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TIG v1.0 Metadata Check for SEND Domain Specification Table Beta 2.1

Metadata check macro is applied and detected issue(s). Please address finding(s) listed below the specification table. An FAQ is available to aid troubleshooting. Release Notes

Variable Name

Variable Label

Type

Controlled Terms, Codelist, or Format

Role

CDISC Notes

Core

STUDYIDStudy IdentifierChar


Identifier

A sequence of characters used by the applicant to uniquely identify the study.

Req

GNTXAID

Genetic Toxicology Assay ID

Char


Identifier

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. TOBA-479 - Getting issue details... STATUS

Req

REFIDReference IDChar


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

Req

PARENT

Parent Reference ID

Char


Identifier

The identifier for the immediate progenitor of a source of information. Identifies the REFID of the parent.

Exp

LEVEL

Reference ID Generation Level

Num


Variable Qualifier

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.

Exp

LVLDESC

Reference ID Level Description

Char

(LVLDESC)

Variable Qualifier

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. TOBA-488 - Getting issue details... STATUS

Perm

Metadata Checks Findings

SDTM & Related IG Metadata Check User Macros FAQ
  • Content: For variable GNTXAID, it is either invalid in the Relationships class domain or not a recognized domain-specific variable
  • Content: For variable LVLDESC, csodelist LVLDESC is a not a recognized SEND CT short name; or, does not confirm to the convention for specifying codelist

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