Define.xml – Case Report Tabulation Data Definition Specification (CRT-DDS)

What is Define.xml?

Define.xml describes the content and structure of datasets and as such, when coupled with standardized SDTM variables, can describe SDTM datasets.

Define.xml can be used to describe any tabular dataset structure and therefore can also be used to describe proprietary datasets.

The actual data for datasets described using Define.xml is usually transmitted using SAS Transport files. 

Business Benefits of Using Define.xml

Define.xml can be used:

• to establish libraries of standards-based or proprietary dataset metadata that can reused from study to study
• to provide an upfront specification to biostatisticians and biostatistical programmers of the target dataset  structure both internally and externally (with CROs partners etc.) 
• during the course of a study to enable a machine driven transformation of ODM or proprietary dataset to SDTM conversion providing a potential reduction in data transformation programming and significant increases in quality 
• to auto generate Define.pdf or sent directly as a Define.xml file for submission purposes as part of an Electronic Common Technical Document (eCTD) submission.

Mark Wheeldon, Formedix CEO, delivered a presentation on the practical uses of Define.xml at the Washington DC CDISC User Group meeting last year.  

Andy Chambers, Formedix Client Solutions Developer, delivered another presentation on Define .xml recently at a CDISC ESUG (English Speaking User Group) meeting in the UK.  

Formedix Products which use the ODM to help you in your Clinical Trials Process:

• Origin^TM Submission Modeller –  A dedicated SDTM and proprietary dataset definition tool utilising Define.xml