Trial Sets allows the submission of detailed information about planned groups of subjects that results as a combination of experimental factors of interest for a study (including experimental parameters, inherent characteristics, and sponsor-defined attributes). A "set" may be a planned subdivision of a trial arm, or may comprise 1 or more trial arms. These datasets are essential to determining whether data comparisons are feasible across different studies.
Trial Sets—One Record per Trial Set Parameter
SDTM v2.1 Metadata Check for Class and Dataset Specification Table Beta 1
Metadata check macro is applied and detected no issues. This notice is provided as a visual reminder. It will be removed during final publication. Release Notes
| # | 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 | C117457 | The standardized or dictionary-derived short sequence of characters used to represent the trial set. | 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" |
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