Safety Operations for ICCC in Clinical Trials Explanation to Sponsors

Safety Operations for ICCC in Clinical Trials Explanation to Sponsors

The pharmaceutical regulations in Japan are prepared in accordance with the agreements of ICH (The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use). However, many interpretations and operations differ from other countries.
In particular, when foreign clinical trial sponsors conduct clinical trials through ICCC (In-Country Clinical Caretaker) in Japan, differences in safety reporting requirements between Japan and other foreign countries often lead to reporting delays or omissions.

To resolve these issues, it is recommended to clarify the roles and operational points of the sponsor, ICCC, and other related vendors in agreed documents such as the Safety Management Plan (SMP).
This document aims to comprehensively cover the points of caution regarding the handling of safety information and serve as a guide to the safety reporting regulations in Japan for foreign vendors planning clinical trials in Japan.