Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
|---|
STUDYID | Study Identifier | Char |
| Identifier | Unique identifier for a study. | Req |
DOMAIN | Domain Abbreviation | Char | TX | Identifier | Two-character abbreviation for the domain. | Req |
SETCD | Set Code | Char |
| Identifier | Short name of the Trial Set. The same element may occur more than once within an Arm. Maximum 8 characters. This represents the Trial Set for which parameters are being submitted. | Req |
SET | Set Description | Char |
| Synonym Qualifier | Long description of a specific Trial Set, as defined by the applicant. | Req |
TXSEQ | Sequence Number | Num |
| Identifier | Unique number for this record within this dataset (This sequence should be unique within the entire dataset because there is no USUBJID.). | Req |
TXPARMCD | Trial Set Parameter Short Name | Char | (STSPRMCD) | Topic | Short character value for the Trial Set parameter described in TXPARM. Maximum 8 characters. | Req |
TXPARM | Trial Set Parameter | Char | (STSPRM) | Synonym Qualifier | Term for the Trial Set parameter. Maximum 40 characters. | Req |
TXVAL | Trial Set Parameter Value | Char |
| Result Qualifier | Value of the Trial Set parameter (e.g., Fed ad libitum or Restricted Feeding when TXPARM is FEEDREG). Some parameters may be subject to controlled terminology. See the Controlled Terms, Codelist, or Format column in Section 7.4.2 that lists all defined Trial Set parameters. | Req |