| name | KSB-D03-K0002 |
| description | Cholestatic Injury: Bile flow impairment presentations, laboratory findings, progression patterns... |
| version | 1.0.0 |
| domain | D03 |
| domain_name | Important ADRs Recognition |
| type | Knowledge |
| proficiency_level | L1 |
| bloom_level | understand |
| triggers | ["explain cholestatic injury","what is cholestatic injury","explain cholestatic injury"] |
| epa_mapping | EPA-01, EPA-02, EPA-05 |
| cpa_mapping | CPA-01, CPA-02 |
| regulatory_refs | ICH-E2A, EMA-GVP-014, EMA-GVP-015 |
KSB-D03-K0002: Cholestatic Injury
Overview
Domain: D03 - Important ADRs Recognition
Type: Knowledge
Proficiency Level: L1 (Novice - Direct supervision required)
Bloom Level: Understand
Description
Bile flow impairment presentations, laboratory findings, progression patterns
Context
- Major Section: Organ System-Specific ADR Patterns
- Section: Hepatotoxicity Recognition and Assessment
EPA Mapping
- EPA-01:3001-3003
- EPA-02:3004-3005
- EPA-05:3011-3012
CPA Pathway
Regulatory References
- ICH-E2A
- EMA-GVP-014
- EMA-GVP-015
Instructions
When this skill is activated, Claude should:
- Demonstrate L1 proficiency in cholestatic injury
- Apply understand level cognitive skills to explain the topic
- Reference relevant regulatory guidance (ICH-E2A, EMA-GVP-014, EMA-GVP-015)
- Connect to related EPAs: EPA-01, EPA-02, EPA-05
Key Competencies
- Bile flow impairment presentations, laboratory findings, progression patterns
Assessment Criteria
- Can explain core concepts independently
- Demonstrates understanding of regulatory context
- Applies knowledge appropriately to PV scenarios
Related Skills
- Other D03 skills in Hepatotoxicity Recognition and Assessment
- Cross-domain integrations per DAG architecture
Generated from PV KSB Framework v1.0 | 2025-12-31
