Date Received:
Bannatyne Campus Research Ethics Boards
P126-770 Bannatyne Avenue
Winnipeg, MB R3E 0W3
Phone: (204) 789-3255
ANNUAL STUDY STATUS REPORT
Research Ethics Board (REB) approval for a research study is for a maximum one-year term only. The Bannatyne Campus
Research Ethics Board (REB) office should receive the request for annual approval with this form no later than 4 weeks before
the expiry date of the most recent Certificate of Initial Approval or Annual Approval. If the Annual Study Status Report is not
submitted by the one-year expiry date, the ethics certificate will automatically expire.
All information must be typewritten in the space provided. Do not leave any section blank. Indicate “not applicable” by typing
N/A. A cover letter is not required for delegated review. Faxed or e-mail submissions/requests will not be accepted.
1. Date of Report:
2. Ethics File Number:
3. Sponsor Protocol Number:
5. Title:
4. Sponsor:
6. Principal Investigator(s):
7. Clinical Trial Registration Number
(if applicable):
NOTE: If you are the lead investigator you must update your Clinical Registry
record promptly and also verify your record on the Registry every 6 months to
ensure publication of the study data will be accepted at a later date.
Has the Clinical Trial Registry been verified/updated?
8. Does the sponsor of this study require full board annual review?
Yes
No
Yes
No
Note: If your study is funded by a US Federal Agency (e.g. NIH, CDC, etc.) annual review may require full Board review.
Delegated annual review is appropriate for US Federal funded studies:

when the research remains active only for long-term follow-up of participants and for participants who have completed all
research-related interventions; and or

Where the remaining activities are limited to data analysis.
9. Has this study been ongoing for more than 5 years?
Yes
No
If yes, please outline the recruitment procedures used and the provisions in place to ensure confidentiality of participants’ personal information.
10. Version date of protocol presently in use:
11. During the last year, were any major changes made to the protocol, consent form(s) and/or recruitment methods?
Yes
No
(If yes, list and briefly summarize any major changes to this study that have been previously approved by the REB since the date of last annual
approval. Note the summary should be a brief note.
12. Provide a brief summary of the progress of the study. REQUIRED. (This can include information on whether the recruitment of participants
or data collection is going according as planned and other details on whether the study implementation is meeting its timelines, etc. Explain
rationale for participants either being withdrawn or discontinued from study.)
NOTE: For retrospective chart review or some database studies please indicate the number of charts/files reviewed in # 13. Providing
approximate numbers may be appropriate for some database studies. Outline the number of participants discontinued or withdrawn in
question #20.
13. Number of participants (or records) screened for eligibility:
14. Number of participants enrolled in study to date:
15. Number of participants (or records reviewed, surveys received, specimens collected for specimen repositories,
etc.) completed study to date:
16. Number of participants currently participating (include participants being followed for further data collection):
17. Is recruitment ongoing?
** Yes
** If YES, please attach to this form a copy of the informed consent document(s) that you are currently using. The documents will be
University of Manitoba Bannatyne Campus Research Ethics Boards
Annual Approval Status Report: Revised May 2014
Faxed or e-mail submissions will not be accepted.
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No
Bannatyne Campus Research Ethics Boards
P126-770 Bannatyne Avenue
Winnipeg, MB R3E 0W3
Phone: (204) 789-3255
reviewed to ensure you are using the most recently approved version and that they meet current Bannatyne Campus REB standards.
Proceed to section #21 if your study is not a clinical trial involving a pharmaceutical product, natural health product, medical device or
surgical intervention.
18. Number of participants, at this site, discontinued due to adverse events:
Description:
19. Number of Serious Adverse Events (SAEs) at this site reported:
Brief Description of SAEs:
20. Number of participants, at this site, discontinued due to serious adverse events:
21. Number of participants, at this site, discontinued due to other reasons:
Description:
All protocol deviations must be reported in a timely manner to the Bannatyne REB as per the guidelines posted on the website.
22. Number of Major protocol deviations since the initial approval or last annual approval date:
List major protocol deviations and date reported to REB:
24. Were there any minor protocol deviations since the initial approval or last annual approval date?
** Yes
No
**If yes, attach a copy of the Bannatyne Campus Minor Protocol Deviation Log.
25. Outline any complaints/concerns your site has received from participants about the research since the last Ethics Board review:
26. Outline the current safety review procedures for this study (i.e. data safety monitoring board (DSMB), drug safety committees, etc.) or
monitoring program. If applicable, also attach a copy of most recent DSMB report.
27. Outline any aspects of this study which should be brought to the attention of the REB (i.e. any new information or knowledge bearing
on the anticipated risks or anticipated benefits, breaches of confidentiality, major protocol violations, etc.).
28. Additional Comments:
Please mail the certificate for annual approval to (NOTE: the certificate of approval will only be mailed to one individual):
Name and Title:
Phone Number:
Address:
Postal Code:
E-mail address (will be used to request clarifications only):
I have reviewed and agree with the content of this report:
Signature of Principal Investigator (or Delegated Co-Investigator)
Date (day/ month/year)
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check you must unprotect the document. After you have completed answering all questions, go to “Tools” on
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DELETE QUESTIONS on this form OR THE SUBMISSION WILL BE RETURNED to the applicant.
University of Manitoba Bannatyne Campus Research Ethics Boards
Annual Approval Status 1, Report Revised May 2014
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