With the new Implementation Guide due to go on public review this coming August, we take a closer look at the scope of SEND 4.0.
The FDA has released a new version of the study data Technical Conformance Guide
A look at the main SEND discussion points at SOT 2023
When it comes to SEND “What is there to talk about?”, actually quite a lot.
The Confirmed Data Endpoints for Exchange (CoDEx) is CDISC’s method of addressing the scope for SEND, down to the individual endpoints.
As work continues on the content and updates for SEND 4.0, there’s a definite change in approach in an effort to make study representation more uniform, and to give implementors much clearer direction.
