CDISC Updates for Clinical Trial Data Now Available in the NCI Thesaurus
Data scientists, clinical and academic researchers, and those working in the pharmaceutical and biotech industries know the importance of adhering to accepted data standards. Not only do these standards make it easier to submit clinical and non-clinical trial data to top regulatory agencies (i.e., U.S. Food and Drug Administration), they also make it possible to share and compare results easily with labs around the world.
NCI’s Enterprise Vocabulary Services (EVS) is at the forefront of developing semantic standards, including the development of the NCI Thesaurus (NCIt). NCIt is an extensive reference terminology-and-biomedical ontology that includes definitions, synonyms, and more on 12,500+ cancers and 21,500+ other diseases and cancer-related conditions.
EVS partners with the Clinical Data Interchange Standards Consortium (CDISC)—the data standard used by researchers and required by regulatory agencies—to develop standardized controlled terminology. NCI staff also serve as active participants within CDISC’s global community, advising on and helping to implement data standards.
Every 3 months, new terms are added to CDISC and updated in the NCIt to ensure standards are maintained across NCI and the broader biomedical community.
The latest terminology additions and changes have now been completed to support Version 2.0 of CDISC’s Study Data Tabulation Model (SDTM) and implementation guide, a standard model for submitting data from human clinical trials. This new release:
- works across the entire suite of CDISC’s lexicon (SDTM, CDASH, SEND, etc.) so that researchers and others have the resources they need to code, analyze, and share data related to cancer and biomedical research.
- maps to standards found in the field (specifically the medical laboratory and observation terminology system known as Logical Observation Identifiers Names and Codes or LOINC®) to allow for accurate mapping between healthcare and regulated clinical research.
- includes new or updated terms to support pancreatic cancer, Crohn’s Disease, type 1 diabetes-exercise and nutrition, and heart failure therapeutic area data standards.
Visit our Resources page to learn more about CDISC Terminology.