1. 28 January 2004 Mineko FUJIMOTO Motohide NISHI Masahiro YOKOKAWA
ODM&LAB sub-team
28 January 2004
Mineko FUJIMOTO
Motohide NISHI
Masahiro YOKOKAWA

2. Technical objectives for ODM
The overall goal of ODM 1.0 was to make available a first release of the definition of the CDISC XML model, in order to support sponsors, vendors, and CRO’s with respect to the design of systems and processes around a standard interchange format.
ODM has released ODM Final Version 1.2 for implementation. This version introduces the XML schema representation of the model and includes several enhancements.

3. LAB central team mission
Define requirements for improving operational laboratory data interchange.
Develop a standard content model for the acquisition and interchange of clinical trials laboratory data
Test the model with complex real laboratory data to assure its functionality
Explore other opportunities to improve laboratory data processing with

4. ODM&LAB team task step and member
Prepare the XML documents for ODM
Understand the CDISC data models
Introduce ODM, LAB demonstration
Identify Japanese requirements
Provide Japanese inputs to central modeling team
25 members, 13 from ODM and 12 from LAB

5. Japanese Requirements
ODM&LAB teams
1st step
2nd step
ODM
translation
ODM manual
LAB
translation
LAB manual
XML
documentation
for ODM
Identify
Japanese Requirements
INPUT to Central

6. XML documents for ODM model
Introduce the XML syntax for ODM model
Guide to understand the XML syntax for ODM model

7. XML documents for ODM model
Contents
1. XML History
2. Advantage of XML
3. XML in the ODM
4. Structure of XML documents
5. Syntax of XML
6. Syntax of DTD
7. Well Formed, Valid Formed
Appendices

8. To Understand ODM model
Translate the specifications and DTD
Specification for ODM Ver1.1
Manual for DTD for ODM Ver1.1

9. Miscellaneous in translation
Use English label, not Japanese
Use English technical term, not Japanese
Other terms based on glossary Ver1.
Glossary ver2 will be adopted to our translations

10. LAB group To understand LAB standard and related terms Code list
LAB specification ver1.0
Code list
HL7 V2.4
LOINC code
NCI Common Toxicity Criteria

11. Schedule 2004 Finalize XML documents ODM LAB Prepare DTD manual
Complete translation of the model specification
Review and understand DTD for ODM
Prepare ODM manual
Introduce ODM demonstration
LAB
Complete translation of LAB specification
Review and understand code list (HL7, LOINC, NCI-CTC)