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Using this Expedited Adverse Event Reportability Assessment Chart, you will learn how to follow the thought process for decisions on whether an adverse event is subject to expedited reporting or not.
A series of graphic aids (11 Human Subject Regulations Decision Charts) for entities who decide if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the US Department of Health and Human Services (HHS) regulations at 45CFR part 46.