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Quality Risk Management for a Decentralized/Hybrid Clinical Trial: A Role Play by Representatives of Key Stakeholders
Session Chair(s)
Paula Horowitz
Program Manager, QA, GCP Software Validation
AbbVie, United States
A cross-functional panel of experts will role-play a risk review meeting discussion to identify, assess, categorize, and prioritize risks of a mock protocol decentralized clinical trial (DCT) and outline potential mitigation activities.
Learning Objective : Outline why risk identification is a fundamental consideration when planning a Decentralized/Hybrid Clinical trial; Define roles and responsibilities for key stakeholders to identify risks for Decentralized/Hybrid Clinical Trial; Identify who are the key stakeholders for a decentralized/Hybrid Clinical trial; Develop fit-for-purpose Oversight Plans.
Speaker(s)
Quality Risk Management for a Decentralized/Hybrid Clinical Trial: A Role Play by Representatives of Key Stakeholders
GINA Lisette Williamson, BSN, MBA
Illingworth, A Syneos Health Company, Spain
Principal Site solutions
Quality Risk Management for a Decentralized/Hybrid Clinical Trial: A Role Play by Representatives of Key Stakeholders
Maryrose Petrizzo, MS
Clinical Quality Assured,LLC, United States
President and Consultant
Quality Risk Management for a Decentralized/Hybrid Clinical Trial: A Role Play by Representatives of Key Stakeholders
Terry Katz, MS
Daiichi Sankyo, United States
Senior Director, Biostatistics and DM Planning and Functional Excellence
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