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 healthcare". Their main project, the described data standard, bears the same name. It is written in XML Schema and alternatively as a legacy Document Type Definition.

CDISC standards

• Study Data Tabulation Model (SDTM)

Highlights: recommended for regulatory submissions since 2004

• Standard for the Exchange of Non-Clinical Data (SEND clinical trial)
• 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)

See also

• Electronic Common Technical Document (eCTD)
• Electronic Data Capture
• Clinical data acquisition
• Clinical Data Management System (CDMS)
• Health Level 7
• Health Informatics Service Architecture (HISA)
• LOINC
• SNOMED
• SNOMED CT
• DICOM
• Clinical trial
• Fast Track Systems
• Medidata Solutions
• Phase Forward
• Image Solutions, Inc.
• United BioSource Corporation
• Octagon Research Solutions, Inc.
• Oracle Clinical
• ClinPhone
• Computerized Systems Used in Clinical Trials (CSUCT)
• JANUS clinical trial data repository
• Formedix

References

• Rebecca Daniels Kush (2003), eClinical Trials: Planning and Implementation, CenterWatch / Thomson Healthcare, ISBN 1-930624-28-X

External links

• Clinical Data Interchange Standards Consortium
• CDISC Standards
• Electronic Common Technical Document (eCTD) (FDA)
• Target Health
• ClinPhone
• Formedix

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