Clinical Data Interchange Standards Consortium

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.

The CDISC Operational Data Model (ODM) is designed to facilitate the regulatory-compliant acquisition, archive and interchange of metadata and data for clinical research studies. ODM is a vendor neutral, platform independent format for interchange and archive of clinical study data. The model includes the clinical data along with its associated metadata, administrative data, reference data and audit information. ODM was first introduced in 1999, and the latest version, 1.3.2, was released in 2012. ODM extensions have been developed to create a number of additional CDISC standards, including Define-XML, Dataset-XML, SDM-XML, and CTR-XML and future planned standard Protocol-XML.

ODM is an XML based standard and it is an XML schema that provides number of constructs for modeling electronic Case Report Forms (CRFs). ODM is often combined with Study Data Model standard to more fully model trial arms or trial activities. ODM is also used in sending forms data from a clinical trial system to an Electronic Health Record (EHR) system.

Define-XML supports the interchange of dataset metadata for clinical research applications in a machine-readable format. An important use case for Define-XML is to support the submission of clinical trials data in CDISC SDTM, SEND or ADaM format to regulatory authorities. The key metadata components to support submissions are:

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