Length: 1-day

Language: See authorized instructor list

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


Course Objectives


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
  • Define-XML Implementation

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


Types of training available: Public | Private | Licensed