The current version of the Study Data Tabulation Model Implementation Guide Version 3.1.2 (SDTMIG v3.1.2) answers to CDSH questions to comply with SDTM terminology.

Some key points to remember:

  • You need to define which codelists will be applied to which questions
  • Most data entry systems require a concise list of potential terms per variable/field
  • SDTM terminology codelists are big, e.g. C66786 – COUNTRY which covers all potential COUNTRYs for all clinical trials / site management
  • Controlled terminology gap – we need to develop new terms

So how SDTM terminology become possible?

In order to improve the efficiency of human drug review through required electronic submissions and standardization of electronic drug application data, FDA and industry leaders are working together in this initiative.

Format in EXCEL

SDTM controlled terminology is extracted from the NCit by an automated procedure that creates a report organized into terminology codelists. These codelists correspond to CDISC variables.

To access SDTM Controlled Terminology visit CDISC website and click on Standards & Innovations –>; Terminology

This is the superset of codelists that are used to both collect and submit SDTM data

Excel Format – Column descriptions in the Controlled Terminology (SDTM subset)

Column. Description
Code (column A) Unique numeric code randomly generated by NCI Thesaurus (NCIt) and assigned to individual CDISC controlled terms.
Codelist Code (Column B) Unique numeric code randomly generated by NCI Thesaurus (NCIt) and assigned to the SDTM parent codelist names. This code is repeated for each controlled term (aka permissible value) belonging to a codelist. As of 9/22/2008, this code was dropped for parent codelist entries, where it created confusion.
**NOTE – light blue highlighting is used to identify the beginning of a new SDTM codelist and its applicable term set.
Codelist Extensible (Yes/No) (Column C) Defines if controlled terms may be added to the codelist. New terms may be added to existing codelist values as long as they are not duplicates or synonyms of existing terms. The expectation is that sponsors will use the published controlled terminology as a standard baseline and codelists defined as “extensible” (or “Yes”) may have terms added by the sponsor internally.
Codelist Name (Column D) Contains the descriptive name of the codelist which is also referred to as the codelist label in the SDTM IG. As with the Codelist Code, the Codelist Name is repeated for each controlled term belonging to a codelist.
CDISC Submission Value (Column E) IMPORTANT COLUMN: Currently (as per SDTMIG 3.1.2) this is the specific value expected for submissions. Each value corresponds to a SDTM Codelist Name as indicated by light blue shading.
CDISC Synonym(s) (Column F) This identifies the applicable synonyms for a CDISC Preferred Term in Column F. **NOTE – this is especially important in instances where a Test name or Parameter Test name contains a corresponding Test Code or Parameter Test Code.
CDISC Definition (Column G) This identifies the CDISC definition for a particular term. In many cases an existing NCI definition has been used. The source for a definition is noted in parentheses (e.g. NCI, CDISC glossary, FDA).
NCI Preferred Term (Column H) This identifies the NCI preferred name for a term as identified in NCIt. **NOTE – This column designates the human readable, fully specified preferred term corresponding to the NCI c-code, and is especially helpful for searching NCIt to get the entire concept with links to all instances of the term.

Above example of the spreadsheet for the ‘Route of Administration‘ codelist.

Reference: Clinical Data Interchange Standards Consortium, Inc (CDISC) Representing Controlled Terminology in CDASH

Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, OpenClinica Open Source and Oracle Clinical.