Instructions to Developers
  • Any boxes that look like this one are directed to the developers and should be resolved and removed before review. 
  • All fill-in-the-blanks should be filled before review.
  • Remember to consult the TAUG Content Guide and any other relevant templates or guides from the TechOps Template Development space.
  • Rename this page to replace "TA" with the full name for the therapeutic area.
  • Replace "<KEY>" at the bottom of the page with the project key for the JIRA project associated with this document, and remove all spaces in the URL.
  • Once any draft standards of interest to this document have been identified, add a DSoI index as a child of this page and link to it under the bullet for "Reading on the Wiki".
    • Use the DSoI Index Template on the TTD space to create the page.
    • Title the page "Draft Standards of Interest to TAUG-__".
    • The link and description should use the following language: "Draft Standards of Interest to TAUG-__ — These are CDISC standards-in-development that have influenced the development of the TAUG-__, and are used in examples and/or modeling advice."
  • If the team has any questions for reviewers at either internal review or public review, add a page titled "Questions for Reviewers" as a child of this page and link to it both under the bullet for "Instructions for Reviewers" and in the "Feedback requested on" box.
    • Use the Questions for Reviewers on the TTD space to create the page.
    • The page should come immediately after "Instructions for Reviewers" in the page tree.
    • The description for the link under "Instructions for Reviewers" should use the following language: "— Specific questions from the team to reviewers are here." 

This is the landing page for the TAUG-__. What would you like to do? 

  • Read the TAUG-__
    There are two options, depending on your reading preference:
    • TAUG-TA compiled — This lets you view the entire document as a single web page, but is more prone to errors with the JIRA Connector.

    • TAUG-TA sections — This displays each section on its own page, and comprises the source of the content displayed on the compiled view. 

  • Look at examples

    • TA examples — This is where all examples used in the TAUG-__ live. 

      Note: Readers are recommended to use this directory only after reading the TAUG-__ in its entirety at least once.

  • Provide feedback

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 such as the TAUG-__.
  • TA001 - Overview of Therapeutic Area User Guides — This is a free introductory course on therapeutic area standards on the CDISC training campus. 
  • Reading on the Wiki — This page touches on some of the ways the Wiki edition of the TAUG-__ 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 their 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.

Feedback requested on:

Security

<Who can see and edit pages.>

Status

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

This document is best read online.

A PDF snapshot of the TAUG-__, exported at <date+time in ISO 8601>, is available for those who prefer to review offline here.

As a courtesy to the _____ Team, please still enter comments in JIRA as described in the Instructions for Reviewers if possible.

Comments on the TAUG-__ should be entered into JIRA at: http:// jira. cdisc. org/ projects/ <KEY>. For more detail, see the Instructions for Reviewers.

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