Implementation of a Management Registry for Storing Clinical Data in a Research Centre
Abstract
In clinical research, there is great concern about the storage and veracity of electronic data to ensure the accuracy of information. Objective: To implement a management registry for storing study data in the cardiovascular area, conducted in a clinical research centre. Methods: This is a retrospective registry and prospective joint study. An electronic database was developed using REDCap software. Data elements were standardised in accordance with the American College of Cardiology Foundation and American Heart Association. Data were extracted from research participants from the clinical studies conducted in our Institution with records of cardiovascular diagnosis that were monitored by the health team from 2009 to 2015. Results: The registry was composed of eight sections: demographic variables, diagnostic tests, laboratory tests, cardiovascular risk factors (CV), comorbidities and pharmacological treatment used, and outcome of patients. Each session consisted of sub-items, totalling 113 variables. Phase III (57.8%) and phase IV (36.8%) studies with mean follow-up of 2+4 years were predominant. We used data from 490 participants randomised to 25 studies, 63 percent men, aged 63 ą 10 years, hypertensive (81.4%), with dyslipidaemia (56.5%), and diabetes 48 (36.3%). Most had previous myocardial infarction (72.7%) and underwent coronary angioplasty (87.2%). Conclusion: The implementation of an electronic database of research on participants with cardiovascular disease was applicable and reproducible in clinical practice, being a low cost and very useful tool to store and share data from multicentre studies of medium and large scale.
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Copyright (c) 2017 Suimara dos Santos, Michelle Dornelles Santarém, Clarissa Garcia Rodrigues, Maria Antonieta Pereira de Moraes
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