Drug Evaluation Committee Introduction of "Collection and Management of Safety Data in Clinical Trials" from CIOMS Working Group VI Report, Chapter 4
Data Science Subcommittee
December 2023
We have decided to republish "Introduction to "Collection and Management of Safety Data in Clinical Trials" from Chapter 4 of the CIOMS Working Group VI Report", which was published in the Pharmaceutical Manufacturers Association of Japan Newsletter as a series of three articles from 2014 to 2015, in the form of a deliverable. This document is a deliverable. This document provides many suggestions on the collection and management of safety data and explains principles that have not faded at all even today, and has been presented as a reference material in many CRC and monitoring-related workshops to this day. We hope you will find it useful in your work related to planning, conducting, and reporting clinical trials/clinical research.
Introduction to "Collection and Management of Safety Data in Clinical Trials" (991KB)
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