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1. This guide does not include address or define regulatory submission requirements. Requirements for data submission are defined and managed by regulatory authorities to whom data are submitted. It is therefore recommended users of this guide review and understand applicable requirements prior to reading this guide.
2. Read the foundational standards upon which this document is based, referenced in Relationship to CDISC Documents, to gain some familiarity with data models and the basic rules for how they are implemented. These standards are available at: http://www.cdisc.org/..
3. Read this guide all the way through (without skipping any sections) at least once.
   1. Read Section 2 Fundamentals of the Standard
   Next, read Introduction to Therapeutic Area Standards
   1.  and/or take CDISC's free training module
    TA001 - Overview of Therapeutic Area User Guides for
   1. <add link here> for an understanding of what to specifically expect from this guide. 
   Read this guide all the way through (without skipping any sections) at least once.
4. Finally, revisit any sections of particular interest.

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