Research Ethics Board (REB)
RENEWAL FORM
The Renewal Form is an application for continuing ethics approval and must be submitted for review
and approval prior to the study’s expiry date. Ethics approval expires each subsequent year from the
day REB approval was initially granted unless otherwise indicated by the NYGH REB. It is the
responsibility of the Principal Investigator to monitor the quality and process of the study in ongoing
fashion and to report annually to the REB. Failure to submit this form prior to the expiry date signifies
that the study does not have REB approval and all research activities must be suspended. Conducting
research without REB approval may result in a notice of non-compliance involving corrective action, up
to and including, termination of the research study.
Study Title:
NYGH REB #:
Multi -Site Study?
YES
Principal Investigator (PI):
NYGH Site Investigator (Site PI):
Date of initial NYGH REB approval:
Funding Agency:
Industry-Sponsored/Supported?
Date of last NYGH REB approval:
NO
YES (If YES, complete the table below.)
NO
Invoicing Information for Industry-Sponsored/Supported Studies
A fee of $500/- Cdn is invoiced for all Industry-Sponsored/Supported Studies applying for continuing
ethics approval.
Invoice to the Following Company:
Contact Name:
Telephone:
E-mail:
Street Address:
Suite:
City:
Province/State:
Country:
Postal/Zip Code:
1. What is the current status of this study at NYGH?
Not yet started
Explain:
On Hold
Explain:
Actively Enrolling*
Closed to Enrollment
Intervention and /or Data Collection
Data Analysis
Manuscript /Publication in progress
* If the study is actively enrolling, please attach a copy of the current Informed Consent Form(s).
Version Date: October 2014
NYGH Research Ethics Board, 3S- Room 377, 4001 Leslie Street, Toronto, ON, M2K 1E1 email: reb@nygh.on.ca
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Research Ethics Board (REB)
RENEWAL FORM
2. How many participants at NYGH?
Were planned for enrollment
Were consented
Were enrolled
Are currently receiving study treatment/intervention
Completed study treatment/intervention & are currently on follow-up
Completed study treatment/intervention & follow-up
Withdrew consent
Were planned for inclusion in a chart review (retrospective or prospective)
Were included in a chart review (retrospective or prospective)
3. Serious Adverse Event (SAE) Information Summary at NYGH:
None
N/A
Total Number of Site SAEs
Please provide the summary of all reportable local SAEs SINCE LAST RENEWAL
YES
4. Have all significant protocol deviations/violations been reported to the REB?
YES
NO
N/A- NO significant deviations/violations to report
5. Does this study have a Data Safety Monitoring Board (DSMB)?
YES
No
N/A
If yes, provide the date of the DSMB Meeting and the REB submission date of the DSMB Meeting
Summary Minutes SINCE LAST RENEWAL:
Date of DSMB Meeting Minutes Letter/Report
Date(s) Submitted to the REB
6. Has the study been stopped, put on hold, or recruitment put on hold, etc., at
reason?
YES
No
N/A
If YES, provide details:
any site, for any
7. Since the last REB approval, is there any new ethical or scientific information outside of a protocol
amendment that would be relevant to the continuing review of this study?
YES
NO
N/A
If YES, provide details.
8. Would any of the new findings impact a participant’s willingness to continue this study?
YES
NO
N/A
If YES, please provide details:
Version Date: October 2014
NYGH Research Ethics Board, 3S- Room 377, 4001 Leslie Street, Toronto, ON, M2K 1E1 email: reb@nygh.on.ca
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Research Ethics Board (REB)
RENEWAL FORM
9. Since the last REB approval, is there any change in the conflict of interest information provided to the
REB for any of the investigators, study staff or members of their immediate family?
YES
NO
If YES, provide details.
10. Amendments submitted SINCE LAST RENWEAL
YES
Please list all protocol amendments since LAST RENEWAL below
None or
Date Submitted
Date Approved by NYGH REB
Amendment Version
Version Date
11. List of current consent and recruitment documents in use
Form Details (ICF, Advert)
Version Date
YES
N/A
N/A
Date Approved by NYGH REB
12. Study personnel information
Please list ALL individuals involved ins conduct of this study at NYGH and whether they have completed
the mandatory training below:
Personnel Name
Study Role
GCP
TCPS2
13. Expected date of study Completion
14. Person completing this form:
Title:
Dept/Div:
Full Address:
Telephone:
First Name:
Institution:
Extension:
Last Name:
Room Number:
E-mail:
Version Date: October 2014
NYGH Research Ethics Board, 3S- Room 377, 4001 Leslie Street, Toronto, ON, M2K 1E1 email: reb@nygh.on.ca
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Research Ethics Board (REB)
RENEWAL FORM
14. Statement of Principal Investigator (PI)/ NYGH Site PI.
I assume full responsibility for the scientific and ethical conduct of this study and agree to conduct this
study in compliance with the Tri-Council Policy Statement: Ethical Conduct for Research Involving
Human Subjects (TCPS), Personal Health Information Protection Act (PHIPA) and any other relevant
regulations or guidelines. I certify that all researchers and personnel involved in this study at this
institution are appropriately qualified and trained to fulfill their role in this study.
_____________________________
Signature of NYGH Principal Investigator
____________________________
Date (dd/mmm/yyyy)
Research Ethics Office Use Only :
NYGH REB # ____________________
Date Submitted :
Date Reviewed:
The NYGH REB has reviewed the information provided and confirms that this study has obtained ethics
approval by way of:
Expedited Review
Full Board Review - Date of Full Board meeting: ____________________
This study is only approved for the following period: __________________ to ____________________
_____________________________________
Dr. W. L. Alan Fung, MD ScD FRCPC
Chair, Research Ethics Board
_________________________
Date (dd/mmm/yyyy)
Reminder date for next REB Submission: ____________________
Invoice # REB Administration Fee (if applicable): ____________________
Version Date: October 2014
NYGH Research Ethics Board, 3S- Room 377, 4001 Leslie Street, Toronto, ON, M2K 1E1 email: reb@nygh.on.ca
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