1. Who makes Controlled Terminology?
You do! Controlled Terminology is developed from user requests, as well as requests from the CDISC Foundational and Therapeutic Area teams, which comprise volunteers from pharma, CROs, government agencies, and academic institutions. Staff from the National Cancer Institute’s Enterprise Vocabulary Services (NCI-EVS) manage the development of Controlled Terminology. Controlled Terminology is reviewed prior to publication in an open, public review process.
2. Why does CDISC create its own terminology instead of pointing to existing terminologies?
To fully support its data model and Foundational Standards, CDISC needs Terminology that conforms to certain business rules, such as length restrictions on TEST/TESTCD and PARM/PARMCD Terminology. CDISC also wants to ensure that whatever Terminology is developed, it has an associated definition for each term and can be bundled into codelists to clearly support its model. CDISC also wants to ensure that its terminology standards remain open and free, without licensing restrictions.
3. What is a package number and how is that different from the CDISC version date?
Controlled Terminology is bundled into packages, which are assigned an alphanumeric name in the form of a capital P followed by a number. These numbers are used to identify packages during development and public review since at any given time within the Controlled Terminology development cycle, up to three packages may be at different stages in their development. You may see these package numbers referenced within team working documents, public review communications emails and Wiki pages, and on the CDISC website. When a Terminology package is published, the package number is replaced by a version date, which can be found within the published Terminology files. This version date is what one should use within the define.xml file when indicating which version of Controlled Terminology is used in the data submission to the regulatory authority.
4. Why didn’t the version date change on a particular Controlled Terminology publication?
When a Terminology subset does not change during a particular quarter (i.e., no new terms are being added and no changes to existing terms have been made), the version data does not change. A version date will only change when changes have been made to the Terminology set.
5. Can I use the Controlled Terminology from examples in published Implementation Guides (IG) or Therapeutic Area User Guides (TAUG)?
We do not recommended using the Controlled Terminology from the examples in published IGs or TAUGs since Controlled Terminology, IGs and TAUGs are published on different timelines and the examples may be out of date with respect to the latest version of Controlled Terminology.
6. Does CDISC make use of other existing terminologies besides Controlled Terminology?
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.
7. Why can’t I find the term I need in a published codelist?
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.
8. What do I do if I can’t find the term I need in a published codelist?
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; therefore synonyms 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 .
9. Can I submit synonyms in my dataset?
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.
10. Can I submit terms that are not synonyms to existing published terms in my dataset?
Yes, as long as the codelist is considered extensible (i.e., the codelist row contains ‘Yes’ in column C).
11. When should I submit a new term request so that it can get into an upcoming package?
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.
12. What is the Changes Log in the Controlled Terminology publication FTP folders and how do I use it?
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.
13. I’d like to join a Controlled Terminology team. How do I volunteer?
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.