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Introduction to Critical to Quality Factors
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

Hosted by Jean Smart

Jan 26, 2022 12:00 PM in Vancouver

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