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)
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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