Adverse Event Reporting
Human subject research is subject to continuing ethics review. As described in Article 1.13 of the Tri-Council Policy Statement (TCPS), the REB review of adverse events is one component of its continuing review.
For all drug studies in Canada Health Canada Food & Drug (Division 5) regulations and ICH guidelines also apply.
SickKids reporting requirements are based on these regulations and guidelines.
Adverse event reporting is the responsibility of the SickKids primary investigator who must complete the SickKids Adverse Event (AE) form including information on the seriousness of the adverse event, assessing whether or not it is a direct consequence of the research intervention, and recommendations for any further action.
Adverse events are reviewed promptly, normally within two business days, and any required followup communicated back to the primary investigator.
For further details, please refer to the REB guidelines.
Forms and Guidelines
* Adverse event reporting guidelines [Word doc]
* Adverse event reporting guidelines [Acrobat]