s Sigrid
on

 

I am using the variable MITSTDTL (Microscopic Examination Detail) to indicate differences between STAINING INTENSITY and STAINING EXTENSIVENESS. However, this variable is not included when evaluating for duplicate records in Pinnacle and therefore warning messages are generating. Should MITSTDTL not to included here?

Forums: SDTM

j Jozef
on August 15, 2019

Hi Sigrid,

It is YOU as a sponsor (and not P21 nor the FDA) who decides what the criteria for duplicate records are by setting the keys for the uniqueness in the define.xml ("KeySequence" attributes). Unfortunately, the software seems to ignore this (might have changed in 3.0.1) and has its own rules about record uniqueness.
Best is to do it correctly in the define.xml, validate with the define.xml provided, and if you then still get warnings, report this as false positives in the Reviewers Guide.

s Sigrid
on August 16, 2019

Hi Jozef,

Thanks for you response.

MITSTDTL was included as a key variable, but it seems not have an effect. I am using the most recent version (3.0.1)

<ItemRef ItemOID="IT.MI.MITSTDTL" OrderNumber="7" Mandatory="No" KeySequence="4"

Best, Sigrid

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