1. Executive Summary

This workbook provides an overview of the current regulatory landscape in Thailand in relation to Decentralized Clinical Trials (“DCTs”). Thailand abides by the regulations set forth by the Thai Food and Drug Administration (FDA). The regulations in Thailand are largely based on those of the USA.

Fully decentralized trials have not been conducted in Thailand. However, elements of decentralization and hybrid trials have been recently incorporated into local studies and there are currently no regulations outlawing the use of these decentralized elements of clinical trials.