NCI Dictionaries

Federal Medication Terminologies

FDA Terminology

CDISC Terminology

NCI Enterprise Vocabulary Services (EVS)

Terminology plays an important role in NCI's research, clinical, and information efforts. NCI is working with many partners to create and publish controlled terminology that can help develop and communicate information useful to scientists, clinicians, patients, and the public. Here are some key resources.

NCI Enterprise Vocabulary Services (EVS) ¹

EVS is a collaborative effort of the NCI Office of Communications ² and the NCI Center for Bioinformatics ³. The EVS provides a set of services and resources, including NCI Thesaurus and NCI Metathesaurus, that facilitate the standardization of terminology across the Institute and the larger biomedical community.

• NCI Thesaurus ⁴
  Published monthly by NCI, this reference terminology and biomedical ontology is used in a growing number of NCI and other systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities. The NCI Thesaurus provides definitions, synonyms, and other information on nearly 10,000 cancers and related diseases, 8,000 single agents and combination therapies, and a wide range of other topics related to cancer and biomedical research. It is maintained by a multidisciplinary team of editors, who add about 900 new entries each month.

• NCI Metathesaurus ⁵
  The NCI Metathesaurus is a comprehensive biomedical terminology database that contains 1,300,000 concepts mapped to 4,600,000 terms with 17,000,000 relationships. NCI Metathesaurus currently contains most public domain vocabularies from the National Library of Medicine's UMLS Metathesaurus ⁶, as well as a growing number of other cancer-related vocabularies.

• NCI Terminology Browser ⁴
  The Web browser used for NCI Thesaurus also provides access to the Medical Dictionary for Regulatory Activities (MedDRA), the Systematized Nomenclature of Medicine Clinical Terms (SNOMED-CT), the Gene Ontology (GO), and other terminologies used by NCI and its partners.

• NCI Dictionary of Cancer Terms ⁷
  A dictionary of about 5,000 cancer and biomedical terms, defined in non-technical language. Terms and definitions are reviewed by a multidisciplinary panel of reviewers, and approximately 50 new and 50 revised terms are included each month. The dictionary is available as a stand-alone resource on every Cancer.gov Web page, and individual terms in many Web documents are also directly linked to their dictionary definitions. The dictionary is also widely used by other institutions and Web sites.

• NCI Dictionary of Genetics Terms ⁸
  A dictionary of more than 100 genetics-related terms written for healthcare professionals. This resource was developed to support the comprehensive, evidence-based, peer-reviewed PDQ cancer genetics information summaries ⁹.

• NCI Drug Dictionary ¹⁰
  A dictionary that contains technical definitions, alternate names, and links to related information for more than 1,200 agents that are being used in the treatment of patients with cancer or cancer-related conditions. Each entry includes a link to a more detailed entry in the NCI Thesaurus, which provides the information presented, as well as links to open and closed clinical trials in NCI's PDQ® Cancer Clinical Trials Registry.

The Federal Medication (FedMed) interagency collaboration is organizing an agreed set of standard, comprehensive, freely and easily accessible Federal Medication Terminologies (FMT) to improve the exchange and public availability of medication information. FedMed is a joint effort of these Federal partner agencies:

• Food and Drug Administration (FDA) ¹¹
• National Cancer Institute (NCI) ¹²
• National Library of Medicine (NLM) ¹³
• Veterans Health Administration (VHA) ¹⁴
• Agency for Healthcare Research and Quality (AHRQ) ¹⁵
• Centers for Medicare and Medicaid Services (CMS) ¹⁶
• Department of Defense (DoD) ¹⁷
• Environmental Protection Agency (EPA) ¹⁸

The FedMed resources and related standards encompass medication and ingredient names, codes, routes of administration, dosage forms, units of presentation, mechanisms of action, physiologic effects, and structure. Participating agencies currently provide the following FMT components and related products:

• FDA's Unique Ingredient Identifier (UNII) codes ¹⁹ for drug ingredients (see FDA Terminology ²⁰ Web page) and National Drug Codes (NDC) ²¹ for prescription medications. FDA makes extensive use of FMT in its Structured Product Labeling (SPL) ²² specifications for medication information.
• NCI Thesaurus (NCIt) for a range of supporting terminology sets and investigational agents. The FedMed-related SPL subsets of NCIt are described and accessible on the FDA Terminology ²⁰ Web page. NCIt as a whole is available via browser ²³, file downloads ²⁴, and application programming interfaces.
• NLM's RxNorm ²⁵ for clinical drug names, a publicly available drug interface terminology RxTerms ²⁶, and DailyMed ²⁷ for viewing and downloading SPL-encoded drug labels.
• VHA's National Drug File Reference Terminology (NDF-RT) formulary. The full public release version of NDF-RT is available here as complete XML data (zipped) ²⁸ and a simple list of terms and codes (text) ²⁹. The release directory ³⁰ includes a ReadMe file ³¹ and other information. Three FMT-related SPL subsets of NDF-RT, also described and accessible on the FDA Terminology ²⁰ Web page, are:
  • Mechanism of Action (Excel ³² or text ³³),
  • Physiologic Effect (Excel ³⁴ or text ³⁵), and
  • Structural Class (Excel ³⁶ or text ³⁷).

The initial FMT terminology set has been endorsed by U.S. Federal standards efforts including the National Committee on Vital and Health Statistics (NCVHS), Consolidated Health Informatics (CHI), the Healthcare Information Technology Standards Panel (HITSP), and the Office of the National Coordinator for Health Information Technology (ONC) within the Department of Health and Human Services (HHS). An overview of the FMT goals, directions, and components is available in a jointly developed PowerPoint presentation ³⁸. The FedMed partners are working with ONC to develop an Interagency Coordination Group that can support coordination, development, and use of the FMT standards.

Please send questions and support requests to: FedMedHelp@hhs.gov

FDA Terminology

The FDA is working with EVS to develop and support controlled terminology in several areas. More than 10,000 FDA terms and codes are stored in NCI Thesaurus (NCIt). This and other terminology used by FDA is updated and made available for download from an NCI File Transfer Protocol (FTP) site ³⁹. FDA terminology subsets are available in each of these four main areas:

1. Structured Product Labeling (SPL) ²² is a document markup standard approved by Health Level Seven (HL7) ⁴⁰, an international medical standards organization, and used by FDA to exchange medication information. The SPL standard specifies use of some 30 sets of controlled terminology. The NCI FTP site provides these SPL resources:

   • NCIt SPL Subsets ⁴¹: Eleven sets of SPL terminology are maintained in NCIt and available for download in Excel ⁴² or text ⁴³ formats. SPL represents countries with ISO 3166-1 Alpha-3 country codes, extracted from NCIt in separate Excel ⁴⁴ and text ⁴⁵ files.

   • NDF-RT SPL Subsets ⁴⁶: The VHA National Drug File Reference Terminology (NDF-RT) maintains terminology used to code these medication properties:

     • Mechanism of Action (Excel ³² or text ³³),
     • Physiologic Effect (Excel ³⁴ or text ³⁵), and
     • Structural Class (Excel ³⁶ or text ³⁷).

   • Problem List Subset ⁴⁷: The Medical Condition component of SPL is coded with the VHA and Kaiser Permanente (VA/KP) Problem List Subset of the Systematized Nomenclature of Medicine Clinical Terms (SNOMED-CT). This set of SNOMED terms and codes is freely reusable worldwide without licensing or intellectual property restrictions. It is available in Excel ⁴⁸, zipped Excel ⁴⁹, and text ⁵⁰ formats, as well as through a specialized browser application ⁵¹.

2. Unique Ingredient Identifier (UNII) ¹⁹ codes are being developed by FDA to uniquely identify all ingredients used in marketed medications in the United States. Each UNII is assigned based on molecular structure, manufacturing process, or other characteristics. FDA provides a full set of published UNII codes ⁵² on its Web site. These codes are also being included in corresponding NCI Thesaurus concepts, and files providing UNIIs with matching NCI concept codes are available for download in Excel ⁵³ and text ⁵⁴ formats.

3. Individual Case Safety Report (ICSR) terminology is used to encode adverse event information for reporting purposes. Fifteen ICSR term sets are maintained in NCI Thesaurus, and are available for download in Excel ⁵⁵ and text ⁵⁶ formats.

4. Center for Devices and Radiological Health (CDRH) ⁵⁷ terminology is under development to encode reporting of medical device problems. Three CDRH term sets, covering Patient Problem Codes, Device Component Codes, and Device Problem Codes, are maintained in NCIt and available for download in Excel ⁵⁸ and text ⁵⁹ formats.



CDISC Terminology

The Clinical Data Interchange Standards Consortium (CDISC) ⁶⁰ is an international, non-profit organization that develops and supports global data standards for medical research. CDISC is working actively with EVS to develop and support controlled terminology in several areas, notably CDISC's Study Data Tabulation Model (SDTM). SDTM is an international standard for clinical research data, and is approved by the FDA as a standard electronic submission format.

CDISC SDTM and other terminology goes through an extensive process of definition, development, and review before it is declared ready for release. Terminology that has completed this process is tagged as "Production," and now includes some 50 SDTM codelists with about 2,200 terms covering demographics, interventions, findings, events, trial design, units, frequency, and ECG terminology. This terminology is maintained and distributed as part of NCI Thesaurus, and is available for direct download from the CDISC SDTM directory ⁶¹ on an NCI File Transfer Protocol (FTP) site in both Excel ⁶² and text ⁶³ formats.

CDISC also leads the Clinical Data Acquisition Standards Harmonization (CDASH) project, which develops clinical research study content standards in collaboration with sixteen partner organizations including NCI. NCI EVS maintains and distributes CDASH controlled terminology as part of NCI Thesaurus. More information is available at CDISC's CDASH Web page ⁶⁴.

The CDISC New Term Request ⁶⁵ web page handles suggestions for both new terminology and changes to existing terminology. The CDISC Term Request Tracking ⁶⁶ web page helps members of the CDISC community review and comment on all submitted requests.