Drug Evaluation Committee Recommendations on the Collection and Reporting of Safety Data
May 2024
This document was published in 2009 by the Statistics and Direct Marketing Subcommittee, the predecessor to the Data Science Subcommittee. Drawing on bridging strategies based on the ICH E5 guideline and experience with international joint development, it identified the specific data required for safety evaluation and called for a reevaluation of how safety data had traditionally been handled in Japanese clinical trials.Since this document continues to serve as a reference for many individuals involved in clinical trials, post-marketing surveillance, and clinical research, we have decided to republish it.
Recommendations on the Collection and Reporting of Safety Data