This paper describes a novel approach used to develop a patient profile reporting application using Base SAS in the Windows NT Operating System. A patient profile report is a display of the clinical study data that is collected for an individual patient, organized by time and data category. Patient profiles are often used to report clinical study information to the FDA as part of a regulatory submission. The approach used was to publish the patient profile report as data (to a SAS dataset), containing all of the appropriate titles, data, footnotes and pagination information. This paper discusses the development methodology employed in this project, the patient profile report requirements and patient profile application architecture.
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