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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

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

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

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

 e

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

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

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