For REB Use Only
ST. MICHAEL’S RESEARCH ETHICS BOARD (REB)
AMENDMENT AND ADMINISTRATIVE CHANGE REQUEST FORM
This form is available in MS WORD and can be downloaded at: www.stmichaelshospital.ca
Handwritten submissions are NOT acceptable
This form is to be used for study changes not involving a change in investigator or change in study personnel. This form
should only be used after the study has received initial REB approval.
Date:
REB #:
Study Title:
SMH Principal Investigator:
Study Approval Date:
Study Approval Expiry Date:
1. Please indicate all items to be amended:
Protocol
Amendment/Addendum
Changes
Study Objectives, Procedures or Design
Study Instruments (e.g. Questionnaires)
Duration of Study
Funding Agency
Number of Participants
local
global
Participants Recruitment Process
Inclusion/Exclusion Criteria
Participant Compensation
Known or Anticipated Harms/Risks
Potential Benefits
Case Report Forms/ Data Collection
Forms
Amendment/Admin Change Request Form
Ver. 21-Nov-2014
Recruitment/Consent
Process/Information
Consent Form(s)
Invitation Letters/emails/scripts
Information Letters/emails/scripts
Recruitment Material(s)
Study Poster/Advertisement
Other Tools, specify:
Other (Please list here)
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1.
Please describe each change. Please provide a rationale for each change listed.
(Example: A serum creatinine test is added at day 28 to assess for nephrotoxicity.)
2.
Will there be any change to the risk, discomfort or
inconvenience to study participants as a result of the
amendment?
Please explain:
3. Do the requested change(s) require modification to other study
document(s) (e.g., consent form(s); other study document(s)?
Yes
No
Yes
No
If Yes, please provide the REB with two (2) copies of the revised study document(s)
(e.g., consent form(s); other study document(s), as applicable). One (1) clean copy & one (1) tracked copy.
4. Is the proposed amendment a result of an adverse event?
If Yes, was the adverse event reported to the REB?
Yes
Yes
No
No
If No, please report this to the REB immediately.
5. Current status of the study. Check all that apply:
Enrolling Participants
Enrollment Complete
Follow-Up Complete
Other (describe):
Follow-Up Only
6. What follow-up action do you propose for participants who are already enrolled in the
study?
Inform Study Participants as soon as possible
Explain how the new information was or will be disseminated:
Re-consent study participants with revised consent form (when REB approval obtained)
Other (Please describe:
)
No Action Required (Please justify:
)
7. Does this Amendment require a submission to Health Canada?
Yes
No
If Yes, please provide the REB with a copy of the applicable Health Canada authorization
(e.g., No Objection Letter; Acknowledgement of Notification)
Note: If this amendment includes a revised protocol, please ensure that any applicable SMH
services that are being used for this study receive a copy of the updated version (e.g. Research
Pharmacy, Core Laboratory, Medical Imaging, etc.).
Please list all documents submitted with the amendment*:
Title of Included Documents
Version #
Amendment/Admin Change Request Form
Ver. 21-Nov-2014
Version Date
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* Please ensure that you submit a clean copy and a tracked copy of all revised documents. If a tracked copy of
the document (e.g., study protocol; investigator’s brochure) is not necessary/feasible, please provide a summary
of changes.
DECLARATION BY PRINCIPAL INVESTIGATOR
I warrant that this study was conducted/will continue to be conducted in accordance with the Tri-Council Policy Statement
Ethical Conduct for Research Involving Humans (TCPS 2), 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
Amendment/Admin Change Request Form
Ver. 21-Nov-2014
Signature
Date
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