NCI’s Enterprise Vocabulary Services (EVS) develops and maintains semantic standards, including NCI’s Thesaurus (NCIt). Researchers use these data standards (as they are required by regulatory agencies) when reporting findings from clinical trials and other studies.

EVS routinely updates the NCIt to promote consistent data standards and interoperability. The new terminology for female reproductive neoplasms aligns with the latest World Health Organization standards.

 The Clinical Data Interchange Standards Consortium’s (CDISC’s) Study Data Tabulation Model (SDTM) reflects quarterly updates in controlled terminology.

Updates also are captured in CDISC’s Clinical Data Acquisition Standards Harmonization (CDASH), a standardized way of collecting data across studies to ensure they are traceable and transparent.

The updates include:

• 14 new SDTM value sets, 2 new CDASH value sets, 2 new protocol representative model (PRM) value sets, and 1 new Standard for Exchange of Nonclinical Data (SEND) value set.
• terminology to support the SDTM Implementation Guide v3.4.
• terminology to support the CDASH serious adverse events, pancreatic cancer, and Crohn’s Disease therapeutics data standards.

The updates made to CDISC map to the medical laboratory and observation terminology system known as Logical Observation Identifiers Names and Codes or LOINC®). 

These NCIt updates ensure a uniform standard for organizing and formatting research data, further streamlining the data collection, management, analysis, and reporting processes.

Visit our Resources page to learn more about CDISC Terminology.