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On Demand

Training Schedule Options (click on 'Read more...' to view all options)

The Define-XML virtual training consists of contact hours (3 scheduled days of live Zoom instruction at 3 hours each). The CDISC Education Team will email all registered participants a Zoom link one week prior to the start of training. 

NOTE: If you register for a training less than 48 business hours before the start date, please email to confirm your enrollment and receive the Zoom link.

See below for full breakdown of options: 

Region: EU / US
2-4 Feb; 9am-12pm 
US Eastern Time (English)
Check Your Time Zone!

Region: Japan 日本
2-4 Mar; 12:30pm-3:30pm
Japan Standard Time (Japanese)

Region: China 中国
2-4 Mar; 12:30pm-3:30pm
China Standard Time (Mandarin)

*Trainings will be rescheduled or cancelled if minimum enrollment requirements are not met.

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

Course Agenda

  • Module 1: Introduction to Define-XML
  • Module 2: XML Essentials
  • Module 3: Metadata Representation
  • Module 4: Dataset-XML
  • Module 5: Analysis Results Metadata
  • Module 6: Building Define-XML Files

Course-Level Learning Outcomes

At the end of this course, learners will be able to:

  • 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.

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