CDISC Controlled Terminology

Purpose
CDISC Controlled Terminology Reference Standard

Purpose

The CDISC Controlled Terminology standard supports standardizing values for columns in data submitted to the regulatory authorities. Standardization facilitates loads into regulatory databases, data review, and analysis. The initial standardization of values has primarily been in support of SDTM submission data and the CDISC CDASH (Clinical Data Acquisition Standards Harmonization) development of standardized data collection instruments.

CDISC Controlled Terminology Reference Standard

CDISC Controlled Terminology is maintained by and distributed as part of the National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS) Thesaurus. For more information, see References. Periodically, CDISC Controlled Terminology is updated to include the work of numerous terminology project teams. Updates are in the form of new packages or sets of terminology.
The SAS Clinical Standards Toolkit offers snapshots of the NCI EVS Thesaurus. These snapshots are typically coordinated with the release of other CDISC standards that use the thesaurus. Several snapshots are currently supported across several standards.
The SAS Clinical Standards Toolkit offers a tool to import controlled terminology from the ODM XML files that can be downloaded from the NCI CDISC Controlled Terminology FTP site (http://evs.nci.nih.gov/ftp1/CDISC/).
For SDTM, these snapshots are supplied, which support the Study Data Tabulation Model Implementation Guide (SDTMIG):
  • The 201212 snapshot was taken from the NCI EVS Controlled Terminology for SDTM, released December 2012.
  • The 201312 snapshot was taken from the NCI EVS Controlled Terminology for SDTM, released December 2013.
  • The 201406 snapshot was taken from the NCI EVS Controlled Terminology for SDTM, released June 2014.
For SEND, these snapshots are supplied, which support the Standard for the Exchange of Nonclinical Data Implementation Guide Version 3.0 (SENDIG V3.0):
  • The 201212 snapshot was taken from the NCI EVS Controlled Terminology for SEND, released December 2012.
  • The 201312 snapshot was taken from the NCI EVS Controlled Terminology for SEND, released December 2013.
  • The 201406 snapshot was taken from the NCI EVS Controlled Terminology for SEND, released June 2014.
For ADaM, these snapshots are supplied, which support the Analysis Data Model Implementation Guide Version 1.0 (ADaMIG v1.0):
  • The 201101 snapshot was taken from the NCI EVS Controlled Terminology for ADaM, released January 2011.
  • The 201107 snapshot was taken from the NCI EVS Controlled Terminology for ADaM, released July 2011.
  • The 201512 snapshot was taken from the NCI EVS Controlled Terminology for ADaM, released December 2015.
For Questionnaires (QS), the following snapshot is supplied, which supports the Questionnaire Controlled Terminology for the current version of the Study Data Tabulation Model Implementation Guide:
  • The 201312 snapshot was taken from the NCI EVS Controlled Terminology for Questionnaires, released December 2013.
  • The 201406 snapshot was taken from the NCI EVS Controlled Terminology for Questionnaires, released June 2014.
For CDASH, these snapshots are supplied, which support the Clinical Data Acquisition Standards Harmonization Standard Version 1.0 (CDASH STD v1.0):
  • The 201212 snapshot was taken from the NCI EVS Controlled Terminology for CDASH, released December 2012.
  • The 201312 snapshot was taken from the NCI EVS Controlled Terminology for CDASH, released December 2013.
  • The 201403 snapshot was taken from the NCI EVS Controlled Terminology for CDASH, released April 2014.
Note: Although SAS does not provide the SAS Clinical Standards Toolkit with the CDASH standard, the terminology is provided as a convenience.
Each CDISC Terminology standard includes a SAS format catalog (cterms.sas7bcat) and a SAS data set (cterms.sas7bdat). The catalog and data set are found in this global standards library folder (where xxxx is the specific standard (adam, cdash, or sdtm) and YYYYMM is the specific snapshot (201104, 201212, and so on):
global standards library directory/standards/cdisc-terminology1.7/cdisc-xxxx/<current OR YYYYMM>/formats
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