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:
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:
Learners will receive 0.7 CEUs for successfully completing this course.
Attendees should be familiar with the CDISC SDTM and ADaM specification and implementation guides. Prior XML experience is helpful but not required.