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.