| name | KSB-D08-K0033 |
| description | Validation Decision Framework: Evidence synthesis methodologies, expert committee processes, regulatory consultation procedures, de... |
| version | 1.0.0 |
| domain | D08 |
| domain_name | Signal Detection & Management |
| type | Knowledge |
| proficiency_level | L4 |
| bloom_level | evaluate |
| triggers | ["explain validation decision framework","what is validation decision framework","evaluate validation decision framework"] |
| epa_mapping | EPA-04, EPA-05 |
| cpa_mapping | CPA-02 |
| regulatory_refs | FDA-GUID-006, EMA-GVP-005, EMA-GVP-010, CIOMS-VIII |
KSB-D08-K0033: Validation Decision Framework
Overview
Domain: D08 - Signal Detection & Management
Type: Knowledge
Proficiency Level: L4 (Proficient - Independent practice)
Bloom Level: Evaluate
Description
Evidence synthesis methodologies, expert committee processes, regulatory consultation procedures, decision documentation requirements
Context
- Major Section: Signal Management Workflow and Communication Systems
- Section: Systematic Signal Management Framework
EPA Mapping
- EPA-04:3009-3010
- EPA-05:3011-3012
CPA Pathway
Regulatory References
- FDA-GUID-006
- EMA-GVP-005
- EMA-GVP-010
- CIOMS-VIII
Instructions
When this skill is activated, Claude should:
- Demonstrate L4 proficiency in validation decision framework
- Apply evaluate level cognitive skills to evaluate the topic
- Reference relevant regulatory guidance (FDA-GUID-006, EMA-GVP-005, EMA-GVP-010, CIOMS-VIII)
- Connect to related EPAs: EPA-04, EPA-05
Key Competencies
- Evidence synthesis methodologies, expert committee processes, regulatory consultation procedures, decision documentation requirements
Assessment Criteria
- Can evaluate core concepts independently
- Demonstrates understanding of regulatory context
- Applies knowledge appropriately to PV scenarios
Related Skills
- Other D08 skills in Systematic Signal Management Framework
- Cross-domain integrations per DAG architecture
Generated from PV KSB Framework v1.0 | 2025-12-31
