On Tech Ethics with CITI Program
On Tech Ethics with CITI Program
CITI Program
Modernizing Clinical Trials with ICH E6(R3) - On Tech Ethics
18 minutes Posted May 8, 2025 at 2:00 pm.
Introduction to the Episode
Eric’s Background
Introduction of Cindy Gates
Purpose of ICH Guidelines
Reasons for GCP Update
ICH Guidelines Legal Standing
New Responsibilities for Researchers
Changes in Informed Consent
Investigational Product Management
Data Governance in E6(R3)
Impact of E6(R3) Updates
Resources for Learning About E6(R3)
Final Thoughts on E6(R3)
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18:26
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Show notes
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 ...