Page History
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purple font = requires further discussion (or has not yet been discussed) by workstream |
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SETCD
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Set Code
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Char
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Identifier
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Short name of a specific Trial Set to which the results are attributed. Maximum size is 8 characters
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Exp
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SET
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Set Description
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Char
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Synonym Qualifier
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Long description of a specific Trial Set as defined by the sponsor
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Req
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ENID
NEW (must go to SDTM)
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Entity Identifier
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Char
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Identifier
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Entity identifier are unique identifiers used within the study to define the entity or assay platform being exposed (e.g. well, plate) to the test article and the relationship to the trial set or test conditions. Both SETCD and ENID must be populated.
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Exp
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EUID
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Experimental Unit Identifier
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Char
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Experimental Unit Identifier is the unit to which the treatment is applied. Experimental Units are unique identifiers within an assay.
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Exp
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OUID
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Observation Unit Identifier
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Char
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Identifier
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Observation Unit identifier is the unit on which the response is measured. Observation Units are unique identifiers used within the Experimental Unit.
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Perm
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GTREFID
(Do we need this in addition to ENID? Is this for an internal identifier?
contractor organization uses?)
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Specimen Identifier
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Char
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Identifier
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Slide or gel label (for example 1101-1 or 1101-2 for the first and second slides for animal 1101), or sample label for flow cytometry results. May be blank for example when the record represents an animal level result.
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GTTSTDTL
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Measurement, Test or Examination Detail
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Char
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(terminology needed)
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Variable Qualifier of --TESTCD and --TEST
Further description of --TESTCD and --TEST. Example:
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Perm
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GTSTNRLO
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Reference Range Lower Limit-Std Unit
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Num
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Variable Qualifier
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Lower end of normal range or reference range for standardized results (e.g., GTSTRESC, GTSTRESN) represented in standardized units (GTSTRESU).
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Exp
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GTSTNRHI
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Reference Range Upper Limit-Std Unit
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Num
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Variable Qualifier
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Upper end of normal range or reference range for standardized results (e.g., GTSTRESC, GTSTRESN) represented in standardized units (GTSTRESU).
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Exp
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6.3.?.1 ASSUMPTIONS FOR Genetic Toxicology In-Vitro TEST RESULTS (GT) DOMAIN MODEL
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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.
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- ENID is unique within the assay (and a study can have many assays)
- 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
- Different runs would be expected to have different ENID and GTDTC values. In ei.xpt, these are distinguished by different RUNID values.
- 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
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- GTSTRESC and the corresponding numeric GTSTRESN should generally be used to represent standardized format of original results.
- 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.
- 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.
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