Project Scope Central monitoring is an emerging field with an unclear scope, goals and roles. Central monitoring, if executed appropriately, can have a positive impact on data quality, patient safety and clinical trial efficiencies. This project will work to define central monitoring (including differentiating from data management and other forms of data surveillance), and suggest success measures and best practices to ensure a well-connected end-to-end component of quality risk management. The project will provide insight and guidance to address understanding as well as the current and future needs of holistic central monitoring process and capabilities. Strong central monitoring practices can support early-study risk reduction and, through important trend analysis and mitigation, decrease preventable errors that can have an impact on patient safety or clinical trial conclusions. Our approach will encourage exploration of different approaches versus recommendations so as not to deter sponsor innovation (e.g. points to consider). In Scope
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Project Leads | |
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Nicole Stansbury (Syneos Health) | nicole.stansbury@syneoshealth.com |
Anne Lawrence (AbbVie) | anne.lawrence@abbvie.com |
Objectives and Deliverables | Timelines |
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White Paper – Challenges in Central Monitoring Implementation | Q32022 |
White Paper – Defining Central Monitoring Value | Q42022 |
CURRENT STATUS Q1/2022 |
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Project approved Q1 2022 |
Project Members | Organisations |
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Andy Lawton | Independent |
Catherine Sinclair | GSK |
Chaitali Tripathi | Janssen Research & Development |
Christine Redieske | AbbVie |
Crupa Kurien | Pfizer |
Diana Cheung | Janssen Research & Development |
Georgina Wood | Cyntegrity |
Gregory Long | Roche |
Jean Mulinde | FDA |
Lynne Cesario | Pfizer |
Marion Wolfs | Janssen Research & Development |
Priti Gupta | Industry |
Rohit Singh | Independent |
Samantha Hewlett | Amgen |