The Clinical Data Interchange Standards Consortium (CDISC) & US National Cancer Institute - Enterprise Vocabulary Services (NCI EVS) to Collaborate on the Development of CDISC SHARE

Online, October 28, 2010 (Newswire.com) - CDISC standards now cover the entire biomedical research process, from protocol representation through analysis and reporting. Over the last two years 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 CDISC Shared Health And Clinical Research Electronic Library (CDISC SHARE) is envisioned as a global, accessible, electronic library, which through advanced technology, enables precise and standardized data element definitions that can be used within applications and across studies to improve biomedical research and its link with healthcare. This new initiative seeks to develop multi-dimensional, machine-readable clinical study metadata that is based on ISO data standards and the BRIDG model.

The US National Cancer Institute - Enterprise Vocabulary Service (NCI-EVS) has a long tradition of working with partners to create and publish controlled terminology and has collaborated with CDISC since 2004 to develop and publish CDISC controlled terminology for the entire suite of CDISC standards (e.g. the SDTM, CDASH, SEND, etc.). NCI has agreed to include CDISC SHARE system requirements in the development of their enhanced semantic infrastructure.

Dave Iberson-Hurst, CDISC Technical Architect said, "CDISC is moving from the world of implicit understanding to the world of the explicit understanding". CDISC SHARE will facilitate this novel approach to developing machine-readable clinical metadata standards. Frank Rockhold, Chair of the CDISC Board of Directors, stated, "SHARE is a significant shift in the way that CDISC will create its standards and will allow for acceleration in the development of new therapeutic area standards. The first release will contain the existing SDTM and CDASH standards and should be available for use in the second half of 2011 with new content following shortly after. 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."

About CDISC: CDISC is a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata. The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. CDISC standards are vendor-neutral, platform-independent and freely available via the CDISC website. Additional information on CDISC can be found on the website at www.cdisc.org.

About The National Cancer Institute - Enterprise Vocabulary Services: NCI-EVS provides a set of services and resources, including NCI Thesaurus and NCI Metathesaurus, that facilitate the standardization of terminology across the Institute and the larger biomedical community. Terminology plays an important role in NCI's research, clinical, and information efforts. NCI is working with many partners to create and publish controlled terminology that can help develop and communicate information useful to scientists, clinicians, patients, and the public.