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Variable_order Dataset_name Variable_name Variable_label Type Codelist Role Core CDISC_notes
1 TD STUDYID Study Identifier Char Identifier Req Unique identifier for a study.
2 TD DOMAIN Domain Abbreviation Char Identifier Req Two-character abbreviation for the domain.
3 TD TDORDER Sequence of Planned Assessment Schedule Num Timing Req A number given to ensure ordinal sequencing of the planned assessment schedules within a trial.
4 TD TDANCVAR Anchor Variable Name Char Timing Req A reference to the date variable name that provides the start point from which the planned disease assessment schedule is measured. This must be a referenced from the ADaM ADSL dataset (e.g., "ANCH1DT"). Note: TDANCVAR will contain the name of a reference date variable.
5 TD TDSTOFF Offset from the Anchor Char ISO 8601 duration Timing Req 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 either zero or a positive value and will be represented in ISO 8601 character format.
6 TD TDTGTPAI Planned Assessment Interval Char ISO 8601 duration Timing Req The planned interval between disease assessments represented in ISO 8601 character format.
7 TD TDMINPAI Planned Assessment Interval Minimum Char ISO 8601 duration Timing Req The lower limit of the allowed range for the planned interval between disease assessments represented in ISO 8601 character format.
8 TD TDMAXPAI Planned Assessment Interval Maximum Char ISO 8601 duration Timing Req The upper limit of the allowed range for the planned interval between disease assessments represented in ISO 8601 character format.
9 TD TDNUMRPT Maximum Number of Actual Assessments Num Record Qualifier Req 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.