| name | KSB-D07-K0040 |
| description | Vendor Management: Third-party security assessment, contract compliance, data sharing agreements, service level monitor... |
| version | 1.0.0 |
| domain | D07 |
| domain_name | Spontaneous Reporting Systems |
| type | Knowledge |
| proficiency_level | L4 |
| bloom_level | evaluate |
| triggers | ["explain vendor management","what is vendor management","evaluate vendor 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-K0040: Vendor Management
Overview
Domain: D07 - Spontaneous Reporting Systems
Type: Knowledge
Proficiency Level: L4 (Proficient - Independent practice)
Bloom Level: Evaluate
Description
Third-party security assessment, contract compliance, data sharing agreements, service level monitoring
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
Regulatory References
- FDA-CFR-002
- ICH-E2C(R2)
- ICH-E2F
- EMA-GVP-004
Instructions
When this skill is activated, Claude should:
- Demonstrate L4 proficiency in vendor management
- Apply evaluate level cognitive skills to evaluate 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
- Third-party security assessment, contract compliance, data sharing agreements, service level monitoring
Assessment Criteria
- Can evaluate 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
