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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. Entity Identifier:
   1. ENID is unique within the assay (and a study can have many assays)
   2. Replicates vs. Run 
      • need planned (ei.xpt) separate from the actual (gt.xpt)
      • If tests run at the same time, they are replicates and are assigned the same RUNID
      • If tests are run at separate times, they are runs and the RUNIDs are distinct
   3. Different runs would be expected to have different ENID and GTDTC values. In ei.xpt, these are distinguished by different RUNID values.
   4. Entities that are replicates of each other would be expected to
      • have different ENID values
      • be in the same trial set (SETCD values)
      • have the same RUNID values
3. Results Definition:
   1. GTSTRESC and the corresponding numeric GTSTRESN should generally be used to represent standardized format of original results.
   2. GTSTNRLO and GTSTNRHI for reference range in standard units are "Expected" because this is critically important to understand the results of many of the test results. Follow guidelines from OECD when appropriate.
   3. 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.
4. Timing Variables:
   1. The planned incubation time is represented in the EI variables RFENDLO and RFENDHI.
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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