Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

Grouping variables are a subset of Identifier and Grouping Qualifier variablesused to group records in datasets by study, domain, across subjects, by subject, and for a subject. When used per this guidance, grouping variables and their values adhere to the following hierarchy below. :


Metadataspec

Hierarchy of Grouping Variables

STUDYID


DOMAIN

--CAT

--SCAT

USUBJID

--GRPID

...

Metadataspec
VariablesRecord GroupingPurpose of Grouping

STUDYID

By Studystudy

All records with the same STUDYID value are a group of records that describe that study.

DOMAIN

By Domaindomain

All records with the same DOMAIN value are a group of records that describe that domain.

--CAT, --SCAT

Across Subjectssubjects

--CAT and --SCAT values subset groups of tests within a domain and apply to all subjects within the domain. 

USUBJID

By Subjectsubject

All records with the same USUBJID value are a group of records that describe that subject.

--GRPID

For Subjectssubjects

All records in the same domain with the same --GRPID value are a group of records within USUBJID. 

...

The optional grouping identifier variable --GRPID may be used in all domains that are based on the general observation classes. --GRPID identifies relationships between records within a USUBJID within a single domain and has no inherent meaning across subjects or across domains. Relationships between observations are defined by assigning the same unique character value to the --GRPID variable for sets of related observations. The values used for --GRPID can be any values the applicant chooses; however, if the applicant uses values with some embedded meaning (rather than arbitrary numbers), those values will be consistent. 

...