- First, read the foundational standards upon which this document is based—SDTM based—Study Data Tabulation Model (SDTM) v2.0, the SDTM Implementation Guides (SDTMIG v3.4 and the SDTMIG for Medical Devices (SDTMIG-MD 1) 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/.
- 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.
- Read this guide all the way through at least once.
- Finally, revisit any sections of particular interest.
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All general caveats for therapeutic area (TA) standards given in the the Introduction to Therapeutic Area Standards apply to this document.
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