Hi! My name is Svetlana and I’m self-confessed RBQM convert. It wasn’t always that way. When I first started out in my career as a monitor, it was my job to check the sites’ work and it made sense to me to review everything. And I do mean everything. As I progressed through my career and moved into different roles, I began encountering this thing called Risk-Based Monitoring, but it didn’t fully touch ground for me. It seemed like a poor alternative to what I was used to and what seemed like the best insurance for the quality of the collected data.
However, over time, I was seeing it more and more, and I decided I need to dig deeper. Joining conferences and listening to presentations and demonstrations taught me a lot. It took some time, but I started to see the potential benefits from a risk-based approach. I realised that if you break down the parts of the study conduct and the data collection into smaller packets for detailed analysis and are able to see how those packets change in time, then it’s obvious you would concentrate on the things that are most important.
Last year I had the opportunity to join TRI and I’m glad I did. I was impressed that they wanted to take on board the views of CRAs and sites in their approach to RBQM. And since working with both Sponsor and CRO teams I’ve seen the benefits or RBQM for myself. Best part is when we’re working with a client team and going through a Protocol Risk Assessment to decide on critical variables, KRIs and QTLs. My favourites are the ones where you can see improvement trends in site performance (old habits die hard 😊). It is so satisfying to show the study teams something new about their study and hear them say “we’d never have thought of that”. That’s when I know I’m an RBQM convert.