What is Risk Based Monitoring?
Risk based monitoring is a new monitoring model that has been accepted by the European Medicines Agency and the Food and Drug Administration. It is an innovative risk based approach that focuses on critical study parameters and relies on a combination of monitoring and analytics to oversee patient safety and data review.
Why Risk Based Monitoring?
There are successful factors to field monitoring, such as proximity and close collaboration to site staff for site engagement and guidance, recruitment acceleration and early detection and resolution of issues. However, field monitoring also has challenges in achieving continuous remote data review and the ability to keep on top of data queries. Risk based monitoring can improve trial data quality by the early detection of inconsistent and missing data, protocol deviations and unreported adverse events. This can facilitate a smoother transition to database lock, with timely data entry and review, and ongoing data cleaning. It can also provide an overview of patient data across visits and various sites to identify patterns, thereby preparing field monitors with comprehensive analysis and focused data points before field visits.
Identifying and assessing risks
A risk based approached involves identifying the critical data and key risks that have the most impact on subject safety, site quality, ICH-GCP and protocol compliance. It is important to decide on key risk indicators for trials and to design a monitoring plan that identifies standard key risk indicators as well as key risk indicators that respond to parameters unique to a trial. This is to ensure that early warning signals can be detected and mitigation actions can be tracked. Examples of site quality indicators include number and type of protocol deviations, number and type of queries and timely query resolution. The monitoring plan should have clear roles of accountability and responsibility to ensure complete risk assessment, to help enable a continuous flow of study data to reduce risk and to improve compliance and trial quality.
Mobius Medical can assist you to learn more about the risk based monitoring model and how it can be applied to your study.