In a complex industry with many moving cogs, there’s a fair amount of puzzlement surrounding the varying terminologies used in study monitoring. This may well be exacerbated by the fact that three major organizations – the EMA, FDA and the Clinical Trials Transformation Initiative Project (CTTI) – have each produced guidance documents that differently define practices of monitoring and quality in clinical trials.

This checklist will provide some clarity on how and when to use, specifically, the risk-based monitoring (RBM) term when conducting clinical trials. What’s essential is that the term ‘RBM’ must be used when the monitoring approach comprises of the following three features:

1) Risk-based Monitoring

According to the FDA, “[RBM] directs sponsor oversight activities on preventing or mitigating important and likely risks to data quality and to processes critical to human subject protection and trial integrity by appropriate use of centralized monitoring and reliance on technological advances.”

What’s important to note with RBM is that it consists of different components:

  • Quality planning where specific study risks are assessed and management plans created
  • Study specific monitoring plan defining including appropriate mix of central, remote and on-site monitoring activities to address  the risks defined in quality planning stage
  • Central review of data modifies execution of monitoring activities and triggering interventions on site level

Source: Marcin Makowski/John Rodermund (AstraZeneca)

One of the common mistakes sponsor companies make when implementing RBM is when it enforces one of the aforementioned factors without taking into account all of them.

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For instance, monitors and study leads often presume RBM is a reduced form of source data verification (SDV). Similarly, there are some approaches to RBM implementations that are based around centralized monitoring.

So with that in mind, below are some of the basic fundamentals implementing RBM:

  • Technology – is needed to integrate data from various systems (in this case IVRS and C-lab data) and effectively communicate the findings to monitors as well as track management of the identified issues
  • Real-time data entry at site and real time data management – with focus on timely data entry and cleaning enables timely central data review for trend analysis
  • New monitors’ capabilities – these are needed to handle centralized monitoring signals of new nature (based on probability rather than evident errors) via remote communication channels (in contrast to traditional on-site visits)

Source: Marcin Makowski/John Rodermund (AstraZeneca)

2) Centralized Monitoring

When considering the abovementioned definition of RBM, centralized monitoring (CM) could be considered a component of risk-based monitoring. It involves monitors who remotely track study data and site performance away from where the clinical trial is taking place. What’s more, classic CM uses straightforward statistical models to identify outliers in data streams.

While CM is a core part of RBM, it is possible to implement CM in a study without the other elements of RBM. For example, the main team can retrieve emerging data while site monitoring activities remain unaffected.

3) Quality by Design

According to CTTI, Quality by Design (QbD) is a term that describes the all-encompassing approach to quality in clinical trials by adopting the plan-do-check-act methodology. It could be argued that CTTI views RBM as a part of QbD, and to that end, TransCelerate regards QbD as an element of RBM.

In Summary

While the interchangeable use of RBM, QbD and CM may cause ambiguity among staff in clinical organizations, that only stresses the need to form a consensus around the use of one term. The term ‘RBM’ specifically should only be used when all three aspects of monitoring exist when implemented in a clinical study.


*Adapted from Defining Quality by Design, Risk-based Monitoring and Centralized Monitoring by John Rodermund and Marcin Makowski, AstraZeneca