Drug Evaluation Committee Introduction to "Collection and Management of Safety Data in Clinical Trials" From CIOMS Working Group VI Report, Chapter 4
Data Science Expert Committee
December 2023
We have decided to republish in the form of a deliverable the article "Introduction to "Collection and Management of Safety Data in Clinical Trials" from Chapter 4 of the CIOMS Working Group VI Report," which appeared in the JPMA Newsletter as a three-part series from 2014 to 2015. 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)