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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
Class
Relationships
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

GNTXAID

Genetic Toxicology Assay ID

CharIdentifier

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

Req

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.4

Req

REFIDReference IDChar


IdentifierA sequence of characters used to uniquely identify a source of information.
5

Req

PARENT

Parent Reference ID

Char


Identifier

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

Identifies the REFID of the parent.

6

Exp

LEVEL

Reference ID Generation Level

Num


Variable Qualifier
REFID

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

Identifies the level number of the reference ID.

7

Exp

LVLDESC

Reference ID

Generation

Level

Descriptn

Description

Char

(LVLDSCRS)

Variable Qualifier
LEVEL

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