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Receiver operating characteristic (ROC) analysis has been used in a broad variety of medical imaging studies during the past 15 years, and its advantages over more traditional measures of diagnostic performance are now clearly established. But despite the essential simplicity of the approach, workers in the field often find—sometimes only after an ROC study is under way—that a number of subtle issues related to experimental design and data analysis must be confronted in practice. Many of these issues have not been discussed in the literature in detail, and most are not well known. The purposes of this paper are to make users of ROC methodology in medical imaging aware of potential problems that should be confronted before an ROC study is begun and to indicate, at least broadly, how those problems may be dealt with, given the present state of the art. Some of the issues raised here can be addressed adequately by easily prescribed techniques, whereas others remain difficult and will be resolved fully only by new methodologic developments.