Considerations and challenges when using eSource (DDC: Direct Data Capture) for Clinical Pharmacology Study Results of Mock study

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Keita Nagakura1 , Kenichi Furihata M.D., Ph.D 1 , 2 , Akemi Yokozato 1 , Sanae Fujita , Xin Wang 3 , Nobuto Matsui 3 1P One Clinic, Keikokai Medical Corporation., 2 Graduate of Keio University School of Medicine, 3 FMD K&L Japan K.K.

Background

Although the use of eSource is attracting attention as a means of achieving efficiency and quality improvement in clinical trials, various concerns and issues have been raised here and there as the operation at the institution is replaced by direct input from paper to the system. The results of the Mock trial are reported.

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