What does Risk Based Monitoring mean for the future of the CRA?
I’ve been in clinical research a long time and have seen the role of the CRA evolve over the years, but the recent move towards risk based and centralised monitoring could mean a sea change in the traditional job description of the CRA.
The exact role varies widely from company to company but has generally become more specialised in recent times. When I started as a CRA we did everything from writing the protocol, designing the CRF, trial start up, monitoring, closeout and writing the final report. The bits we didn’t do were data management and statistics. Oh, and we managed all the documentation as well!
Now we have medical writers, regulatory people, study start up specialists, document managers and many more involved in a lot of these processes, and so the CRAs tend to concentrate on monitoring, or oversight of monitoring which has been contracted out.
Early on we also used to do what we called “secondary monitoring” which was often used to train up new CRAs. Once the CRA had retrieved CRF pages from a site (yes they were all paper – it was that long ago!) a more junior CRA would review them again in house to check for errors the CRA had missed at the monitoring visit. They would raise data queries on anything they found and then the pages would be sent on to Data Management. This approach didn’t last very long as it was expensive, but it essentially amounted to an early form of centralised monitoring.
With the new version of ICH GCP and other regulatory guidance, centralised monitoring should, for some trials, be replacing the data checking part of the CRAs role altogether. With the advent of electronic data capture we can review CRFs remotely and sometimes even perform SDV remotely too. This means that either the CRA doesn’t visit the site at all, or if they do visit they can skip the CRF review and SDV part and concentrate on site issues and the relationship with site staff.
This means that we now have two separate parts to the CRA role and these two parts require different skills.
The skills needed for a good CRA have always been an interesting mix. You need someone with great attention to detail and a task focus, but also great with people and a good people focus to establish and maintain a working relationship with the site. Finding people with both sets of skills has long been a challenge as most people tend towards one end of the spectrum or the other.
As we split out the two key aspects of the CRA role – data quality review done centrally and people management of the site, I wonder if we need to create new roles with new skill sets and competencies? Centralised monitoring needs more of the attention to detail and analytical skills and the on-site monitoring role will likely become much more about people skills and problem solving. Obviously there will be some overlap, centralised monitors need to communicate with site staff by phone, e-mail etc and work on problem solving with them, and on site monitors need to fact check and review site files, but generally the roles could be more focussed on one aspect or the other. So will we end up with new job titles such as Central CRA and Site CRA? This approach could open opportunities to make the most of our CRAs, there are those that want to be a CRA but don’t want to travel, and there are those who love the travel and the working with people, but find CRF review and SDV a bit boring….
We would be very interested to hear your views on this and any ideas you are working on to maximise efficiency in this new risk based and centralised monitoring world.