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SD0005
s
Sergiy
on March 19, 2018
It's a bug in the check algorithm.
Hi Rie,
It's a bug in the check algorithm.
To be applied for as many cases possible, SD0005 looks for uniqueness of --SEQ value within a combination of USUBJID, POOLID and SPDEVID variables value, if any of these 3 variables is present.
USUBJID and POOLID are mutually exclusive variables. So, the check works correctly for them.
SPDEVID may be utilized in addition to USUBJID. This case is not covered.
A bug will be fix in the next release of the validator.
Thank you for your finding!
Kind Regards,
Sergiy
According to the SDTM IG for Medical Devises V1.0, DISEQ should be unique within a parameter within a device (SPDEVID) within dataset for DI domain, but for other domains, --SEQ should be unique within every subject/device combination within dataset.
Why does SD0005 always fire when SPDEVID is not unique wuithin a device, but unique within every subject/device combination?
Thsnks for your help.