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Begins 02 Mar 2022
Available capacity: 30

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 February*
09:00 - 12:00
US Eastern Time (English)
Check Your Time Zone!

*While this course is scheduled to begin in February, it is the last training of the January EU/US Virtual Training MonthIt will be taught in English and begins at 09:00 US Eastern Time.

Region: Japan 日本
2 - 4 March*
12:30 - 15:30
Japan Standard Time (Japanese)

*While this course is scheduled to begin in March, it is the last training of the February Asia Virtual Training MonthIt will be taught in Japanese and begins at 12:30 Japan Standard Time.

Region: China 中国
2 - 4 March
12:30 - 15:30
China Standard Time (Mandarin)

While this course is scheduled to begin in March, it is the last training of the February Asia Virtual Training Month. It will be taught in Mandarin and begins at 12:30 China Standard Time.

*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.

Date: 02 Mar 2022
Start Time: 12:30
End Time: 15:30
Instructor : CDISC Authorized Instructor
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