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TOBA-79 - Getting issue details... STATUS

TOBA-246 - Getting issue details... STATUS

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

Metadata check macro is applied. Make sure all Confluence WIKI macros e.g., JIRA, Status, are removed prior to publication. This notice is provided as a visual reminder. It will be removed during final publication. 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

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 applicant-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

ISO 21090 NullFlavor
TOBA-446 - Getting issue details... STATUS

Record Qualifier

Null flavor for the value of TSPARM, to be populated only if TSVAL is null.

Perm

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