Define.xml

Define.xml (Case Report Tabulation Data Definition Specification) is a document that FDA required for drug submission. It describes the structure and contents of the data collected during the clinical trial process. Because Define.xml can increase the level of automation and improve the efficiency of the Regulatory Review process, FDA likes to have it with drug submission. 

The define.xml standard is based on the CDISC Operational Data Model (ODM), which is available at http://www.cdisc.org/standards/index.html

To generate the code for Define.xml, there are three challenges [1] that average SAS programmers need to overcome: 

 1. Basic understanding of XML 

 2. Thorough understanding of the CDISC-specific XML structure of Define.xml 

 3. SAS expertise to generate the XML code The first two challenges are fundamental

There are no alternatives or shortcuts to them. However, there are alternatives to the third one. Instead of SAS or XML tools, SDTM specifications and Microsoft Excel can be used to program Define.xml in a practical and efficient way.