By name: "KSB-D05-K0016" description: "Protocol Safety Design: Primary safety endpoints, stopping rules, dose modification protocols, safety run-in periods..." version: "1.0.0" domain: "D05" domain_name: "Clinical Trials PV" type: "Knowledge" proficiency_level: "L3" bloom_level: "apply" triggers: - "explain protocol safety design" - "what is protocol safety design" - "apply protocol safety design" epa_mapping: "EPA-02, EPA-04, EPA-08" cpa_mapping: "CPA-01, CPA-07" regulatory_refs: "EMA-REG-004, ICH-E6"
KSB-D05-K0016: Protocol Safety Design
Overview
Domain: D05 - Clinical Trials PV Type: Knowledge Proficiency Level: L3 (Competent - Minimal supervision) Bloom Level: Apply
Description
Primary safety endpoints, stopping rules, dose modification protocols, safety run-in periods
Context
- Major Section: Clinical Trial Regulatory Framework and Safety Requirements
- Section: Comprehensive Safety Planning Framework
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:
- Demonstrate L3 proficiency in protocol safety design
- Apply apply level cognitive skills to apply the topic
- Reference relevant regulatory guidance (EMA-REG-004, ICH-E6)
- Connect to related EPAs: EPA-02, EPA-04, EPA-08
Key Competencies
- Primary safety endpoints, stopping rules, dose modification protocols, safety run-in periods
Assessment Criteria
- Can apply core concepts independently
- Demonstrates understanding of regulatory context
- Applies knowledge appropriately to PV scenarios
Related Skills
- Other D05 skills in Comprehensive Safety Planning Framework
- Cross-domain integrations per DAG architecture
Generated from PV KSB Framework v1.0 | 2025-12-31