Tools for Clinical Trials Management: Handling the Norm and the Outliers

Brinkley, James F and Ach, Daniel and Franklin, Joshua D and Anderson, Nicholas R and Stevens, Anne and Tarczy-Hornoch, Peter (2007) Tools for Clinical Trials Management: Handling the Norm and the Outliers. In: American Medical Informatics Association Fall Symposium. p. 5.

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While planning for the newly funded University of Washington Institute of Translational Health Sciences (ITHS) the informatics core has begun to assess the information management needs of ITHS investigators with relatively small scale datasets, who generally do not have the funds to purchase expensive commercial systems. Our preliminary conclusion from this effort is that the majority of investigators are engaged in relatively standard clinical trials, the data from which can be organized into a common schema such as the CDISC Operational Data Model (ODM), and for which a number of software tools have been developed. However, a minority of investigators has nonstandard data management needs; hence no single schema will handle these needs. These users present a difficult problem since custom development can be prohibitively expensive.

Item Type: Book Section
Additional Information: From Clinical Research Informatics Expo
Uncontrolled Keywords: amia2007
Subjects: All Projects > Clinical Research Data Management
Depositing User: Jim Brinkley
Date Deposited: 30 Nov 2007
Last Modified: 24 Jul 2017 23:45

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