January 24, 2007 This directory contains documentation, data files, and other resources related to controlled terminology used by the Clinical Data Interchange Standards Consortium (CDISC). NCI Enterprise Vocabulary Services (EVS) is working actively with CDISC to develop and support controlled terminology in several areas, notably CDISC's Study Data Tabulation Model (SDTM). Contents: ReadMe.txt (this file) SDTM (directory for SDTM data files etc.) 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 integrated and distributed as part of NCI Thesaurus. Further information is available at: CDISC: http://www.cdisc.org EVS: http://evs.nci.nih.gov NCI Thesaurus: http://nciterms.nci.nih.gov/ Additional documentation, data files, and tools will be provided soon.