CDISC Terminology

Purpose

The CDISC 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.

Release Dates

CDISC-Terminology-200810	Comprised of SDTM Packages 1, 2A, and 2B, and Labtest Packages 1 and 2. September 24, 2008.
CDISC-Terminology-201003	All SDTM controlled terminology developed and in production as of March 8, 2010, comprised of SDTM Packages 1, 2A, 2B, 3, and 4, and Labtest Packages 1, 2, 3, and 4. Also contains commonly used controlled terminology in the CDASH 1.0 standard.

CDISC Terminology Reference Standard

CDISC 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 Terminology is updated to include the work of numerous terminology project teams. Updates are in the form of new packages or sets of terminology.

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. Two snapshots are currently supported:

The CDISC-Terminology-200810 snapshot was taken in October 2008 in support of SAS Clinical Standards Toolkit 1.2. This snapshot supports CDISC SDTM 3.1.1.
The CDISC-Terminology-201003 snapshot was taken in March 2010 in support of SAS Clinical Standards Toolkit 1.3. This snapshot supports CDISC SDTM 3.1.2.

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 the following global standards library folder (where xxxxxx is the specific snapshot (200810 or 201003):

<global standards library directory>/standards/cdisc-terminology-xxxxxx-1.3/formats.

The following 60 code lists (SAS formats) are in the cumulative CDISC-Teminology-201003 snapshot:

Supported CDISC Terminology Code Lists/Formats

Code List/Format Name	Description	Unique Values
ACN	Action Taken with Study Treatment	7
AESEV	Severity/Intensity Scale for Adverse Events	3
AGESPAN	Age Span	8
AGEU	Age Unit	5
COUNTRY	Country	246
DATEST	Drug Accountability Test Name	2
DATESTCD	Drug Accountability Test Code	2
DICTNAM	Dictionary Name	7
DOMAIN	Domain Abbreviation	45
DSCAT	Category for Disposition Event	3
EGMETHOD	ECG Test Method	22
EGSTRESC	ECG Result	109
EGTEST	ECG Test Name	46
EGTESTCD	ECG Test Code	46
ETHNIC	Ethnic Group	4
EVAL	Evaluator	15
FREQ	Frequency	50
FRM	Pharmaceutical Dosage Form	168
IECAT	Category for Inclusion/Exclusion	2
LBTEST	Laboratory Test Name	580
LBTESTCD	Laboratory Test Code	580
LOC	Anatomical Location	303
MARISTAT	Marital Status	9
METHOD	Method	65
MICROORG	Microorganism	868
MSRESCAT	Microbiology Susceptibility Testing Result Category	7
NCF	Never/Current/Former Classification	3
NCOMPLT	Completion/Reason for Non-Completion	16
ND	Not Done	1
NRIND	Reference Range Indicator	4
NY	No Yes Response	4
OUT	Outcome of Event	6
PKUNIT	PK Parameter Units of Measure	208
POSITION	Position	10
RACE	Race	5
RELTYPE	Relationship Type	2
ROUTE	Route of Administration	112
SCCD	Subject Characteristic Code	7
SEX	Sex	4
SEXPOP	Sex of Participants	3
SIZE	Size	3
SKINCLAS	Skin Classification	6
SKINTYP	Skin Type	3
SOC	CDISC System Organ Class	26
SPECCOND	Specimen Condition	8
SPECTYPE	Specimen Type	41
STENRF	Relation to Reference Period	7
TBLIND	Trial Blinding Schema	3
TCNTRL	Control Type	3
TDIGRP	Diagnosis Group	1
TINDTP	Trial Indication Type	5
TOXGR	Common Terminology Criteria for Adverse Events	5
TPHASE	Trial Phase	12
TSPARM	Trial Summary Parameter Test Name	24
TSPARMCD	Trial Summary Parameter Test Code	24
TTYPE	Trial Type	8
UNIT	Unit	310
VSRESU	Units for Vital Signs Results	14
VSTEST	Vital Signs Test Name	14
VSTESTCD	Vital Signs Test Code	14