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. 2010;7(1 Suppl):S46-55.
doi: 10.1177/1740774510373495. Epub 2010 Jul 5.

Quality control of phenotypic forms data in the Type 1 Diabetes Genetics Consortium

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Quality control of phenotypic forms data in the Type 1 Diabetes Genetics Consortium

Letitia H Perdue et al. Clin Trials. 2010.

Abstract

Background: When collecting phenotypic data in clinics across the globe, the Type 1 Diabetes Genetics Consortium (T1DGC) used several techniques that ensured consistency, completeness, and accuracy of the data.

Purpose: The aim of this article is to describe the procedures used for collection, entry, processing, and management of the phenotypic data in this international study.

Methods: The T1DGC ensured the collection of high quality data using the following procedures throughout the entire study period. The T1DGC used centralized and localized training, required a pilot study, certified all data entry personnel, created standardized data collection forms, reviewed a sample of form sets quarterly throughout the duration of the study, and used a data entry system that provided immediate feedback to those entering the data.

Results: Due to the intensive procedures in developing the forms, the study was able to uphold consistency among all clinics and minimal changes were required after implementation of the forms. The train-the-trainer model was efficient and only a small number of clinics had to repeat a pilot study. The study was able to maintain a low percentage of missing data (<0.001%) and low duplicate data entry error rate (0.10%).

Conclusions: It is critical to provide immediate follow-up in order to reinforce training and ensure the quality of the data collected and entered.

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Figures

Figure 1
Figure 1
Error, warning, and informational messages in the T1DGC data entry system.
Figure 2
Figure 2
T1DGC interactive query system.
Figure 3
Figure 3
T1DGC interactive query system, examples of queries.

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