CLINICAL RESEARCH STUDY IMPACT APPROVAL FORM:
Required for Ontario Cancer Research Ethics Board (OCREB) Applications
Submit this completed form to the Sunnybrook Clinical Studies Resource Centre (CSRC), Room C835.
Full Study Title:
Short Title / Code:
OCREB #: Protocol #:
Principal Investigator (PI) Name (type in or print clearly):
This form is required for all Ontario Cancer Research Ethics Board (OCREB)applications whereby the proposed research involves the use hospital resources and/or where research education and awareness is necessary
Steps to determine and obtain Program/Department/Division Authorizations:
It is an institutional requirement that all clinical research studies obtain approval from each program/department/division impacted in any way by the study.
- PI identifies each Program/Department/Division where the study involves the use of hospital resources and/or where research education and awareness is necessary, and provides each Primary Contact with the following documents:
- Summary document outlining the impact for each selected area (e.g. a chart outlining the impact on nursing staff time, length of stay, plan to conduct in-service etc.)
- Department specific forms as applicable (e.g. Lab Research Form; Medical Imaging Forms)
- Study Protocol (if requested by the Primary Contact person)
- The Primary Contact is responsible for approaching the appropriate individual(s) within the Program/Department/Division to review the relevant study documents listed above and for obtaining the appropriate authorizing signatures.
- Authorizing signatories are responsible for ensuring the appropriate review has taken place before signing the form.
- A signature below attests that the Authorizing Signatory has received full information about the study’s impact and has agreed to the conduct of this study in their area(s) of responsibility as per the negotiated agreement with the PI. Please note that the expected turn-around time for review and sign off is 2 weeks.
Principal Investigator Attestation:
I have reviewed the form and determined that this study involves hospital resources, and/or patient care areas, and/or staff. I attest that to the best of my knowledge I have indicated the areas where authorizations are necessary and have obtained the appropriate signatures as indicated on the form. I confirm that although OCREB approval may have been issued, study activation will not occur until all required authorizations are obtained and submitted to the Clinical Studies Resource Centre.
I have reviewed the form and attest that this study does not involve any hospital resources, patient care areas or staff and that NO authorizations are required for the conduct of this study. (Submit this page only).
PI Signature:______Date:
(yyyy.mmm.dd)
Director / Keith Laycock / Signature: / Date:
(yyyy.mmm.dd)
Brain SciencesProgram
(e.g., Stroke, Mental Health) / Primary Contacts:
Beth Linkewich – Stroke Research
Lois Fillion – all other Brain Sciences Research
Operations Director / Lois Fillion(signature required for all Brain Sciences Program Research including Stroke) / Signature: / Date:
(yyyy.mmm.dd)
Director, Regional Stroke Program / Beth Linkewich / Signature: / Date:
(yyyy.mmm.dd)
Community Program
(e.g., Medical Units, GeriatricDayHospital, HIV Clinic, etc.) / Primary Contact: Lois Fillion
Operations Director / Lois Fillion / Signature: / Date:
(yyyy.mmm.dd)
Family Practice Unit / Primary Contact: Dr. Mary Tierney
Co-Director PCRU / Dr. Mary Tierney / Signature: / Date:
(yyyy.mmm.dd)
Health Data Resources / Primary Contact: Research Department x5923
Signature on this form not required. Contact HDR for required forms.
Holland MSK Program
(e.g., Holland Centre, SCIL, Fracture Clinic) / Primary Contact: Anne Marie MacLeod
Operations Director / Anne Marie MacLeod / Signature: / Date:
(yyyy.mmm.dd)
Infection Prevention & Control / Primary Contact: Sandra Callery
Director / Sandra Callery / Signature: / Date:
(yyyy.mmm.dd)
Information Services / Primary Contact:Oliver Tsai
Director / Oliver Tsai / Signature: / Date:
(yyyy.mmm.dd)
Laboratories (select below) / Primary Contact:names below with Asterisk * as needed
Anatomic Pathology Manager / Gail Sanders * / Signature: / Date:
(yyyy.mmm.dd)
Blood & Tissue Bank Manager / Lisa Merkley * / Signature: / Date:
(yyyy.mmm.dd)
Clinical Pathology Manager (Hem, Chem, Flow) / Eva Proctor * / Signature: / Date:
(yyyy.mmm.dd)
Lab Information Systems / Suzanne Waldman * / Signature: / Date:
(yyyy.mmm.dd)
MicrobiologyActing Manager / Gail Sanders * / Signature: / Date:
(yyyy.mmm.dd)
Molecular Diagnostic Labs / Dr. David Cole * / Signature: / Date:
(yyyy.mmm.dd)
Outpatient Phlebotomy and ECGs / Eva Proctor* / Signature: / Date:
(yyyy.mmm.dd)
Medical Imaging / Primary Contact:Thayalasuthan Vivekanandan “Vivek”
Director / Henry Sinn / Final Approval Signature: / Date:
(yyyy.mmm.dd)
MRI - Research / Primary Contact:Caron Murray
Technologist / Caron Murray / Signature: / Date:
(yyyy.mmm.dd)
Director / Dr. Kullervo Hynynen / Signature: / Date:
(yyyy.mmm.dd)
Odette Cancer Centre Program
(e.g. T wing, Surgical Oncology, Medical Oncology, etc.) / Primary Contact: names below with an asterisk* as needed
Chemotherapy Unit / Kathy Beattie* / Signature: / Date:
(yyyy.mmm.dd)
Radiation Therapy / Steve Russell * / Signature: / Date:
(yyyy.mmm.dd)
Physics / Kathy Mah * / Signature: / Date:
(yyyy.mmm.dd)
Odette Cancer Centre Pharmacy / Shenur Jamani * / Signature: / Date:
(yyyy.mmm.dd)
Manager / Flay Charbonneau / Signature: / Date:
(yyyy.mmm.dd)
Primary Nursing and Access Outpatient Clinic(s) / Sherrol Palmer-Wickham* / Signature: / Date:
(yyyy.mmm.dd)
Cystoscopy Suite / Mary Glavassevich* / Signature: / Date:
(yyyy.mmm.dd)
Oncology Inpatient Unit / C2 – Eleanor Miller*
C6 – Smitha Casper-DeSouza*
D6 – Mary Glavassevich* / Signature: / Date:
(yyyy.mmm.dd)
Other / Signature: / Date:
(yyyy.mmm.dd)
Other / Signature: / Date:
(yyyy.mmm.dd)
Signatures below are required following review and sign off by the above contacts (e.g. post OCC service agreement(s))
Operations Director / Yvette Matyas* / Signature: / Date:
(yyyy.mmm.dd)
Odette Cancer Research Program Director / Dr. Gregory Czarnota* / Signature: / Date:
(yyyy.mmm.dd)
OR & Related Services
(e.g. Pre-Admission, Same Day Surgery, OR, PACU, Short Stay Unit, Regional Processing Centre, Transfusion Medicine, Endoscopy, Colposcopy, Medical Outpatients, etc.) / Primary Contact: Cynthia Holm
Operations Director / Cynthia Holm / Signature: / Date:
(yyyy.mmm.dd)
Pharmacy / Primary Contact:John Iazzetta
Coordinator Drug Information Service (e.g. acute care, Veterans Centre, Outpatient Pharmacy) / Dr. John Iazzetta / Signature: / Date:
(yyyy.mmm.dd)
Photography -Medical / Primary Contact:Raymond Boyer
Manager / Raymond Boyer / Signature: / Date:
(yyyy.mmm.dd)
Plexxus / Primary Contact: Elizabeth Deveau
Director, Purchasing / Elizabeth Deveau / Signature on this form not required. See FAQs on Research Ethics Pages for Plexxus instructions.
Privacy Office / Primary Contact: Jeff Curtis
Chief Privacy Officer / Jeff Curtis / Signature on this form not required. Contact the Privacy Office if a Privacy Impact Assessment is required.
Schulich Heart Program
(Cardiology and CV units, E2 labs, Cath labs, Inpt. ECGs + Interpretation, etc.) / Primary Contact: Susan Michaud
Operations Director / Susan Michaud / Signature: / Date:
(yyyy.mmm.dd)
TECC Program
(e.g. Emergency Department, D5, C5, CrCU, CVICU, RTBC, D4ICU, B5ICU, etc.) / Primary Contact: Debra Carew
Operations Director / Debra Carew / Signature: / Date:
(yyyy.mmm.dd)
Veterans Centre
(all K and L Wing) / Primary Contact: Dorothy Ferguson
Operations Director / Dorothy Ferguson / Signature: / Date:
(yyyy.mmm.dd)
Women & Babies Program
(e.g. M4 and M5) / Primary Contact: Jo Watson
Operations Director / Jo Watson / Signature: / Date:
(yyyy.mmm.dd)
Other : Specify / Primary Contact:
Director / Signature: / Date:
(yyyy.mmm.dd)
NOTE: Add additional sheets for any areas not listed above
Form Version date: 2012-06-25Page 1 of 4