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Archive: ICH E8 (R1): Designing Quality into Clinical Studies

Course #: BI16106
May 7, 2024

Course Description

ICH E8 (R1) is intended to identify and modernize the present conduct of clinical research, including clinical trial design, planning, management, and conduct. In clinical research, quality assurance activities of retrospective document checking, monitoring, auditing, or inspection are essential, and there has been an overreliance on these tasks versus relying on designing quality into clinical studies during development and throughout clinical research. This web seminar covers the importance of designing quality into clinical trials with a focus on Quality by Design (QbD) of clinical studies, critical factors to quality, essential identification of quality factors, establishing a culture that supports critical thinking and open dialogue regarding proactive quality versus reliance on tools/checklists, and stakeholder engagement.

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Learning Objectives

  • Describe ICH E8 (R1): Designing quality into clinical studies
  • Define critical factors to quality in ensuring human subject protection and generation of reliable and meaningful results
  • Identify an appropriate framework for the identification and review of essential elements of quality in clinical studies
  • Discuss maintenance and quality control of the TMF

Who Should Attend

  • Managers/Directors: Clinical Operations, Clinical Research, Data Management, Quality Management, Compliance, Process Improvement, Risk Management, Quality Risk Management
  • Study Managers/Project Managers
  • Clinical Research Associates/Monitors
  • Regulatory Affairs Professionals
  • Biostatisticians, Data Managers
  • Clinical Research Nurses, Clinical Research Coordinators, Clinical Investigators


Andy Lawton

Click here for complete trainer biographies


Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.