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USE OF THE “STUDY DAY” VARIABLES
The permissible Study Day variables (–DY, –STDY, and –ENDY) describe the relative day of the observation 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 decremented 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…
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