section: Post-Authorization Study Design Framework and Methodological Foundation
• Section: Regulatory Requirements and Guidelines Integration

EPA Mapping

• EPA-02:3004-3005
• EPA-04:3009-3010
• EPA-05:3011-3012

CPA Pathway

• CPA-02, CPA-07

Regulatory References

• FDA-STAT-001
• FDA-CFR-006
• EMA-GVP-009

Instructions

When this skill is activated, Claude should:

1. Demonstrate L1 proficiency in post-authorization safety study protocols
2. Apply understand level cognitive skills to explain the topic
3. Reference relevant regulatory guidance (FDA-STAT-001, FDA-CFR-006, EMA-GVP-009)
4. Connect to related EPAs: EPA-02, EPA-04, EPA-05

Key Competencies

• EU PASS requirements, FDA post-marketing study commitments, regulatory submission standards, protocol approval processes

Assessment Criteria

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

Related Skills

• Other D09 skills in Regulatory Requirements and Guidelines Integration
• Cross-domain integrations per DAG architecture

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