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Operational Data Model (ODM) - XML

ODM-XML* is a vendor-neutral, platform-independent format for exchanging and archiving clinical study data. ODM-XML includes all information (clinical data, along with its associated metadata, administrative data, reference data, and audit information) necessary to share among different software systems during study setup, operation, analysis, submission and for long-term retention as part of an archive to facilitate the regulatory-compliant acquisition, archive and exchange of metadata and data. ODM has become the language of choice for representing case report form content.

1.3.2
December 1, 2013

ODM-XML is a vendor-neutral, platform-independent format for exchanging and archiving clinical study data. ODM-XML includes all information (clinical data, along with its associated metadata, administrative data, reference data, and audit information) necessary to share among different software systems during study setup, operation, analysis, submission and for long-term retention as part of an archive to facilitate the regulatory-compliant acquisition, archive and exchange of metadata and data.ODM has become the language of choice for representing case report form content.

 

 

ODM-XML v1.3.2 is the most current version of the standard. A number of CDISC standards have been developed by extending ODM-XML including: Define-XML, SDM-XML, Dataset-XML, CTR-XML and CT-XML. ODM-XML provides a common base structure for these standard extensions easing the learning curve and implementation complexity.

Downloads:
FileSize
Package icon ODM v1.3.2130.96 KB
1.3.1
February 11, 2010
Downloads:
FileSize
Package icon ODM Version 1.3.166.97 KB
1.3
January 26, 2007

This version includes numerous
enhancements and new features in support of regulatory data submission
and eCRF application support.

Significant changes are the
addition of support for new data formats including partial dates,
booleans, URLs, hex and base 64 binary, hex and base 64 float data and
the introduction of support for typed clinical data transmission. Typed
data transmission will allow for more efficient, higher quality clinical
data interchange as adopters incorporate this functionality into their
ODM enabled applications. Other important changes include the
incorporation of some Define.XML extensions back into the core ODM:
Description element that can be used at any ODM Metadata level and the
Rank attribute for the ODM CodeList element.

Changes made based
on comments received during the review period are documented in Changes
in ProductionVersion.html in the Posting Package.

A more complete
introduction to the new features in ODM 1.3 can be found in section 2.5
of the ODM 1.3 specification.

Downloads:
FileSize
Package icon ODM 1.378.32 KB
1.2.1
January 10, 2005

ODM Final Version 1.2.1 Model Released for
Implementation in January 2005

To better support vendor
extensions, the Version 1.2.1 Schema should be referenced instead of the
ODM Version 1.2.0 Schema in applications and XML files.

Downloads:
FileSize
Package icon ODM 1.2.123.82 KB
1.2
January 1, 2004

Final Version 1.2 Model Released for Implementation in January 2004

Downloads:
FileSize
Package icon ODM 1.2172.91 KB
1.1
April 1, 2002

Final Version 1.1 Model Released for Implementation in April 2002