By name: "KSB-D04-K0007" description: "7-Day Fatal/Life-Threatening: Urgent reporting requirements for the most serious events..." version: "1.0.0" domain: "D04" domain_name: "Individual Case Safety Reports" type: "Knowledge" proficiency_level: "L1" bloom_level: "understand" triggers: - "explain 7-day fatal/life-threatening" - "what is 7-day fatal/life-threatening" - "explain 7-day fatal/life-threatening" epa_mapping: "EPA-01, EPA-04, EPA-09" cpa_mapping: "CPA-01, CPA-04" regulatory_refs: "ICH-M1 (MedDRA), ICH-E2B(R3)"
KSB-D04-K0007: 7-Day Fatal/Life-Threatening
Overview
Domain: D04 - Individual Case Safety Reports Type: Knowledge Proficiency Level: L1 (Novice - Direct supervision required) Bloom Level: Understand
Description
Urgent reporting requirements for the most serious events
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:
- Demonstrate L1 proficiency in 7-day fatal/life-threatening
- Apply understand level cognitive skills to explain the topic
- Reference relevant regulatory guidance (ICH-M1 (MedDRA), ICH-E2B(R3))
- Connect to related EPAs: EPA-01, EPA-04, EPA-09
Key Competencies
- Urgent reporting requirements for the most serious events
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
Generated from PV KSB Framework v1.0 | 2025-12-31