Conjoint Health Research Ethics Board (CHREB)
Research Services, University of Calgary
3rd Floor, MacKimmie Library Tower (MLT 300)
2500 University Drive N.W. Calgary, AB T2N 1N4
localsae@ucalgary.ca | (403) 220-4283
Form 3: CHREB LOCAL SERIOUS ADVERSE EVENT (SAE) REPORT
Please complete this form to report a local serious adverse event that is deemed to be an unanticipated
problem in accordance with Canadian Association of Research Ethics Boards (CAREB) standards1 - any
incident, experience, or outcome that meets all of the following criteria:

Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are
described in the protocol-related documents, such as the REB-approved research protocol and
informed consent document, the Investigator Brochure; and/or (b) the characteristics of the
research participant population being studied; and

Related or possibly related to participation in the research. Possibly related means there is a
reasonable possibility that the incident, experience, or outcome may have been caused by the
investigational product(s) or procedures involved in the research; and

Suggests that the research places research participants or others at a greater risk of harm (including
physical, psychological, economic, or social harm) than was previously known or recognized.
Upon becoming aware of a local serious adverse event, the Principal Investigator (PI) should assess
whether the adverse event represents an unanticipated problem. If there is any uncertainty whatsoever,
we encourage investigators to report the event. Sponsors may mandate that events that do not meet the
above criteria still be reported to the CHREB.
A local serious adverse event should be reported to the CHREB using this form template within 15 calendar
days of the PI becoming aware of it. Fatal or life-threatening reportable local adverse events should be
reported to the CHREB within 7 calendar days.
Complete 1 form per SAE and send it as an attachment to localsae@ucalgary.ca. In the e-mail subject line,
please include the study ethics ID#.
Ethics ID#:
Complete study title:
Principal Investigator:
Phone:
E-mail:
Coordinator:
Phone:
E-mail:
Participant ID:
Participant initials:
Age:
Sex: M ☐
F☐
Manufacturer's SAE # (if applicable):
Date of SAE (DD/MM/YYYY):
Date PI notified of SAE (DD/MM/YYYY):
Q1. Explain any time lapse in reporting to the CHREB (>7 days for fatal or life-threatening SAEs; >15 days for
all other local SAEs) from the date the PI was notified of the event.
1
Canadian Association of Research Ethics Boards (CAREB). (2010). Guidance on Reporting of Unanticipated
Problems Including Adverse Events to Research Ethics Boards in Canada.
Available on the CHREB website: http://ucalgary.ca/research/files/research/140903-adverse-event-unanticipatedproblem-reporting-guidelines.pdf
March 2015
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Q2. Initial diagnosis of SAE:
Q3. Was the SAE a natural progression of disease? Yes ☐
No ☐
Q4. Was the SAE an expected outcome from the study treatment?:
Q5. This report is:
Initial ☐
Follow-Up ☐ (#___)
Q6. At the time of the SAE, the participant was: Actively on Study ☐
Q7. Outcome of SAE (indicate
all that apply)
Q8. In the opinion of the PI, is
the SAE related to the study
drug, device or procedure?
Q9. Action taken as a result of
the SAE (indicate all that
apply)
Expected ☐
Unexpected ☐
Final ☐
On Follow-Up ☐
Off Study ☐
Death
Life threatening
Hospitalization – Initial or prolonged
Disability
Congenital anomaly
Medically significant event
Other, specify:
If ‘not related’,
please clarify why
this SAE is being
reported to the
CHREB:
☐Sponsor
requirement
Definitely related
Probably related
Possibly related
Not related
Unknown
Hospitalization
Study treatment altered (e.g. drug dose
changed)
Study treatment temporarily suspended
Study treatment stopped (e.g. drug stopped or
device removed)
☐Other, please
explain:
Q10. Comments:
Q11. If noted in "Action taken" (Q9, above) that study treatment was stopped, is the participant
still being followed-up according to the study protocol?
YES ☐
NO ☐
If NO, please comment:
Q12. Synopsis of SAE:
Provide a brief description of the SAE (reason for/cause of the event, symptoms, diagnosis, and
concerning trend, if relevant).
If you feel a longer narrative would assist, write in letter format (on appropriate letterhead) and submit
with this form. Please DO NOT submit additional documents unless requested by the CHREB or Sponsor.
Ethics ID #:
PI Name:
Participant #:
Participant Initials:
March 2015
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In the opinion of the
PI, does the SAE
warrant…
Q13. Closure of the study? Yes ☐
No ☐
Q14. Changes to the Study Procedure? Yes ☐
No ☐
Q15. Revisions to the Informed Consent Form?* Yes ☐
No ☐
Q16. Advising the affected participant verbally? Yes ☐
No ☐
*NOTE: If ICF changes are required, please submit any changes as a modification. In the modification cover
page please indicate that a corresponding local SAE report was submitted.
I have reviewed the details pertaining to the SAE reported above and confirm the contents are accurate:
Signatures:
Principal Investigator:
Date:
Study Coordinator:
Date:
Prepared by:
Thank you for this local SAE report, which will be added to your file. Automatic acknowledgment of
receipt will be generated by localsae@ucalgary.ca. Signed formal acknowledgement (below) will follow
in the ordinary course of correspondence from the Chair.
For office use only:
Further follow-up required? Yes/No
If Yes, specify:
_________________________________
Adverse Event Monitor (name)
Date: DD/MM/YYYY ________________
Acknowledged and accepted.
Your report will be received by the full board at its meeting on ___________________ (date).
Signature: _______________________
Date: ________________________
Stacey Page, PhD.
Chair, Conjoint Health Research Ethics Board
Ethics ID #:
PI Name:
Participant #:
Participant Initials:
March 2015
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