d Deepika
on

 

Hi,

We have protocol that is split into multiple parts/studies - we are debating if we should create SDTM/ADaM separate for each part or combine them - We expect it to be under one SAP, CSR. Are there any FDA requirements for these and any recommendation/expereince of one approach vs the other.

 

Thanks

Deepika

Forums: SDTM

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.