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In most cases, the EHRs and EDCs don’t communicate, so in order to share that data with trial organisers, staff members at medical centres must manually copy data between the EHR and an EDC. If all medical centres are connected and can stream data, we can build an infrastructure that makes it more attractive to run clinical trials.”.
The key to data integrity compliance is a well-functioning data governance system 1 , 2 in which the data flow path for all business processes and equipment—such as in manufacturing, laboratory, and clinical studies—is fully understood and documented by a detailed process data flow map. April 2015. Schmitz, U.
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