By name: "KSB-D04-K0025" description: "Dose-Response Relationships: Temporal patterns, rechallenge data, dose modification effects..." version: "1.0.0" domain: "D04" domain_name: "Individual Case Safety Reports" type: "Knowledge" proficiency_level: "L1" bloom_level: "understand" triggers: - "explain dose-response relationships" - "what is dose-response relationships" - "explain dose-response relationships" epa_mapping: "EPA-01, EPA-04, EPA-09" cpa_mapping: "CPA-01, CPA-04" regulatory_refs: "ICH-M1 (MedDRA), ICH-E2B(R3)"
KSB-D04-K0025: Dose-Response Relationships
Overview
Domain: D04 - Individual Case Safety Reports Type: Knowledge Proficiency Level: L1 (Novice - Direct supervision required) Bloom Level: Understand
Description
Temporal patterns, rechallenge data, dose modification effects
Context
- Major Section: Global Regulatory Requirements for ICSRs
- Section: Medical and Scientific Evaluation
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 dose-response relationships
- 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
- Temporal patterns, rechallenge data, dose modification effects
Assessment Criteria
- Can explain core concepts independently
- Demonstrates understanding of regulatory context
- Applies knowledge appropriately to PV scenarios
Related Skills
- Other D04 skills in Medical and Scientific Evaluation
- Cross-domain integrations per DAG architecture
Generated from PV KSB Framework v1.0 | 2025-12-31