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Posts Tagged ‘risk-based monitoring in clinical trials’

Is Risk-Based Monitoring Just A Fad?

  While some of you might be hoping that RBM is just a trendy idea that we’ll soon forget, I have to say that when regulatory agencies take the time to draft and produce guidance documents on the topic… 

Is Risk-Based Monitoring Compliant?

  When we think of compliance, we think of consistency. Compliance depends on following the same processes and procedures over and over, across the board. After all, that’s why we have all of those SOPs, right? When we’re used to conceptualizing compliance this way, the notion of risk-based monitoring can certainly lead to cognitive dissonance. […]

Does Risk-Based Monitoring Cheat In Source Data Verification?

  Because risk-based monitoring does not involve 100% source data verification (SDV), unlike traditional monitoring, it’s understandable that RBM could seem sort of like “cheating.” But, research has shown that 100% SDV does not consistently result in higher quality data. In other words, the cost of 100% SDV outweighs the potential benefits. 

Is Risk-Based Monitoring Rigorous Enough?

  In RBM, not all sites are monitored the same way and not all source data is 100% verified. This can make it seem like the monitoring that IS happening isn’t as rigorous or in-depth as it should be…with “should” being the operative word. 

Does Risk-Based Monitoring Shift The Burden Onto Sites?

  When site personnel hear that their sponsors have switched to RBM and will no longer be sending monitors at regular intervals throughout the study, they might feel like they’ve been abandoned and that now the burden of executing the study perfectly is 100% on them. Au contraire, my friends! In an RBM strategy, sites […]

Is Risk-Based Monitoring The Same As Remote Monitoring?

  While it’s true that both terms include “monitoring,” it’s not true that they’re synonymous. In fact, remote monitoring is actually a subset of risk-based monitoring – a type or form of monitoring, rather than a monitoring strategy, like RBM.