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17-Sep-2020 - 17-Sep-2020

J29 Process Thinking in Clinical Trials

  • Location:
    • Cedar Court
    • White Waltham
    • Maidenhead, Berkshire
    • SL6 3LW
    • England
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The Course

ICH E6 (R2) has emphasized the importance of risk management in relation to ensuring subject safety and rights as well as data integrity in clinical trials. Understanding, oversight and improving clinical trial processes, is a fundamental way of managing these risks. this course demonstrates ways to map processes, how to measure them and to understand how they might fail. It provides a tool kit for root cause analysis and provides approaches to improve processes so as to minimize risk. Throughout, examples are used from clinical trials and participants are encouraged to practise the skills they learn. 

Learning Objectives

By the end of this course, you will be able to...

  • Understand the relevance of process thinking in clinical trials
  • Learn how to map processes
  • Learn how to review processes for potential weaknesses and develop preventive actions
  • Practise a method of root cause analysis that goes beyond the normal "Five Whys" approach
  • Understanding different types of actions and how to develop actions to help prevent recurrence of issues (CAPA)
  • Understand how metrics can be used to monitor processes

Course Outline

  • ICH E6 (R2) - Process understanding and risk
  • How to map a process
  • Assessing to process for risk
  • What to do when a process goes wrong - corrections and root cause analysis
  • Preventing further failures (CAPA) 
  • Monitoring process health