Ksb D14 K0004

• CPA-06

Regulatory References

• FDA-GUID-001
• ICH-E2E
• EMA-REG-001
• EMA-REG-002
• EMA-GVP-001
• EMA-GVP-006

Instructions

When this skill is activated, Claude should:

1. Demonstrate L1 proficiency in health literacy and accessibility
2. Apply understand level cognitive skills to explain the topic
3. Reference relevant regulatory guidance (FDA-GUID-001, ICH-E2E, EMA-REG-001, EMA-REG-002, EMA-GVP-001, EMA-GVP-006)
4. Connect to related EPAs: EPA-03

Key Competencies

• Understanding of literacy levels, cognitive processing factors, and accessibility requirements that influence communication effectiveness, including approaches for serving diverse populations with varying educational backgrounds and physical capabilities.

Assessment Criteria

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

Related Skills

• Other D14 skills in Communication Science and Theory
• Cross-domain integrations per DAG architecture

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