Drug Evaluation Committee Basic Policy on Safety Forms for Clinical Trials
Data Science Subcommittee
February 2023
As E19 has reached Step 4, it is assumed that awareness of the importance of safety profile assessment will further increase in the future. Therefore, this report proposes a basic approach from the planning of analysis to the reporting of analysis results through a study of standard safety information to be included in safety forms in order to systematically evaluate safety profiles.
Published February 2023
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee DS Subcommittee
FY 2017 Ongoing Task Force 4 / FY 2022 Ongoing Task Force 9