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Define-XML files are an essential component of a CDISC data submission to the US FDA and Japan PMDA. In the Define-XML training course you will learn:
- XML Essentials
- How to represent metadata for SDTM and ADaM, Datasets, variables, codelists and value level metadata
- ODM-based XML for datasets
- Analysis Results Metadata
- How to manage Define-XML implementation challenges
After completing this course, you will be able to:
- Identify and explain the role of the essential XML elements required to generate a Define-XML document.
- Identify the metadata elements that are necessary for representing SDTM and ADaM datasets, variables and codelists.
- Correctly and accurately represent the traceability metadata required for SDTM and ADaM study dataset submissions.
- Identify use cases when Value Level or Parameter level metadata is required and be able to accurately represent that metadata using Define-XML.
- Effectively manage challenges that arise when implementing Define-XML for a given study.
- Explain the relationship between the Define-XML, the ODM and the other CDISC Data Exchange 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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