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TIG v1.0 Metadata Check for SDTM Domain Specification Table Beta 3.2

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 NameVariable LabelTypeControlled Terms, Codelist, or FormatRoleCDISC NotesCore
STUDYIDStudy IdentifierChar
IdentifierUnique identifier for a study.Req
DOMAINDomain AbbreviationCharTAIdentifierTwo-character abbreviation for the domain.Req
ARMCDPlanned Arm CodeChar
TopicARMCD is limited to 20 characters and does not have special character restrictions. The maximum length of ARMCD is longer than that for other "short" variables to accommodate the kind of values that are likely to be needed for crossover trials. For example, if ARMCD values for a 7-period crossover were constructed using 2-character abbreviations for each product and separating hyphens, the length of ARMCD values would be 20.Req
ARMDescription of Planned ArmChar
Synonym QualifierName given to an arm or exposure group.Req
TAETORDPlanned Order of Element within ArmNum
TimingNumber that gives the order of the element within the arm.Req
ETCDElement CodeChar
Record QualifierETCD (the companion to ELEMENT) is limited to 8 characters and does not have special character restrictions. These values should be short for ease of use in programming, but it is not expected that ETCD will need to serve as a variable name.Req
ELEMENTDescription of ElementChar
Synonym QualifierThe name of the element. The same element may occur more than once within an arm.Perm
TABRANCHBranchChar
RuleCondition subject met, at a "branch" in the trial design at the end of this element, to be included in this arm (e.g., "Randomization to PRODUCT X").Exp
TATRANSTransition RuleChar
RuleIf the trial design allows a subject to transition to an element other than the next element in sequence, then the conditions for transitioning to those other elements, and the alternative element sequences, are specified in this rule (e.g., "Responders go to washout").Exp
EPOCHEpochChar(EPOCH)TimingName of the trial epoch with which this element of the arm is associated.Req
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