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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:

  • XML Essentials

  • Metadata for submission datasets

  • ODM-based XML for datasets

  • Analysis Results Metadata

  • How to manage Define-XML implementation challenges

Current Course Material Used: 
Define-XML v2.0 Specification, ODM v1.3.2

Attendees should be familiar with the CDISC SDTM and ADaM specification and implementation guides. Prior XML experience is helpful but not required.

Course Length: 
1 Day
Course Type: 
Public, Private, Licensed