1. First, read 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 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 at least once.
  4. Finally, revisit any sections of particular interest.

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  • As this document ages, parts of it may become outdated.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 standards given in the Introduction to Therapeutic Area Standards apply to this document.

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