SD1001 for Integrated Data

a Arun

on November 11, 2010

Hello All

I hava a question Regarding the Rule ID SD1001. This rule specifies duplicate Subjects within a speciifc study. How would you consider the the above rule for Integration data (ISS). We always expect duplicates across multiple studies and the Validator results show this as a High Severity Error. Any suggestions how we can prevent the occurance of this error in Integrated data.

Thanks

Arun

Forums: SDTM

m Max

on November 12, 2010

P21

Re: SD1001 for Integrated Data

Hi Arun,

Thanks for your feedback. This issue has been identified as a bug with both SDTM v3.1.1 and SDTM v3.1.2 configurations. To fix the issue please replace rule SD1001 definition with the following:

<val:Unique ID="SD1001" Variable="SUBJID" GroupBy="STUDYID" When="SUBJID != ''" Message="Duplicate SUBJID" Description="The value of Subject Identifier for the Study (SUBJID) variable must be unique for each subject within the study." Category="Consistency" Type="Error" Severity="High"/>

This bug fix will also be included in the upcoming v1.2 release of the configurations.

Regards,
Max

a Arun

on November 12, 2010