Variable Name | Variable Label | Type | Controlled Terms, Codelist or Format1 | Role | CDISC Notes | Core |
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STUDYID | Study Identifier | Char |
| Identifier | Study identifier of the parent record(s). | Req |
RDOMAIN | Related Domain Abbreviation | Char | (DOMAIN) | 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). | Req |
IDVAR | Identifying Variable | Char* |
| Identifier | Identifying variable in the dataset that identifies the related record(s). Examples: --SEQ, --GRPID. | 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 applicant's operational dataset. | Req |
QLABEL | Qualifier Variable Label | Char |
| Synonym Qualifier | This is the long name or label associated with QNAM. The value in QLABEL cannot be longer than 40 characters. This will often be the column label in the applicant's original 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 | Since QVAL can represent a mixture of collected (on a CRF), derived, or assigned items, QORIG is used to indicate the origin of this data. | Req |
QEVAL | Evaluator | Char* |
| Record Qualifier | Used only for results that are subjective (e.g., assigned by a person or a group). Should be null for records that contain objectively collected or derived data. Some examples include "ADJUDICATION COMMITTEE", "STATISTICIAN", "DATABASE ADMINISTRATOR", "CLINICAL COORDINATOR", etc. | Exp |