Define-XML

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

Learning Outcomes

• 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.