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Metadataspec
VariablesRecord GroupingPurpose of Grouping

STUDYID

By Study

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

DOMAIN

By Domain

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

--CAT, --SCAT

Across Subjects

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

USUBJID

By Subject

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

--GRPID

For Subjects

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


The optional grouping identifier variable --GRPID is Permissible in all domains that are based on the general observation classes. It is used to identify relationships between records within a USUBJID within a single domain (e.g., intervention records for a combination therapy where treatments in the combination varies from subject to subject). In such cases, the relationship is defined by assigning the same unique character value to the --GRPID variable. The values used for --GRPID can be any values the sponsor chooses; however, if the sponsor uses values with some embedded meaning (rather than arbitrary numbers), those values should be consistent across the submission to avoid confusion. It is important to note that --GRPID has no inherent meaning across subjects or across domains.

Using --GRPID in the general-observation class domains can reduce the number of records in the RELREC, SUPP--, and CO datasets, when those datasets are submitted to describe relationships/associations for records or values to a "group" of general observation class records.

Differences Between Grouping Variables

The primary distinctions between -CAT/ SCAT and --GRPID are:

  1. --CAT/--SCAT are known (identified) about the data before it is collected.
  2. --CAT/--SCAT values group data across subjects.
  3. --CAT/--SCAT may have some controlled terminology.
  4. --GRPID is usually assigned during or after data collection at the discretion of the sponsor.
  5. --GRPID groups data only within a subject.
  6. --GRPID values are sponsor-defined, and will not be subject to controlled terminology.

Therefore, data that would be the same across subjects is usually more appropriate in --CAT/--SCAT, and data that would vary across subjects is usually more appropriate in --GRPID.

The primary distinctions between -CAT/ SCAT and --REFID are:

  1. --CAT/-SCAT are usually textual descriptions of the data designed into the collection vehicle/process, and --REFID is usually a tracking number/value of some type assigned to an object being tracked (e.g., a blood sample).
  2. ASK LOU ANN ABOUT THIS SECTION




In domains based on the Findings general observation class, the --RESCAT variable can be used to categorize results after the fact. --CAT and --SCAT by contrast, are generally predefined or used at the point of collection, not after assessing the value of findings results. 

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