SEND 3.1: Giving Your Submission a "Vital" Upgrade
The SEND [Standard for Exchange of Nonclinical Data] Implementation Guide v3.1, "SEND 3.1," changes the model for the reporting of cardiovascular and respiratory endpoints. SEND 3.1 became effective 15 March 2019 for NDA submissions and 15 March 2020 for IND submissions, and overlaps with the effective period of the previous version, SEND 3.0. Through the introduction of two new domains, Cardiovascular Test Results [CV] and Respiratory Test Results [RE], content changes will be enacted in the Vital Signs [VS] domain. Gaining familiarity with the key changes to ensure compliance with both SEND 3.0 and SEND 3.1 are important to build confidence in upcoming submissions, which are likely to include SEND datasets of both versions.