A microcomputer-based data entry system has been developed by the Food and Drug Administration as a method of reporting adverse drug reactions that are required by pharmaceutical manufacturers to be periodically submitted to the Agency on an official form. This microcomputer system may also be useful for other interested health professional concerned with the safety of drugs and biologics. The system provides a mechanism by which the entered data can be converted to the format acceptable for use by most currently available data management and statistical packages.
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