The Changing Role of Data Management in Clinical Trials with EDC

One of the most important aspects of data collection and analysis in a clinical study is creating quality assurance sources which will ensure data integrity. As the globalization of clinical research increase, there is a need for a timely recording of events as they unveil without any unnecessary delays which may end up adding additional cost to a research study, in question. Hence, incorporating the electronic data capture (EDC) system to data management portfolio is a necessary means to overcoming the cumbersome workload in a clinical study. The “EDC/eClinical approach, shifts the burden of work to predeployment, and from reactive per instance to proactive per project”, which simply compared the burden of work in a traditional data collection system to a modern EDC system (Pratt, 2006). The comparison indicated that the burden of work in an EDC system increases significantly at the designing (planning stage) and development stage and then

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