The CDISC SHARE project was initiated by members of the CDISC Board of Directors, CDISC leadership and volunteers in 2007. Early work began with a stakeholder analysis to define the initial proposed scope of CDISC SHARE. In 2009, a pilot project using Mayo Clinic’s LexGRID semantic wiki tool was conducted, which verified the potential value for CDISC SHARE and highlighted the need for a more controlled metadata repository environment with strong governance. Work proceeded after that to define detailed requirements and to begin organizing CDISC content so it would be CDISC SHARE-ready: well defined, mapped to BRIDG and ISO 21090 complex data types and clearly expressing relationships between collected CDASH elements and SDTM tabulations.
In 2012, CDISC entered into a partnership with the Critical Path Institute, FDA and TransCelerate BioPharma Inc. (TCB) to establish the CFAST Initiative and the Therapeutic Area Data Standards Program, which quickly recognized the need for a metadata repository as an essential infrastructure component to support the development of numerous Therapeutic Area standards. With TCB’s strong support, CDISC engaged in a formal evaluation process to identify solution providers with CDISC SHARE, resulting in the selection of a commercial metadata repository product in June 2013, followed thereafter by the public launch of CDISC SHARE.
TCB continues to be a financial supporter of the ongoing model development and hosting of the CDISC SHARE metadata repository.
A CDISC SHARE Steering Committee consisting of members of the academic, biopharmaceutical, clinical research organization (CRO), and information technology sectors was convened in 2015 to provide guidance and help set priorities for ongoing CDISC SHARE development activities.