TU03
It's Easy If You Know How: Importing, Processing, and Exporting CDISC XML with SASŪ
Michael C Palmer, Zurich Biostatistics, Inc.

The Clinical Data Interchange Standards Consortium (CDISC) has published an XML-based clinical data standard that will make it easier for a pharmaceutical company or other study sponsor to develop a single, low maintenance, vendor-independent gateway for c linical trials data, including central lab results and FDA-compliant data archiving. The tutorial will cover the basics of data-centric XML, the structural and semantic requirements of CDISC's Operational Data Model (ODM) standard, and techniques for impor ting, processing, and exporting clinical data in SAS using the ODM. The tutorial is needed because SAS users accustomed to flat or relational files have found it challenging to import, process, and export CDISC XML. Trouble has come from two characteristic s of XML. First, it is a text stream, and, second, it is hierarchical in structure. SAS, on the other hand, is oriented towards data in fields and flat or relational file structures. CDISC is a consortium of some 60 leading pharmaceutical companies and v