How to Use CDASH Controlled Terminology

By Shannon Roznoski | EDC Product Manager, Forte Research Systems
July 29th, 2016

Summary: Shannon Roznoski of Forte discusses controlled terminology and the uses of these standardized lists of terminology.

Estimated reading time: 3 minutes

In my last CDASH series article, I walked through the Demographics (DM) domain of the CDASH standard. In the next installment of this series, we’ll cover controlled terminology.

What is CDASH controlled terminology?

In collaboration with the National Cancer Institute’s Enterprise Vocabulary Services (EVS), CDISC developed standardized lists of terminology to be used with CDISC standards such as SDTM, CDASH, ADaM, and SEND, allowing for consistency throughout the data collection and reporting process. Controlled terminology files can be downloaded from the NCI Terminology Resources page. Here you will find both the CDASH and SDTM controlled terminology files.

CDASH identifies the basic data collection fields needed from a clinical, scientific and regulatory perspective to enable more efficient and consistent data collection at the investigative sites.* Controlled terminology is used in several CDASH domains, such as VS (Vital Signs) and AE (Events). The CDASH controlled terminology appears in Appendix A of the CDASH standard document and is a subset of the larger SDTM terminology. A benefit of the CDASH controlled terminology is the smaller file size, making it slightly easier to navigate than SDTM.

How to use it.

The controlled terminology is available in several formats including txt, Excel, odm.xml, pdf, html and OWL/RDF. The Excel format is the most convenient for browsing and searching. Other formats are easier to use programmatically. The document also contains a ‘ReadMe’ tab that defines each column.

The Definition column of the CDASH standard will reference controlled terminology in curly braces. For example {VSTEST} is the controlled terminology for the question “What is the vital sign test name?”

CDASH curly braces image

To find the list referenced in the CDASH standard, search column E (CDISC Submission Value) of the SDTM controlled terminology document for “VSTEST.” The codelist name is “Vital Signs Test Name.” From there, filter Column D (Codelist Name) for “Vital Signs Test Name.” This will give you a list of all the values in that codelist. You must use the values in Column E (CDISC Submission Value) in your SDTM datasets.

In Column F (CDSIC Synonym(s)), you will find a list of allowed alternate values. These can be used for data collection, in CRFs and for mapping purposes, but need to be translated into the submission value (column E) when being converted into SDTM datasets. For CRF templates, the synonym is often what you will want to use to ensure clarity for site staff entering the data.

CDASH Cont Term image column F

When building the codelists for your CRF form, you may use all of the terms, or a subset, based on the needs of your protocol. For example, a common set of Vital Signs Test Codes on a single form may be Systolic Blood Pressure, Diastolic Blood Pressure and Pulse Rate.

Can I add my own terms?

When building CDASH CRFs you may find that the specified codelist contains some, but not all, of the values that you require for your protocol. This has been taken into account in the controlled terminology. Column C (Codelist Extensible) in the controlled terminology indicates whether you are allowed to add terms to the codelist. If the column is marked ‘yes,’ you are allowed to add new items as long as they are not duplicates or synonyms of an existing one.

For codelists where Codelist Extensible is No, requests for new terms must be made through the new term request page and can’t be added by individual sponsors.

Summary

Controlled terminology facilitates cross-protocol analysis and the exchange of information between clinicians and researchers. CDASH standards support the streamlining of processes within protocols and help you stay in compliance with FDA submission standards.

*Clinical Data Acquisition Standards Harmonization (CDASH), www.cdisc.org, January 18, 2011.

About the Author

Shannon Roznoski is the EDC Product Manager at Forte Research Systems, responsible for the strategic planning and management of Overture EDC. Prior to joining Forte, Shannon worked for 14 years at Covance in various roles including early phase data management and project management. She earned a Bachelor of Science in Horticulture from the University of Wisconsin Madison and is a CCDM through SCDM.

Website: Forte Research Systems

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