CDISC Mapping 2: ODM, MindMaps and References

This training program will highlight key differences between SDTM and ADaM models and process flows. It will also focus on key differences between the seven CDISC classes and on best practices to create Dataset.XML from SAS. Attendees will gain a better understanding of the structure and syntax of ODM-XML files as well.

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Last Recorded Date: Mar-2019

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Learning Objectives:
  • Understand key differences between SDTM and ADaM models and process flows
  • Understand key differences between the seven CDISC classes
  • How to create Dataset.XML from SAS
  • Better understand structure and syntax of ODM-XML files using examples
Areas Covered in the Webinar:
  • MindMaps - SDTM and ADaM Domains, SDTM Variable Types and Roles
  • CDISC Quick References
  • Understanding Seven CDISC Classes
  • Study Reference Files
  • SDTM and ADaM Dataset Models and Process Flows
  • Creating and QCing Define.xml & Dataset-XML
  • Creating Dataset.XML from SAS
  • ODM-XML File Structure and Content
    • Global Element Order
    • Understanding Tagsets
    • Components – Metadata, Clinical Data, Administrative, Reference and Audit
Who Will Benefit:

This course is intended for anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Professionals in the pharmaceutical, biotechnology and medical device industries who want to be Good Clinical Practices (GCP) compliant in relation to regulatory submission environment will benefit from this course. Effective and practical solutions to address real-world issues will be provided.

This course is recommended for:

  • SAS Statistical Programmers
  • Quality Assurance Specialists
  • SAS Statistical Managers
  • Medical Writers
  • Statisticians
  • Regulatory Affairs Associates
  • Clinical Data Managers
  • Directors, Statistical Programming
  • CRO Professionals
  • Health Care Professionals
  • Research University Specialists
Instructor Profile:
Sunil Gupta Sunil Gupta

SAS Global Forum Conference Presenter Mentor, SAS

Sunil Gupta is an international speaker, best-selling SAS author, and a global corporate trainer. He is the principal SAS/CDISC consultant at Gupta Programming since 1994. Most recently, he taught both of his CDISC online classes with the University of California at San Diego and SAS Institute India. Mr. Gupta will start to teach the new Sharpening Your SAS Skills online class for UCLA Extension in 2016. In 2011, he launched his unique SAS resource blog, SASSavvy.com, for smarter SAS searches. Currently, SAS Savvy’s membership consists mostly of SAS programmers, university students and pharmaceutical corporate accounts.

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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