Serious Adverse Event Report

A serious adverse event is an unanticipated and unintended consequence involving a study subject defined as “reportable” to the REB according to the research protocol or an applicable research regulation; whether or not a relationship to the investigational product or experimental procedure has been established. The Serious Adverse Event Report is used to notify the REB of the incident according to the timeline required by the applicable regulatory authority.

Serious Adverse Event Report [doc]   Serious Adverse Event Report [pdf]

Annex D - Summary of Local Adverse Events
When submitting an SAE Report involving an MUHC study subject to the REB the Investigator must append “Annex D” that serves as
the 'Local Summary' log of all reportable SAEs' arising from conduct of the study. Note: Only a document in Word is suitable for this particular form. .

Annex E - Summary of Non-Local AdverseEvents
When submitting an SAE Report not involving an MUHC study subject to the REB the Investigator must append “Annex E” that serves as the 'Non-Local Summary' log of all reportable SAEs' arising from conduct of the study.
 Note: Only a document in Word is suitable for this particular form. «BACK TO FORMS