Abstract
The safety of subjects who volunteer to participate in clinical trials is paramount. The (ICH-Good Clinical Practice) guidelines assert that ‘the rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society’. This chapter describes the internationally accepted standard of the ICH-GCP guidelines. It introduces important clinical research terminology, and provides definitions of various types of adverse events, describes the roles and responsibilities of investigators and sponsors, and the processes needed to promote safety through the assessment, recording, evaluating and reporting of adverse events during the design and conduct of clinical trials.
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References
Central Committee On Research Involving Human Subjects (CCMO) (2015) SAEs/SUSARs [Online]. http://www.ccmo.nl/en/saes-susars
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International Conference on Harmonisation (2015) ICH official web site: ICH [Online]. http://www.ich.org/home.html
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Senior, H. (2015). Assessing and Reporting Adverse Events. In: Nikles, J., Mitchell, G. (eds) The Essential Guide to N-of-1 Trials in Health. Springer, Dordrecht. https://doi.org/10.1007/978-94-017-7200-6_10
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DOI: https://doi.org/10.1007/978-94-017-7200-6_10
Publisher Name: Springer, Dordrecht
Print ISBN: 978-94-017-7199-3
Online ISBN: 978-94-017-7200-6
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