Risk Based Monitoring
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Hi all,
At the CRCTU we usually perform on-site monitoring visits, however paused these in March 2020 due to COVID-19, and implemented remote monitoring. We initially only requested remote monitoring for high-risk or dose-finding trials, and are now branching out to request these for all of our trials.
In the meantime we are writing a risk assessment to allow our Monitors to return to on-site monitoring, with some caveats. This will mean that we are likely to be requesting a mix of on-site and remote for some time yet.
I would really like to know whether other trials units have done similar/or whether you already did remote monitoring/have resumed on-site monitoring/don’t do either?
Also, although we request the data required to do reduced checks, prioritising patient safety, some sites are starting to push back on these requests, and ask that we come in person instead. Has anyone else experienced this?
Thanks!
Susie Mee
QA Manager at CRCTU
Susie Mee
Quality Assurance Manager
Cancer Research UK Clinical Trials Unit (CRCTU)
University of Birmingham
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