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.

1. 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: a. 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.) b. Department specific forms as applicable (e.g. Lab Research Form; Medical Imaging Forms) c. Study Protocol (if requested by the Primary Contact person)

2. 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.

3. Authorizing signatories are responsible for ensuring the appropriate review has taken place before signing the form.

4. 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)

Form Version date: 2013-12-04 Page 1 of 5 CLINICAL RESEARCH STUDY IMPACT APPROVAL FORM: Required for Ontario Cancer Research Ethics Board (OCREB) Applications

Biomedical Engineering Primary Contact: Keith Laycock Director Keith Laycock Signature: Date: (yyyy.mmm.dd)

Brain Sciences Program Primary Contacts: (e.g., Stroke, Mental Health) Beth Linkewich – Stroke Research Lois Fillion – all other Brain Sciences Research Operations Director Lois Fillion (signature Signature: Date: required for all Brain (yyyy.mmm.dd) Sciences Program Research including Stroke) Director, Regional Beth Linkewich Signature: Date: Stroke Program (yyyy.mmm.dd)

Community Program Primary Contact: Lois Fillion (e.g., Medical Units, Geriatric Day Hospital, HIV Clinic, etc.) Operations Director Lois Fillion Signature: Date: (yyyy.mmm.dd)

Family Practice Unit Primary Contact: Dr. Mary Tierney 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 Primary Contact: Anne Marie MacLeod (e.g., Holland Centre, SCIL, Fracture Clinic) Operations Director Anne Marie MacLeod Signature: Date: (yyyy.mmm.dd)

Holland MSK Program Primary Contact: names below with an asterisk* as needed (e.g., Holland Centre, SCIL, Fracture Clinic) Pharmacy Frayda Gorenstein* Signature: Date: (yyyy.mmm.dd) Signature below by Operations Director is required following review and sign off by the above contacts

Operations Director Anne Marie MacLeod* Signature: Date: (yyyy.mmm.dd)

Imaging (Medical/Radiology) Primary Contact: Cindy Matheson Director Henry Sinn Final Approval Signature: Date: (yyyy.mmm.dd)

Imaging – Research *excluding IRCCI – Primary Contact: names below with an asterisk* as needed see Schulich Heart Program

Research MRI Ruby Endre*, Signature: Date: Technologist (yyyy.mmm.dd) Dr. Kullervo Hynynen, Signature: Date: Director (yyyy.mmm.dd)

Other research Dr. Kullervo Hynynen*, Signature: Date: imaging (i.e. U/S and Director (yyyy.mmm.dd) elastography),specify: Form Version date: 2013-12-04 Page 2 of 5 CLINICAL RESEARCH STUDY IMPACT APPROVAL FORM: Required for Ontario Cancer Research Ethics Board (OCREB) Applications

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 Gail Sanders * Signature: Date: Manager (yyyy.mmm.dd)

Blood & Tissue Lisa Merkley * Signature: Date: Bank Manager (yyyy.mmm.dd)

Clinical Pathology Eva Proctor * Signature: Date: Manager (Hem, Chem, (yyyy.mmm.dd) Flow)

Lab Information Suzanne Waldman * Signature: Date: Systems (yyyy.mmm.dd)

Microbiology Joseph Kuzma * Signature: Date: Manager (yyyy.mmm.dd)

Molecular Dr. David Cole * Signature: Date: Diagnostic Labs (yyyy.mmm.dd)

Outpatient Anne Marie Phillips*, Signature: Date: Phlebotomy and ECGs Supervisor (yyyy.mmm.dd) Lisa Merkley, Signature: Date: Director (yyyy.mmm.dd)

Odette Cancer Centre Program Primary Contact: names below with an asterisk* as needed (e.g. T wing, Surgical Oncology, Medical Oncology, etc.) Chemotherapy Unit Kirsty Wield* Signature: Date: (yyyy.mmm.dd) Radiation Therapy Steve Russell * Signature: Date: (yyyy.mmm.dd) Dr. Greg Czarnota, Signature: Date: Chief of Radiation (yyyy.mmm.dd) Oncology

Physics Dr. Arjun Sahgal * Signature: Date: (yyyy.mmm.dd) Dr. Greg Czarnota, Signature: Date: Chief of Radiation (yyyy.mmm.dd) Oncology

Odette Cancer Shenur Jamani * Signature: Date: Centre Pharmacy (yyyy.mmm.dd) Manager Flay Charbonneau Signature: Date: (yyyy.mmm.dd)

Form Version date: 2013-12-04 Page 3 of 5 CLINICAL RESEARCH STUDY IMPACT APPROVAL FORM: Required for Ontario Cancer Research Ethics Board (OCREB) Applications

Primary Nursing/ Sherrol Palmer- Signature: Date: Access to Outpt Clinic(s) Wickham* (yyyy.mmm.dd) Cystoscopy Suite Denyse Henry* Signature: Date: (yyyy.mmm.dd) Oncology Inpatient C2 – Eleanor Miller* Signature: Date: Unit C6 – Smitha Casper- (yyyy.mmm.dd) DeSouza* D6-Mary Glavassevich* Breast Centre Holly Krol* 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 Janice Stewart* Signature: Date: (yyyy.mmm.dd) Medical Director, Dr. Claire McCann* Signature: Date: Clinical Research/Trials, (yyyy.mmm.dd) Odette Cancer Center

OR & Related Services Primary Contact: Cynthia Holm (e.g. Pre-Admission, Same Day Surgery, OR, PACU, Short Stay Unit, Regional Processing Centre, Transfusion Medicine, Endoscopy, Colposcopy, Medical Outpatients, etc.) Operations Director Cynthia Holm Signature: Date: (yyyy.mmm.dd)

Pharmacy Primary Contact: John Iazzetta Coordinator Drug Dr. John Iazzetta Signature: Date: Information Service (yyyy.mmm.dd) (e.g. acute care, Veterans Centre, Outpatient Pharmacy)

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 Primary Contact: names below with an asterisk* as needed

Cardiology and CV units, Operations Director Signature: Date: E2 labs, Cath labs, Inpt. Susan Michaud* (yyyy.mmm.dd) ECGs + Interpretation, ECHO, etc. IRCCI – Imaging Research Director: Signature: Date: Research Centre for Graham Wright* (yyyy.mmm.dd) Form Version date: 2013-12-04 Page 4 of 5 CLINICAL RESEARCH STUDY IMPACT APPROVAL FORM: Required for Ontario Cancer Research Ethics Board (OCREB) Applications Cardiac Intervention

St. John’s Rehab Program Primary Contact: Dr. Manuel Gomez

Director, St. John’s Dr. Manuel Gomez Signature: Date: Rehab Research (yyyy.mmm.dd) Program

TECC Program Primary Contact: Debra Carew (e.g. Emergency Department, D5, C5, CrCU, CVICU, RTBC, D4ICU, B5ICU, etc.) Operations Director Debra Carew Signature: Date: (yyyy.mmm.dd)

Veterans Centre Primary Contact: Dorothy Ferguson (all K and L Wing) Operations Director Dorothy Ferguson Signature: Date: (yyyy.mmm.dd)

Women & Babies Program Primary Contact: names below with an asterisk* as needed (e.g. M4 and M5) NICU Pharmacy Carla Findlater* Signature: Date: (yyyy.mmm.dd) Signature below by Operations Director is required following review and sign off by the above contacts

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: 2013-12-04 Page 5 of 5