Tokyo, Japan - Define-XML (IN-PERSON)

EPS

Japan, 〒162-0822 Tokyo, Shinjuku City, Shimomiyabicho, 2−23 つるやビルディング
つる家ビル(TSURUYA BLDG.)

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.

After purchasing a virtual training, you will automatically receive a Confirmation Email with the following:

• an order number
• link to the CDISC Learning Management System (LMS)

You can immediately access the online training materials in the LMS.

Within 24 hours, you will be assigned to your specific virtual Zoom seminar event.

You will receive a Training Booking Confirmation Email with the following:

• event details (including a Zoom meeting link)
• an iCal attachment

Please contact us if you do not receive these emails within 24 hours.