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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 Section 2.3, System Conformity.
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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 patient participating 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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