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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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