For REB Use Only
ST. MICHAEL’S RESEARCH ETHICS BOARD (REB)
CONTINUING REVIEW FORM
This form is available in MS WORD format and can be downloaded at: www.stmichaelshospital.com/research/reb.php
Handwritten submissions are NOT acceptable
Use this form if you are requesting Continuing Review and approval of this study. If the study is either cancelled or completed (i.e.
there is no further participant involvement, data collection, data transfer, data clarification, or access to participants’ medical
records), please instead submit a Study Closure Report Form. All other submissions, such as amendments, administrative changes,
DSMB Meeting Minutes, or changes to investigators/study personnel, should be submitted separately.
Date:
REB #:
Study Title:
SMH Principal Investigator:
Study Original Approval Date:
Annual/Interval Review Date:
Continuing Review Interval:
1. Current Study Status
What is the current status of this study? (Check all that apply)
Study not started
Explain:
On Hold
Explain:
Actively Enrolling
Study is:
On-target
Ahead of schedule
Behind
Closed to Enrollment
Active Intervention and/or Data Collection
Data Analysis
Manuscript/Publication in progress
Has the study been stopped, put on hold, or recruitment put on hold, etc., at
any site, for any reason?
Yes
No
If YES, provide details (include dates):
Continuing Review Form
Ver.01-Jun-2015
Page 1 of 4
2. Summary of Study Participant Enrollment
No enrollment to date. Reason:
Retrospective Study Data (e.g. Retrospective Chart Review/Biological Specimens Studies)
Complete each line
Target number of participant charts or biological samples approved by the SMH REB to be
reviewed (per original submission and/or amendment).
Number of charts reviewed/specimens accessed to determine eligibility.
Number of participant charts in retrospective chart review.
Number of biological samples utilized for this study.
Prospective Study Data (e.g. Clinical Trials, Qualitative Studies, Registries, Prospective Chart Reviews, etc.)
Complete each line
a.
b.
c.
d.
e.
Target number of participants approved by the SMH REB to be enrolled (per original submission
and/or amendment).
Number of participants approached by SMH study site personnel.
Number of participants consented by SMH study site personnel.
(should equal sum of a to e below)
Number of participants consented, but have not yet started intervention/data collection.
Number of participants who have withdrawn their consent or have been withdrawn (e.g.
screen failures, early withdrawal/termination).
(please itemize under #3 below)
Number of participants currently receiving study intervention (e.g. study drug,
questionnaires, tests, or procedures done for study purposes).
Number of participants currently in post-intervention follow-up.
Number of participants who have completed the study (including completed follow-up)
and no further contact for study purposes is planned.
3. Summary of Participant Withdrawal/Termination (SMH Site Only)
Participant
Study
Number
Withdrawn
or
Terminated
(W/T)?
Date of
Withdrawal/
Termination
Reason/description of
withdrawal/termination (e.g.
screen failures, withdrew
consent, lost to follow-up etc.)
(if known)
4. Serious Adverse Event (SAE) Information Summary (SMH Site Only)
None or
N/A
Actions Taken to Ensure the
Participant’s Safety
None or
N/A
Please provide the REB with a summary of all reportable LOCAL SAEs SINCE LAST RENEWAL:
Participant
Date of
Description of Serious
Date
Outcome
Study
Onset
Adverse Event
Reported to
Number
REB
Continuing Review Form
Ver.01-Jun-2015
Page 2 of 4
5. Data Safety Monitoring Board (DSMB) Reports
Does this study have a Data Safety Monitoring Board (DSMB)?
Yes
No
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. Protocol Amendment Summary
None or
N/A
Detail all protocol amendments SINCE LAST RENEWAL, protocol number and date, and date of REB
approval.
Date submitted to
Protocol Version
Protocol Version Date
Health Canada
Date approved by
(dd-mmm-yyyy)
REB
Number
Approval
REB
Required? (Y/N)
7. Summary of Consent Documents (e.g. Main, Genetic, Letter(s) of Information, etc.)
N/A
Please list the consent form(s)/recruitment document(s) currently in use.
Consent Form
Version Date (dd-mmm-yyyy)
Date approved by REB
8. Summary of Recent Findings
Is there any new information in the literature, interim findings, or preliminary
results that would change the rationale, procedures, study design, and/or
risk/benefit profile for this study since the last review?
Yes
No
Yes
No
If yes, please describe:
9. Study Monitoring
Has this study been monitored by the sponsor, SMH, or others external to the
research team since the last continuing review?
If yes, state who monitored the study (i.e. sponsor, CRO) and list the dates or frequency of the monitoring
visits:
What actions have been taken in response to this external monitoring?
10. Study Personnel Information
Please list all individuals (e.g. Investigators, coordinators, and any other study personnel including students, trainees,
fellows, etc.) involved in conducting research activities at St. Michael’s Hospital (i.e. any involvement at the SMH
site, on behalf of SMH, with SMH participants/charts/identifiable data, etc.) and whether they have completed the
mandatory training below:
Note: If a non-SMH study staff will be performing study conduct on site, or accessing SMH patient records/personal information/personal health information,
they are required to register with the Office of Research Administration as a research visitor/volunteer, and they must also complete the mandatory training.
Study Role
Personnel Name
(i.e. PI, Co-I, Research
Assistant, etc.)
e.g. John Smith
Continuing Review Form
Ver.01-Jun-2015
Co-ordinator
Study Tasks
(*indicate numbers from the
task list below)
1,2,4,5
GCP
13 module 7 module
x
TCPS 2
x
Page 3 of 4
*Study Tasks:
1 - Chart review 3 - Participant recruitment
5 - Study protocol assessments/procedures
2 - Data collection 4 - Obtain informed consent 6 - Protocol development only
9 - Manuscript preparation (aggregate data only)
7 - Data entry
8 - Data analysis
11. Continuation of the Study
Provide a rationale as to why this study approval should be renewed.
DECLARATION BY INVESTIGATOR
I warrant that this study 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].
In addition, I affirm that all individuals listed above have completed the mandatory training and education (as
applicable) in accordance with St. Michael’s institutional requirements.
Printed Name of SMH Principal
Investigator
Continuing Review Form
Ver.01-Jun-2015
Signature
Date
Page 4 of 4