Electronic Issues for IRBS: Administrative And Regulatory
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Drug Informarion Journal. Vol. 35, pp. 107-113, 2001 F’rinted in the USA. Ail rights reserved.
ELECTRONIC ISSUES FOR IRBS: ADMINISTRATIVE AND REGULATORY MATTHEWD. WHALEN,PHD President, Chesapeake Research Review, Inc., Columbia, Maryland
REBECCAKUSH,PHD Chief Scientific Officer, Next Phase International, Austin, Texas, and President, Clinical Data Interchange Standards Consortium, Austin, Texas
FELIXA. KHIN-MAUNG-GYI, FHARMD,MBA CEO, Chesapeake Research Review, Inc., Columbia, Maryland
Technology to streamline clinical research is advancing largely in three focal areas: electronic submission, electronic data capture; and applications for process improvement and management. New technologies are also ideal for providing the communication infrastructure to create ‘virtual teams’ from distributed members through a new type of ‘connectivity’ that also supports the trend in our society toward diminishing timeframes for such communications. When considering the functional composition of the clinical research team, common roles typically include the sitektudy coordinators, the monitors/clinical research associates (CRAs), the project manager(s), data manager(s), and possibly a medical monitor or a client representative if the trial is conducted by a contract research organization (CRO). Rarely is the institutional review board (IRB)included. The central IRB (independent or medical center consortia-based) can serve as a valuable resource to teams, individually and as a whole. Flows of information involving the IRB most amenable to technology are: Initial submissions to the IRB, informed consent documentation, continuing reviews/final reports, and adverse events. Key Words: IRB; Technology; Process improvement
THE BIOPHAFWACEUTICAL PRODUCT (in databases) and for analyzing these data to development industry has been, albeit rather determine the results of clinical trials. More slowly in comparison with other industries, recently, there has been a surge of technoloadopting additional uses of technology over gies applied to the area of drug discovery, the past decade. This industry has long relied that is, the creation andor identification of on computers for entering and housing data potential compounds for the market. These compounds require testing prior to market approval; hence, a significant bottleneck is developing at this juncture in the overall drug Presented at the DIA Workshop “Electronic Data Capdevelopment process, which now takes on ture and New Technologies,” November 1999, Durham, the order of 10 years and half a billion dollars North Carolina. Reprint address: Dr. Matthew D. Whalen, Chesaper drug. peake Research Review, Inc., The Chesapeake BuildIn an effort to streamline the clinical reing, 9017 Red Branch Road, Suite 202, Columbia, MD search and review processes, several types of 21045.
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Matthew D. Whalen, Rebecca Kush, and Felix A. Khin-Maung-Gyi
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applications involving technology are being tested and/or employed. T
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