ATTENTION ALL RESEARCHERS:
November 19, 2010
As of July 8, 2009, there will be a change in process for studies submitted to the CCMB RRIC for review and
approval, related to sign-offs by departments impacted by the study and the signature of the privacy officer for
CCMB on the PHIA form for research studies:
1) Please continue to submit the required number of collated research proposal packages (as described on the most
recent version of the RRIC study submission form on the J drive) to the RRIC secretary (Jennifer Cabral), noting the
submission deadlines
2) Jennifer Cabral will assign an RRIC number to the proposal and will send a copy of the proposal package to each
of the departments impacted by the study* for signature, as well as to the CCMB privacy officer for the CCMB
PHIA form for research studies and to all other members of the RRIC. (*It is the researcher's responsibility to
indicate which departments are impacted on the RRIC study submission form. From this point on, it will NOT be the
responsibility of the researcher to initiate contact with the representatives of the departments impacted or with the
CCMB privacy officer for approval).
3) If any of the designates for the departments impacted or the CCMB privacy officer have any questions or
concerns about the proposal, they will contact the researcher to address those issues. If necessary, they will arrange
to meet with the researcher to address the issues.
4) The research proposal will be reviewed at the next RRIC meeting scheduled after the researcher has submitted the
package to Jennifer Cabral. However, RRIC approval will not be granted until all of the impacted departments have
signed off and the PHIA form for research has been signed by the privacy officer at CCMB. A copy of the signed
CCMB PHIA form for research for the study will be sent to the researcher with the RRIC letter of approval for the
study.
Rochelle Yanofsky, MD
Chair, CCMB Research Resource Impact Committee (RRIC)
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Original Submission
Yes
No
If no, state date of revised submission
Study Submission Form
Research Resource Impact Committee – RRIC
This form must be completed for research studies and approved by RRIC, REB and regulatory bodies before any study work is
initiated. The following types of studies MUST be submitted to RRIC for review and approval.
a) Studies which involve the review of CCMB patient records;
b) Studies which involve any type of contact with CCMB patients (including surveys and questionnaires);
c) Studies which involve the use of tissue or body fluids from CCMB patients;
d) Studies which may have a significant impact on CCMB resources (staff, equipment, or other), and which may
adversely affect the availability of those resources for routine patient care.
e) Studies which may generate data interesting enough to be possibly published
Note:
1) Retroactive approval WILL NOT be granted. All impacted departments must be consulted & sign off (section 8.0)
2) Contracts are reviewed by the RRIC Contract Sub-committee. Refer to the J drive, RRIC folder regarding the deadlines
for contract submission and the processes and guidelines for contract review.
Study Information
Study Title:
Objectives of the Study:
1.0
Who will introduce the study to the participants?
Who will obtain informed consent?
Will you use CCMB space to conduct portions of the study?
Type of Study:
Qualitative
Quantitative
Chart Review
Other
______________
A written Research Proposal is required even for Chart Reviews. (Please refer to document RRIC Requirement for a
Written Research Proposal for Chart Reviews.)
Researcher Information
2.0
3.0
4.0
Principal Investigator:
Address:
Phone:
Study Coordinator:
Address:
Phone:
Fax:
E-mail:
Institution:
Fax:
E-mail:
Trainee
a) Is the Researcher a Trainee?
b) Are any trainees involved in the project?
c) Has the trainee form been signed by the supervisor?
Yes
Yes
Yes
No
No
No
If yes, refer to 3c)
If yes, refer to 3c)
Correspondence to be directed to:
Principal Investigator
Study Coordinator
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5.0
6.0
7.0
Research funding
5.1 Is the study funded by industry?
5.2 Is there a budget for the study?
Study conducted at:
CCMB – MacCharles
If other, specify:
Yes
Yes
No
No

Provide copy under section 11.0
CCMB – St. Boniface
Other
Recruitment
If
unknown,
please
consult
Estimated
start
date of
studywith Cancer Registry/Epidemiology to determine accrual numbers.
Estimated duration of study
Estimated end date for accrual (if applicable)
Estimated number of participants locally
Estimated number of paper charts required
CCMB Services
Will CCMB services be used?
If yes, please indicate with a check mark.
Service Required
 Department
Require access to Cancer

Cancer Registry
Registry Database
Mail outs
Assistance with study design
Epidemiology
Assistance with data analysis
Nursing care
Chemotherapy/
Supportive Therapy
Hematology
Nursing
8.0
Health Information
Service/Health
Records
Clinical
Trials Office/
Clinical
Investigations Office
(CIO) (includes BMT
Registry)
Pharmacy
Draw and/or prepare samples
for shipping/freezing
Introduce study to patients
Nursing care
View electronic charts only
Pull/View hardcopy chart
Retrieval of chart if off-site in
storage ($16.00 fee per chart)
Mailouts
PHIA related (see section 9.3)
Screen patients for
eligibility
Obtain patient consent
Conduct patient evaluations
Data Management
Study Activation and
Maintenance
Dispense medication & prep.
Patient Education
Store/Order/Receive Drugs
Accountability records
Yes
No
Contact Person
Gail Noonan
787-2157
Signature
Date/Comment
Comment
Dr. Jane Griffith
235-3277
Dr. Anne Katz
787-4495
Dr. Anne Katz
787-4495
Dr. Anne Katz
787-4495
Jacqueline
Sholdice
787-2266
Kathryn Dyck
787-2127
Pat Trozzo
787-8902
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Patient and Family
Support Services,
including:
- Psychosocial
-
Oncology
Speech
Language
Pathology and
other rehab
services
Nutrition
Services
Breast Cancer
Centre of
Hope and
Patient and
Family
Resource
Centre
Radiation Therapy
Planning
Radiation Therapy
Treatment
Medical Engineering
Medical Physics
Screening Programs
Interview patients/families
Give potential participants info
about the study
Emotional support
Participation in study may
raise anxiety/distress
Studies related to nutrition
Studies related to speech
language pathology
RT Treatment Plans
Quality Control
Documentation submission
RT Imaging – Simulation or
Treatment Unit
RT Treatment

Dedicated Medical Devices
requiring future Preventative
Maintenance & Calibration
Introduction /Assess new
medical device for study
Evaluate Canadian Standards
Association approval for clinical
equipment used in study
Rad. Therapy Credentials
Rad. Therapy. Data
Submissions
Require access to screening
databases
Recruit study subjects
Assist with data analysis
Pull charts/films
Mail outs
Jill Taylor-Brown
787-1325
Sandra Iftody
787-4784
Cynthia Penner
787-4844
Rick Howard
787-8021
Jeff Bews
787-1804
Marion Harrison
788-8632
Other, please
specify.
9.0
9.1
Has the study been approved by the relevant CCMB Disease Site Group (DSG) Chair or designate?
Yes (attach copy)
No
If no, Please justify:
9.2
Research Ethics Board (REB) Approval.
Biomedical REB
Health REB
Nursing REB
Yes (attach copy)
 Pending
9.3
Other

All members of the Research Team, including secretaries and trainees have signed a PHIA Pledge and
commit to protect our patients’ personal health information.
Yes
No
If no, contact the Privacy Officer Designate for CCMB (Jacqueline Sholdice at 787-2266)
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10.0
Billing
A fee of $500.00 per study is applicable for all pharmaceutical/private industry studies.
Applicable
Applicable

Please
makeNot
cheque payable
to CancerCare
Manitoba.
Send to:
CCMB Research Resource Impact Committee
c/o Jennifer Cabral
CancerCare Manitoba
Room ON5020, 675 McDermot Avenue
Winnipeg, MB R3E 0V9
Telephone: (204) 787-4170
Fax: (204) 787-2190
E-mail: jennifer.cabral@cancercare.mb.ca
Enclosures:
TWELVE collated study packages (excluding the REB approval letter*) are required at time of initial study
submission. Each package should include the following,
11.0
1 Copy of the Protocol/Research Proposal REQUIRED FOR ALL STUDIES (including chart reviews. Please refer
to last line in Section 1.0.)
1 Copy of the Consent Form
1 Copy of the Cover Letter
1 Copy of the completed CCMB RRIC Study Submission Form
1 Copy of the Signed PHIA Agreement
1 Copy of the Signed CCMB DSG Approval Form
1 Copy of the REB Submission Form including the data capture form (for chart review studies)
1 Copy of the Study Budget (if applicable)
1 Copy of the Approval Form for Trainees for each trainee involved in the study
* 1 Copy of the Research Ethics Board Letter of Approval – submit as soon as available
1 Copy of CCMB Supply Agreement (for studies without contracts in which data and/or materials are to be sent
to another centre – even if anonymized)
Signatures:
____________________________________
Signature of Principal Investigator
12.0
____________________________
Date
____________________________________
Printed Name of Principal Investigator
____________________________________
Signature of Department Head
____________________________
Date
____________________________________
Printed Name of Department Head
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