SD1013

Pinnacle 21 Support SDTM
1

Hi Kjell,

You are right. This is a bug in the SDTM v3.1.2 configuration. The rule should look like this:

<val:Condition ID=“SD1013” Test=“TAETORD == ‘’” When=“ETCD == ‘UNPLAN’” Message=“TAETORD should be null for unplanned element” Description=“When subject’s experience for a particular period of time is represented as an unplanned Element, where Element Code (ETCD) is equal to ‘UNPLAN’, then Planned Order of Elements within Arm (TAETORD) should be null.” Category=“Consistency” Type=“Warning” Severity=“Medium”/>

I’ll make sure this issue is resolved in the upcoming v1.2 release of the configurations.

Thanks
Max

2

It seems that the validation definition for the SD1013 rule in config-sdtm-3.1.2.xml has been made opposite to the intention.

Test=“TAETORD != ‘’”

should be changed to

Test=“TAETORD == ‘’”