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Improving Clinical Trial Risk Management: How To Leverage the IRB's Designed Purpose
Session Chair(s)
Mitchell Parrish, JD, RAC
President
H Clinical, United States
IRBs are in a unique position to impact risk management in clinical trials. Their role is designed to protect research participants, but this can equate to furthering best practices in risk management and quality management systems. Two case studies will be discussed and three concrete examples given into how both institutional and central IRBs can further improve risk management, and those quality systems designed facilitate such management, through education, expanded feedback, and coordinating of information from all aspects of a clinical trial.
Learning Objective : Describe the intersection between the IRB and risk management in clinical trials; Discuss the current state of risk management and quality management systems; Identify how IRBs can engage with sponsors, CROs, and research sites to improve overall risk management of a trial.
Speaker(s)
Approach to Advancing Proactive Quality Through the Implementation of an Integrated Quality Risk Management Framework
Fidelle Jarmon, MS
Janssen, United States
Director, Risk Management, Bioresearch Quality and Compliance
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