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What is an adverse event and what do I need to do if one occurs during my study?

April 26, 2017adverse event occurs study

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What is an adverse event and what do I need to do if one occurs during my study?

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Injury to subjects, breaches of confidentiality and unapproved deviations from the protocol are examples of adverse events that must be reported to the IRB and the research halted if necessary. The researcher must immediately report such events to the IRB and submit the Adverse Event Report.