| name | KSB-D09-K0037 |
| description | Study Conduct Quality Control: Site monitoring procedures, investigator training, protocol deviation management, audit preparation ... |
| version | 1.0.0 |
| domain | D09 |
| domain_name | Post-Authorization Studies |
| type | Knowledge |
| proficiency_level | L1 |
| bloom_level | understand |
| triggers | ["explain study conduct quality control","what is study conduct quality control","explain study conduct quality control"] |
| epa_mapping | EPA-02, EPA-04, EPA-05 |
| cpa_mapping | CPA-02, CPA-07 |
| regulatory_refs | FDA-STAT-001, FDA-CFR-006, EMA-GVP-009 |
KSB-D09-K0037: Study Conduct Quality Control
Overview
Domain: D09 - Post-Authorization Studies
Type: Knowledge
Proficiency Level: L1 (Novice - Direct supervision required)
Bloom Level: Understand
Description
Site monitoring procedures, investigator training, protocol deviation management, audit preparation protocols
Context
- Major Section: Post-Authorization Study Design Framework and Methodological Foundation
- Section: Quality Management and Validation Framework
EPA Mapping
- EPA-02:3004-3005
- EPA-04:3009-3010
- EPA-05:3011-3012
CPA Pathway
Regulatory References
- FDA-STAT-001
- FDA-CFR-006
- EMA-GVP-009
Instructions
When this skill is activated, Claude should:
- Demonstrate L1 proficiency in study conduct quality control
- Apply understand level cognitive skills to explain the topic
- Reference relevant regulatory guidance (FDA-STAT-001, FDA-CFR-006, EMA-GVP-009)
- Connect to related EPAs: EPA-02, EPA-04, EPA-05
Key Competencies
- Site monitoring procedures, investigator training, protocol deviation management, audit preparation protocols
Assessment Criteria
- Can explain core concepts independently
- Demonstrates understanding of regulatory context
- Applies knowledge appropriately to PV scenarios
Related Skills
- Other D09 skills in Quality Management and Validation Framework
- Cross-domain integrations per DAG architecture
Generated from PV KSB Framework v1.0 | 2025-12-31
