Upcoming Public Training Opportunities:
Define-XML files are an essential component of a CDISC data submission to the US FDA. In the Define-XML training course you will learn:
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.
CDISC also offers this course through Private Training and Licensed Training.