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The Impact on Clinical Research Sites When Direct Data Entry Occurs

October 1, 2014

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Data Services

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Article

In 2010, the European  Medicines Agency (EMA) issued a “Reflection Paper Expectations for Electronic  Source Data and Data Transcribed to Electronic Data Collection Tools in Clinical Trials,” and in 2013, the United States Food and Drug Administration  (FDA) issued the “Guidance for Industry: Electronic Source Data in Clinical  Investigations”. These documents support the concept of the use and  acceptance of eSource documents in lieu of paper records by regulatory  agencies. e

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SCRS InSite
The Society for Clinical Research Sites
October 1, 2014
http://myscrs.org/insite/

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