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Trials 2011
Can an online clinical data management service help in improving data collection and data quality in a developing country setting?Abstract: Data items entered were checked for inconsistencies automatically when submitted online. The data were divided into primary and secondary data items. We analysed both the total number of errors and the change in error rate, for both Primary and Secondary items, over the first five month of the trial.In the first five months 51 patients were entered. The Primary data error rate was 1.6%, whilst that for Secondary data was 2.7% against acceptable error rates for analysis of 1% and 2.5% respectively.The presented analysis shows that after five months since the introduction of the CTDMS the Primary and Secondary data error rates reflect acceptable levels of data quality. Furthermore, these error rates were decreasing over time. The digital nature of the CTDMS, as well as the online availability of that data, gives fast and easy insight in adherence to treatment protocols. As such, the CTDMS can serve as a tool to train and educate medical doctors and can improve treatment protocols.Data collection concerning medical needs is required to assess the effectiveness of interventions and current health care practices [1]. Furthermore, data collection by Electronic Medical Record (EMR) systems has been proven to be helpful in data collection for scientific research and can be helpful in improving healthcare. These EMR systems allow for the early identification of missing data and the patients possibly loss-to-follow-up, which is essential for the conduct of proper scientific research [2-6].A Clinical Trial Data Management service (CTDMS) has been introduced for running a multicenter clinical trial in Indonesia and in the Netherlands. The same system has also been introduced for monitoring treatment results of Nasopharyngeal Carcinoma (NPC) in Indonesia.In most countries NPC is an orphan disease, but overall has a worldwide incidence of 80.0000 new cases per year, being endemic in Northern Africa, Southern China and Hong Kong, and the South-East Asian peninsula, including Malay
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