Research Western

Adverse Events Reporting

Research Picture

HSREB Unanticipated Problem Reporting

HSREB Protocol Deviations/Violation Form

Please see: Protocol Deviation/Violation Guidance. Required Documentation (in addition to Protocol Deviation/Violation Form):

Adverse Event Reporting

Please see the Unanticipated Problem Reporting-Adverse Events guideline document to determine which SAEs require reporting to the REB. If the submission does not meet the reporting requirements for events that constitute Unanticipated Problem, the submission will be withdrawn. Please submit your report in ROMEO.

Local Sites:

Non-Local Sites: