Paper 163-2009
A SASR Programmer's Guide to Generating Define.xml
Michael Molter, INC Research, Raleigh, NC
ABSTRACT
How would you like to be able to generate a Define.xml with just a few simple PROC PRINT statements? Not
possible, right? Believe it or not, with a well thought-out metadata environment, we can make this dream come true,
but it won't happen overnight.
CDISC's requirement of an XML-based metadata document introduces at least three potentially new challenges to
the SASR programmer asked to generate it. One is at least a basic understanding of XML. A second is a thorough
understanding of the CDISC-specific XML structure of Define.xml. A third is the use of SAS to generate it. All three of
these tasks most likely lie outside the scope of what a SAS programmer building clinical databases, tables, listings,
and graphs ever needed to know. This paper addresses all three of these challenges. After a brief discussion of XML
basics, we will study carefully the structure of Define.xml. With these tools in place, we'll see how the ODS Markup
destination provides a powerful tool for generating the final document with the familiar PRINT procedure.
INTRODUCTION
The Clinical Data Interchange Standards Consortium (CDISC) and pharmaceutical regulatory agencies (such as the
Food and Drug Administration (FDA)) are introducing several changes in the clinical trials submission process, and
with them, several challenges to SAS programmers in the industry. Among such challenges is Define.xml, an XML-
based submission of a study's metadata designed to tell a regulatory reviewer everything they need to know about
the data being submitted. Under the umbrella of Define.xml are many sub-challenges, the collection of which can
make the generation of Define.xml an intimidating task. For starters, there's the organization of metadata.
Something that may have received minimal attention at most, in the past, we are now not only forced to think about it,

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