XML for Electronic Submission: A Possible Better Alternative to SAS Transport Files

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. Its hierarchical data structure allows XML to establish relationships among elements and other inside/outside sources. As the use of XML gains momentum, it may be accepted by the FDA as a data format for electronic submissions. The SAS transport file has worked as a FDA archival standard for several years but it has its drawbacks. For example, SAS transport files are stand-alone data sets and no explicit relationship can be associated among data sets. Another drawback is that only a limited number of other technologies can process data to or from SAS data sets or SAS transport files. An experimental XML engine was therefore created in SAS 8.0 to import and export XML data files. This paper will introduce the concepts 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. A possible bug in SAS 8.2 XML engine is also reported.