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Compliance Made Easy

Wolf Ondracek: Jul 17, 2015 2:58:00 PM

Being compliant with clinical trial rules and regulations is not always at the top of the list of researchers and investigators, or of the organization to which they belong. When researchers are involved in industry sponsored studies, compliance is taken care of by the sponsor or the contract research organization that runs the study. But in the case of investigator initiated trials, the researchers often struggle with ensuring a sufficient level of compliance.


The Myth of Auto Query Rate - Is it really the key metric for quality?

Keith Howells: Jul 16, 2015 10:02:00 AM

Imagine you’re a site coordinator just starting to fill out a long form in some EDC system, when you get interrupted. You press “Save” to keep the data entered so far, and the form lights up like a Christmas tree. There are red asterisks everywhere due to queries on all the empty required fields. What a scary sight. When you get a chance to return to the entry task, you plough through every one of those required fields and conscientiously fill in every one of those “change reason” prompts. “Thank heavens that’s done”, you think. Then you get a call from the sponsor indicating that your site has been selected for a higher level of monitoring, because you’ve tripped a metric for the “Auto Query” rate which indicates your site is at a high risk for quality problems. You’re kidding, right? Unfortunately not. According to widely advertised publications, the “Auto Query” rate is claimed as the leading metric for determining a risk-based monitoring strategy, so our long-suffering site coordinator is going to be doubly-punished for what is essentially a product problem.