Introduction to Critical to Quality Factors

Event Organization
Clinical Trials BC


The ICH E8R1 ‘General Considerations in Clinical Trials’ document ties Quality with Trial conduct and ICH E6R2 ‘Good Clinical Practice’. Critical Quality Factors should be determined for each study. Risks that could impact those Critical to Quality Factors should also be identified. This session covers introductory materials for CtQ basics and application at site and institution level.

Target group

Intermediate level research team staff and QA personnel

Pre- requisite

Risk Management training is helpful but not necessary

Learning Objectives

The learner will:

  • Recognize key terms associated with CtQ
  • Describe the process of identification to review of CtQ
  • Understand the relationship of CtQ with risk
  • Identify some common CtQ for a site


More details about the educational sessions on ICH E8(R1) document's topics:

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