|
The Clinical Data Interchange Standards Consortium (CDISC) is an open, multidisciplinary, neutral, 501(c)(3) non-profit standards developing organization (SDO) that has been working through productive, consensus-based collaborative teams, since its formation in 1997, to develop global standards and innovations to streamline medical research and ensure a link with healthcare. 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". The CDISC Vision is "informing patient care and safety through higher quality medical research". The CDISC suite of standards supports medical research of any type from protocol through analysis and reporting of results. They have been shown to decrease resources needed by 60% overall and 70-90% in the start-up stages when they are implemented at the beginning of the research process . They are harmonized through a model that is now not only a CDISC standard but also an HL7 standard on the path to becoming an ISO/CEN standard, thus giving the CDISC standards (harmonized together through BRIDG) international status and accreditation. ==CDISC History== * Late 1997 - Started as a Volunteer group * Summer 1998 - Invited to form DIA SIAC * 1999 - SDS v1.0; ODM v0.8 * 2000 - SDS v1.1 * Feb 2000 - formed an Independent, non-profit organization * Dec 2001 - Global participation * 2001 - SDS v2.0; ODM v1.0 * 2002 - ODM v1.1; ADaM Models * 2003 - LAB v1.0; SDTM v1/SDTM-IG v3.0;BRIDG Model Initiated; SEND 1.0 * 2004 - LAB v1.1; ODM v1.2; SDTM v3.1 * 2005 - Define.xml Implementation; Release (v1.0); SEND v.2; ODM v1.2.1; SDTM v1.1/SDTMIG v3.1.1; ODM mapped to HL7 RIM * 2006 - BRIDG v1.0, v1.1; BRIDG posted as open source model * 2007 - ODM v1.3; LAB & SDTM Aligned; BRIDG posted as open source model * 2008 - BRIDG v2.0, v2.1, v2.2; CDASH v1.0; eSDI Document Published * 2009 - SDTM v1.2/SDTMIG 3.1.2; ADam v2.1; Imaging CRFs; CDISC-IHE RFD and RPE * 2010 - Protocol Representation Model;(PRM) v1.0; BRIDG v3.0; ODM v1.3.1; HHS-ONC/HITSP Interoperability Specification #158; CDISC-IHE RPE * 2011 - CDASH v1.1; SEND v3.0; Study Design XML v1.0 * 2013 - SDTM v1.4/SDTMIG v3.2 * 2014 - SHARE R1 抄文引用元・出典: フリー百科事典『 ウィキペディア(Wikipedia)』 ■ウィキペディアで「Clinical Data Interchange Standards Consortium」の詳細全文を読む スポンサード リンク
|