ksb-d05-k0002

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:

1. Demonstrate L1 proficiency in fda clinical trial regulations
2. Apply understand level cognitive skills to explain the topic
3. Reference relevant regulatory guidance (EMA-REG-004, ICH-E6)
4. 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

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Generated from PV KSB Framework v1.0 | 2025-12-31