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Manage episode 481404891 series 3440731
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Discusses the updated International Council for Harmonisation (ICH) Guideline for Good Clinical Practice known as E6(R3) and what it means for researchers.
Our guest today is Cindy Gates, JD, RN, an experienced leader in human subjects research protections and clinical research. Cindy has previously worked at WIRB, the University of California Davis, the University of Miami, the Houston Methodist Medical Center, and George Washington University.
This episode is co-hosted by Eric D. Kupferberg, PhD, Associate Director of Clinical Research Education at CITI Program.
Additional resources:
- ICH E6(R3): https://www.ich.org/page/efficacy-guidelines#6-2
- CITI Program’s ICH E6(R3): An Introduction course: https://about.citiprogram.org/course/ich-e6r3-an-introduction/
Chapters
1. Modernizing Clinical Trials with ICH E6(R3) - On Tech Ethics (00:00:00)
2. Introduction to the Episode (00:00:03)
3. Eric’s Background (00:00:14)
4. Introduction of Cindy Gates (00:00:39)
5. Purpose of ICH Guidelines (00:02:17)
6. Reasons for GCP Update (00:03:41)
7. ICH Guidelines Legal Standing (00:05:15)
8. New Responsibilities for Researchers (00:06:03)
9. Changes in Informed Consent (00:08:29)
10. Investigational Product Management (00:11:06)
11. Data Governance in E6(R3) (00:12:50)
12. Impact of E6(R3) Updates (00:14:22)
13. Resources for Learning About E6(R3) (00:16:39)
14. Final Thoughts on E6(R3) (00:17:07)
38 episodes
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