Enhancing clinical research quality and safety through specialized nursing
We use a risk-based auditing system to determine what study visits are required to be audited (higher risk), and then randomly select 50% of the rest (lower risk) to also audit. We are finding that this is still a large number of charts to audit weekly and are wondering if anyone has a similar system in place and what percentage of charts you are auditing.
Thanks for the help!
Why did you select 50%? I've seen some NIH monitoring plans only use random 10% (back in the day before RBM). As a site director in 2000s, we adopted 10% for our internal QA (chart audits). Just know if your SOP says one thing- you are bound to it. Should the SOP and internal monitoring plan be adjusted downward? Carolynn
When I was a monitor at MD Anderson, we would monitor the first three patients enrolled, then would monitor 100% of patients for Phase I trials and 30% for all other phases - and we monitored all visits. It eventually became burdensome, and the policy was changed to only monitor for so long. These were well defined in the IND Department policies and the monitoring plan for each study.
I think you just need to make sure that whatever you decide is appropriate is delineated in policy and monitoring plan. - Brandi
This is so helpful!! Thank you so much Carolynn and Brandi!
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