The problems encountered using a manual system to manage data generated by clinical trials at Smith Kline and French, are highlighted. The development of a computer sys tem for handling clinical trials' data, using database tech niques, is presented. The problems encountered and the bene fits gained from using both hierarchical tree and network structures are discussed. The disciplines enforced by a com puter system necessitated some changes in the design of the documents used to record the raw data. These changes are described. About half of the clinical trials' data are quali tative or textual, and the problems inherent in computerising this type of data and their solutions are presented.
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References
1.
World Health Organisation, International Monitoring of Adverse Reactions to Drugs, Adverse Reaction Terminology (1976).
2.
World Health Organisation, International Classification of Diseases, Eighth Revision ( 1965).
