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For TIG Use cases....

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.

ADaM specifications in this guide are instructions for implementing the ADaM to build analysis datasets for representation of collected or derived data. ADaM dataset specifications for the TIG are provided in:

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