j Jozef
on

 

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.

Forums: SDTM

Sergiy
on February 28, 2022

Hi Jozef, 

Please clarify rule you refer to? There is no SD005 in P21 Validator.

Thank you,
Sergiy

j Jozef
on March 1, 2022

SD0005 false positive

Sergiy
on March 1, 2022

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  

 

Want a demo?

Let’s Talk.

We're eager to share and ready to listen.

Cookie Policy

Pinnacle 21 uses cookies to make our site easier for you to use. By continuing to use this website, you agree to our use of cookies. For more info visit our Privacy Policy.