The Association of Clinical Research Professionals

ICH Gap Analysis

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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

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provides clinical researchers with valuable guidelines to promote the safety, conduct, design, and reporting of clinical trials. This eLearning assessment has been specifically designed to test knowledge of these ICH Guidelines, while assessing your ability to analyze and apply the principals in common clinical research settings.

Designed in a game-like format using five ICH categories (listed below), 12 questions per category are presented in multiple choice and true/false format. A score of at least 75% is required in order to advance to each category. A score below 75% results in the option to begin that category again until a passing score is achieved.

ICH Categories Covered Include:

  • E2A – Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
  • E6(R2) – Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice
  • E8 – General Considerations for Clinical Trials
  • E9 – Statistical Principles for Clinical Trials
  • E11 – Clinical Investigation of Medicinal Products in the Pediatric Population

Learning Objectives

  • Assess your Basic Knowledge of the ICH Guidelines related to Clinical Research
  • Assess your ability to analyze principals of these ICH Guidelines
  • Assess your ability to apply the principals of these ICH Guidelines to your work setting

Audience

All clinical research personnel.

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