Timing

SDTM v2.1 Metadata Check for Class and Dataset Specification Table Beta 1

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#	Variable Name	Variable Label	Type	Format	Role	Usage Restrictions	Variable C-code	Definition	Notes	Examples
1	VISITNUM	Visit Number	Num		Timing		C83101	An assigned numeric identifier that aligns to the chronological order of a clinical encounter.	Numeric version of VISIT, used for sorting. VISITNUM does not have to be an integer value.	1, 1.1, 503.75
2	VISIT	Visit Name	Char		Timing		C171010	The label for a protocol-defined clinical encounter.
3	VISITDY	Planned Study Day of Visit	Num		Timing		C171011	The planned study day of a clinical encounter relative to the sponsor-defined reference start date.	Should be an integer.
4	TAETORD	Planned Order of Element Within Arm	Num		Timing		C83438	An assigned numeric identifier that gives the planned order of the element within the trial arm of the study.	See Section 5.1.1.2, Trial Arms.
5	EPOCH	Epoch	Char		Timing		C71738	A time period defined in the protocol with a study-specific purpose.	The epoch associated with an observation is determined by the start date or start date and time of the observation, or the date/time of collection if start date/time is not collected (see Section 5.1.1.2, Trial Arms).
6	RPHASE	Repro Phase	Char		Timing	Not in human clinical trials			Reproductive phase with which the reproductive stage of the reproductive path is associated. Defined in Trial Paths domain. The RPHASE variable is Required when any Reproductive Phase Day variable is used.
7	RPPLDY	Planned Repro Phase Day of Observation	Num		Timing	Not in human clinical trials	C170506	The day within the reproductive phase on which the test or observation was scheduled to occur.	Expressed as an integer.
8	RPPLSTDY	Planned Repro Phase Day of Obs Start	Num		Timing	Not in human clinical trials	C170508	The day within the reproductive phase on which the test or observation was scheduled to begin.	Expressed as an integer.
9	RPPLENDY	Planned Repro Phase Day of Obs End	Num		Timing	Not in human clinical trials	C170507	The day within the reproductive phase on which the test or observation was scheduled to end.	Expressed as an integer.
10	--DTC	Date/Time of Collection	Char	ISO 8601 datetime or interval	Timing		C82515	The date or date and time of the assessment or the specimen or data collection from the subject, represented in a standardized character format.
11	--STDTC	Start Date/Time of Observation	Char	ISO 8601 datetime or interval	Timing	Not in Findings class domains	C82517	The start date or date and time of an intervention or event, represented in a standardized character format.	The start date of a Findings class record is stored in the --DTC variable.
12	--ENDTC	End Date/Time of Observation	Char	ISO 8601 datetime or interval	Timing		C82516	The end date or date and time of an intervention, event, or finding, represented in a standardized character format.
13	--DY	Study Day of Visit/Collection/Exam	Num		Timing		C170993	The number of days from the sponsor-defined reference start date to the date of collection (--DTC), used in study data tabulation.	The sponsor-defined reference start date is RFSTDTC in Demographics.
14	--STDY	Study Day of Start of Observation	Num		Timing	Not in Findings class domains	C171005	The number of days from the sponsor-defined reference start date to the start of an intervention or event (--STDTC), used for study data tabulation.	The sponsor-defined reference start date is RFSTDTC in Demographics.
15	--ENDY	Study Day of End of Observation	Num		Timing		C170995	The number of days from the sponsor-defined reference start date to the end of an intervention, event, or finding (--ENDTC), used for study data tabulation.	The sponsor-defined reference start date is RFSTDTC in Demographics.
16	--NOMDY	Nominal Study Day for Tabulations	Num		Timing	Not in human clinical trials	C170498	The nominal study day, relative to the sponsor-defined reference start date, 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 (e.g., for output on a tabulation report).
17	--NOMLBL	Label for Nominal Study Day	Char		Timing	Not in human clinical trials	C170499	The name for a protocol-defined nominal study day.	As presented in the study report.
18	--RPDY	Actual Repro Phase Day of Observation	Num		Timing	Not in human clinical trials	C170504	The day within the reproductive phase on which the test or observation occurred.	Expressed as an integer.
19	--RPSTDY	Actual Repro Phase Day of Obs Start	Num		Timing	Not in human clinical trials	C170509	The day within the reproductive phase on which the test or observation began.	Expressed as an integer.
20	--RPENDY	Actual Repro Phase Day of Obs End	Num		Timing	Not in human clinical trials	C170505	The day within the reproductive phase on which the test or observation ended.	Expressed as an integer.
21	--XDY	Day of Obs Relative to Exposure	Num		Timing				The actual study day of an intervention, event, or finding, derived relative to the first exposure to any protocol-specified treatment or product. Expressed in integer days relative to RFXSTDTC in Demographics.
22	--XSTDY	Start Day of Obs Relative to Exposure	Num		Timing	Not in Findings class domains			The actual study day of the start of an intervention or event, derived relative to the first exposure to any protocol-specified treatment or product. Expressed in integer days relative to RFXSTDTC in Demographics.
23	--XENDY	End Day of Obs Relative to Exposure	Num		Timing				The actual study day of the end of an intervention, event, or finding, derived relative to the first exposure to any protocol-specified treatment or product. Expressed in integer days relative to RFXSTDTC in Demographics.
24	--CHDY	Day of Obs Rel to Challenge Agent	Num		Timing				The actual study day of an intervention, event, or finding, derived relative to the first exposure to the challenge agent that induces the disease or condition that the investigational treatment is intended to cure, mitigate, treat, or prevent. Expressed in integer days relative to RFCSTDTC in Demographics.
25	--CHSTDY	Start Day of Obs Rel to Challenge Agent	Num		Timing	Not in Findings class domains			The actual study day of the start of an intervention or event derived relative to the first exposure to the challenge agent that induces the disease or condition that the investigational treatment is intended to c ure, mitigate, treat, or prevent. Expressed in integer days relative to RFCSTDTC in Demographics.
26	--CHENDY	End Day of Obs Rel to Challenge Agent	Num		Timing				The actual study day of the end of an intervention, event, or finding derived relative to the first exposure to the challenge agent that induces the disease or condition that the investigational treatment is intended to cure, mitigate, treat, or prevent. Expressed in integer days relative to RFCSTDTC in Demographics.
27	--DUR	Collected Duration	Char	ISO 8601 duration	Timing		C170992	The collected length of time during which an observation continues, represented in a standardized character format.	Used only if collected on the CRF and not derived.
28	--TPT	Planned Time Point Name	Char		Timing		C171029	The description of the time when a protocol-defined activity is planned to occur, used for study data tabulation.	This may be represented as an elapsed time relative to a fixed reference point (e.g., time since last dose). See --TPTNUM and --TPTREF.	"PREDOSE", "1 HOUR POST-DOSE"
29	--TPTNUM	Planned Time Point Number	Num		Timing		C82545	The numeric identifier of when an observation is planned to occur.	Used in sorting.
30	--ELTM	Planned Elapsed Time from Time Point Ref	Char	ISO 8601 duration	Timing		C170994	The interval of time between a planned time point and a fixed reference point, represented in a standardized character format.	The fixed reference point is in --TPTREF. This variable is useful where there are repetitive measures. Not a clock time or a date/time variable, but an interval.
31	--TPTREF	Time Point Reference	Char		Timing		C171030	The description of a time point that acts as a fixed reference for a series of planned time points, used for study data tabulation.	Description of the fixed reference point referred to by --ELTM, --TPTNUM, --TPT, --STINT, and --ENINT.	"PREVIOUS DOSE", "PREVIOUS MEAL"
32	--RFTDTC	Date/Time of Reference Time Point	Char	ISO 8601 datetime or interval	Timing		C82518	The actual date or date and time of a time point that acts as a fixed reference for a series of planned time points, represented in a standardized character format.	The fixed reference point is in --TPTREF.
33	--STRF	Start Relative to Reference Period	Char		Timing		C82559	The characterization of the start of an observation relative to the study 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.
34	--ENRF	End Relative to Reference Period	Char		Timing		C82557	The characterization of the end of an observation relative to the study 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.
35	--EVLINT	Evaluation Interval	Char	ISO 8601 duration or interval	Timing		C82534	The planned time interval for which an observation is assessed, represented in a standardized character format.	Usually used with --DTC to describe an interval of this duration that ended at the time represented in --DTC.	"-P2M" to represent a period of the past 2 months as the evaluation interval for a question from a questionnaire.
36	--EVINTX	Evaluation Interval Text	Char		Timing		C117044	A textual description of the planned time interval for which an observation is assessed, where the interval is not able to be represented in a standardized character format.	A value that cannot be represented in ISO 8601 format.	"LIFETIME", "LAST NIGHT", "RECENTLY", "OVER THE LAST FEW WEEKS"
37	--STRTPT	Start Relative to Reference Time Point	Char		Timing		C82560	The characterization of the start of an observation relative to a reference time point.	The sponsor-defined reference time point is in --STTPT.
38	--STTPT	Start Reference Time Point	Char		Timing		C82575	The description or date and/or time of a time point that acts as a fixed reference for characterizing the start of an observation.	This is the sponsor-defined reference point referred to by --STRTPT.	"2003-12-15", "VISIT 1"
39	--ENRTPT	End Relative to Reference Time Point	Char		Timing		C82558	The characterization of the end of an observation relative to a reference time point.	The sponsor-defined reference time point is in --ENTPT.
40	--ENTPT	End Reference Time Point	Char		Timing		C82574	The description or date and/or time of a time point that acts as a fixed reference for characterizing the end of an observation.	This is the sponsor-defined reference point referred to by --ENRTPT.	"2003-12-25", "VISIT 2"
41	MIDS	Disease Milestone Instance Name	Char		Timing				The name of a specific instance of a Disease Milestone Type (MIDSTYPE) described in the Trial Disease Milestones dataset (see Section 5.1.4.3, Trial Disease Milestones). This should be unique within a subject. Used only in conjunction with RELMIDS and MIDSDTC.
42	RELMIDS	Temporal Relation to Milestone Instance	Char		Timing				The temporal relationship of the observation to the Disease Milestone Instance Name in MIDS.	"IMMEDIATELY BEFORE", "AT TIME OF", "AFTER"
43	MIDSDTC	Disease Milestone Instance Date/Time	Char	ISO 8601 datetime or interval	Timing				The start date/time of the Disease Milestone Instance Name in MIDS.
44	--STINT	Planned Start of Assessment Interval	Char	ISO 8601 duration	Timing		C117061	The start of a planned assessment interval relative to a reference time point, represented in a standardized character format.	The reference time point is in --TPTREF. As this variable describes planned timing of an assessment, caution should be exercised when using outside of the Findings class of domains. In an Events or Interventions domain, it may refer to the interval over which --OCCUR is assessed.
45	--ENINT	Planned End of Assessment Interval	Char	ISO 8601 duration	Timing		C117042	The end of a planned assessment interval relative to a reference time point, represented in a standardized character format.	The reference time point is in --TPTREF. As this variable describes planned timing of an assessment, caution should be exercised when using outside of the Findings class of domains. In an Events or Interventions domain, it may refer to the interval over which --OCCUR is assessed.
46	--DETECT	Time in Days to Detection	Num		Timing	Not in human clinical trials	C117041	The number of days from the start of dosing to the earliest detection of a condition or pathogen.
47	--PTFL	Point in Time Flag	Char		Timing	Only in Findings class specimen-based domains: BS, CP, GF, IS, LB, MB, MS, MI, PC, PP			An indication that the specimen was collected at a single point in time. The value is "Y" or null.
48	--PDUR	Planned Duration	Char	ISO 8601 duration	Timing	Only in Findings class specimen-based domains: BS, CP, GF, IS, LB, MB, MS, MI, PC, PP			Planned duration of a finding. For a sample-based finding, this could apply to the planned duration of specimen collection.

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