Providence St. Joseph’s and St. Michael’s Healthcare (“Network”)
Research Ethics Board (REB)
Protocol Deviation Reporting Form
Complete this form electronically (i.e. not handwritten) and submit two (2)signed hard copies to the REB.
Note: In this form, Providence Healthcare is referred to as “PHC”, St. Joseph’s Health Centre as “SJHC”, and St. Michael’s Hospital as “SMH”
REB #: Sponsor:
Study Title:
Network Lead Applicant:
See ‘Guidelines for Reporting Protocol Deviations to the REB’ at:
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 research participants’ 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.
Please report only protocol deviation(s) that involve research participants or procedures that occur under the jurisdiction of the NetworkREB.
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-enrollment (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 Site 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 SiteInvestigator, 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)
Date Reported to Information Access and Privacy (dd-mmm-yyyy):
PHC / SJHC / SMH
At which Network site did the deviation occur? / ☐ / ☐ / ☐ /
Which Network sites are involved in this study? / ☐ / ☐ / ☐ /
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 #: / Age (years) at time of event:
Gender:
Date of Protocol Deviation
(dd-mmm-yyyy): / Date 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 (Please provide a detailed description of how the event was handledincluding any corrective actions for this event.)
Future Actions to Prevent Reoccurrence(Please provide a detailed plan to prevent reoccurrence.)
Participant(s) outcome of the event (if known).
Was/were the research participant(s) informed of the event?
If no, please explain: / YES
/ NO
Please include details of any communications with the Sponsor:
If the Sponsor was not notified, please explain:
IMPACT ASSESSMENT / YES / NO
Does the Protocol Deviation impact the research participants’rights, safety, or well-being? / /
Does the Protocol Deviation compromise the scientificintegrity of the entire study? / /
Is the Protocol Deviation repetitive in nature anddoes it affect the research participants’rights, safety, or well-beingor the scientificintegrity 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’. / /
Site Investigator Comments:
DECLARATION BY SITE INVESTIGATOR
As the Site Investigator, I have reviewed the protocol deviation 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 (TCPS2), the Ontario Personal Health Information Protection Act (PHIPA) 2004, the Network 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 Site Investigator / Signature**Original Ink or electronic/digital signature / Date
FOR REB OFFICE USE ONLY
No further action required
Further Action Required (select all that apply, and explain):
Protocol change Consent Form change Follow-Up Report Other
Explain:
Full Board Review? Yes No
Other Comments:
Printed Name of REB Chair or designee / Signature / Date
Protocol Deviation Reporting FormPage 1 of 3
Version Date:07-Jun-2018