"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
.Timing v1.5, 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/Exam",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."
--NOMDY ,"Nominal Study Day for
Tabulations",Num ,"The nominal study day used by data-collection and reporting systems for
grouping records for observations that may be scheduled to occur on different
days into a single study day (such as for output on a tabulation report). Not to
be used with human clinical trials."
--NOMLBL ,"Label for Nominal Study
Day",Char ,"A label for a given value of --NOMDY, within a domain, as presented in the
study report. Not to be used with human clinical trials."
--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."
--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."
--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""."
MIDS ,"Disease Milestone
Instance Name",Char ,"The name of a specific instance of a Disease Milestone Type (MIDSTYPE)
described in the Trial Disease Milestones dataset (See Section 3.5). This
should be unique within a subject. Used only in conjunction with RELMIDS
and MIDSDTC."
RELMIDS ,"Temporal Relation to
Milestone Instance",Char ,"The temporal relationship of the observation to the Disease Milestone
Instance Name in MIDS. Examples: IMMEDIATELY BEFORE, AT TIME
OF, AFTER."
MIDSDTC ,"Disease Milestone
Instance Date/Time",Char ,"The start date/time of the Disease Milestone Instance Name in MIDS, in
ISO8601 format."
--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."
