Some studies include subjects who are related to each other, and in some cases it is important to record those relationships. Studies in which pregnant women are treated and both the mother and her child(ren) are study subjects are the most common case in which relationships between subjects are collected. There are also studies of genetically based diseases where subjects who are related to each other are enrolled, and the relationships between subjects are recorded.

RELSUB Dataset

SDTM v2.1 Metadata Check for Class and Dataset Specification Table Beta 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 NameVariable LabelTypeFormatRoleVariable(s) QualifiedUsage RestrictionsVariable C-codeDefinitionNotesExamples
1STUDYIDStudy IdentifierChar
Identifier

C83082

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



2USUBJIDUnique Subject IdentifierChar
Identifier

C69256

A sequence of characters used to uniquely identify a subject across all studies for all applications or submissions involving the product.

Either USUBJID or POOLID must be populated.
3POOLIDPool IdentifierChar
Identifier

C117053A sequence of characters used to uniquely identify a group of subjects that have been pooled together.If POOLID is entered, POOLDEF records must exist for each subject in the pool and USUBJID must be null. Either USUBJID or POOLID must be populated.
4RSUBJIDRelated Subject or Pool IdentifierChar
Identifier



Identifier used to identify a related subject or pool of subjects. RSUBJID will be populated with either the USUBJID of the related subject or the POOLID of the related pool.
5SRELSubject RelationshipChar
Record Qualifier



Describes the relationship of the subject identified in USUBJID or the pool identified in POOLID to the subject or pool identified in RSUBJID.

« Pool Definition Dataset

Device-subject Relationships Dataset »

  • No labels