ksb-d04-k0008

name	KSB-D04-K0008
description	Non-Expedited Reporting: Periodic safety update reports and aggregate data submission...
version	1.0.0
domain	D04
domain_name	Individual Case Safety Reports
type	Knowledge
proficiency_level	L1
bloom_level	understand
triggers	["explain non-expedited reporting","what is non-expedited reporting","explain non-expedited reporting"]
epa_mapping	EPA-01, EPA-04, EPA-09
cpa_mapping	CPA-01, CPA-04
regulatory_refs	ICH-M1 (MedDRA), ICH-E2B(R3)

KSB-D04-K0008: Non-Expedited Reporting

Overview

Domain: D04 - Individual Case Safety Reports Type: Knowledge Proficiency Level: L1 (Novice - Direct supervision required) Bloom Level: Understand

Description

Periodic safety update reports and aggregate data submission

Context

• Major Section: Global Regulatory Requirements for ICSRs
• Section: Expedited Reporting Requirements

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 L1 proficiency in non-expedited reporting
2. Apply understand level cognitive skills to explain 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

• Periodic safety update reports and aggregate data submission

Assessment Criteria

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

Related Skills

• Other D04 skills in Expedited Reporting Requirements
• Cross-domain integrations per DAG architecture

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