Page History

The ADaM establishes a standard way to build datasets that support analaysis needsanalysis 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 .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. 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.