The Impact of
Electronic Data Capture on
Clinical Data Management
Perspectives from the Present into the Future
Electronic data capture (EDC)-based clinical trials offer operational and
cost-effective approaches for ongoing data entry via the Internet for...
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The Impact of
Electronic Data Capture on
Clinical Data Management
Perspectives from the Present into the Future
Electronic data capture (EDC)-based clinical trials offer operational and
cost-effective approaches for ongoing data entry via the Internet for
clinical sites; medical monitoring; monitoring by clinical research associates (CRAs), including initial review of data in the home office and then
performing source document verification at the study site; identification of
potential errors by data management; and determination of the status of
the clinical trial by project management.
1-4
Ten years ago, Kelly and Oldham5
discussed the challenges of implementing EDC and the potential
advantages in clinical development.
Kuchenbecker and colleagues6
foresaw
the emerging role of Internet technologies for data acquisition and predicted the eventual common use of EDC in the pharmaceutical industry.
Banick7
predicted that with EDC, time to database lock could be reduced by
43% and queries
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