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The start and end dates (and times when applicable) of an applicant-defined reference period for a study are represented using variables RFSTDTC and RFENDTC, respectively, in the Demographics (DM) domain. Applicants may also define dates/times, in addition to a study reference period, from which to reference the relative timing of observations. In both cases, such dates are used as references from which to populate the variables described below.

Metadataspec
NumVariable PopulationImplementation
1Days Relative relative to a Reference Start Datereference start date

Variables --DY, --STDY, and --ENDY represent the timing of observations in days relative to the reference start date in RFSTDTC where the value of:

  • --DY is the relative day of the date populated in --DTC for the observation,
  • --STDTC is the relative day of the date populated in --STDTC for the observation; , and
  • --ENDY is the relative day of the of the date populated in --ENDTC for the observation.

All relative day values will be integers and there will be no study day 0. The reference start date is considered day 1 and the study day value is increased by 1 for each date following the reference start date and decreased by 1 for each date prior to the reference start date, e.g.:

--DY = (date portion of --DTC) - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC
--DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC
2Days Relative relative to Other Applicant-Defined Reference Datesother applicant-defined reference dates

Days may be represented Applicants may represent days relative to other applicant-defined reference dates beyond a reference period for a study. In such cases:

  • Relative days will be represented in a nonstandard variable (NSV) in a --SUPP dataset associated with the domain. 
  • All relative day values will be integers and there will be no day 0.
  • The reference date is considered day 1 and the relative day value is increased by 1 for each date following the reference date and decreased by 1 for each date prior to the reference date.
3

Timing

Relative to a Reference Start Date

of observation start relative to the reference period 

  • Variable --STRF represents the timing of observations relative to an applicant-defined reference period represented in RFSTDTC and RFENDTC, when relative timing such as "BEFORE", "PRIOR", "ONGOING"', or "CONTINUING" is collected instead of a an actual date and is collected in relation to the applicant-defined study reference period.
  • Variable --STRF is used to identify the start of an observation relative to the sponsorapplicant-defined study reference period.
  • Allowable values for --STRF are "BEFORE", "DURING", "DURING/AFTER", "AFTER", and "UNKNOWN". Although "COINCIDENT" and "ONGOING" are in the STENRF codelist, they describe timing relative to a point in time rather than an interval of time, so are not appropriate for use with --STRF variables. It would be unusual for an event or intervention to be recorded as starting "AFTER" the study reference period, but could be possible, depending on how the study reference period is defined in a particular study.
4Timing Relative to a Reference End Dateof observation end relative to the reference period 
  • Variable --STRF ENRF represents the timing of observations relative to an applicant-defined reference period represented in RFSTDTC and RFENDTC, when relative timing such as "BEFORE", "PRIOR", "ONGOING"', or "CONTINUING" is collected instead of a an actual date and is collected in relation to the applicant-defined study reference period.
  • Variable --ENRF is used to identify the end of an observation relative to the sponsorapplicant-defined study reference period.
  • Allowable values for --ENRF are "BEFORE", "DURING", "DURING/AFTER", "AFTER" and "UNKNOWN". If --ENRF is used, then --ENRF = "AFTER" means that the event did not end before or during the study reference period. Although "COINCIDENT" and "ONGOING" are in the STENRF codelist, they describe timing relative to a point in time rather than an interval of time, so are not appropriate for use with --ENRF variables.

Timing Relative to Reference Points

Applicants may define time fixed reference points within a study from which to reference the relative timing of observations. In such cases, timepoints are used as references from which to populate the variables described below.

Metadataspec
NumVariable PopulationImplementation
1

Observation start timing relative to a fixed reference point

Timing Relative to a Fixed Reference Time Point

--STRTPT, --STTPT, --ENRTPT, and --ENTPT


  • Variable --STTPT represents an applicant-defined fixed
time
  • reference point that characterizes the start of an observation.
  • Allowable values for --STTPT are a description of or the date and/or time of the fixed reference time point. 
  • Variable --STRTPT represents the start of an observation relative to a reference time point
.
  • Allowable values 
  • contain values similar to --STRF and --ENRF, but may be anchored with any timing description or date/time value expressed in the respective --STTPT and --ENTPT variables, and are not limited to the study reference period. Unlike the variables --STRF and --ENRF, which for all domains are defined relative to one study reference period, the timing variables --STRTPT, --STTPT, --ENRTPT, and --ENTPT are defined by each sponsor for each study. Allowable values for --STRTPT and --ENRTPT are as follows.

If the reference time point corresponds to the date of collection or assessment:

  • Start values: An observation can start BEFORE that time point, can start COINCIDENT with that time point, or it can be UNKNOWN when it started.
  • End values: An observation can end BEFORE that time point, can end COINCIDENT with that time point, can be known that it did not end but was ONGOING, or it can be UNKNOWN when it ended or if it was ongoing.
  • AFTER is not a valid value in this case because it would represent an event after the date of collection.

If the reference time point is prior to the date of collection or assessment:

  • represented in --STTPT. Allowable values are that an observation can:
    • start "BEFORE" the reference point,
    • start "AFTER" the reference point,
    • start "COINCIDENT" with the reference point, or
    • be "UNKNOWN" when it started.
2

Observation end timing relative to a fixed reference point

  • Variable --ENTPT represents an applicant-defined fixed reference point that characterizes the end of an observation. Allowable values for --ENTPT are a description of or the date and/or time of the fixed reference time point. 
  • Variable --ENRTPT represents the start of an observation relative to a reference time point represented in --ENTPT. Allowable values are that an observation can:
  • Start values: An observation can start BEFORE the reference point, can start COINCIDENT with the reference point, can start AFTER the reference point, or it can be UNKNOWN when it started.
  • End values: An observation can end BEFORE the reference point, can end COINCIDENT with the reference point, can end AFTER the reference point, can
    • end "BEFORE" the reference point,
    • end "COINCIDENT" with the reference point,
    • end "AFTER" the reference point,
    • be known that it did not end but was "ONGOING", or
    it can
    • be "UNKNOWN" when it ended or if it was ongoing.

Although "DURING" and "DURING/AFTER" are in the STENRF codelist, they describe timing relative to an interval of time rather than a point in time, so are not allowable for use with --STRTPT and --ENRTPT variables.

3Planned intervals relative to a fixed reference point

When

f

instances of an activity are scheduled at planned time intervals relative to a fixed reference point (e.g.,

administration of a dose

an exposure), the following timing variables

should

will be used:

VariableDescription of Use
--TPTREF
: the
Represents a description of the fixed reference point
event or "anchor"
from which the planned observation will be made
, usually the dose (e.g., "Day 1 Dose"; "Day 1, Dose 1").
--RFTDTCRepresents the actual date/time of the value of --TPTREF
--ELTM
:

Represents the planned elapsed time from the fixed

reference point event (e.g., a dose)

timepoint reference to the planned observation

, in ISO 8601 format, which

. The value of this variable is usually also reflected in the value of variable --TPT

label. For example, if an observation is planned for 30 minutes after the day 1 dose (e.g., --TPT = "30 minute postdose"), --TPTREF would be "Day 1 Dose" with an --ELTM of PT30M.

.

--TPTRepresents
--TPT:
the label for the time point relative to
–TPTREF planned observation, typically reflecting --ELTM. For example, if --TPT is "30 minute postdose," then --ELTM would be PT30M; a "1 hour" --TPT would have an --ELTM of PT1H .
the value of --TPTREF
--TPTNUM
: indicates
Represents the order of
the time points (TPT) relative to the fixed reference point (TPTREF) for the category and/or subcategory (CAT/--SCAT) of data within a domain. The ordering/sequence number of the time point (e.g., 1, 2, 3) is sponsor-defined, but is usually at least unique within the given interval. For example, for a given day with 3 time points (pre-dose, 30 minutes post-dose, 1 hour post-dose), --TPTNUM could be 1 for pre-dose, 2 for 30 minutes post-dose, and 3 for 1 hour post-dose, to establish their relative order.

For each unique planned time point (--TPT), there must be a one-to-one relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is determined by a combination of the domain, fixed reference point (TPTREF), and (if present) category and/or subcategory (CAT/--SCAT).

Other variables (e.g., --TESTCD, --METHOD) may also be needed in some cases to define uniqueness. When this occurs, clarification should be provided as a comment to --TPTNUM in the define file.

--RFTDTC is used to represent the actual date/time of the fixed reference point (--TPTREF).
time points represented in --TPT relative to the value of --TPTREF


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