Trial Sets (TX)

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	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		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

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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Trial Sets (TX)