| 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
Regulatory References
- FDA-STAT-001
- FDA-CFR-006
- EMA-GVP-009
Instructions
When this skill is activated, Claude should:
- Demonstrate L1 proficiency in post-authorization safety study protocols
- Apply understand level cognitive skills to explain the topic
- Reference relevant regulatory guidance (FDA-STAT-001, FDA-CFR-006, EMA-GVP-009)
- 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
Generated from PV KSB Framework v1.0 | 2025-12-31
