Some observations on the collection of medical event data.
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.
D002986:Clinical Trials as Topic; D003625:Data Collection; D004341:Drug Evaluation / Q000379:methods*; D064420:Drug-Related Side Effects and Adverse Reactions; D005568:Forms and Records Control; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration