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
Successful Course Completion
- In order for a leaner to successfully complete a course:
- An education representative or learner will complete training registration.
- A learner will complete formative assessment survey
- 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.
Attendees should be familiar with the CDISC SDTM and ADaM specification and implementation guides. Prior XML experience is helpful but not required.