SDTM

Hello,

THe excel output from OpenCDISC states that there is a problem with IETESTCD not matching TITESTCD but I checked and they both have valid values that match.

Regards,

David

Hi guys, I've finally got test data written for all the Janus/WebSDM checks except for the following few. In general, it looks pretty good.

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

In checking out openCDISC, I happened across 2 checks firing from our internal checking program, but not from this tool: IR4127: LBORNRHI = 30 and LBORNRLO = 125 IR4134: EXDOSE = 0 and EXDOSU = I believe the above data should fire the noted check. I also note that the Protocol Deviations (DV) dataset doesn't have a definition in the HYBRID config. I assume this is just not yet added at this time. There are others missing as well (PC, PP, some SUPPQUALs, etc). Thanks, Diane