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How important is data quality to you?

Wolf Ondracek: Aug 19, 2015 2:46:00 PM

Are the quality and integrity of your clinical trial data important to you? The answer of course should be: Yes! Extremely important! Collecting data is the very reason why you run your clinical trials. The data is all you have to confirm your scientific hypothesis. It is gold in your hands. So naturally the quality of the data should be your top priority. And there is no data quality without demonstrated data integrity, because if your data are not protected against uncontrolled manipulation, they basically lose their value.

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.