Important note to reviewers:
- Yellow highlighted rows are variables that are NEW to SDTM
- Green highlighted rows are variables that exist in SDTM but need revision in some way (e.g., SETCD is not currently listed for a findings class dataset for SEND).
gt.xpt, genetic toxicology in vitro test results TOBA-14 - Getting issue details... STATUS - Findings. One record per test per observation time per entity, Tabulation.
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
|---|---|---|---|---|---|---|
STUDYID (1) | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | |
ASSAYID | Assay Identifier | Char | Identifier | Sponsor defined identifier for the assay within the study. | Req | |
DOMAIN (2) | Domain Abbreviation | Char | GT | Identifier | Two-character abbreviation for the domain. | Req |
SETCD (1) | Set Code | Char | Identifier | Short name of a specific Trial Set to which the results are attributed. Maximum size is 8 characters. | Exp | |
EUID (2) | Experimental Unit Identifier | Char | Identifier | Experimental Unit Identifier is the unit to which the treatment is applied. Experimental Unit Identifiers are unique within an assay. | Exp | |
OBUID (3) | Observation Unit Identifier | Char | Identifier | Observation Unit identifier is the unit on which the response is measured. Observation Unit Identifiers are unique within an Experimental Unit. | Exp | |
GTSEQ (9) | Sequence Number | Num | Identifier | The sequence number must be unique for each record within a domain. Sequence number given to ensure uniqueness of records within a domain. May be any valid number. | Req | |
GTGRPID (10) | Group ID | Char | Identifier | Optional group identifier, used to link together a block of related records within a subject in a domain. | Perm | |
GTTESTCD (1) | Lab Test or Examination Short Name | Char | (GTTESTCD) | Topic | Short name of the measurement, test, or examination described in GTTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in GVTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., “1TEST” is not valid). GVTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: RVERT, CYTOTOX. | Req |
GTTEST (2) | Lab Test or Examination Name | Char | (GTTEST) | Synonym Qualifier | Long name for GTTESTCD. The value in GTTEST cannot be longer than 40 characters. Examples: Revertants, Cytotoxicity. | Req |
GTORRES (28) | Result or Findings as Collected | Char | Result Qualifier | Result of the measurement or finding as originally received or collected. | Exp | |
GTORRESU (29) | Unit of the Original Result | Char | (UNIT) | Variable Qualifier | The unit for the original result. The unit of the original result should be mapped to a synonymous unit on the Controlled Terminology list. | Exp |
GTCELLEV | Number of Cells Evaluated | Num | Result Qualifier | The number of cells evaluated. | Perm | |
GTCOLSRT (32) | Collected Summary Result Type | Char | (COLSTYP) | Variable Qualifier | Used to indicate the type of collected summary result. For example, MAXIMUM, MINIMUM, and MEAN | Perm |
GTSTRESC (37) | Standardized Result in Character Format | Char | New code list needed | Result Qualifier | Contains the result value for all findings, copied or derived from GTORRES in a standard format or standard units. GTSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in GTSTRESN. For example, if a test has results NONE, NEG, and NEGATIVE in GTORRES and these results effectively have the same meaning, they could be represented in standard format in GTSTRESC as NEGATIVE. For other examples, see general assumptions. | Exp |
GTSTRESN (39) | Standardized Result in Numeric Format | Num | Result Qualifier | Used for numeric results or findings in standard format; contains the numeric form of GTSTRESC. GTSTRESN should store all numeric test results or findings. | Exp | |
GTSTRESU (40) | Unit of the Standardized Result | Char | (UNIT) | Variable Qualifier | Standardized unit used for GTSTRESC, GTSTRESN, GTSTRLO, and GTSTRHI. | Exp |
GTSTAT (61) | Completion Status | Char | (ND) | Record Qualifier | Used to indicate when a test is not done or result is missing. Should be null if a result exists in GTORRES. | Perm |
GTREASND (62) | Reason Not Done | Char | Record Qualifier | Describes why GTSTAT is NOT DONE, such as BROKEN EQUIPMENT or SPECIMEN LOST. | Perm | |
GTSPEC (66) | Specimen Material Type | Char | Record Qualifier | The type of sample material taken from a biological entity. "SERUM", "PLASMA", "URINE", "DNA", "RNA" | Perm | |
GTSPCCND (68) | Specimen Condition | Char | ? | Record Qualifier | Free or standardized text describing the condition of the specimen. Example: PRECIPITATION PRESENT, CONTAMINATION PRESENT, etc. If multiple conditions are present on a sample, concatenate the values with a semicolon and no spaces as a separator | Perm |
GTSPCUFL (69) | Specimen Usability for the Test | Char | (NY) | Record Qualifier | Describes the usability of the specimen for the test. Should be N if the specimen is not usable; otherwise it should be null. | Perm |
GTMETHOD (74) | Method of Test or Examination | Char | Record Qualifier | Method of the test or examination. Examples: MANUALLY COUNTED, INSTRUMENT COUNTED | Exp | |
GTRUNID (75) | Run ID | Char | Record Qualifier | A sequence of characters used to uniquely identify a particular run of a test on a particular batch of samples. | Perm | |
GTEXCLFL (95) | Exclusion Flag | Char | (NY) | Record Qualifier | Y if the result should be excluded from all calculations, otherwise null. | Perm |
GTREASEX (96) | Reason for Exclusion | Char | Record Qualifier | The reason the result should be excluded from all calculations. Used only when GTEXCLFL is Y. | Perm | |
GTDTC | Date/Time of Collection | Char | ISO 8601 datetime or interval | Timing | The date or date and time of the assessment or the specimen or data collection from the subject, represented in a standardized character format. | Perm |
6.3.?.1 ASSUMPTIONS FOR GENETIC TOXICOLOGY IN VITRO TEST RESULTS (GT) DOMAIN MODEL
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.
- Meaning of null values in EUID and OBID:
- Records with the same EUID but different RUNID refer to separate entities (e.g., a unique tube, plate, or well) being observed.
- 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)
- Records with the same OBUID but different RUNID refer to separate entities (e.g., a unique tube, plate, or well) being observed.
- If the OBUID is null, the result applies to the experimental unit
- Within a run, the OBUID is unique within an experimental unit and uniquely identifies the entity on which the observation is made (e.g., a unique tube, plate, or well)
- Results Definition:
- GTSTRESC and the corresponding numeric GTSTRESN should generally be 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 Section 4.5.1.3 concerning TESTS NOT DONE does not apply to this domain.
- 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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