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Analysis dataset specifications 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. ADaM dataset structures applicable to TIG use cases are listed described in the table below:

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are Guidance in this section implements the ADaM for TIG Product Description, Product Impact on Individual Health, and Product Impact on Population Health use cases and provides:

• Section x.x, Specifications for Product Description
• Section x.x, Specifications for Nonclinical
• Section x.x, Specifications for Individual Health

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For TIG use cases, there are two streams that are not yet covered by the ADaM standard, however the individual health stream is very similar to the analyses done in drug development and the general ADaM structures will cover these types of datasets. however Product Health is not subject-based and therefore updates to the ADaM standard are needed to allow for identifiers in addition to the currently allowed USUBJID and SPEVID. For Population Health there is an analysis dataset section that addresses reference data which captures historic trends and results that are used as input for study analyses.   there is a proposed stucture to cover these types of data.

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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. Currently the ADaM standards do not cover non-subject data. A reference dtata standard has been proposed to be used in the populaiton health examples section  and may be included in a future of the ADaM documents.

Domain specifications will be used with all guidance in this section and are organized with one specification per domain or dataset.All domain specifications begin with a description, expected name, and record structure for the resulting dataset. A domain specification table follows to describe dataset variables and their attributes. Assumptions for the domain are also provided to further guide implementation. Domain specification tables are structured to present one row for each variable with columns to describe expected attributes of the variable in resulting datasets. The order of variables in a domain specification table reflects the expected order of variables in the resulting dataset.

The columns in a domain specification table are:

The columns in an ADaM dataset specification table are:

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