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.", and its operational values are based on those of the Economy of Communion in Freedom. 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
• Feb 2000 - formed an Independent, non-profit organization
• Dec 2001 - Global participation

CDISC standards

• Study Data Tabulation Model (SDTM)
  • Highlights: recommended for FDA regulatory submissions since 2004.
• Study Data Tabulation Model SDTM Implementation Guide (SDTM-IG)
  • Gives a standardized, predefined collection of submission metadata "Domains" containing extensive variable collections.
• Analysis Data Model (ADaM)
  • Designed to complement the SDTM submission by detailing the statistical analysis performed on the clinical trial results.
• Standard for Exchange of Non-clinical Data (SEND)
  • The animal trial equivalent of SDTM.
• Operational Data Model (ODM)
  • The highlights of ODM: includes audit trail, utilizes XML technology, machine- and human- readable, all information are independent from databases, storing of ODM is independent from hard- and software.
• Laboratory Data Model (LAB)

The Lab standard is used for exchange of laboratory data between labs and CROs

• Case Report Tabulation Data Definition Specification (CRT-DDS)
  • Also referred to as "define.xml", a machine readable version of the regulatory submission "define.pdf".
• Clinical Data Acquisition Standards Harmonization (CDASH)
  • Defines a minimal data collection set for sixteen safety SDTM Domains, harmonizing element names, definitions and metadata. The objective is to establish a standardized data collection baseline across all submissions.
• CDISC Terminology
  • Defines controlled terminology for SDTM and CDASH, provides extensible lists of controlled terms designed to harmonize data collected across submissions.

CDISC registered solutions providers

CDISC maintains a list of solutions providers, subject matter experts and consultants deemed to have sufficient knowledge and experience implementing the various CDISC standards.

ODM and EDC integration

Electronic Data Capture (EDC) systems can be certified as compliant with the Operational Data Model (ODM) by CDISC. There are two main types of integration, ODM Import and ODM Export.

ODM Import

Full import allows importing of ODM-formatted clinical data (MetaData and Data). MetaData only import allows only the importing of MetaData. This is useful for setting up the EDC system to capture data. Basically allows third party software to define the forms, variables etc. used in the EDC system. This provides a EDC vendor-neutral system for defining a study.

ODM Export

The EDC system will generate ODM data files for further processing.

See also

• Electronic Common Technical Document (eCTD)
• Electronic Data Capture
• Clinical data acquisition
• Clinical Data Management System (CDMS)
• Data model
• Data warehouse
• Health Level 7
• Health Informatics Service Architecture (HISA)
• LOINC
• SNOMED
• SNOMED CT
• DICOM
• Clinical trial

Further reading

• Rebecca Daniels Kush (2003), eClinical Trials: Planning and Implementation, CenterWatch / Thomson Healthcare, ISBN 1-930624-28-X
• A J de Montjoie (2009), 'Introducing the CDISC Standards: New Efficiencies for Medical Research', CDISC Publications

External links

• Official website