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The Risks of KRI in RBM: A Response to “A Roadmap for Implementing Risk-Based Monitoring and Quality Management"


By Penny Manasco - June 11, 2019

There are a myriad of articles on RBM implementation. Some authors have us jumping immediately into tool selection before we have even determined WHAT we need to measure. It is essential that we identify Errors that Matter for each protocol and how we will identify whether systematic errors occur. Hopefully this paper will encourage you to step back and define the important errors that need to be monitored. Only then can you determine whether the tool you choose will meet your needs. I'm also encouraging all companies to systematically evaluate different RBM approaches, just as we evaluate different therapies--moving toward Evidence-Based Clinical Research and Quality Oversight.

http://www.appliedclinicaltrialsonline.com/risks-kri-rbm-response-roadmap-implementing-risk-based-monitoring-and-quality-management