Check: Response assessment on or before first exposure

pharmaverse / sdtmchecks

Analysis facing checks for SDTM data

https://pharmaverse.github.io/sdtmchecks/

Apache License 2.0

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Check: Response assessment on or before first exposure #404

Open harriscw opened 3 months ago

harriscw commented 3 months ago

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

sarabodach commented 3 months ago

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 commented 3 months ago

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 commented 3 months ago

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