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 4: LOCAL PROTOCOL VIOLATION/ DEVIATION REPORT
The CHREB does not distinguish between protocol violations and deviations. A protocol violation is an
unanticipated or unplanned divergence or departure from the current study approved by CHREB (i.e.,
research protocol, consent forms). Please complete this form to report a protocol violation if, in the opinion
of the Principal Investigator, it meets at least one of the following criteria:
1. Compromises the scientific integrity of the study, or
2. Constitutes or may constitute a potential safety risk to participants enrolled in the protocol, or
3. Are otherwise submitted at the discretion of the Principal Investigator or Sponsor.
If there is any uncertainty whatsoever, we encourage investigators to report the violation, including minor
deviations that collectively show a concerning trend for which the CHREB should be made aware.
A protocol violation arising from changes to eliminate immediate safety risks to the study participants must
be reported to the CHREB within 7 calendar days of the PI becoming aware of them. All other violations
should be reported to the CHREB within 15 calendar days of the PI becoming aware of them.
Complete 1 form per protocol violation and send it as an attachment to localsae@ucalgary.ca. In the email subject line, please include the study ethics ID#.
Ethics ID#:
Complete study title:
Principal Investigator:
Phone:
Email:
Coordinator:
Phone:
Email:
Participant ID: ___________
Participant initials: __________
Date of violation (DD/MM/YYYY):
Date of report (DD/MM/YYYY):
Age: _____________
Sex: M ☐
F☐
Date PI notified of violation (DD/MM/YYYY):
Q1. Explain any time lapse in reporting to the CHREB (>7 days for protocol violations arising from changes to
eliminate immediate safety risks to the study participants; > 15 days for all other violations) from the date the
PI was notified of the violation.
Q2. Brief description of the violation:
March 2015
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Q3. Brief description of how/why the violation occurred and how it was resolved by the PI and study team:
Q4. At the time of the protocol violation, the participant was:
In pre/screening phase ☐
Actively on study ☐
On follow-up ☐
Off study ☐
Comments, if required:
Q5. In the opinion of the Principal Investigator, does this protocol violation compromise the scientific
integrity of the study?
YES ☐
NO ☐
If YES, please comment:
Q6. In the opinion of the Principal Investigator, did this protocol violation increase the possible risk to the YES ☐
participant?
NO ☐
If YES, please comment:
Q7. Was the protocol violation the result of an error or incorrect action by the sponsor, investigator(s) or
his/her staff?
YES ☐
NO ☐
If YES, please comment on what measures will ensure this will not occur in the future:
Q8. Was the violation due partially or wholly to actions of the participant?
YES ☐
NO ☐
If YES, please comment on what measures will ensure this will not occur in the future:
Q9. Does the violation show a concerning trend for which the CHREB should be made aware? YES ☐ NO ☐
If YES, please specify:
Q10 - Q13
In the opinion of the
PI, does the protocol
violation warrant…
Q10. Closure of the study? Yes ☐
No ☐
Q11. Changes to the study procedure? Yes ☐
No ☐
Q12. Revisions to the Informed Consent Form?* Yes ☐
No ☐
Q13. Advising the affected participant(s) verbally? Yes ☐
No ☐
(If yes, attach suggested script)
*NOTE: If ICF changes are required, please submit any changes as a modification. In the modification cover
page please indicate that a corresponding protocol violation report was submitted.
Supporting documentation should be retained by the Principal Investigator and be made available upon
request.
Ethics ID #:
PI Name:
Participant #:
Participant Initials:
March 2015
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I have reviewed the details pertaining to the protocol violation reported above and confirm the contents
are accurate:
Signatures:
Principal Investigator:
Date:
Study Coordinator:
Date:
Prepared by:
Thank you for this local protocol violation 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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