Browsing by Subject "FDA"
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Item Compare and Contrast Traditional (Paper) and New (Electronic) Clinical Data Collection Systems Perspective of the Investigative Site(2005-05-01) Tsai, David C.; Harold Sheedio; Don Peska; Myoung KimTsai, 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.Item Gaining New Insights on Improving the Current System of Institutional Review Boards Research Site Interaction: A Novel Approach(2008-05-01) Bangalore, Kiran; Harold SheedloThe debate on the flaws and challenges faced by the Institutional Review Board (IRB) has been going on from its inception. The Office of Inspector General (OIG) in the department of Health and Human Services along with the FDA have reported on the current situation calling upon experts to find solutions to the laborious and inefficient human subject protection protocol review system. In spite of the emergence of thousands of IRB' s and newer proposed models of review systems, the current system still remains inefficient. This is a problem faced in all countries and there is an overwhelming need for an efficient, ethically equipped, and standard system to review, regulate and monitor clinical research. A national standardized clinical research review board (CRRB) would enable in safely securing research and its subjects and advance science and ethics.