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
Ann Arbor, MI - Define-XML (IN-PERSON)
Thurs, 25 July 2024
Ann Arbor
9:00am - 6:00pm US Eastern Time
$1,400.00
Product Name | Date | Region | Time | Price | |
Ann Arbor, MI - Define-XML (IN-PERSON) | Thurs, 25 July 2024 | Ann Arbor | 9:00am - 6:00pm US Eastern Time | $1,400.00 |