Risk-Based Quality Management
Risk-based quality management is an adaptive approach that directs monitoring focus and activities to the evolving areas of greatest need which have the most potential to impact patient safety and data quality.
Thought Leadership on RBQM
Since 2019, ACRO’s RBQM Working Group has administered a yearly survey focused on industry adoption of risk-based monitoring (RBM) and risk-based quality management (RBQM) components and produced a yearly report on its findings. Informed by conversations with FDA, the aim of the survey is to evaluate ACRO member companies’ adoption of risk-based monitoring to better understand how the larger framework of RBM and RBQM are being adopted across the clinical trial industry.
In 2025, ACRO released its latest report detailing the results from the sixth annual RBM/RBQM landscape survey, exploring trends in the data from 2019-2024.
Explore ACRO’s RBQM resources below: