Clinical Data Interchange Standards Consortium

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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[citation needed]. 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[edit]

  • 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

Overview of CDISC standards[edit]

  • Dataset.XML DataSet-XML)
    • Enables communication of study results as well as regulatory submission to FDA (pilot since 2014).[1]
  • 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.

Individual CDISC standards[edit]

Operational Data Model (ODM)[edit]

Operational Data Model (ODM) was the first CDISC standard defined. The first version was introduced in 1999. The latest version is 1.3.2 released in 2012.[2] The syntax defined by ODM is used by other CDISC standards, such as DataSet-XML and define.xml.

define.xml[edit]

Data Definition Specification, more often referred to as as "define.xml" is an ODM based standard that defines names of variables collected during a study. The current version is 2.0 published in 2012.


CDISC registered solutions providers[edit]

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[edit]

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[edit]

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 an EDC vendor-neutral system for defining a study.

ODM Export[edit]

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

See also[edit]

Further reading[edit]

  • 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

references[edit]

  1. ^ "Dataset". 
  2. ^ "ODM". 


External links[edit]