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standards now cover the entire biomedical research process, from protocol representation through analysis and reporting. 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.
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.”