What Does Risk-based Monitoring Mean for QA Auditing?

By now, we all know that risk-based monitoring isn’t just about changing the role of the CRA; it’s transforming the way clinical studies are managed.  So what does that mean for QA teams who audit these new processes?  Polaris president Celine Clive led a roundtable discussion about RBM and its implications for auditing at November’s North Carolina Regulatory Affairs Forum (NCRAF) meeting.

It’s a slippery subject.  Traditional monitoring relied on the gold standard of on-site visits every 4-8 weeks and 100% SDV.  RBM is not replacing this standard with another.  RBM is a framework for customizing a monitoring approach for each study, and guess what -- “custom” is a lot trickier to audit than “standard.”