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 one-day course 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
At the end of this course, learners will be able to:
- Describe the purpose of ODM to set the stage for ODM implementation.
- Interpret clinical trial data and metadata in ODM in order to plan a successful ODM implementation project.
- Explain how the ODM administrative data supports US FDA requirements for computer systems used in clinical trials.
- Recognize how ODM harmonizes with other standards.
- 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
Continuing Education Units (CEUs)
The learner must receive a score of 80% or higher on the Final Assessment to earn 0.7 CEUs.
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