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Risk-Based Quality Management DMEG

Risk Based Quality Management (RBQM) Data Management Expert Group

The RBQM data management expert group focuses on driving thought leadership discussions with respect to Risk-based Quality Management (RBQM) in clinical trials and how to drive data quality and integrity outcomes that surpass legacy ways of working, enhancing the resources available to data managers. The group meets on a monthly basis to share thought leadership and experience in implementing RBQM and different approaches to monitoring and processing clinical data.  This is a constantly evolving and dynamic area of clinical trials with many organisations across the industry being at different stages of their adoption. ACDM’s RBQM team are currently discussing different approaches to detecting clinical trial risk from within the data, such as using Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), Statistical Monitoring, Source Data Review (SDR) and where appropriate, Source Data Verification (SDV). The team discuss implementation approaches, impact on roles and responsibilities, impact to data management, adaptive approaches and demonstrable value. 
The RBQM group aims to further the development and skill-set of our wider ACDM community and would be delighted to invite more members to our growing RBQM team. We look forward to hearing from you.
If you have any interest in joining this group, please click here

Risk Based Quality Monitoring Expert Group members

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Rich Davies (Chair)
VP, Solution Expert | CluePoints

Belinda Howe
Senior Project Manager | Monash University

Lorena Rodríguez
Principal Clinical Data Manager | Cmed

Katie Jarvis
Director, Head of Clinical Data Management | Orchard Therapeutics

Nicola Mockler
Data Management Operations Manager | Cancer Research UK

Raven Brothers
Associate Director of Clinical Data Abstraction | Natera

Nina Reyes
Manager Clinical Data Management | IQVIA

Helen Smith
Senior Data Coordinator | PHASTAR

Achilleas Zaras
Sales Engineer | eClinical Solutions

Rachel Oakley
Senior Director | Cmed

Magdalena Kozlowska
Director, Clinical Data Management Group | GSK

Claire Bennett
Director, Clinical Data Management | Fortrea

Tanya du Plessis (Chair)
Chief Data Strategist and Solutions officer | Bioforum

Peter Sec
Associate Manager, Clinical Data Sciences | Premier Research

Jonny Wilks
Data Manager | MAC Clinical Research

Sivakumar Pazhamalai
Manager, Data management | GSK

Marcel van Willigen
Data Manager | Julius Clinical