"Variable
Name ",Variable Label ,Type ,Description
VISITNUM ,Visit Number ,Num ,"Clinical encounter number. Numeric version of VISIT, used for sorting."
VISIT ,Visit Name ,Char ,Protocol-defined description of a clinical encounter.
VISITDY ,"Planned Study Day
of Visit",Num ,Planned study day of VISIT. Should be an integer.
TAETORD ,"Planned Order of
Element within Arm",Num ,"Number that gives the planned order of the Element within the Arm (see Trial
Arms, Section 3.2.2 )."
EPOCH ,Epoch ,Char ,"Epoch associated with the start date/time of the observation, or the date/time
of collection if start date/time is not collected. (See Section 3.2.2)."
--DTC ,"Date/Time of
Collection",Char ,"Collection date and time of an observation represented in IS0 8601 character
format."
--STDTC ,"Start Date/Time of
Observation",Char ,Start date/time of an observation represented in IS0 8601 character format.
--ENDTC ,"End Date/Time of
Observation",Char ,End date/time of the observation represented in IS0 8601 character format.
--DY ,"Study Day of
Visit/Collection/Exa
m",Num ,"Actual study day of visit/collection/exam expressed in integer days relative to
the sponsor-defined RFSTDTC in Demographics."
--STDY ,"Study Day of Start
of Observation",Num ,"Actual study day of start of observation expressed in integer days relative to
the sponsor-defined RFSTDTC in Demographics."
--ENDY ,"Study Day of End of
Observation",Num ,"Actual study day of end of observation expressed in integer days relative to
the sponsor-defined RFSTDTC in Demographics."
--DUR ,Duration ,Char ,"Collected duration of an event, intervention, or finding represented in ISO
8601 character format. Used only if collected on the CRF and not derived."
--TPT ,"Planned Time Point
Name",Char ,"Text description of time when a measurement or observation should be taken
as defined in the protocol. This may be represented as an elapsed time relative
to a fixed reference point, such as time of last dose. See --TPTNUM and --
TPTREF."
--TPTNUM ,"Planned Time Point
Number",Num ,Numeric version of planned time point used in sorting.
--ELTM ,"Planned Elapsed
Time from Time
Point Ref",Char ,"Planned Elapsed time in ISO 8601 character format relative to a planned fixed
reference (--TPTREF) such as “Previous Dose” or “Previous Meal”. This
variable is useful where there are repetitive measures. Not a clock time or a
date/time variable, but an interval, represented as ISO duration."
--TPTREF ,"Time Point
Reference",Char ,"Description of the fixed reference point referred to by --ELTM, --TPTNUM,
and --TPT. Examples: PREVIOUS DOSE, PREVIOUS MEAL."
--RFTDTC ,"Date/Time of
Reference Time
Point",Char ,"Date/time for a fixed reference time point defined by --TPTREF in ISO 8601
character format."
--STRF ,"Start Relative to
Reference Period",Char ,"Identifies the start of the observation as being before, during, or after the
sponsor-defined reference period. The sponsor-defined reference period is a
continuous period of time defined by a discrete starting point and a discrete
ending point represented by RFSTDTC and RFENDTC in Demographics.
Note: This variable will be deprecated (phased out) in a future (post SDTM
v1.4) release. The functionality of this variable can be replaced by the use of -
-STRTPT with --STTPT = RFSTDTC."
--ENRF ,"End Relative to
Reference Period",Char ,"Identifies the end of the observation as being before, during or after the
sponsor-defined reference period. The sponsor-defined reference period is a
continuous period of time defined by a discrete starting point and a discrete
ending point represented by RFSTDTC and RFENDTC in Demographics.
Note: This variable will be deprecated (phased out) in a future (post SDTM
v1.4) release. The functionality of this variable can be replaced by the use of -
-ENRTPT with --ENTPT = RFENDTC."
--EVLINT ,Evaluation Interval ,Char ,"Duration of interval associated with an observation such as a finding --
TESTCD, represented in ISO 8601 character format. Example: -P2M to
represent a period of the past 2 months as the evaluation interval for a
question from a questionnaire such as SF-36."
--EVINTX ,"Evaluation Interval
Text",Char ,"Evaluation interval associated with an observation, where the interval is not
able to be represented in ISO 8601 format. Examples: LIFETIME, LAST
NIGHT, RECENTLY, OVER THE LAST FEW WEEKS."
--STRTPT ,"Start Relative to
Reference Time
Point",Char ,"Identifies the start of the observation as being before or after the sponsor
defined reference time point defined by variable --STTPT."
--STTPT ,"Start Reference
Time Point",Char ,"Description or date/time in ISO 8601 or other character format of the sponsor
defined reference point referred to by --STRTPT. Examples: ""2003-12-15"" or
""VISIT 1""."
--ENRTPT ,"End Relative to
Reference Time
Point",Char ,"Identifies the end of the observation as being before or after the sponsor
defined reference time point defined by variable --ENTPT."
--ENTPT ,"End Reference Time
Point",Char ,"Description or date/time in ISO 8601 or other character format of the sponsor
defined reference point referred to by --ENRTPT. Examples: ""2003-12-25"" or
""VISIT 2""."
--STINT ,"Planned Start of
Assessment Interval",Char ,"The start of a planned evaluation or assessment interval in ISO 8601 character
format relative to the Time Point Reference (--TPTREF)."
--ENINT ,"Planned End of
Assessment Interval",Char ,"The end of a planned evaluation or assessment interval in ISO 8601 character
format relative to the Time Point Reference (--TPTREF)."
--DETECT ,"Time in Days to
Detection",Num ,"The number of days from the start of dosing to the earliest detection of a
condition or pathogen."
