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SD005 duplicate RESEQ value
SergiyHi Jozef, Please clarify…
Hi Jozef,
Please clarify rule you refer to? There is no SD005 in P21 Validator.
Thank you,
Sergiy
SergiyI reproduced your case and confirm this as a bug.
Hi Jozef,
Thank you for details! I reproduced your case and confirm this as a bug.
SD0005 algorithms does not work correctly. If both USUBJID and SPDEVID variables are present, then SD0005 rule algorithm complies 2 separate checks for uniqueness of --SEQ value for each USUBJID and SPDEVID variable. In your case, you may utilized this device for some previous subject. So, SD0005 complains about the same RESEQ for the same SPDEVID. It's false-positive message.
The fixed version of SD0005 rule will be available in the next release of P21 validation engine.
Thank you again!
Kind Regards,
Sergiy
SDTMIG 3.3 (FDA).
In my RE datasets, I have measurements for which the same device was used. So, I have more than one measurement per unique device.
Although my values of RESEQ are unique for each measurement within each subject, I get a large numbers of errors SD005 "Duplicate value for RESEQ variable".
Example:
row 1: USUBJID=21, SPDEVID=DEV33, RESEQ=1
row 2: USUBJID=21, SPDEVID=DEV33, RESEQ=2
It looks as the software wants to have SPDEVID being unique within each subject, which has nothing to do with RESEQ.
SDTM-IG shows a lot of examples where SPDEVID is not unique within each subject, e.g. page 227.