I agree with the ICH E6(R3) EWC - Change is the greatest challenge

Hi, my name is Macarena and I am an RBQM Operations Consultant at TRI. I trained as a Biochemist, have a PhD. in Cancer Biology and held a post-doctorate fellow role in Neurodevelopment before moving into clinical research. I’m therefore used to reviewing reams of data and identifying signals that inform my decisions and conclusions.


When I first read the FDA 2010 guidance on Risk-Based Approach to Monitoring, I didn’t need to be converted. Because of my background and training, a risk-based approach already made sense to me. So it surprises me that over a decade later there are still lots of people in the sector who don’t understand RBQM. Indeed, it’s not unusual to meet someone who hasn’t even read E6(R2).


A big part of the challenge is that there are so many different views on what RBQM means, even within the same organization. But if you don’t understand the RBQM process and how it impacts and benefits your clinical trials, how can you make good decisions?


Fortunately, not everyone is resistant to change. I’ve recently finished a project with an organization that had a refreshing approach to learning and developing their RBQM maturity. When I first spoke to them they had created and implemented some tools, but they weren’t getting the results they’d hoped for. That was because they had only implemented part of the quality management process set out in E6(R2), but not all of it.


We took them through each of the seven steps in E6(R2) 5.0 and worked out what was critical to them as an organization. We then developed Integrated Strategic Monitoring Plans that helped bring the whole risk-based approach together. They had developed the processes, we just helped make them work. And they were lovely people to work with because they “got it” and wanted to improve.


For those organizations and people that don’t get it, we need to try and understand why. E6 compliance is a requirement, so we have to implement it, right?


There is a lot of talk about Change Management in the sector. The Executive Working Committee (EWC) of ICH E6(R3) recently said it was the “greatest challenge”.


While lots of organizations use the phrase “Change Management”, they are empty words if you don’t train your people and bring them on board. If people don’t understand it, don’t get it or don’t want to get it, RBQM just doesn’t work. I’ve seen that for myself. The EWC were right. Change is the greatest challenge.