Risk-Based Monitoring
Risk-based monitoring 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 has run an annual landscape survey of RBM and RBQM implementation in the clinical research industry and produced a yearly report on its findings.
In 2024, ACRO released its latest publication, “Risk-Based Quality Management: A Case for Centralized Monitoring,” which provides a real-life example of centralized monitoring implementation using a clinical trial from clinicaltrials.gov. The paper demonstrates how centralized monitoring can help to provide a holistic view of aggregate clinical trial data and earlier identification of emergent issues, enabling organizations to make data-driven decisions more quickly.
In addition to their report published in DIA’s Therapeutic Innovation & Regulatory Science journal, ACRO’s RBQM Working Group also published their 2024 RBQM Summary Report, highlighting significant trends and takeaways from five years of RBM/RBQM landscape survey data.
Explore ACRO’s RBQM resources below: