| # | Variable Name | Variable Label | Type | Format | Role | Variable(s) Qualified | Usage Restrictions | Variable C-code | Definition | Notes | Examples |
|---|
| 1 | STUDYID | Study Identifier | Char |
| Identifier |
|
| C83082 | A sequence of characters used by the sponsor to uniquely identify the study. |
|
|
| 2 | DOMAIN | Domain Abbreviation | Char |
| Identifier |
|
| C49558 | An abbreviation for a collection of observations, with a topic-specific commonality. | 2-character abbreviation, which must be "TX". |
|
| 3 | SETCD | Set Code | Char |
| Identifier |
|
|
|
| Short name of a specific trial set, as defined by the sponsor. Maximum 8 characters. This represents the trial set for which parameters are being submitted. |
|
| 4 | SET | Set Description | Char |
| Synonym Qualifier | SETCD |
|
|
| Long description of a specific trial set, as defined by the sponsor. |
|
| 5 | TXSEQ | Sequence Number | Num |
| Identifier |
|
|
|
| Unique number for this record within this dataset. |
|
| 6 | TXPARMCD | Trial Set Parameter Short Name | Char |
| Topic |
|
|
|
| Short character value for the trial set parameter described in TXPARM. Maximum 8 characters. |
|
| 7 | TXPARM | Trial Set Parameter | Char |
| Synonym Qualifier | TXPARMCD |
|
|
| Term for the trial set parameter. Maximum 40 characters. |
|
| 8 | TXVAL | Trial Set Parameter Value | Char |
| Result Qualifier |
|
|
|
| Value of the trial set parameter. Some parameters may be subject to controlled terminology. | "Fed ad libitum" or "Restricted Feeding" when TXPARM is "FEEDREG" |