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On Demand

Course Description:

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
  • 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

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