"Variable
Name ",Variable Label ,Type ,Description
STUDYID ,Study Identifier ,Char ,Unique identifier for a study.
DOMAIN ,"Domain
Abbreviation",Char ,"Two-character abbreviation for the domain, which must be TD."
TDORDER ,"Sequence of
Planned
Assessment
Schedule",Num ,"A number given to ensure ordinal sequencing of the planned assessment schedules
within a trial."
TDANCVAR ,"Anchor Variable
Name",Char ,"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 ADSL dataset e.g. ANCH1DT. Note: TDANCVAR is to contain the name of
a reference date variable name."
TDSTOFF ,"Offset from the
Anchor",Char ,"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."
TDTGTPAI ,"Planned
Assessment
Interval",Char ,"The planned interval between disease assessments represented in ISO 8601 character
format."
TDMINPAI ,"Planned
Assessment
Interval
Minimum",Char ,"The lower limit of the allowed range for the planned interval between disease
assessments represented in ISO 8601 character format."
TDMAXPAI ,"Planned
Assessment
Interval
Maximum",Char ,"The upper limit of the allowed range for the planned interval between disease
assessments represented in ISO 8601 character format."
TDNUMRPT ,"Maximum
Number of Actual
Assessments",Num ,"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."
