A Prototype Data Management and Analysis System for Clinical Investigators

An Initial Functional Description

by W. L. Sibley, Marsha Hopwood, Gabriel F. Groner, Norman A. Palley

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The initial functional specifications for a minicomputer-based prototype data management and analysis system to be used in investigating the role of such systems in clinical research. This prototype is being developed as part of the CLINFO project, which is sponsored by the Division of Research Resources of the National Institutes of Health. In addition to its data management and analysis capabilities, the prototype will collect data that will be used to evaluate its effectiveness in clinical research centers, where the prototype will be installed on an experimental basis. The discussion of the functional specifications is preceded by a review of the requirements leading to the need for the functions. The requirements and the specifications form the foundation for the detailed design documents that will be produced before actual system implementation begins. (See also R-1539, R-1542.)

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