October 9, 2008

This directory contains data files and documentation for controlled
terminology used by the Clinical Data Interchange Standards Consortium (CDISC)
to support Study Data Tabulation Model (SDTM) Implementation Guide Version
3.1.1 (IG 3.1.1).  It represents all SDTM controlled terminology developed and
in production to date, comprising SDTM Packages 1, 2A & 2B and Labtest
Packages 1 & 2.  Additional SDTM Terminology is in development (SDTM Package
3, Labtest Package 3) and will be moved into production in the fall of 2008.
This will be the final major release of terminology for SDTM IG 3.1.1.  Any
future additions to the 3.1.1 terminology set will be handled via a
terminology maintenance process to be implemented later this year.  

Contents:

Archive                       (directory for earlier file versions)
ReadMe.txt                    (this file)
SDTM Terminology.xls          terms by codelist, Excel format
SDTM Terminology.txt          terms by codelist, text format
                                (omits column 'K: Notes')
SDTM Changes.txt              date and description of term changes
                                (same as "Changes" tab in Excel file)
SDTM CDISC ReadMe.doc         Copy of Excel ReadMe tab in Word 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.

Further information is available at:
     http://www.cancer.gov/cancertopics/terminologyresources/CDISC