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30.06.2010
EPC, June Edition, 30 June 2010. Debra Jendrasek and Greg Johnson of Chiltern examine a new model of leadership designed to get the best out of EDC studies
Electronic data capture (EDC) has become the norm for new clinical studies. Therefore, it is now critical to understand how EDC changes the way we work. Many papers and presentations have focused on how EDC forces the study team to prepare for set-up earlier
than they would have done for a similar study conducted on paper. The EDC start-up timeframe is loaded with deliverables that could have waited weeks, or even months, to be completed in a paperled world. In an EDC study, most of the deliverables are now due long before the first patient is enrolled. The people and tools that are used to oversee these deliverables and deadlines are major contributors to the success of the study start-up phase and help to prepare the project team for a study that will be successful throughout the process.
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