An announcement from the Clinical Data Interchange Standards Consortium (CDISC) describes the release of a final version 1.1 Specification for the Operational Data Model (ODM). The XML-based Operational Data Model "provides a format for representing the study metadata, study data, and administrative data associated with a clinical trial. It represents only the data that would be transferred among different software systems during a trial, or archived after a trial. It need not represent any information internal to a single system, for example, information about how the data would be stored in a particular database." The version 1.1 release includes the text of the specification, with XML DTDs and supporting documentation. ODM v1.1 Final "represents the culmination of more than three years of effort by a multi-disciplinary team of pharmaceutical and biotechnology sponsors and technology vendors; the development team believes the CDISC 1.1 DTD is now ready for widespread adoption among sponsors, vendors and CROs to facilitate the interchange of clinical trial data."
From the announcement:
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.
From the mission statement: "CDISC is an open, multidisciplinary, non-profit organization committed to the development of industry standards to support the electronic acquisition, exchange, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development. The mission of CDISC is to lead the development of global, vendor-neutral, platform independent standards to improve data quality and accelerate product development in our industry."
- Announcement 2002-05-09: "CDISC Releases XML Model for Clinical Data Interchange."
- "Overview of the CDISC Operational Data Model for Clinical Data Acquisition and Archive." Based on CDISC DTD 1.1 Final. April 26, 2002. [cache]
- "Specification for the Operational Data Model (ODM)." From: Clinical Data Interchange Standards Consortium. Version 1-1-0. April 26, 2002.
- Operational Data Model (ODM) Version 1.1- Final. ZIP distribution. See the document listing. [cache]
- ODM v1.1 XML DTD; see also the version with PEs for vendor extensions [cache DTD, DTD with PEs]
- Clinical Data Interchange Standards Consortium (CDISC) website
- "A Multidisciplinary Approach to Data Standards for Clinical Development: Progress Update." By Rebecca Kush. 6 pages. Reprinted from Applied Clinical Trials Volume 11, Number 4 (April 2002), pages 35-44.
- "It's Easy If You Know How: Importing, Processing, and Exporting CDISC XML with SAS." By Michael C. Palmer (Zurich Biostatistics). February 2002. 4 pages.
- Announcement 2001-11-08
- "Clinical Data Interchange Standards Consortium" - Main reference page.