---
name: thomasmoreai/ksb-d07-k0033
source: https://app.decimal.ai/s/thomasmoreai-ksb-d07-k0033@1/SKILL.md
source_sha256: 5afe0893e756
---

# KSB-D07-K0033: Policy Interpretation

## Overview
**Domain:** D07 - Spontaneous Reporting Systems
**Type:** Knowledge
**Proficiency Level:** L1 (Novice - Direct supervision required)
**Bloom Level:** Understand

## Description
Guidance document analysis, regulatory precedent evaluation, interpretation consistency, implementation planning

## Context
- **Major Section:** Global Spontaneous Reporting System Architecture
- **Section:** Global Regulatory Framework Navigation

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

## CPA Pathway
- CPA-02, CPA-05

## Regulatory References
- FDA-CFR-002
- ICH-E2C(R2)
- ICH-E2F
- EMA-GVP-004

## Instructions

When this skill is activated, Claude should:

1. **Demonstrate L1 proficiency** in policy interpretation
2. **Apply understand level** cognitive skills to explain the topic
3. **Reference** relevant regulatory guidance (FDA-CFR-002, ICH-E2C(R2), ICH-E2F, EMA-GVP-004)
4. **Connect** to related EPAs: EPA-02, EPA-04, EPA-05

### Key Competencies
- Guidance document analysis, regulatory precedent evaluation, interpretation consistency, implementation planning

### Assessment Criteria
- Can explain core concepts independently
- Demonstrates understanding of regulatory context
- Applies knowledge appropriately to PV scenarios

## Related Skills
- Other D07 skills in Global Regulatory Framework Navigation
- Cross-domain integrations per DAG architecture

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