Define-XML

• Identify and explain the role of the essential XML elements required to generate a Define-XML document. 

• Identify the metadata elements that are necessary for representing SDTM and ADaM datasets, variables and codelists. 

• Correctly and accurately represent the traceability metadata required for SDTM and ADaM study dataset submissions. 

• Identify use cases when Value Level or Parameter level metadata is required and be able to accurately represent that metadata using Define-XML. 

• Effectively manage challenges that arise when implementing Define-XML for a given study. 

• Explain the relationship between the Define-XML, the ODM and the other CDISC Data Exchange standards.
  

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