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.
Register today for trainings at this discounted introductory price!
오늘 등록하고 할인된 입문 가격으로 훈련을 신청하세요.
Available Sessions:
Product Name
Date
Region
Time
Price
Seoul, Korea - Define-XML (IN-PERSON - KoNECT)
Fri, 15 November 2024
Korea
09:00-18:00 KST
$970.00
Product Name | Date | Region | Time | Price | |
Seoul, Korea - Define-XML (IN-PERSON - KoNECT) | Fri, 15 November 2024 | Korea | 09:00-18:00 KST | $970.00 |