Risk Based Quality Management (RBQM) Data Management Expert Group
What is a DMEG?
A Data Management Expert Group (DMEG) is a specialised forum established by the Association for Clinical Data Management (ACDM) to bring together professionals with deep expertise in specific areas of clinical data management. These groups aim to foster collaboration, share best practices, and drive forward the industry’s standards and innovations. Each DMEG focuses on a unique aspect of data management, supporting the ACDM community by providing insights, organising events, and producing thought leadership content.
RBQM DMEG
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.
Resources developed by the RBQM DMEG
RBQM DMEG Chair
Rich Davies (Chair)
VP, Solution Expert | CluePoints