/ Horizon Health Network Research Ethics Board
c/o Ethics Services
Saint John Regional Hospital, 2nd Floor
400 University Avenue / PO Box 2100,
Saint John, N.B., Canada E2L 4L2
Tel: (506) 648-6094Fax: (506) 648-7734

AMENDMENT FORM

Please submit form by REB Submission Deadline. Incomplete forms will not be reviewed.

  1. RESEARCH STUDY/PROTOCOL
Full Title:
Principal Investigator: / Current REB approved Protocol Version #/ Date: /
Telephone #: / Horizon Health Network (HHN) File #:
Study Coordinator: / Protocol Number:
Has this Study been approved at other Horizon Health Network Sites? Yes No (If yes, where?)
  1. AMENDMENT DETAIL
This study is Opened, Closed, Suspended, or Conditionallyapproved to Recruitment.
There are Participants enrolled.
This amendment is for administrative purposes only Yes No.
Number of participants that are receiving treatment with a medication or device.
The changes involve the Protocol, Informed Consent Form, Advertisements, or Other (Please explain)
.
The changes affect the study methodology, sample size, Primary Endpoints, Secondary Endpoints
Other:
Study participants will be / will not be re-consented.
Is there a change to the risk benefit ratio as a result of this amendment Yes No
3. AMENDMENT INFORMATION
*For Protocol and Informed Consent submissions,PLEASE provide the following:
“Tracked Changes” copy of the revised Sponsor consent (with changes underlined), (if sponsored study).

Document Type

/ Version Number/Date / Document Name / Description - Only documents requiringapproval

Protocol *

/ /
Consent* / /
Advertisement / /
Other / /
It is the responsibility of the Principal Investigator/Research Coordinator to ensure that departments/programs/nursing units and/or other areas impacted by this amendment receive a copy of pertinent documents and the relevant training as per the Health Canada regulations
Version Date: March 2015 / © Horizon Health Network – Ethics Services
Internal Working Document / Page 1 of 2
  1. Other Related Documents
Please note a summary of changes is required with the submission of all amendments
  • Amendment Summary of Changes Yes
  • PI Signature Page (protocol) Yes N/A
  • TPD No Objection Letter * Yes N/A Control Number: Letter Date:
  • TPD Notification Only Yes N/A
Does the amendment involve changes to the Informed Consent due to an update to the Investigator’s Brochure or Product Monograph?*
Yes No
* Amendment approval will be granted upon receipt of this document (if applicable)
* Please ensure that an “Updated Investigator’s Brochure and/or Product Monograph” form is submitted to the REB.
4. AMENDMENT DETAILS
(4.1) What are the changes? (Please provide a brief outline of the Amendment. PLEASE, DO NOT LEAVE THIS SECTION BLANK)
(4.2) Why are the changes being made?(Please provide a brief outline of the Amendment. PLEASE, DO NOT LEAVE THIS SECTION BLANK)
(4.3) What is the rationale for the amendment? (Please provide a brief outline of the Amendment. PLEASE, DO NOT LEAVE THIS SECTION BLANK)
5. IDENTIFICATION
______
Principal Investigator (Print) / ______
Signature / ______
Date
For Departmental Use Only
Pre-Meeting Review
REB Member/Delegate/Office Staff Print Name______
Signature______
Date______
Research Ethics Board Review
Expedited Review
Full Board Review / Meeting Date / ______
REB Member/Delegate Print Name______
Signature______
Date______
Approved Yes No See attached Appendix
Please provide a “Clean Copy” of the Protocol or Informed Consent upon approval of the amendment.
Version Date: March 2015 / © Horizon Health Network – Ethics Services
Internal Working Document / Page 1 of 2