Using PROC TEMPLATE to Convert SAS Data to Define.XML

• Activity Number: 189
• Type: Contributed
• Date/Time: Monday, August 1, 2011 : 10:30 AM to 12:20 PM
• Sponsor: Section for Statistical Programmers and Analysts
• Author(s): Matthew Wiedel and Lucius A. Reinbolt*+ and Aleksandra Stein and Vanessa Huang and Steven Kirby and Nancy Wang
• Companies: Celerion Corporation and i3 Statprobe and Celerion Corporation and Celerion Corporation and Celerion Corporation and Celerion
• Keywords: PROC TEMPLATE ; Define.xml ; Metadata

Abstract

Well formed data contains all information necessary to understand study results and conclusions, but that information is not accessible to a general audience. For data to gracefully speak to end users, further information is needed. A define.xml is the additional resource the reader needs to fully appreciate the data. Based on FDA guidance, a define.xml document is now the default standard for use with CDISC SDTM data. A two-step data-driven process is used to create a SAS define.xml document. The first step is the metadata creation which produces 6 SAS define data sets. A data mining approach is utilized to describe the many levels of information within the data. The next step is the integration of SAS define data into an xml formatted document utilizing a robust SAS PROC TEMPLATE approach. Sorted metadata is restructured and transformed into a group of tagsets that comprise the define document. The benefit of this approach is the concise and powerful application of PROC TEMPLATE. It presents the data through a series of define events triggered by the levels of metadata. The proc template code is simple to alter and run, allowing more time to focus on the data itself.