SD1001

a Ana

on May 10, 2010

Hi. I am new to using openCDisc. Just downloaded and trying to test it in my system and finding that the rule SD1001 - Duplicate SUBJID pops up. My question is the SUBJID doean't have to be unique if the SITEID is different. In my dataset, the USUBJID is different for all the subjects. But I have SUBJID 001, 002 for 2 SITEIDs (01, 02). When I look at the Implementation guide example for the DM dataset, i do see SUBJID of 001, 002 multiple times with different SITEID. Since this is marked as HIGH severity, would like to check this with this group. Is this part of the openCDisc validation rule? i don't see this in WebSDM rules.

Thanks

Ana

Forums: Validation Rule Suggestions

m Max

on May 10, 2010

P21

Re: SD1001

Hi Ana,

We had this same question come up recently. The issue is that there is an inconsistency in the implementation guide. If you look at SUBJID description in SDTMIG v3.1.2 (page 54) it states: "Subject identifier, which must be unique within the study." But then it's contradicted with the DM example that shows the same SUBJID for different SITEIDs.

We will bring this up with the recently formed CDISC Validation project team to get a clarification. In the meantime I would recommend that you make SUBJID unique within the study just to be safe.

Thanks,
Max

a Ana

on May 11, 2010

SD1001

Hi Max

Thanks for the response. This is change from 3.1.1 and the Change history is not mentioned of this change. The validation check I ran was for the 3.1.1. So may be we don't need to worry if we are using the 3.1.1 since the IG for that do not speicify SUBJID needs to be unique. This seems to be change only from 3.1.2

Thanks

Ana

a Anthony

on May 13, 2010

SUBJID vs. USUBJID

Also, the example on pg 57 of the SDTMIG v3.1.2 §5.1.1.2 is a typographical error (rows 5 and 6). The intention is to have a unique subject identifier within a study. USUBJID is a unique subject identifier across all studies for submission applications.