July 22, 2011 This directory contains data files and documentation for controlled terminology used by the Clinical Data Interchange Standards Consortium (CDISC) to support the Analysis Data Model (ADaM) Implementation Guide Version 1.0 (ADaM v1.0). It represents all ADaM 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) ADaM CDISC ReadME.doc ReadMe tab in ADaM terminology file, doc format ADaM Publication Date Stamp.txt information regarding current version date of ADaM terminology ADaM Terminology Changes.xls detailed description of term changes (Excel) ADaM Terminology Changes.txt detailed description of term changes (text) ADaM Terminology.OWL.zip terms by codelist, OWL/RDF format ADaM Terminology.html terms by codelist, html format ADaM Terminology.odm.xml terms by codelist, ODM XML format ADaM Terminology.pdf terms by codelist, PDF format ADaM Terminology.txt terms by codelist, text format ADaM Terminology.xls terms by codelist, Excel format ReadMe.txt (this file) Background: SDTM and ADaM are international standards for clinical research data, 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 ADaM 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