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  • Read Conformance Rules
  • View the examples and figures
    • TIG Examplesexamples — This is where all examples used in the document are located. 

    • TIG Diagramsdiagrams — This is where all figures used in the document are located.
  • Provide feedback
    • Instructions for Reviewers — This is where to find detailed instructions for how to use JIRA to provide feedback on the document.

Other resources you may find helpful:

Introduction to Therapeutic Area Standards — This provides an overview of what to expect, and what not to expect, from a therapeutic area user guide.

  • Reading on the Wiki — This page touches on some of the ways the Wiki edition of the document has been optimized for web use, with which a reader new to the CDISC Wiki may be unfamiliar. 
  • TA Specification — This is a spreadsheet that provides information, for newer and proposed domains and variables, on relationships with versions of SDTM and the SDTMIG.

    Info

    TA Specifications were developed to assist FDA in their testing processes, but can also provide implementers with advice on how to adapt the representation of data shown in the TAUG to different versions of the standards. TA Specifications are provided as a resource to reviewers; we are not seeking comment on the TA Specification. However, we would appreciate being informed of inconsistencies in the content of the TA Specification and the TA User Guide.

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standard, which means that it is still in development and not yet ready for provisional or general use. 

Comments on this document should be entered into JIRA at: https://jira.cdisc.org/projects/TOBA. For more details, see the Instructions for Reviewers.