DM07
Preparing the SASŪ Software Programming Environment for Regulatory Submission
Sunil K. Gupta, Gupta Programming

For pharmaceutical companies, there is a push to prepare SAS(r) programs for clinical study reporting and analysis. By utilizing a clinical data warehouse design strategy, SAS(r) programs can be set up in advance of the study completion to facilitate the generation of the final study analysis, tables, listings, and graphs. Issues in data warehouse structure and technology and industry standards will be discussed. This paper reviews the process of establishing a standard method to prepare the SAS(r) softw are programming environment (SAS/BASE(r), SAS/ACCESS(r), SAS/AF(r), SAS/FSP(r), SAS/STAT(r), SAS/GRAPH(r)) for regulatory submissions. By incorporating best practices in the data collection, data entry, data cleaning and data reporting of clinical studie s, the generation of the final end result will be more efficient. The software tool used to facilitate this process is complementSoft ASAP software application with Clinical Reporting Templates.