Back to Agenda
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; Discuss developing fit-for-purpose Oversight Plans.
Speaker(s)
Panelist
Gina Lisette Williamson, BSN, MBA
Illingworth, A Syneos Health Company, Spain
Associate Director 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
Panelist
Terry Katz, MS
Daiichi Sankyo, United States
Senior Director, Biostatistics and DM Planning and Functional Excellence
Have an account?