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ISO/IEC 11179

the singe ISO standard that lays out much of what is required for the definition and maintenance of data elements; stops short of the entire requirements, but is the best set of rules available

Part 1 of ISO 11179

framework for the Specification and Standardization of Data Elements

Part 2 of ISO 11179

classification for data elements

Part 3 of ISO 11179

basic attributes of data elements

Part 4 of ISO 11179

rules and guidelines for the formulation of data definitions

Part 5 of ISO 11179

naming and identification principles for data elements

Part 6 of ISO 11179

registration of data elements

National Cancer Instititute

has done much work in creating data element registries

Cancer Data Standard Repository (caDSR)

registry of common data elements created by NCI

Enterprise Vocabulary Service (EVS)

registry of terminology used by CDSR; created by NCI; includes SNOMED-CT, MedDRA, VA NDF-RT, LOINC, HL7, NCI Thesaurus

cancer Biomedical Informatics Grid (caBIG)

overseen by the National Cancer Institute Center for Biomedical Informatics and Information Technology; addresses the needs of all constituencies in the cancer community -researchers, clinicians, patients- to share data and knowledge, simplify collaboration, speed research to get diagnostics and therapeutics fro bench to bedside faster, and more cost-effectively; addresses a critical problem facing both basic and clinical researchers today; an explosion of data that requires new approaches for collection, management, and analysis; is widely applicable to other therapeutic areas

Activities of caBIG

development of Vocabularies and Common Data Elements; evaluate and integrate systems for vocabulary and ontology content development used throughout caBIG system. and establish a review process that classifies vocabulary into bronze, silver, gold categories with rigid rules for definition

Clinical Data Interchange Standards Consortium (CDISC) products

Study Data Tabulation Model, Operational Data Model; and The Clinical Data Acquisition Standards Harmonization (CDASH)

Date elements

a master set is a necessary part of semantic interoperability and must include a fully defined set of attributes, use ISO 11179 as the base for the master set; it must be a global effort

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