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shareqc_sdtm20sdtm21_ds
PurposeTD
#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.



2DOMAINDomain AbbreviationChar
Identifier

C49558An abbreviation for a collection of observations, with a topic-specific commonality.2-character abbreviation, which must be "TD".
3TDORDERSequence of Planned Assessment ScheduleNum
Timing



A number given to ensure ordinal sequencing of the planned assessment schedules within a trial.
4TDANCVARAnchor Variable NameChar
Timing



A reference to the date variable name that provides the start point from which the planned disease assessment schedule is measured. This must be referenced from the ADaM subject-level (ADSL) dataset (e.g., ANCH1DT).

Note: TDANCVAR is to contain the name of a reference date variable name.


5TDSTOFFOffset from the AnchorChar

ISO 8601 duration

Timing



A fixed offset from the date provided by the variable referenced in TDANCVAR. This is used when the timing of planned cycles does not start on the exact day referenced in the variable indicated in TDANCVAR. The value of this variable will be a non-negative duration.


6TDTGTPAIPlanned Assessment IntervalCharISO 8601 durationTiming



The planned interval between disease assessments.
7TDMINPAIPlanned Assessment Interval MinimumCharISO 8601 durationTiming



The lower limit of the allowed range for the planned interval between disease assessments.
8TDMAXPAIPlanned Assessment Interval MaximumCharISO 8601 durationTiming



The upper limit of the allowed range for the planned interval between disease assessments.
9TDNUMRPTMaximum Number of Actual AssessmentsNum
Record Qualifier



This variable must represent the maximum number of actual assessments for the analysis that this disease assessment schedule describes. In a trial where the maximum number of assessments is not defined explicitly in the protocol (e.g., assessments occur until death), TDNUMRPT should represent the maximum number of disease assessments that support the efficacy analysis, encountered by any subject across the trial at that point in time.