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STUDYID

Study Identifier

Char

Identifier

Unique identifier for a study.

Req

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

SET

Set Description

Char

Synonym Qualifier

Long description of a specific Trial Set as defined by the sponsor

Req

ENID

NEW (must go to SDTM)

Entity Identifier

Char

Identifier

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.

Exp

GTSEQ

Sequence Number

Num

Identifier

The sequence number must be unique for each record within an ENID and a trial set.

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

(Do we need this in addition to ENID? Is this for an internal identifier?

contractor organization uses?)

Specimen Identifier

Char

Identifier

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.

Perm

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 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

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

GTTSTDTL

(Do we need this? Can we cite useful examples?)

Measurement, Test or Examination Detail 

Char

(terminology needed)

Variable Qualifier of --TESTCD and --TEST

Further description of --TESTCD and --TEST. Example:

Perm

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

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

GTSTNRLO

Reference Range Lower Limit-Std Unit

Num

Variable Qualifier

Lower end of normal range or reference range for standardized results (e.g., GTSTRESC, GTSTRESN) represented in standardized units (GTSTRESU).

Exp

GTSTNRHI

Reference Range Upper Limit-Std Unit

Num

Variable Qualifier

Upper end of normal range or reference range for standardized results (e.g., GTSTRESC, GTSTRESN) represented in standardized units (GTSTRESU).

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

GTSPCCND

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

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

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