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TA001: Overview of Therapeutic Area User Guides

On Demand

Therapeutic Area User Guide, Module 1 provides an overview of the structure of Therapeutic Area User Guides. It describes concept maps and metadata, shows the relationship between foundational standards and TA User Guides, and also discusses how to review draft TA User Guides.

Module-Level Learning Outcomes:

  • describe the CFAST organization, stakeholders, and high level TA standards development process
  • describe deliverables for each development process stage
  • discuss the development of concept models/maps and how they are used
  • use the concept metadata structures
  • explain the Therapeutic Area User Guides (TA User Guides) and where the concepts fit into the existing CDISC models
  • apply best practices for reviewing and contributing feedback on TA User Guides during public review periods

Language: English | Duration: 02:10:14 | CEUs: 0.2

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