Standard for Exchange of Non-clinical Data

Having a common model to which the industry can conform enables benefits such as the ability for vendors to develop tools, for inter-organizational data exchange that is consistent in format regardless of the parties involved, and so on.

Endpoints typically map to domains (essentially, datasets), with a number of variables (a.k.a., columns or fields).

Feedback from this pilot and continuous efforts to more closely align this implementation with the SDTM for human clinical trials led to development of SEND 2.3, but without widespread adoption.

By 2007, an FDA pilot was announced, during which time the SEND team worked on the SENDIG (implementation guide).

In December 2014, the FDA CDER and CBER divisions released guidance for industry enforcing the usage of SEND as part of Investigational New Drug (IND) and Biologic License Application (BLA) submission to the US Food and Drug Administration.