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  1. First, read _______________________ to gain some familiarity with _______________________. These standards are available from: the foundational standards upon which this document is based—Study Data Tabulation Model (SDTM) v2.0, the SDTM Implementation Guides (SDTMIG v3.4 and the SDTMIG for Medical Devices (SDTMIG-MD) v1.1), Analysis Data Model (ADaM) v2.1, and the ADaM Implementation Guide (ADaMIG) v1.3—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/.
  2. Next, read the Introduction to Therapeutic Area Standards (at http://wiki.cdisc.org/x/SSy8AQ) and/or take CDISC's free training module training module TA001 - Overview of Therapeutic Area User Guides (at https://secure.trainingcampus.net/uas/modules/trees/store/wcatalog.aspx?cat=1015&ci=4&vtype=2&pi=0) to be sure to know  for an understanding of what to expect from a therapeutic area user guide such as this documentthis guide. 
  3. 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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titleInstructions to Developers

Completing this section

  • Fill in the blanks in step 1 with (a) the names of the foundational standards upon which this document is based, and (b) what, in general, the reader should already be familiar with before reading this guide (such as the CDISC data models and their general rules for implementation).
  • Fill in the blank in the paragraph below with the tiny link (such as the one to Introduction to Therapeutic Area Standards above) to the Draft Standards of Interest (DSoI) page for the guide; or if there are no draft standards of interest, remove the paragraph.
  • All fill-in-the-blanks must be replaced with actual text before the document can go to internal review.

Expanding on this section

  • The instructions above, and both paragraphs below, are all extensible. They can also be modified slightly, so long as their basic meaning is unaltered.
  • Any additional instructions should not be simply appended to the end of the steps above, but be inserted so that the entire set of instructions reads in approximate chronological order.
  • Any companion documents (or list of such) should be added to the first paragraph below, either before or after the sentence provided depending on whether you think they're more or less important and/or interesting than the DSoIs. More important/interesting companion documents go first.
  • Any additional caveats or disclaimers — assuming they do not simply restate a general caveat already given in Introduction to Therapeutic Area Standards — should be added to the second paragraph below, after the sentence provided.
  • Additions to the steps above should be written in the imperative; to the paragraphs below in the indicative (see also: Grammatical mood at Wikipedia).

Draft standards of interest to this document are listed at: _____________________.

Some things to bear in mind while reading this document:

  • This document does not replace or supersede the foundational CDISC standards or their implementation guides, and should not be used as a substitute for any other CDISC standard.
  • This document generally does not repeat content already published in another CDISC standard.
  • This document is not and does not try to be an exhaustive documentation of every possible kind of data that could be collected in relation to cardiac imaging for Duchenne Muscular Dystrophy.
  • As this document ages, parts of it may become outdated. Please bear in mind the release date when contrasting advice and/or modeling in this guide against that in other CDISC standards.
  • The examples in this document use CDISC Controlled Terminology where possible, but some values that seem to be controlled terminology may still be under development at the time of publication, or even especially plausible "best-guess" placeholder values. Do not rely on any source other than the CDISC value set in the National Cancer Institute Thesaurus for controlled terminology (available at http://www.cancer.gov/research/resources/terminology/cdisc).

All general caveats for therapeutic area All general caveats for TA standards given in the Introduction to Therapeutic Area Standards (http://wiki.cdisc.org/x/SSy8AQ) apply  apply to this document.

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