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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.

    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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