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Shareqc_sdtm21_ds
PurposeTX
GNTXAID
#Variable NameVariable LabelTypeFormatRoleVariable(s) QualifiedUsage RestrictionsVariable C-codeDefinitionNotesExamples
1STUDYIDStudy IdentifierChar
Identifier

C83082

A sequence of characters used by the sponsor to uniquely identify the study.



2
Status
colourRed
titleNEW VAR
Genetic Toxicology Assay IdentifierCharIdentifierTobacco IG only

A sequence of characters that uniquely identifies a genetic toxicology assay within a study.

MNVIT, MLA3DOMAINDomain AbbreviationChar
Identifier

C49558

An abbreviation for a collection of observations, with a topic-specific commonality.

2-character abbreviation, which must be "TX".
43SETCDSet CodeChar
Identifier

C117457The 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.
54SETSet DescriptionChar
Synonym QualifierSETCD


Long description of a specific trial set, as defined by the sponsor.
65TXSEQSequence NumberNum
Identifier



Unique number for this record within this dataset.
76TXPARMCDTrial Set Parameter Short NameChar
Topic



Short character value for the trial set parameter described in TXPARM. Maximum 8 characters.
87TXPARMTrial Set ParameterChar
Synonym QualifierTXPARMCD


Term for the trial set parameter. Maximum 40 characters.
98TXVALTrial Set Parameter ValueChar
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"