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  1. This guide does not include 


  1. Read

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  1. the foundational standards upon which this document is

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  1. 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:

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  1. http://www.cdisc.org/.
  2. Next, read Introduction to Therapeutic Area Standards and/or take CDISC's free training module TA001 - Overview of Therapeutic Area User Guides for an understanding of what to expect from this guide. 
  3. Read this guide all the way through (without skipping any sections) at least once.
  4. Finally, revisit any sections of particular interest.







The SDTMIG is best read online, so the reader can benefit from the many hyperlinks to internal and external references. The following guidelines may be helpful in reading this document:

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