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.
Download ODM v1.3.2
CDISC offers an ODM certification program to provide assurance that your ODM-capable products can produce OD-XML files with a high level of conformity to the published specifications.
* Previously referred to as ODM, the name of the standard has been changed to align with the XML family of products.
Download ODM v1.3.1