SD1083 Missing DSDY variable, when DSDTC variable is present

Pinnacle 21 Support SDTM
1

Hi Manolya,

This is an additional FDA requirement for submission data specified in CDER Common Data Standards Issues Document v1.1.

Kind Regards,

Sergiy

2

Hi,

I have populated DSDTC and DSSTDTC and only included DSSTDY. Do I really need DSDY in the dataset also? If so, why is it not in the SDTMIG?

Best regards