Inconsistency in Severity-Janus Column of the OpenCDISC SDTM Validation Rules version 3.1.1 document

Pinnacle 21 Support SDTM
1

Hi Diane, Thanks for pointing that out! I’ll take a look and make the necessary changes. Regards, Tim

2

Hi guys, I noticed that for a few checks, the Janus severity listed in your document doesn’t match the severity listed in the document on the FDA website. Thought you’d want to know: IR4137 OpenCDISC = missing, FDA Website = Low IR4138 OpenCDISC = High, FDA Website = Check not listed IR4509 OpenCDISC = High, FDA Website = Medium IR4511 OpenCDISC = High, FDA Website = Medium IR4513 OpenCDISC = High, FDA Website = Medium R4008 OpenCDISC = High, FDA Website = Medium All WebSDM severity values matched. Thanks, Diane