Clinical Data Interchange Standards Consortium

Clinical Data Interchange Standards Consortium (CDISC) is a non-profit organization, whose mission is "to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of health-care". Their main project, the described data standard, bears the same name. The data standards are defined as a series of Models, which can be expressed using an underlying electronic format. The preferred electronic format is XML, using the Operational Data Model (ODM) as a base XML Schema.

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)
• 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 basline 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.

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

References

This article includes a list of references, related reading or external links, but its sources remain unclear because it lacks inline citations. Please improve this article by introducing more precise citations where appropriate. (July 2009)

• 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

CDSIC 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. CDSIC registered solutions providers

External links

This article's external links may not follow Wikipedia's content policies or guidelines. Please improve this article by removing excessive or inappropriate external links. (July 2009)

• Clinical Data Interchange Standards Consortium
• CDISC Standards
• Electronic Common Technical Document (eCTD) (FDA)
• Target Health
• ClinPhone
• Formedix
• Phoenix Data Systems
• TAKE Solutions - Life Sciences

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