Abstract
The objective of this chapter is to provide an overview of safety planning and monitoring along with the analysis and communication of clinical trial safety data. Safety planning requires an assessment of the available information relevant to the safety of the product including epidemiology data, nonclinical and clinical data, and information on related products. Ongoing benefit risk assessments of the investigational medical product are achieved through the frequent evaluation of data from all available sources. Quantitative and qualitative analyses are performed using statistical methodologies and medical judgment on data at the level of individual clinical trial as well as aggregate data level of product. These analyses aim to distinguish adverse drug reactions from adverse events and to determine the important risks for the product. Regulatory reporting and communication of safety information to the health authorities, institutional review boards, ethics committees, clinical trial investigators and subjects are also discussed. A systematic approach to product safety monitoring throughout clinical development is critical to characterizing the evolving safety profile of an investigational medical product.
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