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

Posted by Keith Howells on 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.

It doesn’t have to be this way. When you’re booking a flight on the web, you don’t expect to get all the way to the “Confirm Purchase” button, and then get told that the transaction is invalid because the return date is earlier than the departure date. Heck, that was three pages ago and you expect to have been told of the problem immediately. If you select a one-way flight, you expect to only see only place to enter the flight date, rather than have to know that in this instance you should leave the second row blank. Why do EDC systems have to be so 90’s in their approach of waiting till everything has been entered and only then carrying out the validation?

Fortunately it doesn’t have to be this way. The same AJAX technology that makes commercial web sites so easy to use is available in some EDC systems. This means that the user is guided field-by-field to enter consistent data. Mark an AE as continuing and you cannot type anything into the “Stop date” field. Mark it as not continuing and you must enter a stop date. By the time you press “Save”, you know the data is self-consistent, and you’re not going to get a jarring electric shock of red asterisks. We recently profiled six years of data for TrialMaster® studies, and found the “Auto Query” rate is an order of magnitude less than is publicized for other EDC products. There’s the same level of overall data quality, but one tenth the level of site irritation. Is that valuable? Is that important enough to change out your EDC vendor? Before you answer, visit a site and listen for those muffled squeals of anguish and frustration. Then you’ll know.


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Tags: Data Quality, Data Queries