CDISC RELEASES NEW XML DATA MODEL

Austin, TX - 6 November 2001 - The Clinical Data Interchange Standards Consortium (CDISC) announced the publication of Version 1.1 of the CDISC Operational Data Model (ODM). This new version of the model, which was developed by a cross-functional team representing pharmaceutical and biotechnology companies, technology providers, and contract research organizations, represents a substantial improvement over Version 1.0.

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. With increasing requirements for clinical trial data transfers, the ODM is expected to significantly improve efficiencies within the industry. ODM facilitates a reusable, standard method for both metadata and clinical data transfer, making individual study transfers much less time-consuming.

"The ODM Version 1.1 model represents a major milestone in clinical system interoperability," said Wayne Kubick, Director on the CDISC Board and Technical Coordinator. "We believe this version meets the most essential needs for clinical data interchange and will be widely implemented throughout the industry."

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 an extensive documentation set and a set of tools to encourage early adoption by the industry.

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.

"GlaxoSmithKline (GSK) is pleased to have been an active and ongoing contributor to the development of the ODM model," said Marc Citrin, GSK's representative to the CDISC Industry Advisory Board. "Our sponsorship of events and presence at both the July Connectathon in Denver and the European Connectathon demonstrate GSK's continued commitment to the success of CDISC."

CDISC encourages support from industry participants and feedback on this model, with an intent to issue a final release version of the ODM 1.1 by the end of 2001. The model and documentation are posted on the CDISC website (www.cdisc.org) for comment.

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.

For more detailed information about the Clinical Data Connectaton or CDISC in general, please visit the CDISC website at www.cdisc.org.

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