| name | KSB-D08-K0045 |
| description | AI Credibility Evidence Structure: Mastery of FDA AI/ML credibility evidence framework including model verification (code accuracy, mat... |
| version | 1.0.0 |
| domain | D08 |
| domain_name | Signal Detection & Management |
| type | Knowledge |
| proficiency_level | L4 |
| bloom_level | evaluate |
| triggers | ["explain ai credibility evidence structure","what is ai credibility evidence structure","evaluate ai credibility evidence structure"] |
| epa_mapping | EPA-04, EPA-05 |
| cpa_mapping | CPA-02 |
| regulatory_refs | |
KSB-D08-K0045: AI Credibility Evidence Structure
Overview
Domain: D08 - Signal Detection & Management
Type: Knowledge
Proficiency Level: L4 (Proficient - Independent practice)
Bloom Level: Evaluate
Description
Mastery of FDA AI/ML credibility evidence framework including model verification (code accuracy, mathematical correctness), validation (fitness for intended use), and applicability assessment (relevance to real-world conditions). Understanding of credibility evidence structure with context of use specification, verification activities, validation against reference data, and uncertainty quantification. Knowledge of iterative credibility assessment throughout AI lifecycle and documentation requirements for regulatory submissions.
Context
- Major Section: AI Credibility and Validation
- Section: Credibility Evidence Framework
EPA Mapping
- EPA-04:3009-3010
- EPA-05:3011-3012
CPA Pathway
Regulatory References
Instructions
When this skill is activated, Claude should:
- Demonstrate L4 proficiency in ai credibility evidence structure
- Apply evaluate level cognitive skills to evaluate the topic
- Reference relevant regulatory guidance (general PV standards)
- Connect to related EPAs: EPA-04, EPA-05
Key Competencies
- Mastery of FDA AI/ML credibility evidence framework including model verification (code accuracy, mathematical correctness), validation (fitness for intended use), and applicability assessment (relevance to real-world conditions). Understanding of credibility evidence structure with context of use specification, verification activities, validation against reference data, and uncertainty quantification. Knowledge of iterative credibility assessment throughout AI lifecycle and documentation requirements for regulatory submissions.
Assessment Criteria
- Can evaluate core concepts independently
- Demonstrates understanding of regulatory context
- Applies knowledge appropriately to PV scenarios
Related Skills
- Other D08 skills in Credibility Evidence Framework
- Cross-domain integrations per DAG architecture
Generated from PV KSB Framework v1.0 | 2025-12-31
