- The GT domain captures in vitro data collected by the lab executing the study or received from a provider. This domain is designed for exchanging data for the following in vitro tests: neutral red cytotoxity assay, bacterial reverse mutation assay (also known as Ames), mammalian cell gene mutation assay, and micronucleus assay. Other in vitro tests have not yet been modeled in this version of this domain.
- Results:
- GTSTRESC (or corresponding numeric GTSTRESN) is used to represent standardized format of original results.
- 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.
- Other Assumptions:
- The discussion in SENDIG Section 4.5.1.3, Tests Not Done, does not apply to this domain.
- GTEXCLFL and GTREASEX are Permissible and used to indicate when a result is to be excluded from further analysis. TOBA-502 - Getting issue details... STATUS In these cases GTREASEX should contain the reason for exclusion.
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