Device domains for human clinical studies

Pinnacle 21 Support SDTM
1

Hi Saravanan,

Pinnacle 21 Community v2.2.0 has a special configuration “SDTM MD 1.0” for validation of clinical data with Medical Devices.

It is based on SDTMIG-MD 1.0 and the latest SDTMIG 3.2.

Kind Regards,

Sergiy

2

Thanks Sergiy, that helped.

-Saravanan

3

Can I include device domains DI and DU with human clinical trial SDTM submission? My study captures some device information related to CT imaging.

I tried to include this in the submission package, but I got a “Dataset class not recognized” for DI. (DI is defined as special purpose domain in SDTM IG for medical devices)

DU was accepted as custom Findings domain

Thanks,

Saravanan