Validation of database management system applications for clinical trials

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.