Alphabet Soup - GCP ICH E6: Good Clinical Practice Review and Updates

Wednesday, May 31, 2017 - 2:00pm to 3:00pm

GCP ICH E6 – that’s a lot of acronyms and feels like alphabet soup, but we can make sense of it all.  In the world of research, we have regulations and the Good Clinical Practice ICH E6 are available as one of the best “how-to guidelines” to meet them in our clinical trials.  They have been in place and adopted by the US Food and Drug Administration (FDA) and the European Union as guidelines since 1996 and were codified as law in other countries such as Japan.  The ICH E6 standards were just revised in 2016 in response to new technology and evolving research.  This webinar will address the basics of the GCP standards that are still in place along with the updates as of 2016.  We will discuss how they are operationalized to ensure that sites are in compliance and can provide good documentation that meet the stated goals of GCP standards.  

Learning Objectives:

  • Identify the basic goals and elements of the Good Clinical Practice Standards.
  • Discuss the updates from 2016 and the goal of each of these new standards.

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Tonya K. Edvalson, Regulatory Coordinator, Intermountain Healthcare for Women and Newborn Research Department
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