Large Scale Standard Macros - A Methodical Approach to Development and Implementation

Much of the analysis for clinical trials in the pharmaceutical industry is done with very large standard macros. The use of these macros facilitates the goal of standardizing and accelerating the production of clinical reports within a company. Each standard macro is typically specialized to analyze and report on a specific type of data such as efficacy, safety, drug interactions, or demographics. The challenges encountered during the development of large scale SAS macros and the development process adopted at Boehringer-Ingelheim will be described. This methodical approach improves development efficiency and maintainability. Essential elements of the approach that will be covered include the software development life cycle, macro storage and versioning, modular program structure, program documentation, and common macro tools. Introduction The development and implementation process for large scale SAS macros in company-wide applications can quickly become unmanageable. Specifications, code complexity, code maintainability, life cycle management and testability are just some of the problems faced. Clearly, an organized approach is needed. This paper will describe the methodology and tools that are used at BoehringerIngelheim to address these issues. These methods and tools were derived from established software development practices. For the purpose of this paper, we define a large scale macro as one that performs significant data collection, massaging, analysis and/or reporting tasks. We will often refer to these as ‘systems’ or ‘macro systems’ because they are complex and perform many functions. For example, one of the large scale macros developed for Boehringer-Ingelheim is used for analysis and reporting of lab data and creates over 30 different types of standard reports and has thousands of lines of code. The methodology and associated tools have been successfully applied to the development and implementation process of many large and small macros at our company. The challenges posed by designing large-scale macros Large macros bring with them a range of associated potential problems. The following is an overview of the major issues involved: Structure: When a macro contains hundreds of steps, it is clearly impractical to simply write the code in one big macro. It makes more sense to break the code down by function into Applications NESUG 18