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Risk Based Quality Management (RBQM) DMEG

The RBQM Data Management Expert Group is dedicated to advancing thought leadership in Risk-Based Quality Management (RBQM) in clinical trials. The group explores how RBQM can improve data quality and integrity beyond traditional methods, ultimately enhancing the support available to data managers.

Meeting monthly, the group shares practical experience and insights on implementing RBQM, including various strategies for monitoring and processing clinical trial data.

RBQM is a dynamic and evolving field, with organisations across the industry at different stages of adoption. The ACDM RBQM DMEG is currently exploring a range of methods for detecting clinical trial risks within data, including Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), statistical monitoring, Source Data Review (SDR), and, where appropriate, Source Data Verification (SDV). Discussions cover implementation strategies, the impact on roles and responsibilities, implications for data management, adaptive approaches, and measurable value.

The RBQM group’s core aim is to support the growth and upskilling of the wider ACDM community in this critical and fast-developing area.

Risk Based Quality Management (RBQM) DMEG

The RBQM Data Management Expert Group is dedicated to advancing thought leadership in Risk-Based Quality Management (RBQM) in clinical trials. The group explores how RBQM can improve data quality and integrity beyond traditional methods, ultimately enhancing the support available to data managers.

Meeting monthly, the group shares practical experience and insights on implementing RBQM, including various strategies for monitoring and processing clinical trial data.

RBQM is a dynamic and evolving field, with organisations across the industry at different stages of adoption. The ACDM RBQM DMEG is currently exploring a range of methods for detecting clinical trial risks within data, including Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), statistical monitoring, Source Data Review (SDR), and, where appropriate, Source Data Verification (SDV). Discussions cover implementation strategies, the impact on roles and responsibilities, implications for data management, adaptive approaches, and measurable value.

The RBQM group’s core aim is to support the growth and upskilling of the wider ACDM community in this critical and fast-developing area.

Resources

The RBQM DMEG is beginning to build a collection of resources to support advancing thought leadership in Risk-Based Quality Management in clinical trials. The first of these is “Examples of Risk-Based Quality Management Practices on Small-Scale Clinical Trials,” designed to discuss many of the RBQM concepts.

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RBQM Small Study.

View Here 〉

Members

Rich Davies | DMEG Chair

Vice President, Solution Expert | CluePoints

My journey into clinical data management began during my Computer Science degree at De Montfort University, which included a placement year at Fisons Pharmaceuticals in Loughborough. There, I worked on implementing a newly acquired CDMS called Clintrial. After graduating, I returned to Fisons before joining BBN, the creators of Clintrial, and have since worked with various eClinical solution providers.
 
Much of my career has focused on EDC systems like Phase Forward/Oracle, witnessing the shift from paper to digital. I’ve also worked with a wide range of supporting systems, from Pharmacovigilance and ePRO to CTMS, Regulatory Management, and now Risk-Based Quality Management at CluePoints.
Rich

Rich Davies | DMEG Chair

Vice President, Solution Expert | CluePoints

My journey into clinical data management began during my Computer Science degree at De Montfort University, which included a placement year at Fisons Pharmaceuticals in Loughborough. There, I worked on implementing a newly acquired CDMS called Clintrial. After graduating, I returned to Fisons before joining BBN, the creators of Clintrial, and have since worked with various eClinical solution providers.
 
Much of my career has focused on EDC systems like Phase Forward/Oracle, witnessing the shift from paper to digital. I’ve also worked with a wide range of supporting systems, from Pharmacovigilance and ePRO to CTMS, Regulatory Management, and now Risk-Based Quality Management at CluePoints.
Rich

Interested in Joining?

The RBQM DMEG would be delighted to welcome more members to our growing RBQM team. For more information on joining, please click here.