Timeframes, fixed points in time, and other milestones may be defined in the context of a study as references to which the timing of other collected observations is related.
In general observation class domains, days relative to the reference start date or in relation to applicant-defined reference dates may be represented for observations.
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Num | Variable Population | Implementation |
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1 | Days Relative to the Reference Start Date | Variables --DY, --STDY, and --ENDY represent 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
| 2 | Days Relative to Applicant-Defined Reference Dates | Applicants may represent days relative to applicant-defined reference dates. In such cases: - Values will be integers.
- The reference date will be day 1.
- Relative days will be represented in a nonstandard variable (NSV) in a --SUPP dataset associated with the domain.
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