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.

HL7 is a standards development organization dealing with data standards for all health care operations; CDISC is oriented to biopharmaceutical drug development only. Because of HL7's broader scope it hasn't dealt much with the nuances of clinical trials, while CDISC hasn't dealt with health care applications important to HL7 such as reimbursements and order processing. Meanwhile, the clinical drug research industry in general has not participated historically in HL7, viewing it as a different industry and application. The differences are the industry, user community, and different standards, as CDISC deals only with clinical trials or regulatory submissions..." [from the Mission Statement and FAQ document]

XML schemas and/or DTDs are provided, for example, in connection with the Operational Data Model (ODM) Final Version 1.2, the CDISC LAB Base Model Version 1.0.1, and the Microbiology Extension for the LAB Base Model.

[May 09, 2002]   Clinical Data Interchange Standards Consortium Publishes CDISC Operational Data Model (ODM).    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." [Full context]

[November 08, 2001]   Clinical Data Interchange Standards Consortium Releases Enhanced XML CDISC Operational Data Model.    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." [Full context]

An announcement of 2000-11-28 from the Clinical Data Interchange Standards Consortium (CDISC) describes the completed development of FDA safety domain metadata models and an XML DTD for clinical data interchange. The XML DTD and associated documentation from the CDISC Operational Data Modeling Group are available for download. The announcement says, in part: "The Clinical Data Interchange Standards Consortium has achieved two significant milestones towards its goal of standard data models to streamline drug development and regulatory review processes. CDISC participants have completed metadata models for the 12 safety domains listed in the FDA Guidance regarding Electronic Submissions and have produced a revised XML-based data model to support data acquisition and archive. The Submissions Data Standards team has been working since early 1999 to define a metadata model that is designed to: (1) provide regulatory submission reviewers with clear descriptions of the usage, structure, contents and attributes of all submitted datasets and variables; (2) allow reviewers to replicate analyses, tables, graphs and listings with minimal or no transformations; (3) enable reviewers to easily view and subset the data used to generate any analysis, table, graph or listing without complex programming. This team, under the leadership of Wayne Kubick of Lincoln Technologies, and Dave Christiansen of Genentech, presented their metadata models to a group of representatives at the FDA on October 10 and discussed future cooperative efforts with Agency reviewers. The CDISC Operational Data Modeling (ODM) Working Group released their Version 1.0 model for data acquisition, interchange and archive. A small, interdisciplinary team was formed in September of 1999 to examine two different XML-based data interchange models (which had been separately put forward by PHT/Lincoln Technologies and by Phase Forward) -- specifically to assess the feasibility of developing an integrated, CDISC standard data and metadata model to support data acquisition. The resulting CDISC model is based on the Extensible Markup Language (XML), which is gaining wide acceptance as a general data interchange framework, and has been determined to be an effective approach to clinical data interchange. The goal of the CDISC XML Document Type Definition (DTD) Version 1.0 is to make available a first release of the definition of this CDISC model, in order to support sponsors, vendors and CROs in the design of systems and processes around a standard interchange format. 'The release of the CDISC Version 1.0 DTD provides the industry with a foundation of standards that will support unprecedented improvements in the quality and efficiency of future data interchange,' said Ken Harter, senior systems analyst, Amgen Inc. Both CDISC models can be reviewed at http://www.cdisc.org/publications.html. Comments are requested by January 31, 2001 and should be posted using the CDISC Web site Discussions option. CDISC is a non-profit organization with a mission to lead the development of standard, vendor-neutral, platform-independent data models that improve process efficiency while supporting the scientific nature of clinical research in the biopharmaceutical and healthcare industries."

"The overall goal of DTD 1.0 is to make available a first release of the definition of the CDISC DAS model, in order to support sponsors, vendors, and CROs in the design of systems and processes around a standard interchange format. The technical focus in the development of DTD 1.0 has been the definition of structures to represent the three major information components relating to a clinical trial: (1) clinical study metadata (item definitions and protocol); (2) clinical study administrative data (users and access privileges); (3) clinical study data (complete record of patient data and audit trail). This includes representation of metadata capable of supporting either direct electronic, or paper-based, data collection and capture of clinical data. Several longer-term objectives of the CDISC DAS data model are not fully supported in the DTD 1.0 version. These additional capabilities, which will be developed in later versions of the standard, include: (1) support for complex 'use case' interoperability between systems (e.g., incremental data interchange, two-way data interchange); (2) representation of queries and query resolution linked to clinical data; (3) support for long-term clinical data archive..."

[June 21, 1999] An announcement describes a Clinical Trial Data Model which is being submitted to the W3C in order to "accelerate Clinical Trial Data Exchange Standards." Phase Forward Incorporated has announced that it will be submitting its "established eXtensible Markup Language (XML)-based data model of their InForm Web-based clinical trial data collection and management software to key industry standards organizations to jumpstart the development of a data interchange model. The Phase Forward Document Type Definition (DTD) data model written in XML will be presented to the Clinical Data Interchange Standards Committee (CDISC), a special interest group of the Drug Information Association (DIA), at its meeting on June 28, 1999. Additionally, Phase Forward also has plans to submit its DTD to the Health Level 7 (HL7) organization and the World Wide Web Consortium (W3C). CDISC, HL7, and the W3C are the primary standards organizations focused on establishing a data model and XML-based Document Type Definition (DTD) for the healthcare informatics industries."

Principal References

• "XML in Clinical Research and Healthcare Industries." General references.
• CDISC Web site
• CDISC Standards:
  • Operational Data Modeling (ODM). See also the ODM Progress Report and Future Plans.
  • Submissions Data Standards (SDS V3.1) (SDS V3.0)
  • Analysis Dataset Model (ADaM)
  • Laboratory Standards (LAB)
  • Protocol Representation Group (PRG)
  • Standard for Exchange of Non-clinical Data
• CDISC Members and Sponsors
• CDISC Publications
• CDISC Public Discussion Forum
• CDISC FAQ document

Articles, News, Early References

• Digital ECG Data Submissions:

  • "FDA XML Data Format Design Specification." Draft C. April 18, 2002. "The FDA desires to use XML as the underlying technology for the specification. This matches the Agency's strategic direction for data submissions. It is also aligned with other industry initiatives such as the CDISC's Submission Data Model (SDM)... This specification document exists for the purpose of defining the design of the FDA XML Data Format (FDADF) and ensuring that all interested individuals and organizations involved with the project have the same understanding of the data format design... The document covers the design for the waveform data format as well as relevant submission information. Areas addressed by this document include identifying design elements that meet the requirements for the data set previously specified in the FDA XML Data Format Requirements Specification[1] which was initiated after the FDA's meeting on November 19th, 2001[2]. Applicability and interaction with other standards bodies and data definitions, e.g. CDISC and HL-7, as well as current practice with SAS submission data sets is also discussed. Design for the structure of the data on electronic media is also covered..." [cache]
  • "FDA XML Data Format Requirements Specification." March 21, 2002. "This specification document exists for the purpose of defining the specific requirements of the FDA XML Data Format (FDADF) and ensuring that all interested individuals and organizations involved with the project have the same understanding of the data format requirements. This document is not a policy document on methodologies to perform clinical trials or how to measure ECG's or data in any other modality..." [cache]

• 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]

• CDISC Corporate Sponsors

• Operational Data Modeling Group. ODM XML documents may be read using an XML-aware browser or a text editor. See the .ZIP archive with a document collection; [cache]

• ODM Overview. "Technical Overview of Version 1.0 of the CDISC ODM Model." 14 pages. [Fall] 2000. "Provides an introduction to the overall structure of the ODM model. It includes a graphical description of the structure, and an overview of the goals of the activity." [cache]

• ODM Version 1.1 preliminary documents:
  • Announcement 2001-11-06: "CDISC Releases New XML Data Model."
  • V1.1 Overview of the CDISC Operational Data Model for Clinical Data Acquisition and Archive [cache]
  • Operational Data Model XML DTD. See also the version with no parameter entities.
  • Specification for the Operational Data Model. Clinical Data Interchange Standards Consortium. Draft Proposed Version 1.1. October 09, 2001.
  • Vendor Extensions to the CDISC ODM DTD. [cache]
  • Version 1.1 .ZIP distribution

• XML DTD. CDISC ODM Model DTD Version Version 1.0. [cache]

• Browsable XML DTD. CDISC ODM Model DTD Version Version 1.0 By T. Bloom S. Cassells A. Diaz D. Fram G. Gordon K. Harter J. Klofft R. Lyons M. Palmer. 99 pages. "A browsable PDF file automatically generated from the DTD. This PDF file includes hyperlinks that facilitate navigation between elements of the model. There is one non-working hyperlink corresponding to a known issue with the model (there is a BaseUnitID but there is no corresponding BaseUnit element). [cache]

• XML Example - "small example of a clinical data file described using the data model." cache

• CDISC Publications and Presentations

• [November 29, 2000] "CDISC Achieves Two Significant Milestones in the Development of Models for Data Interchange."

• Press release: "Phase Forward Submits XML-based Clinical Trial Data Model to Worldwide Standards Organizations. Opens Technology to Accelerate Clinical Trial Data Exchange Standards."