Course Description

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:

  • 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

Learning Outcomes

Course Agenda


Continuing Education Units (CEUs)

Available Sessions:

Product Name Date Region Time Price
Define-XML Mon, 29-31 May, 2023 EU 09:00-12:00 CEST - Zoom $840.00
Define-XML Mon, 25-29 Sep, 2023 US 09:00-12:00 ET - Zoom $840.00