ksb-d05-k0007

name: "KSB-D05-K0007" description: "Investigator Reporting: Serious adverse event reporting obligations, timeline requirements, documentation standards..." version: "1.0.0" domain: "D05" domain_name: "Clinical Trials PV" type: "Knowledge" proficiency_level: "L3" bloom_level: "apply" triggers: - "explain investigator reporting" - "what is investigator reporting" - "apply investigator reporting" epa_mapping: "EPA-02, EPA-04, EPA-08" cpa_mapping: "CPA-01, CPA-07" regulatory_refs: "EMA-REG-004, ICH-E6"

KSB-D05-K0007: Investigator Reporting

Overview

Domain: D05 - Clinical Trials PV Type: Knowledge Proficiency Level: L3 (Competent - Minimal supervision) Bloom Level: Apply

Description

Serious adverse event reporting obligations, timeline requirements, documentation standards

Context

• Major Section: Clinical Trial Regulatory Framework and Safety Requirements
• Section: Safety Reporting and Communication Requirements

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 L3 proficiency in investigator reporting
2. Apply apply level cognitive skills to apply 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

• Serious adverse event reporting obligations, timeline requirements, documentation standards

Assessment Criteria

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

Related Skills

• Other D05 skills in Safety Reporting and Communication Requirements
• Cross-domain integrations per DAG architecture

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