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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 the course, you 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.
Continuing Education Units (CEUs)
Learners will receive 0.7 CEUs for successfully completing this course.
Successful Course Completion
- In order for a learner to successfully complete a course:
- An education representative or learner will complete training registration.
- A learner must attend course for 80% of total course time. Specific attendance requirements are posted in course information pages.
- A learner will complete final course assessment with a score of at least 80% correct.
- A learner will complete summative assessment surveys
- Remediation: The following requirements will be in effect if learner does not successfully complete all parts of training:
- If learner registers for course but fails to complete formative assessment in required time, learner will be notified that they must transfer registration to later date.
- If learner completes formative assessment but does not meet attendance requirement, learner will be notified that they must re-attend course in full.
- If learner meets attendance requirement in full but fails content assessment, learner is given a maximum of two additional re-attempts before being required to re-attend the course in full. Learner will be notified and will receive a certificate of attendance after the third failed assessment attempt.
- If learner successfully completes content assessment but fails to complete summative assessment, learner will be notified and CEUs will be on hold until summative assessment is completed.
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