3 Facts about Risk Based Monitoring you need to understand
Risk Based Monitoring is a new approach of study monitoring. This has been first emphasized as a better method to reduce quality issues by FDA in August 2013 and then EMA in November 2013.
This approach is now also a requirement from ICH-GCP since November 2016 when the ICH-GCP E6 (R2) has been published.
This new approach is more about using new technologies in order to have an ongoing review of data at site, country and global level to be more proactive than reactive and increasing data quality. Risk Based Monitoring is a new way of working which involves all clinical trial stakeholders and requests a new mindset. You will find in this article some tips that can help you to better understand challenges it represents.
Risk Based Monitoring is not about reducing risk
cost but increasing quality
There is a false idea on risk based monitoring regarding
cost reduction. In this new approach, monitors (Clinical Research Associate – CRA)
are going less often to site(s) which imply a
travel cost reduction for sure. Now the time spent to review all study data on
an ongoing basis by all stakeholders is really higher in this new methodology.
This review of data and interpretation of risk indicators on a real time basis
allow to increase the quality of data collected and to be more reactive than
reactive in case of issues or safety alert.
Monitoring is no longer
a task for CRA only
Risk based monitoring requests to have regularly a review of
study data, not only when CRA is on site. Indeed data are reviewed remotely by
the CRA for his centres/patients but it is also analysed on regular basis by
the central monitor. The central monitor can be one new function or
responsibilities and can be divided between data
management, statistician and pharmacovigilance. So the monitoring task is now
divided between several functions, and ICH-GCP E6 (R2) requests to have
monitoring reports prepared for each activities.
Teamwork is a key for the
successful Risk Based Monitoring implementation
The intend of Risk Based Monitoring is to bring silos
between functions in order to increase data quality. Indeed the basis of the
Risk Based Monitoring is the risk analysis. This exercise should be a team
exercise from the start till the end of the
study. What is the team? It is all stakeholders involved in the study since
each function has its own expertise and will bring new potential risk into the
discussion. Now the data review during the study is also not anymore a
matter for CRA only but also for other functions in order to keep track of all
risk indicators and being more proactive.
Do you want to know more about Risk Based Monitoring in Clinical Research? Check out our Risk Based Monitoring blended course!
22/08/2018 By Nelle Stocquart