The Association of Clinical Research Professionals

​​ICH E6(R3) Gap Analysis Tool

​​​​​​This enhanced training course is designed to help clinical research professionals identify gaps in Good Clinical Practice (GCP) knowledge, reinforce critical concepts, and build confidence in applying ICH standards in real‑world settings.

Assess your understanding of foundational, applied, and advanced GCP concepts through four progressive levels, each using scenario‑based assessments that reflect common challenges in clinical trial conduct.
  • Level 1 – Fundamentals
  • Level 2 – Applied Operations
  • Level 3 – Scenario-Based Judgement
  • Level 4 – Advanced Oversight and RBQM

At the conclusion of each level, you’ll receive individualized results that pinpoint where additional review may be helpful. Personalized feedback highlights the specific concepts tied to incorrect responses and directs you to recommended educational resources drawn from the ICH E6(R3) guidelines.

Rather than providing a comprehensive review of every ICH guideline, this course focuses on core principles and expectations—particularly those emphasized in ICH E6(R3)—that are essential to participant protection, data integrity, and overall trial quality. Where appropriate, concepts from other ICH guidelines are incorporated to provide context and reinforce practical application.

Primary ICH guidance referenced includes:

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

This course serves as a self‑assessment and learning support tool, not a graded exam. You are encouraged to use the results, feedback, and curated resources provided at each level to guide your study approach, address identified knowledge gaps, and support ongoing professional development.

At the end of this course, 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