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changes.mady.by.user Lou Ann Kramer

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changes.mady.by.user Christine Connolly

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sdtm20PurposeRELREC1
Metadataspec
keysNotes;Core;Description
shareqc_
send4tig10_ds
ClassRelationships
Domain
#
RELREF

Variable Name

Variable Label

Type

Controlled Terms, Codelist, or Format

Role

Variable(s) QualifiedUsage RestrictionsVariable C-codeDefinitionNotesExamples

CDISC Notes

Core

STUDYIDStudy IdentifierChar


Identifier
C83082

A sequence of characters used by the

sponsor 3

applicant to uniquely identify the study.

2

USUBJID

GNTXAID

Unique Subject Identifier

Genetic Tox Assay ID

CharIdentifierC69256

A sequence of characters used to uniquely identify a subject across all studies for all applications or submissions involving the product.

A short sequence of characters that uniquely identifies a genetic toxicology assay within a study.

Req

4
SETCDTrial Set CodeChar


Identifier

The short sequence of characters used to represent the trial set.

The value "ALL" is used to indicate all trial sets within the assay.

Req

REFIDReference IDChar


Identifier
C82531
A sequence of characters used to uniquely identify a source of information.
5

Req

PARENT

Parent Reference ID

SDTM 2.0:
Parent

Char


Identifier

The identifier for the immediate progenitor of a source of information.

Batch 2: The identifier for the immediate progenitor of the source of information.

Identifies the REFID of the parent.

6

Exp

LEVEL

Reference ID Generation

LevelSDTM 2.0: Specimen

Level

Num


Variable Qualifier
REFID

The generation number of the information source in relation to the first generation of the source of information.

Batch 2: The generation number of a biospecimen in relation to the collected biospecimen that is considered the first generation.

Identifies the level number of the reference ID.

7

Exp

SPEC

LVLDESC

Specimen Type

Reference ID

Generation

The type of sample material taken from a biological entity.

Level Description

Char

(LVLDSCRS)

Variable Qualifier
LEVELC70713

A description of the generation number of the information source in relation to the first generation of the source of information.

Examples: ASSAY, TRIAL SET, EXPERIMENTAL UNIT, OBSERVATIONAL UNIT.

Perm