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.

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

The Academy of Clinical Research Professionals, the independent affiliate responsible for developing and administering ACRP’s certification programs, does not require, endorse, recommend, sponsor, nor participate in the development of any exam preparation resources. The exam preparation materials available on this website have been independently developed by the Association of Clinical Research Professionals (ACRP). ACRP strongly discourages the use of any exam preparation resources from external sources.