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changes.mady.by.user Lou Ann Kramer

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  1. The GT  domain captures in vitro data collected by the lab executing the study or received from a provider
    Jira
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    serverIssue Tracker (JIRA)
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    keyTOBA-450
    . This domain is designed for exchanging data
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    serverIssue Tracker (JIRA)
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    keyTOBA-451
     
    Jira
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    serverIssue Tracker (JIRA)
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    keyTOBA-501
    for data for the following in vitro tests: neutral red cytotoxity assay, bacterial reverse mutation assay (also known as Ames) JirashowSummaryfalseserverIssue Tracker (JIRA)serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45keyTOBA-505, mammalian cell gene mutation assay, and micronucleus assay.  Other in vitro tests have not yet been modeled in this version of this domain.
  2. Results:
    1. GTSTRESC (or corresponding numeric GTSTRESN) is used to represent standardized format of original results.  JirashowSummaryfalseserverIssue Tracker (JIRA)serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45keyTOBA-232
    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.
  3. Other Assumptions:
    1. The discussion in SENDIG Section 4.5.1.3, Tests Not Done, does not apply to this domain.
    2. GTEXCLFL and GTREASEX are Permissible and used to indicate when a result is to be excluded from further analysis.
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      In  In these cases GTREASEX should contain the reason for exclusion.