ACRO’s latest survey on RBQM adoption finds that centralized monitoring is being underutilized despite the potential for increased patient safety oversight and improved data quality. ACRO’s RBQM Working Group is on a mission to help the industry use centralized monitoring more effectively.
Risk Based Quality Management (RBQM) in clinical trials centers on detecting, addressing, preventing, and mitigating risks and threats that could undermine patient safety, trial processes, and data integrity. The overall goal in this Quality by Design (QbD) approach is not to eliminate all errors, but instead to focus on reducing errors that matter and would otherwise threaten trial outcomes or patient safety.
RBQM is a cross-functional framework enhanced by proactive risk monitoring and mitigation to ensure patient safety and overall data quality. Despite the fact that central monitoring can significantly help with overall data quality, adoption by industry is still sporadic and slow. ACRO’s RBQM Team released a paper in December 2024 that discusses how sponsors and CROs can implement centralized monitoring to increase the efficiencies and effectiveness of clinical trial monitoring.