The Association of Clinical Research Professionals

​​ICH E6(R3) Gap Analysis Tool

​​​​​​This self-assessment tool helps clinical research professionals identify strengths and knowledge gaps in their understanding of ICH Good Clinical Practice (GCP), with particular emphasis on the principles and concepts reflected in ICH E6(R3)

Designed to assess rather than teach, this tool evaluates your current knowledge across four progressively challenging levels:
  • Level 1 – Fundamentals
  • Level 2 – Applied Operations
  • Level 3 – Scenario-Based Judgement
  • Level 4 – Advanced Oversight and RBQM

Throughout the assessment, you will receive immediate feedback and targeted recommendations to help identify opportunities for further review and learning. After each level, a personalized summary highlights knowledge domains that would benefit from additional study.

This tool is not intended to predict, replicate, or otherwise represent questions from any certification examination. Where appropriate, concepts from other ICH guidelines are incorporated to provide context and reinforce practical application. Instead, it is designed to help you evaluate your understanding of core GCP concepts, identify learning priorities, and guide future study and professional development.

Primary guidance referenced includes:

  • ICH E6(R3) – Guideline for Good Clinical Practice
  • ICH E2A – Clinical Safety Data Management
  • ICH E8 – General Considerations for Clinical Trials

Additional ICH guidelines and related references are incorporated, as appropriate, to provide context and support the practical application of GCP principles.

At the conclusion of this assessment tool, participants should be able to:

  • ​Evaluate current understanding of foundational, applied, and advanced Good Clinical Practice (GCP) concepts, with emphasis on the principles outlined in ICH E6(R3) and related guidance relevant to clinical trial conduct. 
  • ​Interpret key ICH GCP principles and explain how they support participant protection, data integrity, and trial quality across diverse research settings. 
  • ​Apply ICH GCP principles to common clinical trial scenarios to identify strengths, recognize knowledge gaps, and prioritize areas for targeted review and continued professional development.​ 

Approved for 2.0 ACRP Contact Hours | Available 1 Year from Enrollment Date