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Analysis specifications in this guide are instructions for implementing the to build datasets for representation of collected, assigned, or derived data. Domain specifications for the TIG are provided in:

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

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:

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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