- represent relative days of observations in relation to the reference date where the reference date is day 1.
- starting with the reference date as day 1. They are determined by comparing the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) to the date portion of the subject reference start date (RFSTDTC from the Demographics domain).
The subject reference start date (RFSTDTC) is designated as study day 1. The study day value is incremented by 1 for each date following RFSTDTC. Dates prior to RFSTDTC are decreased by 1, with the date preceding RFSTDTC designated as study day -1 (there is no study day 0). This algorithm for determining Study Day is consistent with how people typically describe sequential days relative to a fixed reference point, but creates problems if used for mathematical calculations because it does not allow for a day 0. As such, Study Day is not suited for use in subsequent numerical computations, such as calculating duration. The raw date values should be used rather than Study Day in those calculations. All study day values are integers. Thus, to calculate Study Day: --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
This method should be used across all domains. |