Drug Evaluation Committee Recommendations on the Collection and Reporting of Safety Data
Data Science Subcommittee
May 2024
This document was published in 2009 by the Statistics and DM Subcommittee, the predecessor of the Data Science Subcommittee, to decoct what data is necessary for safety assessment based on the experience of bridging strategies and international joint development based on ICH E5 guidelines and to review the handling of safety data in old Japanese clinical trials. It urged us to do the same. We decided to republish this document because it is still referred to by many people involved in clinical trials, post-marketing surveillance, and clinical research.
Recommendations on the Collection and Reporting of Safety Data