ODMConform
The CDISC Operational Data Model (ODM) provides a highly flexible means of exchanging data within the clincal trial enterprise. However, we need assurance that the ODM files are correctly structured, to ensure that data will be correctly exchanged. For this reason, Assero have developed a tool that checks the content of ODM files. ODMConform allows you to test, validated or check the compliance and conformance of your ODM files to ensure you comply with the ODM standard.
Features
ODMConform provides that functionality allowing you to check your ODM files easily and quickly during your testing, validation or conformance process providing:
- High Quality Checking – ODMConform performs a whole range of checks on an ODM file, examining the XML structure, ensuring compliance with the ODM schema and then ensuring that the ODM files meets the rules contained within the ODM specfication.
- Multiple File Handling and Results Visualisation – ODMConform is able to handle single or multiple ODM files, automatically collating the files based upon the linkage contained within the FileOID and PriorFileOID attributes. The tool also allows the errors and the XML to be readily viewed with all information easily available.
- Error Messages – Full error messages are provided for all errors detected and these link into the ODM file and the ODM specification.
- ODM Specification – The complete ODM specification is held and can be accessed at any time. When clicking on individual errors, the relevant sections of the specification can be accessed directly.
- ODM Version Support – ODMConform supports V1.1, V1.2 and V1.3 of the ODM.
Using the ODMConform tool, ODM files can be tested for their conformance with the standard. And to assist you, the tool is linked into the ODM standard to allow for a full and clear explanation of all errors detected.
Release History and Downloads
Date Release Details Download
22nd September 2010 R2.3.4 Improved handling of ItemData[Type] elements for ODM V1.3 R2.3.4
23rd August 2010 R2.3.3 Correct bug in schema validation error reporting. R2.3.3
18th August 2010 R2.3.2 Correct bug in handling of customer extensions.
1st February 2010 R2.3.1 Simple re-build for Windows 7 for internal development.
1st May 2009 R2.3.0 Further rules being checked for.
28th April 2009 R2.2.0 Improved handling for large files (largest handled 90Mb).
5th July 2008 R2.1.0 New install mechanism.
16th May 2007 R2.0.2 Fixed bugs when handling large files.
10th April 2007 R2.0.1 Improved error handling.
2nd February 2007 R2.0.0 First release to customers.
25th April 2006 R1.0.37 Bug fixes. Third beta release suitable for distribution to partners. Limited distribution.
12th March 2006 R1.0.36 Allows processing of V1.3 (draft) ODM files. Second beta release suitable for distribution to partners. Limited distribution.
5th January 2006 R1.0.21 First beta release suitable for distribution to partners. Limited distribution.
26th September 2005 R1.0.3 Re-implementation using Microsoft .NET technology. First beta release of the tool.
Limited distribution.
5th June 2005 R1.0.1 Updated release to allow for installation on Windows 2003 Server.
30th May 2005 R1.0.0 First full release.
15th December 2004 R0.0.71 First public beta release.
20th November 2004 R0.0.69 Further updates to beta release.
Limited distribution.
9th October 2004 R0.0.64 Update to beta release.
Limited distribution.
1st October 2004 R0.0.57 First beta release of the tool.
Limited distribution.

