Using Programming and Database Standards to Promote Efficiency *

Abstract

The pharmaceutical industry cannot function efficiently 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 standards are discussed in the areas of programming style, variable names, documentation, formatting, and use of software options. Database standards are discussed in terms of consistency across studies and the effect on programmer efficiency. Software 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 for 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 efficiently.