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.
Available Sessions:
Product Name
Date
Region
Time
Price
Define-XML
Mon, 6 Feb - 8 Feb, 2023
US-EU
09:00-12:00 ET - Zoom
$840.00
Define-XML
Mon, 27 Feb - 1 Mar, 2023
JP
12:30-15:30 JST - Zoom
$672.00
Define-XML
Mon, 29-31 May, 2023
EU
09:00-12:00 CEST - Zoom
$840.00
Define-XML
Wed, 26-28 July, 2023
CH
13:00-16:00 CST - Zoom
$504.00
Define-XML
Mon, 25-29 Sep, 2023
US
09:00-12:00 ET - Zoom
$840.00
Product Name | Date | Region | Time | Price | |
Define-XML | Mon, 6 Feb - 8 Feb, 2023 | US-EU | 09:00-12:00 ET - Zoom | $840.00 | |
Define-XML | Mon, 27 Feb - 1 Mar, 2023 | JP | 12:30-15:30 JST - Zoom | $672.00 | |
Define-XML | Mon, 29-31 May, 2023 | EU | 09:00-12:00 CEST - Zoom | $840.00 | |
Define-XML | Wed, 26-28 July, 2023 | CH | 13:00-16:00 CST - Zoom | $504.00 | |
Define-XML | Mon, 25-29 Sep, 2023 | US | 09:00-12:00 ET - Zoom | $840.00 |