ksb-d04-k0011

name	KSB-D04-K0011
description	Core Data Sheet Requirements: Minimum essential information for valid case reports...
version	1.0.0
domain	D04
domain_name	Individual Case Safety Reports
type	Knowledge
proficiency_level	L3
bloom_level	apply
triggers	["explain core data sheet requirements","what is core data sheet requirements","apply core data sheet requirements"]
epa_mapping	EPA-01, EPA-04, EPA-09
cpa_mapping	CPA-01, CPA-04
regulatory_refs	ICH-M1 (MedDRA), ICH-E2B(R3)

KSB-D04-K0011: Core Data Sheet Requirements

Overview

Domain: D04 - Individual Case Safety Reports Type: Knowledge Proficiency Level: L3 (Competent - Minimal supervision) Bloom Level: Apply

Description

Minimum essential information for valid case reports

Context

• Major Section: Global Regulatory Requirements for ICSRs
• Section: Data Quality and Completeness Standards

EPA Mapping

• EPA-01:3001-3003
• EPA-04:3009-3010
• EPA-09:3020-3022

CPA Pathway

• CPA-01, CPA-04

Regulatory References

• ICH-M1 (MedDRA)
• ICH-E2B(R3)

Instructions

When this skill is activated, Claude should:

1. Demonstrate L3 proficiency in core data sheet requirements
2. Apply apply level cognitive skills to apply the topic
3. Reference relevant regulatory guidance (ICH-M1 (MedDRA), ICH-E2B(R3))
4. Connect to related EPAs: EPA-01, EPA-04, EPA-09

Key Competencies

• Minimum essential information for valid case reports

Assessment Criteria

• Can apply core concepts independently
• Demonstrates understanding of regulatory context
• Applies knowledge appropriately to PV scenarios

Related Skills

• Other D04 skills in Data Quality and Completeness Standards
• Cross-domain integrations per DAG architecture

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