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  1. GT Definition: This domain captures in vitro data collected by the lab executing the study or received from a provider.  This domain is designed for exchanging sample (entity) level data for the following in vitro tests: Neutral Red Cytotoxity Assay, Bacterial Reverse Mutation Assay, Mammalian Cell Gene Mutation Assay, and Micronucleus Assay.  Other in vitro tests have not yet been modeled in this version of this domain.

  2. Meaning of null values in SETCD, EUID, and OBIDOBUID:
    1. Records with the same EUID but different RUNID refer to separate entities (e.g., a unique tube, plate, or well) being observed.
    2. If the EUID is null, the OBUID must be null and the result applies to the trial set (the current example does not show this yet).
    3. Records with the same OBUID but different RUNID refer to separate entities (e.g., a unique tube, plate, or well) being observed.
    4. If the OBUID is null, the result applies to the experimental unit.
    5. If SETCD is null, both the EUID and OBUID must be null and the result applies to the assay.
  3. Within a run, the OBUID is unique within an experimental unit and uniquely identifies the entity on which the observation is made made (e.g., a unique tube, plate, or well) .
  4. Results Definition:
    1. GTSTRESC and the corresponding numeric GTSTRESN should generally be used to represent standardized format of original results.
    2. GTSTAT and GTREASND are Permissible and used to indicate when a test was not completed. In these cases GTSTAT should contain “NOT DONE”; GTORRES, GTSTRESC, and GTSTRESN should be null; and GTREASND should contain the reason for not completing the test.
  5. Other Assumptions:
    1. The discussion in Section 4.5.1.3 concerning TESTS NOT DONE does not apply to this domain.
    2. GTEXCLFL and GTREASEX are Permissible and used to indicate when a test is to be excluded from further analysis. In these cases GTREASEX should contain the reason for exclusion.

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