Adverse Events Reporting

2-I-005 - Decision Tree - SAE Follow-up Reporting

Please use the online system to enter and print copies for local SAE reporting.

For Local On-line registration assistance or for any other questions with the local on-line system, please contact the Office of Research Ethics.

ONLINE (Local AND Non-Local, Other Studies & Spontaneous) Adverse Events Reporting Module

Effective September 1, 2008 - ALL local AND non-local AE's MUST be reported on-line (local requires paper copy follow-up to ORE - see sidebar). The paper form is no longer available. If you need assistance adopting the on-line process or for any questions, please contact the Office of Research Ethics.

Please submit one signed copy of any LOCAL SAE print outs to the Office of Research Ethics.

2-F-007 - Other Studies & Spontaneous Reporting Form

Quick Links

Also of interest:

Helpful SAE Resources

Effective September 15, 2011

Our SAE online reporting system's server has been relocated; please update your bookmarks accordingly.

For local SAEs, please print a copy, have the PI sign and then forward to our office. Hard copies are not required for non-local SAEs.

Health Canada - Food and Drug Regulations (1024 - Clinical Trials) - Regulations Amending Canada's Food and Drugs Act

ICH Topics and Guidelines

ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting Section E2A