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bencovington

Staff

Joined:

Sep 30, 2014

Getting started with risk-based monitoring

Our own Richard Zink has written extensively about the risk-based monitoring (RBM) capabilities in JMP Clinical, both on this blog and, of course, in his book.

Risk-based monitoring diagram

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.

    Read the guide to getting started with risk-based monitoring.