STUDY IMPACT APPROVAL FORM for submission through Unity Health Toronto Research Ethics Board

June 14, 2018 _ last update April 2020 Page 1

INSTRUCTIONS FOR SUBMISSION

Please complete this form for all trials prior to submitting to Unith Health Toronto Research Ethics Board (REB) and forward the completed form to Elizabeth Huggins, Elizabeth.Huggins@unityhealth.to

1. Ensure research study budgets cover incremental costs of all hospital resources required for the research.

2. Principal/Site Investigator (or delegate) identifies each Program/Department where the study will impact hospitalresources and/or where research education and awareness is necessary. Signatures from Department Head/Chief andClinical Program Director are required.

a. Summary document outlining the impact on affected department and/or any specific forms as requested

b. Research ethics board completed application

c. Study protocol

3. Principal/Site Investigator (or delegate) approaches appropriate individual(s) within the Programs/Departmentsidentified in Step #2 (above) to review the study and obtaining signatures in the Resource Authorizationsection. Please provide individual(s) with the following documents to review:

Authorizing signatories are responsible for ensuring the appropriate review has taken place and all hospitalresources required to conduct the research (money, materials, staff) has been approved before signing the form. Asignature attests that the Authorizing Signatory has received full information about the study’s impact and has agreedto the conduct of this study in the hospital or in their area(s) of responsibility.

DEFINITIONSPrincipal Investigator (P.I.): The person responsible for the conduct of the research at SJHC.

Site Investigator: The person responsible for the conduct of the research at SJHC if the study is being conducted at more than one site.

Hospital Resources: Human and material resources including those which are currently paid by and/or accessed through the hospital (e.g.

research department, pharmacy, diagnostic services, medical imaging, equipment, supplies, space, staff time)

Standard of Care: The usual treatments, interventions, and procedures which are part of patient care and may be performed regardless of

study participation.

Incremental Care/Cost: Research specific treatments, interventions, diagnostics, and procedures that are above and beyond standard care.

Research study budgets must cover the incremental costs of all hospital resources required for research. Any treatments, interventions,

diagnostics, and procedures that are funded/budgeted by the clinical trial sponsor are considered to be incremental care/costs.

4.

Study Title:

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Date (dd/mmm/yyyy):

Type of Trial: Clinical Trial Observational Trial Chart Review

CONTACT INFORMATION

Short Title of Study:

Study Funded By (i.e., Sponsor Name):

Principal Investigator Name: Email/phone:

Site Investigator Name: Email/phone:

Co-Investigator Name: Email/phone:

Co-Investigator Name: Email/phone:

Co-Investigator Name: Email/phone:

Co-Investigator Name: Email/phone:

Research Coordinator Name: Email/phone:

Research Coordinator Name: Email/phone:

Primary Contact Name: Email/phone:

NOTE: Clinical Trials must have 2 qualified (regulated) professionals listed on the study

Quality Education Student

Other

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Please list all individuals (e.g., investigators, co-investigators, coordinators, students, trainees, fellows, etc.) involved inconducting research activities at SJHC. This includes any involvement at SJHC, on behalf of SJHC, with SJHC participants, charts, and/or any identifiable data, etc.

Please note: all staff must complete all applicable training.

Please note: If any research activities are being performed by a non-SJHC staff contact Cordelia Cooper, Cordelia.Cooper@unityhealth.to, or Dalbir Singh, Dalbir.Singh@unityhealth.to, to register as a research visitor.

Personnel Study Role (i.e. PI, Site-I, Co-I, Coordinator, Study

RN, etc.)

Study Tasks (*indicate numbers

from the task list below)

TCPS2 (required for anyone conducting research

activities)

GCP (required for anyone conducting research

activities with participant contact)

Division 5 (required for anyone

involved in regulated research

studies)

Coordinator 1,2,4,5 Example: Billy Rubin

Name:

Name:

Name:

Name:

Name:

Name:

Name:

*Study Tasks: 1. Chart review 2. Data Collection 3. Participantrecruitment

4. Obtain informedconsent

5. study protocolprocedures

6. protocoldevelopment

7. Data entry 8. Data analysis 9. Manuscriptpreparation

DECLARATION BY PRINCIPAL/SITE INVESTIGATOR

I affirm that all individuals listed above have completed the mandatory training and education (as applicable) in accordance with St. Joseph's Health Centre institutional requirements and have agreed to the study tasks listed above.

Name of SJHC Principal/ Site Investigator Signature Date (dd/mmm/yyyy)

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RESOURCE AUTHORIZATION REQUIRED

Authorizing signatories are responsible for ensuring the appropriate review has taken place and all hospital resources required to conduct the research has been approved before signing the form. A signature attests that the Authorizing Signatory has received full information about the study’s impact and has agreed to the conduct of this study in the hospital or in their area(s) of responsibility as per the negotiated agreement with the Principal/Site Investigator.

Please Note: All studies require signatures from the Department Head or Chief, Clinical Program Director, and Research Department.

Department Head or Chief Department:

Name:

Signature:

Date(dd/mm/yy):

Clinical Program Director(s)* Department:

Name:

Signature:

Date (dd/mm/yy):

Research Department Name:

Email:

Signature:

Date (dd/mm/yy):

*NOTE: If multiple Clinical Program Directors are impacted, please use the “Other” space allocated on Page 5

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RESOURCE AUTHORIZATION AS APPLICABLE

Approval and signatures must be obtained from all areas in which hospital resources are required for this research study (e.g., Pharmacy, Lab, patient care units, clinics, etc.). Please check all areas that apply and add any additional areas that are impacted under "other".

Authorizing signatories are responsible for ensuring the appropriate review has taken place and all hospital resources required to conduct the research has been approved before signing the form. A signature attests that the Authorizing Signatory has received full information about the study’s impact and has agreed to the conduct of this study in the hospital or in their area(s) of responsibility as per discussions with the Principal/Site Investigator

Pharmacy Name: Jiten Jani Email: Jiten.Jani@unityhealth.to

Signature: Date (dd/mmm/yyyy):

Laboratory Medicine Name: Adnan Khan Email: Adnan.Khan@unityhealth.to

Signature: Date (dd/mmm/yyyy):

Health Records Name: Email:

Signature: Date (dd/mmm/yyyy):

Clinical Informatics Name: Email:

Signature: Date (dd/mmm/yyyy):

Communications Name:Email:communications@unityhealth.to

Signature: Date (dd/mmm/yyyy):

Diagnostic Imaging Name: Lisa Hicks Email: Lisa.Hicks@unityhealth.to

Signature: Date (dd/mmm/yyyy):

Medical Diagnostics Name: Carolyn NolanEmail: Carolyn.Nolan@unityhealth.to

Signature: Date (dd/mmm/yyyy):

Patient Care Manager Clinical Services (i.e., Human Resources, supplies, etc.)

Department:

Name:

Signature: Date (dd/mmm/yyyy):

Other Department:

Name:

Signature: Date (dd/mmm/yyyy):

Other Department:

Name:

Signature: Date (dd/mmm/yyyy):

Other Department:

Name:

Signature: Date (dd/mmm/yyyy):

Other Department:

Name:

Signature: Date (dd/mmm/yyyy):

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PRINCIPAL INVESTIGATOR ATTESTATION AND SIGNATURES

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 study activation will not occur until all required authorizations are obtained and submitted.

I have reviewed the form and determined that this study does not involve hospital resources, and/or patient care areas, and/or staff and that NO authorizations are required for the conduct of this study (except Department Head/Chief, Clinical Program Director, Research Department)

Name: Principal Investigator Signature Date (dd/mmm/yyyy)

Name: Site Investigator Signature Date (dd/mmm/yyyy)

Name: Co-Investigator (if applicable): Signature Date (dd/mmm/yyyy)

Name: Co-Investigator (if applicable): Signature Date (dd/mmm/yyyy)

Note: Clinical Trials must have 2 qualified (regulated) professionals listed on the study

I understand it is my responsibility to ensue contracts with all third parties (e.g., sponsor, external lab, app vendor, online service provider, contracted members of the research team, etc.) are in place before the study begins. Any questions can be directed to researchcontracts@smh.ca