- Subject Characteristics consists of data that is collected once per subject (per test). SC contains data that is either not normally expected to change during the study or whose change is not of interest after the initial collection.
- Sponsors should ensure that data considered for submission in SC (e.g., hair coat, physical markings) do not actually belong in another domain. It is up to the sponsor to determine whether such data have any information relevant to this domain.
- The structure for SC is based on the Findings general observation class. It is an extension of the Demographics (DM) dataset. Any data that can be submitted in the DM variables should not be submitted in SC.
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