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Serious Adverse Events (SAE)
 
Investigators must promptly report to the REB all adverse events that are both serious and unexpected, and any new information regarding the safety of research participants that becomes available during the course of the study. Based on international guidance documents, the following circumstances constitute SAEs: congenital anomalies, significant disability or incapacity, prolonged hospitalization, and any other life-threatening or medically-important events. Occasionally, changes to the study documentation are required as a result of these events.

The Chair and the Director of Pharmacy regularly review the SAE reports. These SAEs are also presented to the REB members for their review. A signed copy of the report will be returned to the Research Assistant/Coordinator or Primary CHEO Site Investigator. Submit an original plus one copy of this Reporting Form – Serious Adverse Events (with appropriate documentation). Reports prepared by the Study Sponsor are also accepted by the Board.

The investigator must verify the dose and administration of all study medications associated with SAEs having occurred at CHEO.  See Policy with respect to considering Medication Error in the Differential Diagnosis of Severe Adverse Events (SAE).

Open this hyperlink to access a pdf. of the required serious adverse event signature page
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