Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
|---|
STUDYID | Study Identifier | Char |
| Identifier | Unique study identifier of the parent record(s). | 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. | 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 | Identifying variable in the dataset that identifies the related record(s). Examples: BWSEQ, CLGRPID. | Exp |
IDVARVAL | Identifying Variable Value | Char |
| Identifier | Value of identifying variable of the parent record(s). | Exp |
QNAM | Qualifier Variable Name | Char |
| Topic | The short name of the Qualifier variable, which is used as a column name in a domain view with data from the parent domain. The value in QNAM cannot be longer than 8 characters nor can it start with a number (e.g., "1TEST" is not valid). QNAM cannot contain characters other than letters, numbers, or underscores. This will often be the column name in the sponsorapplicant's operational dataset. The value in QNAM may not be the same as any variable name defined in another domain or the SDTM. The QNAM should uniquely correspond to a QLABEL within a single domain. | Req |
QLABEL | Qualifier Variable Label | Char |
| Synonym Qualifier | This is the long name or label associated with QNAM. The value in QLABEL should be in title case and cannot be longer than 40 characters. This will often be the column label in the sponsor's operational dataset. | Req |
QVAL | Data Value | Char |
| Result Qualifier | Result of, response to, or value associated with QNAM. A value for this column is required; no records can be in SUPP-- with a null value for QVAL. | Req |
QORIG | Origin | Char |
| Record Qualifier | QORIG is used to indicate the origin of the data. Possible values are COLLECTED, DERIVED, OTHER, and NOT AVAILABLE. See Section 3.2.2.1. | Perm |
QEVAL | Evaluator | Char |
| Record Qualifier | Used only for results that are subjective (i.e., assigned by a person or a group). Should be null for records that contain objectively collected or derived data. Some examples include PATHOLOGIST or VETERINARIAN, etc. | Perm |