A risk-based monitoring process feeds data from study sites into a dashboard, which then alerts the sponsor to situations that need further investigation.
As a complement to the wealth of hands-on information that Richard has created, which primarily covers the mechanics of RBM with JMP software, we decided to publish a brief article on getting started with risk-based monitoring.
The article covers several aspects of RBM, including:
A basic definition.
Why a risk-based approach is better (hint: it's a lot cheaper).
Details about how the monitoring process might work in this new model.
An overview of the risk dashboard, a key piece of an RBM platform.
How to approach the transition to RBM and dealing with organizational change.
If nothing else, we hope the article facilitates some conversations in your organization as you transition to the new world of risk-based trial monitoring.