Date of Award

5-1-2005

Degree Type

Restricted Access Thesis

Degree Name

Master of Science

Field of Study

Clinical Research Management

Department

Graduate School of Biomedical Sciences

First Advisor

Harold Sheedio

Second Advisor

Don Peska

Third Advisor

Myoung Kim

Abstract

Tsai, David C. Compare and Contrast Traditional (Paper) and New (Electronic) Clinical Data Collection Systems-Perspective of the Investigative Site. Masters of Science (Clinical Research Management), April 2006, 83pp., 1 table, 4 figures, bibliography, 12 titles. The emergence of new technology in the form of Electronic Data Capture (EDC) for clinical trials has the potential to overcome the inefficiencies of Traditional Paper Data Capture. However, due to the novelty of Electronic Data Capture Systems in the marketplace, several issues have to be worked out to insure that these systems will be successfully adapted. Among these issues are those concerning personnel training, infrastructure reliability, FDA involvement, and pharmaceutical company acceptance of EDC systems. The emphasis of my clinical research management internship focused on gathering survey responses comparing the two systems in order to determine if the advertise efficiencies of EDC systems were valid.

Comments

Tsai, David C. Compare and Contrast Traditional (Paper) and New (Electronic) Clinical Data Collection Systems-Perspective of the Investigative Site. Masters of Science (Clinical Research Management), April 2006, 83pp., 1 table, 4 figures, bibliography, 12 titles. W 4.5 T877C 2005

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