Exchange of Worldwide Safety Surveillance Data via an International Computer Database

Abstract

International exchange of data via computer-to-computer linkage is illustrated by a worldwide safety surveillance database. Data from postmarketing spontaneous reports is entered into a central database from which reports for regulatory authorities as well as reports for internal usage are generated. The database also provides certain management functions such as prompting for follow-up of cases and tracking of reports due to regulatory authorities. Entry of data may be accomplished by either direct, menu-driven screen entry of by batch entry using microcomputers.