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Comment: minor wording correction in the subject definition, second to last sentence.

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

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. 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 , and archiving of a study are included in the model.

This is version Version 2.0 of the ODM. Section 2.5 5, Changes from Previous Versions provides , provides a summary of the new features. Detailed descriptions of the new features have been incorporated into the text of this document. ODM Version 2v2.0 breaks backward compatibility with previous versions of the model in several ways noted in the Changes from Previous Versions summarySection 2.5 summary. 

ODM v2.0 can be serialized as XML or JSON and an ODM , JSON, or other formats. An ODM XML schema is currently available for each format.

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 Section 2.3, 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 as documented in Section 2.4, ODM Extensions, and many organizations, in addition to CDISC, have created extensions to support requirements that extend beyond those documented in this specification.

ODM is the basis for the Define-XML and Dataset-JSON standard extensions used to represent tabular dataset metadata and data, respectively. These standard extensions target clinical research data, but may be used to represent any tabular dataset. Note that this ODM specification references subjects and subject data. A subject is defined as a participant in the study. 

The ODM has been designed to be compliant with guidance and regulations published by the US Food & Drug Administration (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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