EB01
A Comparison of XML and SAS Xport Files for Electronic Submission
Tianshu Li, Merck & Co., Inc.

The eXtensible Markup Language (XML) is the next generation of ASCII text file. It was developed to describe, transfer, deliver and share data across different platforms and applications. As the use of XML is gaining momentum, it is possible that the FDA m ight accept XML as a data format for electronic submissions in the near future. On the other hand, the SAS transport file has worked as an FDA archival standard for several years but it has its drawbacks. For example, although the SAS transport files are p ortable data sets, only a limited number of other technologies can process data to/from the SAS data sets or SAS transport files. Thus an experimental XML engine was created in SAS 8.0 to import and export XML data files. This paper will introduce the c oncepts of XML and SAS Xport files; compare XML and SAS data structures and assess the pros and cons of these two data structures for electronic submissions.