The CDISC Operational Data Model (ODM), maintained by the CDISC XML Technologies Team, is designed to facilitate the regulatory-compliant acquisition, archive and interchange of metadata and data for clinical research studies. ODM is a vendor neutral, platform-independent format for interchange and archive of clinical study data. The model includes clinical data along with its associated metadata, administrative data, reference data and audit information. All the information that needs to be shared among different software systems during the study setup, operation, analysis, submission or for long-term retention as part of an archive is included in the model.
In the specification document (ODM1-3-2-final.html) section "2.5 Changes from Previous Versions" provides a summary of new features added in this release. Detailed descriptions of the new features have been incorporated into the text of the specification document. ODM Version 1.3.2 is designed to provide backward compatibility with previous versions of the model in most cases, and is completely backward compatible with ODM 1.3.1. 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.
Comments due 27 Apr 2015 (DEADLINE EXTENDED)