Any event that meets the following criteria:
- Protocol Deviation
- Adverse Event
- Other Unanticipated Event
Unanticipated Event: Any incident, experience, or
outcome that meets all of the following criteria:
-
The incident is unexpected (in terms of nature, severity, or
frequency) when considering the research procedures that are
described in the protocols (eg, informed consent document[s],
investigator brochure, product monograph, device manual, etc., or
the characteristics of the research participant population being
studied)
-
The incident or research approach places research participants or
others at a greater risk of harm (including physical,
psychological, economic, or social harm) than was previously known
or recognized
-
The incident, experience, or outcome may have been caused by the
investigational product(s) or procedures involved in the research
UHN REB's process for reporting unanticipated events (including adverse
events and protocol deviations) follows the guidelines laid out by the
'Canadian Association of Research Ethics Boards’ (CAREB). To see the
CAREB guidelines,
click here.
For more more information on unanticipated event reporting at UHN,
please consult the following PDF document (requires Adobe Acrobat
Reader):
Unanticipated Problem Reporting Guidance.
To report an unanticipated event at UHN, please do so via CAPCR.