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General assumptions for the population of values in tabulation variables are provided in this section. Assumptions in this section will be followed and complement more detailed assumptions provided in Domain Specifications.

Values for --REFID are sponsor-defined and can be any alphanumeric strings the sponsor chooses, consistent with their internal practices.

• The sequence number (--SEQ) variable uniquely identifies a record for a given USUBJID within a domain. The variable --SEQ is required in all domains except DM. For example, if a subject has 25 observations in the Vital Signs (VS) domain, then 25 unique VSSEQ values should be established for this subject. Conventions for establishing and maintaining --SEQ values are applicant-defined. Values may or may not be sequential depending on data processes and sources.

Differences Between Grouping Variables Grouping Qualifier variable

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).
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The following assumptions will be implemented for Interventions class domains.

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