March 27, 2015 This directory contains data files and documentation for controlled terminology used by the Clinical Data Interchange Standards Consortium (CDISC) to support Standard for the Exchange of Nonclinical Data Implementation Guide Versions 3.0 and 3.1 (SENDIG V3.0 and SENDIG V3.1). It represents all SEND controlled terminology developed and in production to date as well as specific SDTM codelists that are in production to date. Additional terminology will be developed on an ongoing basis to support all CDISC standards. Other future additions to the SEND terminology set will be handled via the terminology change request and maintenance process. Contents: Archive (directory for earlier file versions) ReadMe.txt (this file) SEND CDISC ReadME.doc ReadMe tab in CDASH terminology file, doc format SEND Publication Date Stamp.txt information regarding current version date of SEND terminology SEND Terminology Changes.txt detailed description of term changes (text) SEND Terminology Changes.xls detailed description of term changes (Excel) SEND Terminology.OWL.zip terms by codelist, OWL/RDF format SEND Terminology.html terms by codelist, HTML format SEND Terminology.odm.xml terms by codelist, ODM XML format SEND Terminology.pdf terms by codelist, PDF format SEND Terminology.txt terms by codelist, text format SEND Terminology.xls terms by codelist, Excel format Background: SEND is an international standard for nonclinical 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