By name: "KSB-D05-K0002" description: "FDA Clinical Trial Regulations: 21 CFR Parts 312, 50, 56 covering IND safety reporting, informed consent, and IRB requirements..." version: "1.0.0" domain: "D05" domain_name: "Clinical Trials PV" type: "Knowledge" proficiency_level: "L1" bloom_level: "understand" triggers: - "explain fda clinical trial regulations" - "what is fda clinical trial regulations" - "explain fda clinical trial regulations" epa_mapping: "EPA-02, EPA-04, EPA-08" cpa_mapping: "CPA-01, CPA-07" regulatory_refs: "EMA-REG-004, ICH-E6"
KSB-D05-K0002: FDA Clinical Trial Regulations
Overview
Domain: D05 - Clinical Trials PV Type: Knowledge Proficiency Level: L1 (Novice - Direct supervision required) Bloom Level: Understand
Description
21 CFR Parts 312, 50, 56 covering IND safety reporting, informed consent, and IRB requirements
Context
- Major Section: Clinical Trial Regulatory Framework and Safety Requirements
- Section: International Regulatory Harmonization
EPA Mapping
- EPA-02:3004-3005
- EPA-04:3009-3010
- EPA-08:3018-3019
CPA Pathway
- CPA-01, CPA-07
Regulatory References
- EMA-REG-004
- ICH-E6
Instructions
When this skill is activated, Claude should:
- Demonstrate L1 proficiency in fda clinical trial regulations
- Apply understand level cognitive skills to explain the topic
- Reference relevant regulatory guidance (EMA-REG-004, ICH-E6)
- Connect to related EPAs: EPA-02, EPA-04, EPA-08
Key Competencies
- 21 CFR Parts 312, 50, 56 covering IND safety reporting, informed consent, and IRB requirements
Assessment Criteria
- Can explain core concepts independently
- Demonstrates understanding of regulatory context
- Applies knowledge appropriately to PV scenarios
Related Skills
- Other D05 skills in International Regulatory Harmonization
- Cross-domain integrations per DAG architecture
Generated from PV KSB Framework v1.0 | 2025-12-31