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Sponsor defined identifier for the assay within the study. An ASSAYIDIssue Tracker (JIRA)

Metadataspec

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Class	Findings
Domain	GT

Variable Name	Variable Label	Type	Controlled Terms, Codelist, or Format	Role	CDISC Notes	Core
STUDYID	Study Identifier	Char		Identifier	Unique identifier for a study.	Req

GNTXAID

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-69

Assay Identifier

Char

Identifier

Jira

showSummary

false

server

Req

serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45keyTOBA-68 value of ALL indicates that it applies to all assays in the study.

DOMAIN

Domain Abbreviation

Char

GT

Identifier

Two-character abbreviation for the domain.

Req

SETCD

Set Code

Char

Identifier

Short name of a specific Trial Set to which the results are attributed. Maximum size is 8 characters.

Exp

GTSEQ

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

Group ID

Char

Identifier

Optional group identifier, used to link together a block of related records within a subject in a domain.

Perm

GTREFID

Reference ID

Char

Identifier

A sequence of characters used to uniquely identify a source of information

. Examples:

(e.g., lab specimen

ID

, petri dish

ID

, flask

ID

, well

ID

, group of petri dishes, group of flasks, an entire assay).	Req
GTTESTCD	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

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-93

GTTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g.,

“1TEST”

"1TEST" is not valid).

GVTESTCD

GTTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: RVERT, CYTOTOX.	Req
GTTEST	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	Result or Findings as Collected	Char		Result Qualifier	Result of the measurement or finding as originally received or collected.	Exp
GTORRESU	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

JirashowSummaryfalse

serverIssue Tracker (JIRA)serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45keyTOBA-81

Number of Cells Evaluated	Num		Result Qualifier	The number of cells evaluated.	Perm
GTCOLSRT	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	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	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	Unit of the Standardized Result	Char	(UNIT)	Variable Qualifier	Standardized unit used for GTSTRESC, GTSTRESN, GTSTRLO, and GTSTRHI.	Exp
GTSTAT	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	Reason Not Done	Char		Record Qualifier	Describes why GTSTAT is NOT DONE, such as BROKEN EQUIPMENT or SPECIMEN LOST.	Perm

GTSPEC

Specimen Material TypeCharRecord Qualifier

The type of sample material taken from a biological entity. "SERUM", "PLASMA", "URINE", "DNA", "RNA"

Perm

GTSPCCND

Specimen Condition

Char

?

(SPECCOND)

Record Qualifier

Free or standardized text describing the condition of the specimen. Example: PRECIPITATION PRESENT,

CONTAMINATION PRESENT

CONTAMINATED, etc.

If multiple conditions are present on a sample, concatenate the values with a semicolon and no spaces as a separator.	Perm
GTSPCUFL	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	Method of Test or Examination	Char		Record Qualifier	Method of the test or examination. Examples: MANUALLY COUNTED, INSTRUMENT COUNTED.

Exp

Perm
GTRUNID	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	Exclusion Flag	Char	(NY)	Record Qualifier	Y if the result should be excluded from all calculations, otherwise null.	Perm
GTREASEX	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. For an Ames test, this is the date the bacterial culture is plated.

Perm

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