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Analysis dataset structures in this guide provide a standard way to build analysis datasets. Currently ADaM has 3 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 do not follow one of the 3 defined structures (ADSL, BDS, OCCDS), are considered to be ADaM datasets with a class of ADAM OTHER. Currently the ADaM standards do not cover non-subject data. A REFERENCE dataset structure has been developed for use in this guide and will be considered for inclusion in future versions of the ADaM.

For the TIG Product Description use case, ADaM fundamental principles will be followed with identifiers in addition to the currently allowed USUBJID and SPEVID. Current ADaM principles and standards are implemented for the Product Impact on Individual Health use case.  For the Product Impact on Population Health use case, the REFERENCE dataset structure addresses reference data which captures historic trends and results that are used as input for study analyses.

ADaM dataset structures applicable to TIG use cases are described in the table below:

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Analysis dataset specifications list standard ADaM variables and define the required characteristics of standard variables (columns) that are frequently needed in ADaM datasets. The ADaM standard requires that these variable names be used when a variable that contains the content defined in the pre-defined ADaM variables sections is included in any ADaM dataset, regardless of dataset class. It also requires these ADaM standard variables be used for the purposes indicated, even if the content of an ADaM variable is a copy of the content of an SDTM dataset variable.

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