Using Programming and Database Standards to Promote Efficiency
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Copyrighl 0 1998 Drug Information Association Inc.
USING PROGRAMMING AND DATABASE STANDARDS TO PROMOTE EFFICIENCY* J. MEIMEIMA, PHD Associate Director. Clinical Data Support and Analysis. Quintiles. Inc., Research Triangle Park, North Carolina
SANDRASCHLOTZHAUER, MS Pnncipal, Schlotzhauer Consulting, Chapel Hill, North Carolina
The pharmaceutical industry cannotfunction eficiently without standards. What is meant, however, by standards for clinical research programming and analysis? How can standards help with the activities of data management, data cleaning, statistical analysis, study tabulation, and statistical writing? Where can descriptions of relevant standards be found? Programming standanis are discussed in the areas of programming style, variable names, documentation, formatting, and use of sofnvare options. Database standards are discussed in terms of consistency across studies and the effect on programmer eficiency. Sofrware standards are also briefly discussed. Because of differences in terminology,first the terms as used in the paper are defined, Disadvantages of standards include the need for a strong corporate culture, requirements for updating standards, and increased overhead f o r tools and management. More importantly, advantages of standards include increased communication and better teamwork, more effective use of programmer time, and increased ability to perform computer systems validation eficiently. Key Words: Data management; Programming standards; Database standards; Validation; Electronic submissions
INTRODUCTION CLINICAL RESEARCH PROGRAMMING and analysis includes the activities of data management, data cleaning, statistical analysis, study tabulation, and statistical report writing. In this context, programming involves a team of database administrators, data managers, statistical programmers, and Reprint address: J. Meimei Ma, Quintiles. Inc., P.O. Box 13979, Research Triangle Park, NC 27709-3979. *TRADEMARKS-All brand and product names are registered trademarks or trademarks of their respective companies.
systems programmers. From an intellectual viewpoint, this area of the pharmaceutical industry cannot function efficiently without standards. The term “standard,” however, is one with multiple definitions. In addition, the word “efficiency” includes multiple meanings. Focusing on how standards are used provides a foundation for justifying the implementation of stahdards. A broad range of standards, from programming style and database structure to software selection, are discussed. The examples focus on analysis programming, but the principles also apply to data management.
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J. Meimei M a and Sandra Schlotzhauer
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TERMINOLOGY Defining Standard A dictionary definition for standard is: “a model to which others must conform” or: “something accepted as a basis for comparison.” This paper distinguishes three different types of standards: de facto, external, and internal. In a computerized
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