Check: Response assessment on or before first exposure

[harriscw]

@sarabodach saw some of this recently. what do you think?

[sarabodach]

Hi @harriscw - Were these unscheduled visits - or incorrect dates for a scheduled visit? Was there anything non-standard about the study design or endpoint?

[harriscw]

Not sure what the visit label was. Study design pretty standard. But intuitively doesn't make sense to check the response to a drug before its been administered. Or on the same day its administered.

[AlcJ123]

• in the ex domain, find per patient date of the first dose; in the ex domain find the first exstdtc per usubjid where exdose>0

compare that to first rs.rsdtc (rs domain.variable) per usubjid where rstestcd = OVRLRESP and RSEVAL==INVESTIGATOR

edit: @AlcJ123 updated