One of the greatest assets a CRA/Monitor can have in the transition from traditional monitoring to a risk-based monitoring model is the ability to think critically and good old-fashion common sense. They need to not only be able to see the forest through the trees, but also see when there’s a palm tree in the middle of a grove of redwoods.
Earlier this week, Barbara (CEO Patient Profiles) and I were on a call with an existing client, a sizeable CRO that will go unnamed, to provide them a demo of our soon-to-be-released QueryMap application (which we are so excited about). We went down the path of how best to flag the data that is an outlier, and which variables in the study are more important in a study than others.
A specific data variable may have a high occurrence of errors. This in the big picture may not really be that big of an issue, particularly if it is not related to patient safety, a primary or tertiary end-point. It is still an indication of quality, but does not need to be triggering the fire alarm. The realization that not all errors are equal, and they do not all carry the same threat of risk to the overall study quality.
For years, CRAs have been very focused on 100% SDV. That is not a critique of them but a reflection of the industry and data review expectations and perceptions. As the industry shifts away from 100% SDV and to either partial or centralized monitoring (whether or not they implement RBM itself is a whole different topic), the need for CRAs does not go away. What it does need is CRAs that can step away from the microscope and look at the bigger picture. Again, not a critique of CRAs, but this is exactly what industry has asked of them, to look at the microscopic level.
As CRAs make that transition, tools like QueryMap and Patient Profiles are there to help. Using these tools for monitoring a study not only helps CRAs in making that transition by focusing them on what really needs to be focused on. The upside for sponsors and CROs is that it helps them to improve the overall study quality while supporting CRAs in the transition to a new monitoring paradigm.