s Saravanan
on

 

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

Forums: SDTM

s Sergiy
on May 23, 2018

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

s Saravanan
on May 23, 2018

Thanks Sergiy, that helped.

-Saravanan

Want a demo?

Let’s Talk.

We're eager to share and ready to listen.

Cookie Policy

Pinnacle 21 uses cookies to make our site easier for you to use. By continuing to use this website, you agree to our use of cookies. For more info visit our Privacy Policy.