The Association of Clinical Research Professionals

ICH Gap Analysis

Member: $14 | Non-Member: $29


This course is approved for 2.0 ACRP contact hours. Accreditation Details

This eLearning course will be accessible for up to one year from the date of purchase.

Course Description

Assess your and your team’s training needs quickly by conducting an ICH gap analysis.

The International Conference on Harmonization (ICH) Guidelines are plentiful. Do you know the details of E2a, E6(R2), E8 and E9 and the Declaration of Helsinki? This eLearning program uses a game to challenge the learner’s knowledge and application of these important efficacy guidelines. Play the game to help prepare for an ACRP Certification Exam, a job in clinical research, or simply to refresh your knowledge of the ICH guidelines. Keep track of items that are scored incorrectly to develop a focused training plan.

Work your way through four increasingly difficult levels of knowledge. Correctly answer at least 80% of the  questions on each level to move to the next level, ultimately ending with a ‘Gold Badge’ confirmation of ICH GCP knowledge.A minimum score of 80% at each of the four increasingly difficult levels of questions will lead to the ultimate ‘Gold Badge’ confirmation of ICH E2a, E6(R2), E8, E9 and Declaration of Helsinki knowledge.

Learning Objectives

  • List the key concepts of the ICH E2a, E6(R2), E8 and E9 guidelines and the Declaration of Helsinki.
  • Apply these key concepts to ensure patient safety and integrity, quality of data and regulatory compliance in the conduct of clinical research.
  • Analyze these key concepts to ensure compliance in the clinical research field.


Clinical Research Professionals with existing knowledge of ICH Guidelines and Declaration of Helsinki who want to assess knowledge gaps

Bring this Program to Your Team — With an eLearning Site License, your team will have access to this and 20+ more training programs covering everything from the “essentials” of clinical research to specialized topics. Delivered on our platform or for use in your learning management system.
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