The Operational Data Model (ODM) is a vendor neutral, platform independent format for interchange and archive of clinical study data. 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 1.3.2 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 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.
Earlier 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.
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.