SDTM + Define.xml rule enhancement

Pinnacle 21 Product Suggestions Validation Rule Suggestions
1

Hi Barry,

There is no check on consistency of define.xml Key Variables vs. variables actually present in datasets.

We are planning a significant enhancement of define.xml validation soon. However it’s not a part of the today’s v2.0 release.

Thanks for your suggestion for new validation check.

Kind Regards,

Sergiy

2

In the SDTM TV dataset, the variable ARMCD exists but no ARM variable exists. The ARM variable in the study define.xml file has been listed as a key. However, when the OpenCDISC Validator executes using both SDTM + define.xml, no errors are fired to indicate this problem. Maybe the errors SD0054, SD0058, or SD0059 should have fired? Not sure if maybe another rule should have fired?