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 SHARE.
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.
Yes, there are multiple instances throughout the SDTM that point to other terminologies, instead of recreating its own. Within SDTM, the –LOINC variable (findings observations class) is used to store the LOINC code. A number of variables within the AE domain (AELLT, AELLTCD, AEDECOD, AEPTCD, AEHLT, AEHLTCD, AEHLGT, AEHLGTCD) are specifically to be used with MedDRA terminology.
There are additional instances when regulators require the use of other non-CDISC terminologies. For instance, the FDA Data Standards Catalog indicates that when TSPARMCD=INDIC, use SNOMEDCT Medical Condition terminology for TSVAL. Please check the most recent versions of the data standards catalogs from FDA and PMDA to ensure that you are using the correct Terminology.
If you can’t find the term you need, it could either be because no one has requested the term or because someone has requested the term and it has been rejected. Controlled Terminology teams develop Terminology based on user requests but do not anticipate the needs of the users. If a term has not been requested, it will not be published. Conversely, in some cases a term may be requested but denied by the Terminology teams. You can find a list of denied requests, including the reason for denial in the green box titled Controlled Terminology Files Related on the Controlled Terminology page of the CDISC website.
First, please check the CDISC synonym column in the Controlled Terminology publication. CDISC rules dictate that a single concept should only have one submission value; thereforesynonyms have been added to help with mapping between internal sponsor lexicons and Controlled Terminology. Second, please check the denied requests file in the green box titled Controlled Terminology Files Related on the Controlled Terminology page of the CDISC website. In some cases, someone may have requested your term of interest and you will find the reason it was denied and information about how to map the concept into the standard. If you still can’t find your term of interest, please submit it on the New Term Request Site.
No. Synonyms are published to help with mapping and finding the correct submission value to use. CDISC Submission Values are part of a conformant dataset and are required as part of a submission to FDA and PMDA.
Yes, as long as the codelist is considered extensible (i.e., the codelist row contains ‘Yes’ in column C).
We recommend submitting terms two months before any package cut-off date to ensure the term is included in that package. The package cut-off date can be found in the Publication Schedule in the green box titled Controlled Terminology Files Related on the Controlled Terminology page of the CDISC website. We cannot guarantee your term will be included in that package but barring any extraordinary circumstances, the team can usually resolve a new term request in that timeframe.
Each quarter, when Controlled Terminology is published with new terms and changes to existing terms, NCI-EVS generates an Excel file that lists the changes made from the previous quarter publication to the current quarter. The Changes Log captures all new terms, changes to existing terms (including submission value, synonyms, and definition changes), and retired terms. Additionally, this file contains implementation instructions for how to map retired terms to new or existing terms.
NCI-EVS has made the program that it uses to generate these files, publicly available on a GitHub site.
We’d love to have you! We have 15 active Terminology teams that meet weekly and biweekly for 1-2 hours, based on focused subject matter areas. You can find the full list of teams on the Controlled Terminology Wiki page.
To become a CDISC volunteer, please visit the Volunteer page of the CDISC web site.