Controlled Terminology



Public Review - Controlled Terminology

Supplemental Files


Controlled Terminology consists of question (e.g., Variables, TESTs and PARMs) and answer(e.g., response codelists, qualifier variable codelists), which are commonly referred to as codelists and are published alphabetically in the Controlled Terminology publication.

The terms within these codelists may have relationships to other terms within other codelists. For instance, a single TEST in the EGTEST codelist may have a finite set of responses located in the EGSTRESC codelist that constitutes a subset of the EGSTRESC codelist. Another instance, a single VSTEST value may have a constrained set of units of measure that are valid for the numeric responses to that VSTEST. These relationships are not readily apparent in the Controlled Terminology publication files.

To address this issue, the Controlled Terminology Teams have created Codetable Mapping Files based on published Terminology, which show relationships between terms in differentControlled Terminology codelists. These supplemental files provide human and machine-readable linkages between published terms across multiple codelists and may be helpful for data QA/QC, CRF building, and data mapping.

The Controlled Terminology teams will continue to update these files as new Terminology is published, as well as develop new domain Codetable Mapping Files. If you are interested in seeing specific content developed, please submit the request through the New Term Request Site. CDISC is concurrently working on the development of electronically consumable formats of this content to be published out of CDISC Library.

SDTMIG3.2 Variable_Codelist

DD Codetable

DS Codetable

CV Codetable

ECG Codetable

Oncology Codetable

Racec-Ethnicc Codetable

RP Codetable

SC Codetable

SEND Codetable

SS Codetable

TS Codetable

VS Codetable


The Unified Code for Units of Measure (UCUM) contains a blueprint for the creation of compliant units of measure from more than 300 terminal unit symbols. UCUM is used in healthcare to populate electronic health records, such as laboratory records in LOINC, and in the ISO IDMP standard.

 

CDISC must specify a single, preferred unit of measure for the pharmaceutical industry to use in data submissions to regulators. Since UCUM does not control mathematical synonymy nor cover all units of measure required by the pharmaceutical industry, CDISC  publishes submission values for units of measure  across multiple codelists that support variables within CDISC findings, interventions, and trial design domains.

To seamlessly toggle between UCUM and CDISC Units, a mapping has been built and is updated quarterly with the CDISC Controlled Terminology publication. For each published CDISC submission value across all UNIT-based codelists in SDTM terminology, the mapping provides valid UCUM expressions associated with that unit concept. This allows a collected UCUM-compliant unit of measure to be easily matched to the appropriate CDISC submission value associated with that concept.

Unit-UCUM Codetable


FDA will require the submission of Logical Observation Identifiers Names and Codes (LOINC®) within clinical LB domain datasets in new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs) for studies starting after 15 March 2020 and for certain investigational new drugs (INDs) for studies starting after 15 March 2021. A recommendations document produced by a LOINC working group, composed of representatives from FDA, NIH, CDISC, and Regenstrief Institute, called for the development of a mapping file to map the most commonly submitted LOINCs in clinical research to the associated CDISC Controlled Terminology components associated with each LOINC part.

LOINC to LB Mapping File

This mapping file is intended to show examples of LOINC code mappings to CDISC variables and terminology to aid researchers’ adoption of the FDA requirement. The file is composed of LOINCs from the 2005 CDISC-LOINC mapping project, the LOINC Top 2000 SI, the LOINC Top 2000 US, as well as CDISC LB domain datasets submitted to FDA from 2014 - 2016. It includes more than 1400 LOINCs across the Chemistry, Hematology, Coagulation, Toxicology, Urinalysis, Serology, and other classes that would be mapped to the CDISC LB domain. The mapping file does not include LOINCs relevant to data that would be mapped to other CDISC domains such as microbiology, pathology, genomics, vital signs, fetal/neonatal screening, or administrative questions. For more information, please refer to the published ReadMe associated with the mapping.

LOINC to LB Mapping Files