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A Metadata Extraction Approach for Clinical Case Reports to Enable Advanced Understanding of Biomedical Concepts
Published on: September 20, 2018
Some observations on the collection of medical event data
Abstract:
A review of the philosophy, strategies, and methods for the collection of medical event (ME) information in clinical trials sponsored by the Research and Development Division of THe Upjohn Company is presented. Goals for collection of ME information for Phase I, II, and III trials are reviewed. Case report form and terminology issues are discussed, with particular emphasis placed on procedures that avoid premature decisions on ME causality and incomplete reporting of events. Procedures for separating the seriousness from the intensity of the MEs are reviewed. Analysis issues are considered insofar as they impact on data collection procedures and goals. Recommendations are made with respect to protocol content, data collection forms, and related analysis issues.
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