The Clinical Data Interchange Standards Consortium (CDISC) is a standards developing organization (SDO) dealing with medical research data linked with healthcare, to "enable information system interoperability to improve medical research and related areas of healthcare". The standards support medical research from protocol through analysis and reporting of results and 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. CDISC standards are harmonized through a model that is also a HL7 standard and is the process to becoming an ISO/CEN standard. 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 v1.0 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 and ADaMIG v1.0; 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, ADaM Examples in Commonly Used Statistical Analysis Methods v1.0 2012 – The ADaM Basic Data Structure for Time-to-Event Analyses v1.0, ADaM Data Structure for Adverse Event Analysis v1.0 2013 – Define-XML Version 2.0, SDTM v1.4/SDTMIG v3.2 2014 – SHARE R1 2015 – ARM v1.0 extension for Define-XML Version 2 2016 – DatasetXML, Therapeutic Areas, CTR-XML, ADaMIG v1.1, ADaM OCCDS v1.0 Overview of standards Dataset.XML (DataSet-XML) Enables communication of study results as well as regulatory submission to FDA (pilot since 2014). Study Data Tabulation Model (SDTM) Recommended for FDA regulatory submissions since 2004. The SDTM Implementation Guide (SDTM-IG) gives a standardized, predefined collection of domains for clinical data submission, each of which is based on the structure and metadata defined by the SDTM. Standard for Exchange of Non-clinical Data (SEND) The SEND Implementation Guide (SEND-IG) provides predefined