What Does Risk-Based Monitoring Mean for QA Auditing?
January 13, 2015
By Laurie Meehan, Social Media Manager, Polaris Compliance Consultants
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.
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