ksb-d05-k0018

name: "KSB-D05-K0018" description: "Emergency Procedures: Unblinding protocols, medical emergency response, serious adverse event management..." version: "1.0.0" domain: "D05" domain_name: "Clinical Trials PV" type: "Knowledge" proficiency_level: "L1" bloom_level: "understand" triggers: - "explain emergency procedures" - "what is emergency procedures" - "explain emergency procedures" epa_mapping: "EPA-02, EPA-04, EPA-08" cpa_mapping: "CPA-01, CPA-07" regulatory_refs: "EMA-REG-004, ICH-E6"

KSB-D05-K0018: Emergency Procedures

Overview

Domain: D05 - Clinical Trials PV Type: Knowledge Proficiency Level: L1 (Novice - Direct supervision required) Bloom Level: Understand

Description

Unblinding protocols, medical emergency response, serious adverse event management

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:

1. Demonstrate L1 proficiency in emergency procedures
2. Apply understand level cognitive skills to explain the topic
3. Reference relevant regulatory guidance (EMA-REG-004, ICH-E6)
4. Connect to related EPAs: EPA-02, EPA-04, EPA-08

Key Competencies

• Unblinding protocols, medical emergency response, serious adverse event management

Assessment Criteria

• Can explain 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