March 25, 2016 The controlled terminology in this spreadsheet supports Study Data Tabulation Model Implementation Guide Version 3.2 (SDTMIG v3.2). It represents all SDTM controlled terminology developed and in production to date. This version is a complete list of all controlled terminology used for both SDTM and CDASH. Additional terminology will be developed on an ongoing basis to support all CDISC standards. Other future additions to the v3.2 terminology set will be handled via the terminology change request and maintenance process. As of the publication on 2010-04-08, the CDISC Preferred Term column (formerly Column F) was removed. It was determined that this column was redundant and confusing to most implementers. Column F now contains CDISC synonyms. The December 18, 2015 release brought changes to the SDTM data files -- notably, the standalone Questionnaires, Ratings, and Scales (QRS) Terminology has been deprecated and its content subsumed into the Study Data Tabulation Model (SDTM) Terminology publication file. Contents: Archive (directory for earlier file versions) CDASH CDISC ReadME.doc ReadMe tab in CDASH terminology file, doc format CDASH Publication Date Stamp.txtinformation regarding current version date of CDASH terminology CDASH Terminology Changes.xls detailed description of term changes (Excel) CDASH Terminology Changes.txt detailed description of term changes (text) (same as "Changes" tab in Excel file) CDASH Terminology.OWL.zip terms by codelist, OWL/RDF format CDASH Terminology.html terms by codelist, HTML format CDASH Terminology.odm.xml terms by codelist, ODM XML format CDASH Terminology.pdf terms by codelist, PDF format CDASH Terminology.txt terms by codelist, text format CDASH Terminology.xls terms by codelist, Excel format ReadMe.txt (this file) SDTM CDISC ReadMe.doc Copy of Excel ReadMe tab in Word format SDTM Publication Date Stamp.txt information regarding current version date of SDTM terminology SDTM Terminology Changes.xls detailed description of term changes (Excel) SDTM Terminology Changes.txt detailed description of term changes (text) (same as "Changes" tab in Excel file) SDTM Terminology.OWL.zip terms by codelist, OWL/RDF format SDTM Terminology.html terms by codelist, HTML format SDTM Terminology.odm.xml terms by codelist, ODM XML format SDTM Terminology.pdf terms by codelist, PDF format SDTM Terminology.txt terms by codelist, text format (omits column 'K: Notes') SDTM Terminology.xls terms by codelist, Excel format 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