m Manolya
on

 

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

Forums: SDTM

s Sergiy
on September 19, 2013

Hi Manolya, 

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

Kind Regards, 

Sergiy

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.