Affiliation:
1. Department of Health Information Management, School of Health Management and Information Sciences, Iran University of Medical Sciences, Tehran, Iran
2. Department of Epidemiology, School of Health, Iran University of Medical Sciences, Tehran, Iran
Abstract
Background:A clinical data management system is a software supporting the data management process in clinical trials. In this system, the effective support of clinical data management dimensions leads to the increased accuracy of results and prevention of diversion in clinical trials. The aim of this review article was to investigate the dimensions of data management in clinical data management systems.Methods:This study was conducted in 2017. The used databases included Web of Science, Scopus, Science Direct, ProQuest, Ovid Medline and PubMed. The search was conducted over a period of 10 years from 2007 to 2017. The initial number of studies was 101 reaching 19 in the final stage. The final studies were described and compared in terms of the year, country and dimensions of the clinical data management process in clinical trials.Results:The research findings indicated that none of the systems completely supported the data management dimensions in clinical trials. Although these systems were developed for supporting the clinical data management process, they were similar to electronic data capture systems in many cases. The most significant dimensions of data management in such systems were data collection or entry, report, validation, and security maintenance.Conclusion:Seemingly, not sufficient attention has been paid to automate all dimensions of the clinical data management process in clinical trials. However, these systems could take positive steps towards changing the manual processes of clinical data management to electronic processes.
Funder
Iran University of Medical Sciences, Tehran, Iran
Publisher
Bentham Science Publishers Ltd.
Subject
Pharmacology,General Medicine
Reference81 articles.
1. Friedman LM, Furberg CD, DeMets DL, Reboussin DM, Granger CB. Fundamentals of Clinical Trials. Switzerland: Springer
2. Wieringa S, Engebretsen E, Heggen K, Greenhalgh T. Has evidence-based medicine ever been modern? A Latour-inspired understanding of a changing EBM.
3. Almassinokiani F, Khodaverdi S, Solaymani-dodaran M, Akbari P, Pazouki A. Effects of vitamin D on endometriosis-related pain: a double-blind clinical trial.
4. Solaymani-Dodaran M, Khalili D, Hosseini H. Iranian registry of clinical trials two years on and the timing of registrations.
5. Johnson MR, Kenworthy-Heinige T, Beck DJ. Research site mentoring: A novel approach to improving study recruitment.
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