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 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. CDSIC registered solutions providers

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

References

• 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

• Clinical Data Interchange Standards Consortium
• CDISC Standards
• Electronic Common Technical Document (eCTD) (FDA)