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

Metadata check macro is applied and detected no issues. 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.

Req

RDOMAIN

Related Domain Abbreviation

Char


Identifier

Two-character abbreviation for the domain of the parent record(s).

Req

USUBJID

Unique Subject Identifier

Char


Identifier

Unique Subject Identifier of the Parent record(s). Either USUBJID or POOLID must be populated, except for certain domain-to-domain relationships (see Section 8.2.3).

Exp

POOLID

Pool Identifier

Char


Identifier

Pool Identifier of the Parent record(s). If POOLID is entered, POOLDEF records must exist for each subject and the USUBJID must be null. Either USUBJID or POOLID must be populated.

Perm

IDVAR

Identifying Variable

Char


Identifier

Name of the identifying variable in the general observation class domain that identifies the related record(s). Examples include BWSEQ and BWGRPID.

Req

IDVARVAL

Identifying Variable Value

Char


Identifier

Value of identifying variable described in IDVAR. For example, if BWSEQ is the variable being used to describe this record, then the value of BWSEQ would be entered here.

Exp

RELTYPE

Relationship Type

Char

(RELTYPE)

Record Qualifier

Identifies the hierarchical level of the records in the relationship. Values are only necessary when identifying a relationship between domains (as described in Section 2.8.5.2). Values should be either ONE or MANY.

Perm

RELID

Relationship Identifier

Char


Record Qualifier

Unique value within a study that identifies the relationship. RELID can be any value the applicant chooses and is only meaningful within the df dataset to identify the related/associated domain records.

Req

Assumptions

  1. Timing variables cannot be added to RELREC datasets.
  2. Additional RELREC assumptions are included in Section 2.8.5.2, Relating Subject Records and Datasets.

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