Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

The 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 ADaM for 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 submissionsThe underlying assumptions, statistical methods, transformations, derivations and imputations performed in the analysis of a clinical trial should be communicated clearly and in such a manner that the values and results can be easily replicated. ADaM metadata facilitates this communication by providing specification of details and links between the general description of the analysis (as found in the protocol’s data analysis section, SAP, or the reported analysis methods), the analysis results, the data used in the analysis, and the SDTM domains.

Pagenav