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This second part looks at how patients are starting to passively report their adverse events (AE ... care providers wish to make the most of this form of social AE report they do not ignore ...

Events that meet the IRB’s reporting criteria should be promptly submitted to the IRB using the electronic Problem Report Form. See the timeline table ... A reportable event is any unanticipated ...

Some unanticipated problems, such as adverse ... report to the HSRO any of the following circumstances promptly and within 7 days of the date the investigator first becomes aware of the problem.