"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."
