Validation of database management system applications for clinical trials

Research output: Contribution to journalArticle

Abstract

This article deals with the organization, methodology, and documentation for user-written mainframe database management system (DBMS) application programs for clinical trials. Validation is defined as a quality-building process, not an error-finding process. Both functional and structural approaches to unit testing are covered. Important differences between DBMS application programs and computational programs and their impact on validation are presented. Validation methodology is presented for data dictionary, data entry, data retrieval, and Statistical Analysis System (SAS) interface, report writing, and security applications. Computer simulation methods, batch versions of interactive programs-independent SAS listings, and shortcuts facilitated by features of certain DBMSs are presented. Recommendations are made to DBMS vendors for needed validation tools.

Original languageEnglish (US)
Pages (from-to)475-480
Number of pages6
JournalTherapeutic Innovation & Regulatory Science
Volume21
Issue number4
DOIs
Publication statusPublished - Jan 1 1987
Externally publishedYes

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Keywords

  • Clinical trials
  • Database management systems
  • Software validation

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Public Health, Environmental and Occupational Health
  • Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

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