By name: "KSB-D07-K0038" description: "Audit Trail Management: User activity logging, data modification tracking, access monitoring, compliance reporting..." version: "1.0.0" domain: "D07" domain_name: "Spontaneous Reporting Systems" type: "Knowledge" proficiency_level: "L1" bloom_level: "apply" triggers: - "explain audit trail management" - "what is audit trail management" - "apply audit trail management" epa_mapping: "EPA-02, EPA-04, EPA-05" cpa_mapping: "CPA-02, CPA-05" regulatory_refs: "FDA-CFR-002, ICH-E2C(R2), ICH-E2F, EMA-GVP-004"
KSB-D07-K0038: Audit Trail Management
Overview
Domain: D07 - Spontaneous Reporting Systems Type: Knowledge Proficiency Level: L1 (Novice - Direct supervision required) Bloom Level: Apply
Description
User activity logging, data modification tracking, access monitoring, compliance reporting
Context
- Major Section: Global Spontaneous Reporting System Architecture
- Section: Privacy and Security Framework Implementation
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:
- Demonstrate L1 proficiency in audit trail management
- Apply apply level cognitive skills to apply the topic
- Reference relevant regulatory guidance (FDA-CFR-002, ICH-E2C(R2), ICH-E2F, EMA-GVP-004)
- Connect to related EPAs: EPA-02, EPA-04, EPA-05
Key Competencies
- User activity logging, data modification tracking, access monitoring, compliance reporting
Assessment Criteria
- Can apply core concepts independently
- Demonstrates understanding of regulatory context
- Applies knowledge appropriately to PV scenarios
Related Skills
- Other D07 skills in Privacy and Security Framework Implementation
- Cross-domain integrations per DAG architecture
Generated from PV KSB Framework v1.0 | 2025-12-31