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.
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.
Final Version 1.2
ODM
Final Version 1.2 Model Released for Implementation in January 2004
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)
