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ADaM establishes a standard way to build datasets that support analysis needs and the efficient generation, replication, and review of analysis results. Guidance in this section implements ADaM for  the TIG Product Description, Product Impact on Individual Health, and Product Impact on Population Health use cases and provides:

  • Fundamental principles that apply to all analysis datasets
  • Dataset structures
  • Metadata for data and results

The TIG covers the fundamentals describing ADaM as well as dataset examples that are typically created to support analyses performed for tobacco submissions.

Content being drafted.

  • Standards for Analysis to guide the implementation of standards for data analysis.
  • Section x.x, Standards for Analysis to specify the principles to follow in the creation

There are three classes of datasets that have been defined for ADaM -

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