The Oasis eTMF Standard group took a bold step forward today with its action to utilize the National Cancer Institute’s (NCI) NCI Thesaurus term repository for storage and curation of eTMF metadata terms and vocabulary. As part of the eTMF vocabulary standardization effort, The OASIS eTMF Standard TC will submit its work to NCI for the eTMF domain for global standardization and publication.
Over the last 15 years, the National Cancer Institute has funded and sponsored a major effort to provide a set of curated clinical and biomedical related terms for organizations globally, located online for all in a free machine-readable database repository. The NCI Thesaurus repository terms are used by organizations globally such as FDA, CDISC, HL7, ICD-10, SNOMED, WHO and many others as a repository and resource for open source controlled vocabulary development.
A controlled vocabulary enables widespread system interoperability through the use of a standardized set of centrally curated terms for a given domain. NCI Thesaurus is an open organization that ensures term consistency and interoperability across domains, and participation and use of the terms are open to anyone worldwide. NCI Thesaurus publishes its terms online at http://ncit.nci.nih.gov/. A graphical view of NCI’s terms and their semantic relationships is published by the National Center for BioMedical Ontology (NCBO) at http://bioportal.bioontology.org/ontologies/NCIT?p=classes
The NCI Thesaurus project is designed to meet the growing need for accurate, comprehensive, and shared interoperable terminologies, covering topics including: cancers, findings, drugs, therapies, anatomy, genes, pathways, cellular and subcellular processes, proteins, and experimental organisms and many more medical and clinical domains.
As part of the Oasis eTMF Standard TC effort to move toward a global ISO standard for the clinical trials area, adoption of NCI as the repository for eTMF terms is a significant step forward that ensures that a single repository of interoperable terms will be available for clinical trial software, systems and study stakeholders globally.
Congratulations to the Oasis TC on taking this step forward today. It’s a key step in the eTMF Standard TC’s journey to develop an interoperable framework and machine readable technology that can help maintain the integrity and interoperability of clinical trial information. SureClinical is a proud sponsor of the OASIS eTMF Standard.