What Does Risk-Based Monitoring Mean For QA Auditing?

By Laurie Meehan,

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?

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.”