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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

STUDYID

Study Identifier

Char


Identifier

Unique identifier for a study within the submission.

Req

GNTXAID TOBA-79 - Getting issue details... STATUS

Genetic Toxicology Assay Identifier

Char


Identifier

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

Perm

DOMAIN

Domain Abbreviation

Char

TS

Identifier

Two-character abbreviation for the domain most relevant to the observation.

Req

TSSEQ

Sequence Number

Num


Identifier

Sequence number used to ensure uniqueness within a TSPARMCD. Allows inclusion of multiple records for the same TSPARMCD, and can be used to join related records.

Req

TSGRPID

Group Identifier

Char


Identifier

Used to tie together a group of related records. This is not the sponsor-defined protocol group number.

Exp

TSPARMCD

Trial Summary Parameter Short Name

Char

(STSPRMCD)

Topic

Short character value for the trial design characteristic described in TSPARM. Value must be 8 characters or less.

Req

TSPARM

Trial Summary Parameter

Char

(STSPRM)

Synonym Qualifier

Term for the trial parameter. Value must be 40 characters or less.

Req

TSVAL

Parameter Value

Char


Result Qualifier

Value of the TS parameter (e.g., "FDA" when TSPARM is GLP Type). The values for some parameters may be subject to controlled terminology. See the Controlled Terms, Codelist, or Format column in Section 7.6.3 that lists all defined parameters. TSVAL can only be null if TSVALNF is populated.

Exp

TSVALNF

Parameter Null Flavor

Char

(NULLFLAVOR)

Record Qualifier

Null flavor for the value of the TSPARMs, which should be included according to the trial summary code table below if and only if TSVAL is null.

Perm

Metadata Checks Findings

SDTM & Related IG Metadata Check User Macros FAQ
  • Content: For variable GNTXAID, it is either invalid in the Trial Design class domain or not a recognized domain-specific variable
  • Content: For variable TSVAL, non-ASCII characters (highlighted text in table), found in CDISC Notes; offending characters list: [ ]
  • Content: For variable TSVALNF, csodelist NULLFLAVOR is a not a recognized SEND CT short name; or, does not confirm to the convention for specifying codelist

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