ST. MICHAEL’S RESEARCH ETHICS BOARD (REB)
PROTOCOL DEVIATION REPORTING FORM
For REB Use Only
ST. MICHAEL’S RESEARCH ETHICS BOARD (REB)
PROTOCOL DEVIATION REPORTING FORM
See ‘Guidelines for Reporting Protocol Deviations to the SMH REB’ and this Reporting Form at:
www.stmichaelshospital.com/research/reb.php
Complete this form and submit two (2) hard copies to the SMH REB.
Submissions that are incomplete will be returned to the submitter.
REB #:
Study Title:
SMH Principal Investigator:
Sponsor #:
Definition:
A Protocol Deviation is an unanticipated or unintentional divergence or departure from the expected conduct of an
approved study that is not consistent with the current approved research protocol, consent document or study
addenda. Deviations may or may not have a significant effect on the research participant’s rights, safety or welfare, or
on the integrity of the data. Deviations are different from amendments in that they generally apply to a single
occurrence or participant and are not intended at the time to modify the entire protocol.
Note: The term ‘protocol deviation’ and ‘protocol violation’ may be used interchangeably.
TYPE of Protocol Deviation:(check all that apply)
change in study procedure(s) initiated to eliminate immediate hazards to research participants
enrolment of a research participant who did not meet all protocol inclusion/ exclusion criteria, whether agreed to
or not by the study Sponsor
over-enrolment (exceeding the target number of participants approved by the REB)
deviation in the consent process (i.e., failure to obtain informed consent, use of an invalid consent form,
missing date of consent, missing signature)
performance of a study procedure not approved by the REB
failure to perform a required study procedure that, in the opinion of the Principal Investigator, may affect
participant safety or data integrity
study procedure (i.e., study visit) performed outside of the required timeframe that, in the opinion of the
Principal Investigator, may affect participant safety or data integrity
study drug/intervention errors (i.e., incorrect study drug/intervention, incorrect dosage of the study drug)
breach of confidentiality whereby a research participant’s personal health information (PHI) is revealed to a
person without a need to know, or by data exposure (i.e., digital device security breach, documents containing
PHI are left unsecured)
Protocol Deviation Reporting Form
Version Date: 01-Jun-2015
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ST. MICHAEL’S RESEARCH ETHICS BOARD (REB)
PROTOCOL DEVIATION REPORTING FORM
Date of Report (dd/mmm/yyyy) :
Name of Protocol Deviation :
Type of Report:
Initial
Follow-Up
Final
If a follow-up or final report, please indicate the REB submission date(s) of previous report(s) (dd-mmm-yyyy) :
Participant Study ID #:
Date of Protocol Deviation
(dd-mmm-yyyy):
Age (years) at time of event:
Gender:
Date SMH Study Team became aware of Protocol
Deviation (dd-mmm-yyyy):
Describe the Protocol Deviation and Reason (Please provide a detailed description of the specific protocol deviation,
including an explanation for the reason of its occurrence and details of any communications with the sponsor regarding this
deviation.)
Corrective Actions and Future Actions to Prevent RE-Occurrence (Please provide a detailed description of how the
event was handled including any corrective actions and any plans to prevent re-occurrence.)
Participant’s outcome of the event (if known).
PROTOCOL DEVIATION NOTIFICATION
Has the study Sponsor been notified of the event?
If no, please explain:
YES
NO
YES
NO
Was/were the research participant(s) informed of the event?
If no, please explain:
IMPACT ASSESSMENT
Does the Protocol Deviation impact the research participant’s rights, safety, or well-being?
Does the Protocol Deviation compromise the scientific integrity of the entire study?
Is the Protocol Deviation repetitive in nature and affects the research participant’s rights,
safety, or well-being or the scientific integrity of the entire study?
Does the Protocol Deviation require change(s) to the study protocol?
If yes, submit the changes using the ‘Amendment and Administrative Change Request Form’.
Does the Protocol Deviation require change(s) to the consent form(s)?
If yes, submit the changes using the ‘Amendment and Administrative Change Request Form’.
Did this Protocol Deviation result in a Serious Adverse Event (SAE) / Unanticipated Problem?
If yes, submit the SAE/Unanticipated Problem using the ‘Local SAE / Unanticipated Problem Reporting Form’.
Principal Investigator Comments:
Protocol Deviation Reporting Form
Version Date: 01-Jun-2015
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ST. MICHAEL’S RESEARCH ETHICS BOARD (REB)
PROTOCOL DEVIATION REPORTING FORM
DECLARATION BY PRINCIPAL INVESTIGATOR
I attest that I as the Principal Investigator (PI) have reviewed the protocol deviation and its safety implications, assessed the
relationship of the protocol deviation to the research study and attest to the accuracy of this report.
I warrant that this study will continue to be conducted in accordance with the Tri-Council Policy Statement Ethical Conduct for
Research Involving Humans (TCPS), the Ontario Personal Health Information Protection Act (PHIPA) 2004, the St. Michael’s
Hospital By-laws, the Catholic Association of Canada Health Ethics Guide, and other relevant laws, regulations or guidelines, [e.g.,
Health Canada Part C, Division 5 of the Food and Drug Regulations, Part 4 of the Natural Health Products Regulations, Medical
Devices Regulations, and ICH/GCP Consolidated Guideline E6].
Printed Name of SMH Principal
Investigator
Signature
Date
TO BE COMPLETED BY THE RESEARCH ETHICS BOARD
I acknowledge that the St. Michael’s Hospital Research Ethics Board has reviewed the documents listed above.
Printed Name of REB Member
No further action required

Protocol Deviation Reporting Form
Version Date: 01-Jun-2015
Further action required
Signature
Date

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