Quality control of phenotypic forms data in the Type 1 Diabetes Genetics Consortium
Autor: | Ana M Wägner, Lotte Albret, Michael W. Steffes, Alan Aldrich, Amanda Loth, Joan E. Hilner, Letitia H Perdue, Rebecca Waterman, Angela Dove, T Dgc, June J Pierce, Beena Akolkar, Elizabeth G. Sides |
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Rok vydání: | 2010 |
Předmět: |
Quality Control
Biomedical Research Internationality Pilot Projects Certification Data entry Global Health 01 natural sciences 010104 statistics & probability 03 medical and health sciences 0302 clinical medicine Humans Medicine 030212 general & internal medicine 0101 mathematics Pharmacology Genetics Informed Consent Data collection business.industry Data Collection Articles General Medicine 3. Good health Diabetes Mellitus Type 1 Phenotype Data quality business |
Zdroj: | Clinical Trials (London, England) |
ISSN: | 1740-7753 1740-7745 |
Popis: | 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 ( Conclusions It is critical to provide immediate follow-up in order to reinforce training and ensure the quality of the data collected and entered. Clinical Trials 2010; 7: S46—S55. http://ctj.sagepub.com |
Databáze: | OpenAIRE |
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