July 22, 2010

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 3.1.2 (IG
3.1.2).  It represents all SDTM controlled terminology developed and in
production to date, comprising SDTM Packages 1, 2A & 2B, 3 and 4 and Labtest
packages 1, 2, 3 and 4. Additional Labtest and Microorganism terminology will be
developed on an ongoing basis. Other future additions to the v3.1.2 terminology
set will be handled via the terminology change request and maintenance process.

The May 1, 2009 release brought changes to the SDTM data files -- notably,
dropping columns J & K -- as noted in the ReadMe file and Excel tab.  A new pair
of change description files provide detailed descriptions of all terminology
changes, including change request tracking numbers and release dates.

The March 8, 2010 release brought changes to the SDTM data files -- notably, the
addition of a controlled terminology subset of SDTM terminology corresponding to
the Clinical Data Acquisition Standards Harmonization Standard 1.0 (CDASH STD
1.0) Appendix A, a listing of commonly used CDISC controlled terminology within
the CDASH standard.

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 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 CDISC ReadMe.doc         Copy of Excel ReadMe tab in Word format
CDASH CDISC ReadME.doc	      ReadMe tab in CDASH terminology file, doc format
CDASH Terminology.txt         terms by codelist, text format
CDASH 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