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Risk Based Monitoring DMEG

Risk Based Monitoring Data Management Expert Group

The RBM 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 RBM 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 RBM 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 RBM team. We look forward to hearing from you.
 
If you have any interest in joining this group, please click here

Risk Based 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, Data Management
Worldwide Clinical Trials

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
Vice President, Data Management
Bionical Emas

Peter Sec
Associate Manager, Clinical Data Sciences
Premier Research