Form 3: CHREB LOCAL SERIOUS ADVERSE EVENT (SAE) REPORT

Please complete this form to report a local adverse event that is deemed to be an unanticipated problem in accordance with Canadian Association of Research Ethics Boards (CAREB) standards[1] - 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 adverse event, the Principle 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 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 . 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 #:

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.

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?: Expected ☐ Unexpected ☐

Q5. This report is: Initial ☐ Follow-Up ☐ (#___) Final ☐

Q6. At the time of the SAE, the participant was: Actively on Study ☐ On Follow-Up ☐ Off Study ☐

Q7. Outcome of SAE (indicate all that apply) / Death
Life threatening
Hospitalization – Initial or prolonged
Disability
Congenital anomaly
Other, specify:
Q8. In the opinion of the PI, is the SAE related to the study drug, device or procedure? / Definitely related
Probably related
Possibly related
Not related
Unknown
Q9. Action taken as a result of the SAE (indicate all that apply) / Hospitalization
Study treatment altered (e.g. drug dose changed)
Study treatment temporarily suspended
Study treatment stopped (e.g. drug stopped or device removed)
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.
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 . 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:
______Date: DD/MM/YYYY ______
Adverse Event Monitor (name)
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:

January 2015

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[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-unanticipated-problem-reporting-guidelines.pdf