The Association of Clinical Research Professionals
ICH Gap Analysis
This assessment tool has been specifically designed to test knowledge of ICH Guidelines, while assessing your ability to analyze and apply the principles in common clinical research settings.
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.
ICH categories covered in this assessment 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
Upon completion of this activity, participants should be able to:
Assess basic knowledge of the ICH Guidelines related to clinical research.
Assess ability to analyze principals of these ICH Guidelines.
Assess ability to apply the principals of these ICH Guidelines to your work setting.