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Analysis dataset structures in this guide provide a standard way to build analysis datasets. These structures are captured in the "CLASS OF DATASET" field in the ADaM metadata. Currently ADaM has 3 structures: the Subject-level Analysis Dataset (ADSL), the Basic Data Structure (BDS), and the Structure for Occurrence Data (OCCDS). Analysis datasets that follow the ADaM fundamental principles and other ADaM conventions but do not follow one of these 3 defined structures 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 the TIG and will be considered for inclusion in future versions of 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.

The following table describves describes ADaM dataset structures applicable to TIG use cases.

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