Operational Data Model

ODM 1-3-1 Public Review Now Open.

You can read full details of the release and make your comments by following this link.

Please add your findings to the comments spreadsheet and send it to Sam Hume samuel.hume@astrazeneca.com before 18 December 2009.

Final Version 1.3 for Implementation

CDISC's Operational Data Modeling Team (ODM) has released ODM Final Version 1.3 for implementation. This version includes numerous enhancements and new features in support of regulatory data submission and eCRF application support.

Significant changes are the addition of support for new data formats including partial dates, booleans, URLs, hex and base 64 binary, hex and base 64 float data and the introduction of support for typed clinical data transmission. Typed data transmission will allow for more efficient, higher quality clinical data interchange as adopters incorporate this functionality into their ODM enabled applications. Other important changes include the incorporation of some Define.XML extensions back into the core ODM: Description element that can be used at any ODM Metadata level and the Rank attribute for the ODM CodeList element.

Changes made based on comments received during the review period are documented in Changes in ProductionVersion.html in the Posting Package.

A more complete introduction to the new features in ODM 1.3 can be found in section 2.5 of the ODM 1.3 specification.

Please post any comments or questions in CDISC’s public Discussion Forum.

• Changes in Production Version (html) Contains responses to comments and also a list of changes
• ODM1-3-0-Final (html) Specification for ODM version 1.3
• ODM1-3-foundation (xsd) Schema containing definitions of the elements, attributes and datatypes that comprise ODM version 1.3 
• ODM1-3-Rev (xsd) Schema containing namespace definitions for ODM Version 1.3
• ODM Example Files (zip)
• XML (xsd) Schema file to enable offline use of examples
• xmlsig-core-schema (xsd) Schema file to enable offline use of examples
• ODM1-3-0Revised (zip) All of the above files in a single zip file

Final Version 1.2.1

ODM Final Version 1.2.1 Model Released for Implementation in January 2005

To better support vendor extensions, the Version 1.2.1 Schema should be referenced instead of the ODM Version 1.2.0 Schema in applications and XML files.

• ODM1-2-1 (xsd) Schema for Final Version 1.2.1 Model
• ODM1-2-1-Foundation (xsd) Defines elements, attributes and structure of the base ODM schema
• ODM1.2.1 Read Me (doc) Describes the new extension methods used in V1.2.1
• ODM1-2-1 (zip) Includes all of the above files in a single zip file

 Final Version 1.2

 ODM Final Version 1.2 Model Released for Implementation in January 2004

• ODM1-2-0 New Features (pdf) Discussion of Final Version of 1.2 new features
• ODM1-2-0 Release notes (txt) Discussion of changes made since the V1.2 draft version
• ODM1-2-0 (html) Primary specification and description of the Final Version 1.2 model
• ODM1-2-0 (xsd) Schema for Final Version 1.2 model
• ODM1-2-0 (dtd) DTD for Final Version 1.2 model
• ODM1-2-0 (zip) Includes all of the above files in a single zip file

Final Version 1.1

ODM Final Version 1.1 Model Released for Implementation in April 2002

• ODM1-1-0-Intro (pdf) Discussion of V1.1 rationale, changes etc
• ODM1-1-0-Overview (pdf) Provides and introduction to the overall structure of teh ODM model. It includes a graphical description of the structure, and an overview of the goals of the activity.
• ODM1-1-0.html Primary specification and description of the Final 1.1 model.
• ODM1-1-0.dtd DTD for the Final V1.1 model.
• ODM1-1-0x.dtd DTD for the final V1.1 model, including parameters to allow vendor extensions.
• ODM1-1-0-ReleaseNotes (pdf) List of changes to the final 1.1 DTD compared with the Draft 1.1 DTD
• ODM1-1-0.zip Includes all of the above files in a single zip file.
• ODM1-1-0-example.xml Example of a version 1.1 ODM xml file for a clinical study.
• ODM V1.1 Use Case: ODM Metadata Transfer The ODM V1.1 provides significant benefits over earlier technologies when providing data collection specifications for third party data providers such as CROs and EDC vendors. This case describes the use of the ODM using three scenarios and includes xml examples.

CDISC Customer Requirements Analysis

White Paper: Vendor Extensions to CDISC ODM DTD (pdf)