1. Executive Summary

This guidebook provides an overview of the current and proposed regulatory landscape applicable in Brazil in relation to Decentralized Clinical Trials (“DCTs”). Brazil abides by the regulations set forth by the National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária (ANVISA). Fully DCTs have not yet been conducted in Brazil. However, hybrid studies have been conducted with an increasing acceptance of decentralized aspects of study design following the COVID-19 pandemic.