A monitor’s perspective on RBM

We investigate a monitor's perspective on risk-based monitoring, and one of the common questions we are asked while supporting the transition to RBM: Risks vs. Issues - What's the real difference?

I recently had the pleasure of meeting with a group of monitors and trainers working on a RBM project.  Over the course of the meeting the team were introduced to terms such as risk, mitigation, thresholds, key risk indicators (KRIs), probability, RAG (red, amber, green) status, root cause analysis …  I could see their eyes widening as they were faced with dashboards and alerts, and the question forming in their heads of ‘What is expected of me?’  The natural response of the monitor was to review the dashboards from a performance perspective and to want to ‘fix the issue’.  To the monitor, risk and issue were one and the same.

 Together we came up with a nice analogy that helped to position risk …

Let us consider an investigator reviewing a hematology lab report……Each lab test is an indicator of patient health and each indicator has a normal range.

The normal range has an upper and lower limit.  If the patient’s result falls in the normal range, typically no further action is required.

If the patient’s result falls outside the normal range, either above or below, the investigator will make an assessment on the clinical significance.  It might be that for the particular patient the value is not unexpected, maybe due to other health factors and so no further action is taken or it is just slightly outside the normal range and so the investigator will apply a ‘watch and wait’ course of action, but no intervention.  Alternatively, it might be the case that for the particular patient the result is concerning requiring action to be taken, perhaps it is quite considerably out of the normal range, a significant change since the last test or there is a worrying trend and so the investigator will apply intervention and take a course of action e.g. further tests, or initiate treatment.

 A similar scenario can apply in RBM. 

In our example, if we consider the lab test as our KRI and the lab normal range as our thresholds.  The investigators role in assessment of lab results is equivalent to the monitors role in assessing the KRI.  The thresholds can be upper and lower limits per team expectations of that specific protocol; if the site is within the tolerance limit or the ‘normal range’, its likely we will not take any action.  However,  if the site goes outside of the normal range for the KRI, we need to consider a closer look at the situation at the site and determine what course of action, if any, we need to take.  It may be that we need to intervene and course correct something that has the propensity to go wrong, but it may also be a case of monitoring the situation, watching for trends, directing further investigation/or analysis or applying a light touch of further training/guidance.

There are so many messages and directives aimed at the monitor of today … What is RBM? How does it differ from remote monitoring? Or central monitoring?  Where do I fit?  How will my role change? …

Here at TRI we aim to demystify RBM for the monitor via a series of blogs and publications …  watch out for more details.

Posted by TRI’s COO, Tammy Finnigan