ICH E8 (R1): Designing Quality into Clinical Studies

Upcoming Courses
Course #: BI14242
January 14, 2021
9:00 AM - 11:00 AM Eastern

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.

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

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, Biostatisticians, Data Managers  
  • Clinical Research Nurses, Clinical Research Coordinators, Data Managers, Clinical Investigators


Andy Lawton

Click here for complete trainer biographies

Registration Fees


Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 2 hours (0.2 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-20-105-L04-P. Released: 9/20.   

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