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| What does risk-based monitoring mean for quality assurance teams who audit clinical studies? |
Internal Project Manager, Polaris Compliance Consultants, Inc.
By now, we all know that risk-based monitoring (RBM) isn’t just about changing the role of the clinical research associate (CRA); it’s transforming the way clinical studies are managed. So what does that mean for quality assurance (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% source data verification (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.”
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