Table 1.

Summary of ODM Strengths

Lifecycle Phase	Summary of Key ODM Strengths
EDC and EHR Infrastructure	ODM’s flexibility and relative simplicity have enabled it to be successfully applied across a number of EHR integration and single source projects. The Retrieve Form for Data Capture Profile (RFD) is a technical framework available to support EHR and ODM integration. ODM is broadly accepted for data collection in clinical research making it the logical target for EHR integration. ODM is increasingly listed alongside HL7 CDA as a supported XML format for healthcare informatics applications. Several European projects are currently working on EHR and EDC integration, including semantic interoperability.
Planning	ODM metadata has become the language of choice for describing CRFs, and has been used broadly for generating user interfaces. The ability to design a study in one system, export it in ODM, and import it into another system has been demonstrated. A study design ODM extension, SDM-XML v1.0, is currently available, and a draft CTR-XML clinical trial registry extension has been released for public review.
Data Collection	The ODM standard is mature, stable, relatively simple to work with, and supported by a broad number of data capture software vendors. The ODM model includes the information necessary to support the clinical research data collection process, including audit trail and digital signatures. Clinical research data web services using ODM have been demonstrated, and ODM has been shown to work as a document or a message.
Data Tabulations and Analysis	Define-XML supports flexibility in structural representations, and provides a rich set of metadata describing the clinical research datasets. Define-XML is broadly used in practice due to its position as a required component of a FDA regulatory submission. Dataset-XML is a new standard for representing data as tabular datasets, such as SDTM or ADaM, that complements the Define-XML metadata.
Study Archival	ODM maintains all the clinical data collected for a study together with the study metadata, and also contains the full audit trail, including electronic signatures. A significant number of data capture and management systems directly export to ODM as an out-of-the-box feature.