CDISC RELEASES XML MODEL FOR CLINICAL DATA INTERCHANGE

Austin, TX - 9 May 2002 - The Clinical Data Interchange Standards Consortium (CDISC) announces the publication of Version 1.1 Final of the CDISC Operational Data Model (ODM). ODM Version 1.1 reflects feedback submitted by early adopters of the Version 1.1 Draft, released in November 2001, and includes a number of incremental improvements and corrections designed to promote industry-wide adoption and use.

"ODM 1.1 Final represents the culmination of more than three years of effort by a multi-disciplinary team of pharmaceutical and biotechnology sponsors and technology vendors," said Wayne Kubick, Director on the CDISC Board and Leader of CDISC Technical Coordination. "We believe the CDISC 1.1 DTD is now ready for widespread adoption among sponsors, vendors and CROs to facilitate the interchange of clinical trial data."

Use of ODM 1.1 and other CDISC models will be demonstrated by 30 companies in the industry at the CDISC Clinical Data Connectathon, held in conjunction with the DIA Annual Meeting on 18 June 2002 in Chicago. In addition, the model is currently undergoing extensive CDISC-sponsored testing by a team of pharmaceutical company and vendor representatives.

"The ODM 1.1 model is capable of supporting a wide range of applications from Sponsor/CRO data exchange to EDC study archive. Companies who are serious about moving to electronic clinical trials have begun developing systems that use the ODM XML model," said Sally Cassells, ODM team leader. "Having a vendor neutral standard for data interchange and archiving will improve the industry's ability to adopt new technologies."

Among the improvements first incorporated into the ODM 1.1 Draft model were increased support for incremental data transfers, support for multiple studies, reusable metadata and more complete archiving of electronic data for clinical trials, increased compatibility with the CDISC laboratory and submission models, and vendor extensibility. ODM 1.1 Final includes other incremental improvements such as reordering of the elements to allow faster processing, addition of new attributes and elements to support better compatibility with the other CDISC models, and clarification of ambiguities in element naming, transaction types and file attributes.

A zip file containing the XML DTDs and documentation can be downloaded here. CDISC encourages feedback and suggestions from all industry participants.

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 Connectathon or CDISC in general, please visit the CDISC website at www.cdisc.org.

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