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Data queries are "questions" about clinical study data that are sent back to investigative sites, primarily by data managers, clinical (site) monitors, medical monitors, and EDC systems (autoqueries). The rate of queries bears a relationship to the quality of data being entered into eCRFs by sites. Therefore, excessive query rates—or rates that are too low—on a site, study, therapeutic, geographic, or enterprise level might indicate a need for intervention, process improvement, or both. Not all queries lead to data corrections and not all corrections are the result of queries. But the trend between query rate and data correction rate should be reasonably similar, which is indeed supported by the Medidata Insights data.
This month's Insights graph represents query rate data from the Medidata Insights metrics warehouse covering 2007–2011 and is based on a subset of closed studies from the overall database of more than 2,500 studies from 16 therapeutic areas and 65 contributing study sponsors. The query rate for each closed study is calculated as the overall rate of queries issued to sites for every 1,000 eCRF data points submitted and is represented as quantiles for multiple studies.
Notably, the data shows that autoqueries (light blue bar) are by far the most prevalent query type, which speaks strongly to the benefit and ROI of EDC. It is estimated that the average cost to resolve each query is $53.87 (Medidata Solutions analysis of PICAS® and CROCAS® data). What's more, the data illustrate that the overall industry query rate over a five-year period in all phases of clinical research was approximately 60 queries per 1,000 data points. Considering that approximately 48 of these 60 queries (80%) on average were autoqueries, the significant cost to finance the armies of site monitors that most organizations employ for so little return must again be questioned. In this case, auto-queries represent a significant form of cost avoidance. The declining trend in percent SDV seen across industry and noted previously supports this observation. Note that non-site queries, such as those issued from a data manager to a site monitor, are excluded from this metric. Also note that only non-derived, non-double data entered (DDE), manually submitted eCRF data points are included in the calculation.