Research and applications Figure 1 The linkage between the value set constructs (ie, enumerated value domain, permissible value, value meaning, and enumerated conceptual domain) of a data element and the UMLS semantic groups (with an example data element, 2429490dFatigue Symptom Prior Surgery Present Ind-3). Note that the ‘Described Value Domain’ is crossed out, as it is not the focus of this paper. The solid lines between the components denote the linkage speciﬁed in the ISO/IEC 11179 standard, and the dotted lines denote the linkage between the terminological annotations and their corresponding semantic types and groups. gender using the codes ‘M’ and ‘F’ can be aligned with another one using the values ‘0’, ‘1’ and ‘9’ by connecting them to the same enumerated conceptual domain. The National Cancer Institute (NCI) has implemented the ISO/IEC 11179 standard in the Cancer Data Standards Reposi- tory (caDSR) for cancer studies.7 However, tools for validating the quality of the NCI registry meta-data are still somewhat limited.8 9 In this context, proﬁling the terminological annota- tions using the uniﬁed medical language system (UMLS) semantic network (SN) has previously been demonstrated as an effective approach for quality evaluation of the standard struc- ture of cancer study CDEs.9 This study focused on the data element concept componentsdobject class and property. It was clear that a principled auditing mechanism would be crucial for ensuring the quality of semantic annotations of the CDE structures in a CDE repository, thus potentially enabling data integration and interoperability across disparate clinical research datasets. The objective of the present study is to extend our previous approach,9 to evaluate the quality of terminological annotations on the value set (ie, enumerated value domain) components of the CDEs in the context of clinical research using both the UMLS semantic types and groups. We integrate the CDEs of the NCI caDSR, the NCI Thesaurus (NCIt) concepts and the UMLS semantic groups using a semantic web framework for a SPARQL-enabled evaluation. We demonstrate that the involvement of multiple semantic groups for asserted termino- logical annotations of permissible values in an enumerated value domain of a CDE is an effective anchor to trigger an auditing point for quality evaluation activities. We perform a preliminary evaluation of the usefulness of our approach. e130 BACKGROUND ISO/IEC 11179 standard ‘The ISO/IEC 11179 standard, formally known as the ISO/IEC 11179 Metadata Registry (MDR) standard, is an international standard for representing metadata for an organization in a metadata registry’.5 ‘The six part standard focuses on the data element as one of the foundational concepts. The purpose of the standard is to maintain a semantically precise structure of data elements’.10 ‘Each data element in an ISO/IEC 11179 metadata registry: (1) should be registered according to the Registration guidelines; (2) will be uniquely identiﬁed within the register; (3) should be named according to Naming and Identiﬁcation Principles; (4) should be deﬁned by the Formulation of Data Deﬁnitions rules; and (5) may be classiﬁed in a Classiﬁcation Scheme.’10 National Cancer Institute caDSR CDEs The caDSR is part of the NCI Cancer Common Ontologic Representation Environment (caCORE) infrastructure, and uses caCORE resources to support data standardization in clinical research cancer studies.7 ‘The system includes an administrator web interface for overall system and CDE management activities. In addition, a suite of specialized end user tools simplify the development, management, and deploy- ment of ISO/IEC 11179 compliant CDEs. The CDE Browser provides public access to caDSR contents for searching, viewing and downloading CDEs in Excel or XML format. Integrated with caCORE Enterprise Vocabulary Services (EVS), the CDE Curation Tool aids developers in consumption of NCI controlled vocabulary and standard terminologies for naming and deﬁning CDEs.’11 J Am Med Inform Assoc 2012;19:e129ee136. doi:10.1136/amiajnl-2011-000739