Tokyo, Japan - Define-XML (IN-PERSON - PPD-SNBL k.k.)

Company name: PPD-SNBL k.k.

Address: St Luke’s Tower 7F, 8-1 Akashi-cho, Chuo-ku, Tokyo 104-0044

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.

• 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

• The learner must receive a score of 80% or higher on the Final Assessment to earn 0.7 CEUs.