St. Joseph's Health Centre – research Ethics board

Amendment and Administrative Change Request Form

Do not fax or e-mail this form.

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:

Principal Investigator:

Local Study Lead (if external PI):

Study Approval Date:

Study Approval Expiry Date:

Research Coordinator (Name and e-mail):

1. Please indicate all items to be amended:

Protocol Amendment/Addendum Changes / Recruitment/Consent Process/Information
Study Objectives, Procedures or Design / Consent Form(s)
Study Instruments (e.g. Questionnaires) / Invitation Letters/emails/scripts
Duration of Study / Information Letters/emails/scripts
Funding Agency / Recruitment Material(s)
Number of Participants
local global / Study Poster/Advertisement
Participants Recruitment Process / Other Tools, specify:
Inclusion/Exclusion Criteria
Participant Compensation / Other (Please list here)
Known or Anticipated Harms/Risks
Potential Benefits
Case Report Forms/ Data Collection Forms
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? / Yes No
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
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? / Yes No
If Yes, was the adverse event reported to the REB?
If No, please report this to the REB immediately. / Yes No
5.  Current status of the study. Check all that apply:
Enrolling Participants Enrollment Complete Follow-Up Only
Follow-Up Complete Other (describe):
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 SJHC 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 # / Version Date

* Please ensure that you submit a clean copy and a tracked copy of all revised documents (or if not tracked, modifications must be highlighted).

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. Joseph’s Health Centre Policies, 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
Principal Investigator
(or Local Study Lead) / Signature / Date

Note: If changes are significant, departmental approval may be requested.

DO NOT FAX OR E-MAIL

Send signed original to the REB office:

St. Joseph’s Health Centre

REB Coordinator

30 The Queensway, Rm 6S604a.

Toronto, ON

M6R 1B5

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Version: January, 2017

(We would like to acknowledge the St. Michael’s Hospital Research Ethics Board for allowing us to adopt this amendment form for our use.)