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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

The ADaM is defined in multiple documents - in the table below are the latest versions of the documents that should be referenced:

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ADaM Implementation Guide v1.3 (29-Nov-2021)

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ADaM Structure for Occurrence Data Implementation Guide v1.1 (29-Nov-2021)

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ADaM Implementation Guide for Non-compartmental Analysis Input Data  v1.0 (29-Nov-2021)

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ADaM Implementation Guide for Medical Devices v1.0 (29-Nov-2021)

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ADaM Conformance Rules v4.0 (29-Nov-2021)

Currently ADaM has three structures: ADSL, BDS, and OCCDS, which correspond to the SUBJECT LEVEL ANALYSIS DATASET, BASIC DATA STRUCTURE, and OCCURRENCE DATA STRUCTURE classes of ADaM datasets. Analysis datasets that follow the ADaM fundamental principles and other ADaM conventions, but which do not follow one of the three defined structures (ADSL, BDS, OCCDS), are considered to be ADaM datasets with a class of ADAM OTHER. Controlled Terminology for the class element of the analysis dataset metadata can be downloaded at http://www.cdisc.org/terminology.

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