Adverse Events Reporting

As for any clinical study it is important to proactively monitor for adverse events, even mild ones, as part of ensuring the safety of participants.

During the study, the investigators and participating practitioners will be responsible for detecting and documenting events meeting the criteria and definition of an adverse event (AE) or serious adverse event (SAE).

An Adverse Event (AE) is any untoward medical occurrence (physical, psychological, social or economic), whether mild, moderate or severe, in a trial subject related to medical management, in contrast to complications of disease.

When an AE/SAE occurs, a Compass Trial Adverse Event Reporting Form should be completed and sent to the attention of: Prof Marion Saville, PO Box 178, Carlton South, VIC, 3053 or scan and email to Prof Marion Saville at directorate@vcs.org.au

If you need assistance in identifying an Adverse Event, or with completing the Form, please contact the Compass Hotline 1800-611-635.