The Clinical Data Interchange Standards Consortium (CDISC) is working with the US National Cancer Institute’s Enterprise Vocabulary Services (NCI-EVS) on a new electronic library designed to help define and standardise data elements for use in biomedical research and healthcare.
The CDISC Shared Health and Clinical Research Electronic Library (CDISC SHARE) will employ advanced technology to enable “precise and standardised data element definitions that can be used within applications and across studies to improve biomedical research and its link with healthcare”, explained the US-based body, set up to develop and support global, platform-independent data standards that enable interoperability of information systems in the sector.
The goal of the collaboration with NCI-EVS is to develop multi-dimensional machine-readable clinical study metadata (i.e., data providing information about an item, document or other data) based on International Organization for Standardization (ISO) data standards and the Biomedical Research Integrated Domain Group (BRIDG) Model.
The BRIDG Model is a Domain Analysis Model conceived through collaboration between stakeholders from CDISC, the HL7 Regulated Clinical Research Information Management Technical Committee (RCRIM TC), the NCI and its Cancer Biomedical Informatics Grid (caBIG), and the US Food and Drug Administration. Its aim is a shared view of dynamic and static semantics for the domain of protocol-driven research and associated regulatory artifacts.
The NCI-EVS has been working with CDISC since 2004 on developing and publishing CDISC-controlled terminology for the entire suite of the Consortium’s standards, such as the Study Data Tabulation Model (SDTM) and the Clinical Data Acquisition Standards Harmonization (CDASH) standard. The NCI has agreed to include CDISC SHARE system requirements in the development of the Institute’s enhanced semantic infrastructure.
According to Frank Rockhold, chair of the CDISC board of directors, the first release of CDISC SHARE will include the existing SDTM and CDASH standards and should be available for use in the second half of 2011, with new content following shortly after that. “This is an important step in the evolution of a content standard which will improve our ability to use research data to help patients in the future,” Rockhold commented.
There are now CDISC standards covering the entire biomedical research process, from protocol representation through to analysis and reporting. Over the last two years, the Consortium noted, “it has become clear that in order to increase the delivery of standards updates and meet the needs of industry and regulatory bodies, CDISC needed a different model to augment its current processes”.
The NCI-EVS provides resources and services, including NICI Thesaurus and NCI Metathersaurus, to facilitate the standardisation of terminology across the National Cancer Institute and the wider biomedical community.