Beginner’s Guide to Risk-Based Monitoring

Meghan Hosely
August 20th, 2019

In clinical research, there are many different data points to track and monitor as the trial moves from phase to phase. One method used to track high-risk data and to address those data points as necessary is called risk-based monitoring (RBM). Since this is a different method than what has typically been used in the past, this article will provide you with a basic understanding of RBM and how it fits in with clinical trials.

What is Risk-Based Monitoring?

Risk-based monitoring is a technique developed in 2012 by TransCelerate, which is used in clinical trials to help fulfill regulatory requirements, moving away from Source Data Verification (SDV) of patient data.

The basic concept of RBM is to focus attention on data, documents and processes. Rather than focusing on everything the data has to offer, RBM pays special attention to high-risk data points, such as anything potentially impacting the participants’ safety during the trial.

According to the ACRP, RBM:

  • Is a customized monitoring approach
  • Includes a risk assessment of critical data
  • Allocates monitoring resources according to risk
  • Uses a mix of centralized and on-site monitoring that takes advantage of technology when appropriate.

Types of RBM

There are two types of RBM: centralized/off-site monitoring and on-site monitoring.

In centralized/off-site monitoring, data evaluation is done remotely at a location other than the clinical investigation site. If needed, staff are empowered to visit the site to evaluate and monitor high-risk data. Overall, centralized monitoring is designed to supplement, not replace, on-site monitoring.

An examiner conducts on-site monitoring while looking at the big picture: reviewing all the documents, eligibility criteria, informed consent, regulatory compliance and understanding of study and protocol. On-site monitoring relies heavily on SDV: the process by which data within the case report form (CRF), or other data collection system, are compared to the original source of information to confirm the data was transcribed accurately.

Even with different types of RBM, one isn’t superior over the other since they serve different purposes. Per best practices, critical data should be reviewed on-site, and less-critical data is best monitored remotely.

How Does RBM Work?

While traditional SDV involves frequent on-site visits, RBM moves away from that approach with their on- and off-site methods, offering a much more unique process of collecting and monitoring data.

RBM is open to interpretation, depending on the clinical site’s needs. RBM relies on a risk assessment, including: the likelihood of errors occurring, impact of such errors on human subject protection and trial integrity. Results from the assessment determines the monitoring plan.

Benefits of RBM

While it is a new approach to monitoring errors, one benefit of RBM is decreased costs. Clinical research staff will spend less time analyzing data because they are focusing more on the high-risk events that happen at sites, rather than all aspects of data. Since less time is spent reviewing data, and data is reviewed only when it absolutely needs to be, it saves the clinical trial money in the end.

Not only does RBM lower the cost of a clinical trial, it allows clinical research staff to focus more of their time on other aspects of their job. Since less time will be spent on analyzing data, more time is freed up to focus on their core accountabilities, and ultimately, more time with their patients.