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SD0006 check - Baseline Flag
s
Sergiy
on October 7, 2015
Hi Manolya,If baseline
Hi Manolya,
If baseline assessments were NOT DONE, then it's a huge data quality issue. Actually it means that you are loosing this subject from analysis of study data.
Kind Regards,
Sergiy
m
Manolya
on October 8, 2015
SD0006 - Baseline Flag
Dear Sergiy,
It is a study where only pregnancy test was perfomed. Therefore, male subjects have a "NOT DONE". So I will probably have to explain it that way.
Thanks!
Hi!
The SD0006 check says that "All subjects should have at least one baseline observation (--BLFL = 'Y') in EG, LB, QS, and VS domains, except for subjects who failed screening (ARMCD = 'SCRNFAIL') or were not fully assigned to an Arm (ARMCD = 'NOTASSGN')". However, what if lbtests are "NOT DONE". Here I do not see to set a baseline flag. Is this check then obsolete?
Thanks!