The Operational Data Model (ODM) is a vendor-independent format used to store, interchange between data management systems, or archive study data, study metadata or administrative data associated with clinical trials. The ODM has been presented to the FDA as the standard for data archiving. This course also provides the basis for Define.XML.
This training consists of:
- Use cases for ODM
- XML basics including an introduction to XSL
- How to represent clinical trial metadata and data using ODM
- How ODM satisfies the FDA's Computers Used in Clinical Trials requirements for data archive
Module 1: Introduction to the ODM
Module 2: Use Cases
Module 3: Why XML?
Module 4: The Model in Detail
Module 5: Interchange Process
Module 6: Other CDISC XML Standards & Compliance
A working knowledge of XML or other mark-up languages is helpful to understanding the material presented.
Continuing Education Units (CEUs)
The learner must receive a score of 80% or higher on the Final Assessment to earn 0.7 CEUs.