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Title: Quality control of phenotypic forms data in the Type 1 Diabetes Genetics Consortium
Authors: Perdue, Letitia H.
Albret, Lotte
Aldrich, Alan
Loth, Amanda
Sides, Elizabeth G.
Dove, Angela
Wägner, Ana 
Waterman, Rebecca
Pierce, June J.
Akolkar, Beena
Steffes, Michael W.
Hilner, Joan E.
UNESCO Clasification: 32 Ciencias médicas
3201 Ciencias clínicas
Keywords: International Genetics
Issue Date: 2010
Journal: Clinical Trials 
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.
ISSN: 1740-7745
DOI: 10.1177/1740774510373495
Source: Clinical Trials [ISSN 1740-7745], v. 7 (sup. 1), p. S46-S55, (Agosto 2010)
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