SDTM v2.1 Metadata Check for Class and Dataset Specification Table Beta 1
Metadata check macro is applied and detected issue(s). Please address finding(s) listed below the specification table. An FAQ is available to aid troubleshooting. 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 | GNTXAIDNEW VAR | Genetic Toxicology Assay Identifier | Char | Identifier | Tobacco IG only | A sequence of characters that uniquely identifies a genetic toxicology assay within a study. | "MNVIT", "MLA" | ||||
| 3 | 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". | ||||
| 4 | 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. | ||||
| 5 | SET | Set Description | Char | Synonym Qualifier | SETCD | Long description of a specific trial set, as defined by the sponsor. | |||||
| 6 | TXSEQ | Sequence Number | Num | Identifier | Unique number for this record within this dataset. | ||||||
| 7 | TXPARMCD | Trial Set Parameter Short Name | Char | Topic | Short character value for the trial set parameter described in TXPARM. Maximum 8 characters. | ||||||
| 8 | TXPARM | Trial Set Parameter | Char | Synonym Qualifier | TXPARMCD | Term for the trial set parameter. Maximum 40 characters. | |||||
| 9 | 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" |
Metadata Checks Findings
SDTM & Related IG Metadata Check User Macros FAQ
- Content: Variable Name GNTXAIDNEW VAR is longer than 8 characters
- Content: For variable GNTXAIDNEW VAR, leading or trailing whitespace found in Definition
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