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Abstract

CLINIC/3000 is an information system designed for an integrated management of clinical trials on the basis of a relational database. The database description has been separated into three levels: the internal schema (which describes how the information is stored and managed by the operating system), the conceptual schema (which describes how a case report and a study protocol can be modelled in a database), and the external schema (which describe how data can be viewed by the users). The information and the relationship between the different sections of a case report form are recorded in a study dictionary. High level languages make the system accessible to any scientists for description and dynamical modification of the structure of a study, for retrieval of information and generation of tables, graphics and standard reports. A local and remote double data entry system ensures integrity of data and a multilevel quality control procedure guarantees consistency of data.

Keywords

Clinical database Minimal database Data definition language Data manipulation language Data entry language

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Clinic/3000: A New Approach for Clinical Database Implementation and Management

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