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Management of Safety Information from Clinical Trials: Report of CIOMS Working Group VI Book
The current report of the CIOMS Working Group VI represents a shift from the management of post-marketing safety information, which relies heavily on spontaneous reports, to the management of clinical trial information, starting from the earliest clinical trials and extending to the post-marketing environment. The CIOMS Working Group VI also represents an expansion in membership to include regulatory, industry and academic representation with experience in the conduct of clinical trials and to include representatives from less developed regions of the world. This book introduces proposals for enhancing the collection, analysis, evaluation, reporting and overall management of safety information from clinical trials. It also discusses the importance of sponsors having a systematic … read more...
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