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Comment: changed to v2 and added some additional text

The Operational Data Model (ODM) is a vendor neutral, platform independent data exchange format, intended primarily for interchange and archive archival of clinical study data pertaining to individual subjects, aggregated collections of subjects, and integrated research studies [

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keyODM2DEV-32
. The model includes the clinical data along with its associated metadata, administrative data, reference data and audit information. All of the information that needs to be shared among different software systems during the setup, operation, analysis, submission or for long term retention as part of an archive is included in the model.

This is version 12.3.2 0 of the ODM. Section 2.5 Changes from Previous Versions provides a summary of the new features. Detailed descriptions of the new features have been incorporated into the text of this document. ODM Version 1.3.2 has been designed to provide 2.0 breaks backward compatibility with previous versions of the model in most cases. In cases where backward compatibility has been impacted, it is due to clarifying the specification to more completely match the original intent of the standard.in several ways noted in the Changes from Previous Versions summary. 

ODM v2.0 can be serialized as XML or JSON and an ODM schema is available for each formatEarlier versions of the model included a DTD. For version 1.2, both an XML Schema and a DTD were provided. Beginning with version 1.3.0 and going forward, only an XML Schema is available.

Clinical data management systems vary significantly in the information they store and the rules they enforce. The ODM model has been designed to represent a wide range of study information so as to be compatible with most existing clinical data management systems. Systems that do not have all of the features represented by the ODM model may still be ODM compatible as long as they comply with the conformity rules provided in the section on System Conformity. 

ODM is the basis for the Define-XML and Dataset-XML standard extensions, and those are used not only for clinical data. However, note that this version of the ODM specification includes references to subjects as defined as a patient participating in the study. ODM has been designed to support extensions, and many organizations, in addition to CDISC, have created extensions to support requirements that extend beyond those documented in this specification.

The ODM has been designed to be compliant with guidance and regulations published by the FDA for computer systems used in clinical studies. This document is intended to be both the formal specification of the ODM and a user guide for those involved in transferring or archiving of clinical data using the model.

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