The CDISC Operational Data Modeling Working Group has published a revised specification for the CDISC Operational Data Model (ODM). This WG of the Clinical Data Interchange Standards Consortium is developing the XML-based ODM standard "to support context, representation, and interchange of the data collected during the course of clinical trials. ODM version 1.1 was developed by a cross-functional team representing pharmaceutical and biotechnology companies, technology providers, and contract research organizations. Among the improvements in ODM Version 1.1 are increased support for incremental data transfers, support for multiple studies, reusable metadata, more complete archiving of clinical trials, increased compatibility with the CDISC clinical laboratory data standards (LAB) and submission data standard (SDS) models, and vendor extensibility. ODM 1.1 is being released with a revised and extensible DTD, together with an extensive documentation set and a set of tools to encourage early adoption by the industry. The ODM is designed to support standard data interchange between various data acquisition sources, such as clinical trial case reports or data captured via an electronic data collection (EDC) application, into an operational database, from which the data are gleaned for analysis and regulatory submission. It also supports archiving of electronic data."

Some enhancements in CDISC ODM version 1.1 include (1) ability to address changes to key data values; (2) expanded transaction support for partial or incremental transfers; (3) expanded metadata descriptions of more complex event structures; (4) support for vendor extension of the DTD; (5) support for including multiple studies and reusable metadata in one file; (6) support for depicting non-patient reference data; (7) increased support for archiving of clinical data and metadata.

From the "Vendor extensions to the CDISC ODM DTD," By Donald Kacher (Oracle Corporation): "While the ODM DTD attempts to provide elements and attributes sufficient to transmit most information about the conduct of a clinical trial, it may be missing elements or attributes needed for various special cases, or for transmission of idiosyncratic information between two databases maintained by the same application. For this reason, CDISC permits the extension of the DTD, under the rules defined here. An extended DTD is one that is a superset of the base DTD. It adds (but never removes) elements or attributes that are needed to make transmitted documents complete and useful to the recipient. An extended DTD may be used where a document compliant with the base DTD would have to be supplemented with information sent by another channel before it could be useful..."

From the announcement:

The ODM Version 1.0 model was implemented by 23 companies in a proof-of-concept CDISC Clinical Data Connectathon in July 2001. This experience has allowed the ODM team to clarify ambiguities, eliminate defects and increase the functionality of the model in their Version 1.1 release. Testing of the Version 1.1 model is being performed and the use of the model was recently demonstrated in the CDISC European Clinical Data Connectathon in Paris, France, on 30 October 2001.

CDISC is an open, multidisciplinary, non-profit organization committed to the development of worldwide standards to support the electronic acquisition, exchange, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development. The CDISC mission is to lead the development of global, vendor neutral, platform-independent standards to improve data quality and accelerate product development in the pharmaceutical industry.

The CDISC Operational Data Modeling Group has been chartered to "develop a vendor independent standard model for the interchange and archiving of clinical trials data with study metadata. It will (1) develop and support the CDISC ODM XML model for clinical trials operational data interchange and archiving. (2) stimulate adoption of the ODM model throughout industry. (3) expand the usability, scope and applicability of the model over time. (4) investigate efforts of other standard-setting organizations (e.g.HL7, NCI Data Model). (5) gather/share representative data models and leverage expertise.