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.

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.

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.

For SDTM, these snapshots are supplied:

200810 snapshot was taken from the NCI EVS Controlled Terminology for SDTM released October 2008 in support of the SAS Clinical Standards Toolkit 1.2. This snapshot supports CDISC SDTM 3.1.1.
201003 snapshot was taken from the NCI EVS Controlled Terminology for SDTM released March 2010 in support of the SAS Clinical Standards Toolkit 1.3. This snapshot supports CDISC SDTM 3.1.2.
201104 snapshot was taken from the NCI EVS Controlled Terminology for SDTM released April 2011 in support of the SAS Clinical Standards Toolkit 1.4. This snapshot supports CDISC SDTM 3.1.2.

For ADaM, this snapshot is supplied:

The 201101 snapshot was taken from the NCI EVS Controlled Terminology for SDTM released January 2011 in support of the SAS Clinical Standards Toolkit 1.4. This snapshot supports CDISC ADaM 2.1.

For CDASH, this snapshot is supplied:

The 201104 snapshot was taken from the NCI EVS Controlled Terminology for SDTM released April 2011 in support of the SAS Clinical Standards Toolkit 1.4. This snapshot supports CDISC CDASH. Although the SAS Clinical Standards Toolkit is not shipped with this standard, the terminology is provided as a convenience for our users.

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 YYYYYY is the specific snapshot (200810, 201101, and so on):

<global standards library directory>/standards/cdisc-terminology1.4/cdisc-xxxx/<current OR
                        YYYYYY>/formats

Here is an example for SDTM:

C:/cstGlobalLibrary/standards/cdisc-terminology-1.4/cdisc-sdtm/201104/formats

The current folder is a convenience and enables you to place the current terminology that you are using within the SAS Clinical Standards Toolkit. The default for this folder is the most recent release of the Controlled Terminology as shipped with the SAS Clinical Standards Toolkit. This table lists the 62 code lists (SAS formats) that are in the cumulative CDISC-Teminology-201104 SDTM 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	119
EGTEST	ECG Test Name	46
EGTESTCD	ECG Test Code	46
ETHNIC	Ethnic Group	4
EVAL	Evaluator	15
FREQ	Frequency	51
FRM	Pharmaceutical Dosage Form	168
IECAT	Category for Inclusion/Exclusion	2
LBTEST	Laboratory Test Name	649
LBTESTCD	Laboratory Test Code	649
LOC	Anatomical Location	303
MARISTAT	Marital Status	9
METHOD	Method	72
MICROORG	Microorganism	871
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
PKPARM	PK Parameters	187
PKPARMCD	PK Parameters Code	187
PKUNIT	PK Parameter Units of Measure	207
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 V4.0	6
TPHASE	Trial Phase	12
TSPARM	Trial Summary Parameter Test Name	30
TSPARMCD	Trial Summary Parameter Test Code	30
TTYPE	Trial Type	8
UNIT	Unit	310
VSRESU	Units for Vital Signs Results	14
VSTEST	Vital Signs Test Name	15
VSTESTCD	Vital Signs Test Code	15