December 20, 2019 This directory contains data files and documentation for controlled terminology used by the Clinical Data Interchange Standards Consortium (CDISC) to support the Define-XML standard Version 2.1. It represents all Define-XML controlled terminology developed and in production to date. Additional terminology will be developed on an ongoing basis. Other future additions to the terminology set will also be handled via the terminology change request and maintenance process. Contents: Archive (directory for earlier file versions) Define-XML CDISC ReadME.doc ReadMe tab in Define-XML terminology file, doc format Define-XML Publication Date Stamp.txt information regarding current version date of Define-XML terminology Define-XML Terminology Changes.xls detailed description of term changes (Excel) Define-XML Terminology Changes.txt detailed description of term changes (text) Define-XML Terminology.OWL.zip terms by codelist, OWL/RDF format Define-XML Terminology.html terms by codelist, html format Define-XML Terminology.odm.xml terms by codelist, ODM XML format Define-XML Terminology.pdf terms by codelist, PDF format Define-XML Terminology.txt terms by codelist, text format Define-XML Terminology.xls terms by codelist, Excel format ReadMe.txt (this file) Background: SDTM and Define-XML are international standards for clinical research data tabulation and submission, and are approved by the U.S. Food and Drug Administration as standard electronic submission formats. CDISC and NCI work together to develop and maintain Define-XML controlled terminology, which is also integrated and distributed as part of NCI Thesaurus. Further information is available at: http://www.cancer.gov/cancertopics/terminologyresources/CDISC