September 30, 2022 This directory contains data files and documentation for controlled terminology used by the Clinical Data Interchange Standards Consortium (CDISC) to support the Digital Data Flow (DDF) project. It represents all DDF 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) DDF CDISC ReadME.doc ReadMe tab in DDF terminology file, doc format DDF Publication Date Stamp.txt information regarding current version date of DDF terminology DDF Terminology Changes.xls detailed description of term changes (Excel) DDF Terminology Changes.txt detailed description of term changes (text) DDF Terminology.OWL.zip terms by codelist, OWL/RDF format DDF Terminology.html terms by codelist, html format DDF Terminology.odm.xml terms by codelist, ODM XML format DDF Terminology.pdf terms by codelist, PDF format DDF Terminology.txt terms by codelist, text format DDF Terminology.xls terms by codelist, Excel format ReadMe.txt (this file) Background: SDTM is an international standard for clinical research data, and is approved by the U.S. Food and Drug Administration as a standard electronic submission format. CDISC and NCI work together to develop and maintain SDTM controlled terminology, which is also integrated and distributed as part of NCI Thesaurus (NCIt). Further information is available at: http://www.cancer.gov/cancertopics/terminologyresources/CDISC