Quick Data Definitions Using SQL, REPORT and PRINT Procedures

Prior to undertaking analysis of clinical trial data, in addition to review of the Protocol, Case Report Forms, and Statistical Analysis Plan, a basic understanding of the SAS data available is crucial for statistical programmers and biostatisticians. Such an understanding can be accessed readily using the DATASETS and CONTENTS procedures. To centralize in one place and increase efficiency by which the information may be reviewed, a quick method using the SAS DICTIONARY library with the SQL, REPORT and PRINT procedures is presented. Through dynamic, data- driven, generation of macro control variables, a hyper linked data definitions document, in multiple formats, may be produced quickly, and with minimal user input. INTRODUCTION AND BACKGROUND Successful programming and analysis of a clinical trial requires a good understanding of both the protocol and statistical analysis plan, and most importantly, the data collected and available for the study. With regards to the SAS datasets, the size, number, and structure of datasets available are all crucial bits of information needed to get started with programming an analysis. Where information is coming from and resides is also important. Specifications can change within a study, or vary greatly between studies and/or therapeutic areas. Therefore, in the absence of already established documentation, a tool to gather all this information together into one or two files quickly at the initial stages of project work is very useful for a programmer or statistician to familiarize them with the SAS datasets. Informally, the DATASETS and CONTENTS procedures in SAS are great for quickly presenting this information throughout the programming process. Alternatively, much of this information also resides in the DICTIONARY library, accessible using the SQL procedure. Furthermore, the flexibility that SQL provides for dynamically creating and storing macro variables offers a powerful method to access and present the information, with little or no user input. Thus, after a few interim steps, the REPORT procedure is used to present the information such that individual users can navigate as needed using hyperlinks. A subsequent optional feature uses the PRINT procedure to present a subset of the data itself.