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STUDY IMPACT APPROVAL FORMfor submission through Clinical Trials Ontario (CTO)
June 14, 2018 _ last update February 2020 Page 1
INSTRUCTIONS FOR SUBMISSION
Please complete this form for all trials prior to submissing through Clinical Trials Ontario (CTO)
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 impacthospital resources and/or where research education and awareness is necessary.
a. Summary document outlining the impact on each 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 documents and obtaining signatures in the ResourceAuthorization section. Provide individual(s) with the following documents to review:
7. Authorizing signatories are responsible for ensuring the appropriate review has taken place and all hospitalresources required to conduct the research has been approved before signing the form. A signature attests that theAuthorizing Signatory has received full information about the study’s impact and has agreed to the conduct of thisstudy in the hospital or in their area(s) of responsibility.
DEFINITIONSPrincipal Investigator (P.I.): The P.I. completes the Provincial Initial Applications.
Site Investigator: The person responsible for the conduct of the research at SJHC. The Site Investigator completes Centre Initial Applications.
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.
5. A Privacy review and approval may be required as per Page 6 of this form. Please contact Laura Tomat,[email protected], as soon as possible to discuss the Privacy review.
6. Once all required signatures are complete please forward this form to Laura Tomat, [email protected] review and signatures from the Research Department and CTO Institutional Representative.
4. Principal/Site Investigator (or delegate) approaches appropriate Department Head/Chief, Clinical ProgramDirector, and Clinical Ethics Director to review the study docuements (as in step #3 above) and obtain signatures inthe Resource Authorization section.
Study Title:
June 14, 2018 _ last update February 2020 Page 2
Date (dd/mmm/yyyy):
Submitting through CTO as a: Provincial Application Provincial and Centre Application Centre (site) Application
CONTACT INFORMATION
Short Title of Study:
Study Funded By (i.e., Sponsor Name):
Principal Investigator Note: this is from the Provincial application
Name: Email/phone:
Site Investigator Note: this is from the Centre application
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
CTO Application Number:
Name of Reviewing REB:(i.e., REB Board of Record)
June 14, 2018 _ last update February 2020 Page 3
Please list all individuals (e.g., investigators, co-investigators, coordinators, students, trainees, fellows, etc.) involved in conducting research activities at SJHC. This includes any involvement at SJHC, on behalf of SJHC, with SJHC participants, charts, identifiable data, etc.
All staff must complete all applicable training and a copy of each individual's certification (i.e. TCPS2, GCP, Division 5) may be requested along with this form.
Please note: If any research activities are being performed by a non-SJHC staff contact Laura Tomat 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.
Name of SJHC Principal/ Site Investigator Signature Date (dd/mmm/yyyy)
June 14, 2018 _ last update February 2020 Page 4
CONFLICTS OF INTEREST
Conflicts of Interest do not imply wrong-doing. It is the responsibility of the Principal/Site Investigator to determine if any of the conflicts listed below apply to any persons involved in the research study or any member of their immediate family. Disclose all contracts and any conflicts of interest (actual, apparent, perceived or potential) relating to this project. Conflict of interest may also arise with regard to the disclosure of personal health information.
Not applicable. There are no Conflicts of Interest to disclose. Yes. Check all that apply
Function as an advisor, employee, officer, director or consultant for the study sponsor Have direct or indirect interest in the drug, device or technology employed in this research study (i.e. inventorship, patents or stocks) Receive an honorarium or other personal benefits from the sponsor (apart from fees for service) Using services of a family member or a company in which you or a family member has a direct interest. Receive direct or indirect financial benefit from the disclosure of personal health information Competing interest (situations in which the researcher may be influenced to draw conclusions against the interest of the sponsor or
another interested party to the study because the researcher or a family member has an opposing interest related to the research, including a legal suit against a company or sponsor or a financial interest in a competing company or product)
Other
Name of SJHC Investigator Signature Date (dd/mmm/yyyy)
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.
Department Head or Chief required for all studies
Department:
Name:
Signature: Date (dd/mmm/yyyy):
Clinical Program Director(s)* required for all studies
Department:
Name:
Signature: Date (dd/mmm/yyyy):
Research Department required for all studies
Name: Laura Tomat Email: [email protected]
Signature: Date (dd/mmm/yyyy):
Clinical Ethics required for CTO Stream only
Name: Michael Szego Email:[email protected]
Signature: Date (dd/mmm/yyyy):
*NOTE: If multiple Clinical Program Directors are impacted, please use the “Other” space allocated on Page 5
June 14, 2018 _ last update February 2020 Page 5
RESOURCE AUTHORIZATION AS APPLICABLE
Approval and signatures must be obtained from all areas in which hospital resources are required. 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: [email protected]
Signature: Date (dd/mmm/yyyy):
Laboratory Medicine Name: Adnan Khan Email: [email protected]
Signature: Date (dd/mmm/yyyy):
Health Records Name: Andrea William Email: [email protected]
Signature: Date (dd/mmm/yyyy):
Clinical Informatics Name: Jenny Liu Email: [email protected]
Signature: Date (dd/mmm/yyyy):
Communications Name:Email:[email protected]
Signature: Date (dd/mmm/yyyy):
Diagnostic Imaging Name: Lisa Hicks Email: [email protected]
Signature: Date (dd/mmm/yyyy):
Medical Diagnostics Name: Carolyn NolanEmail: [email protected]
Signature: Date (dd/mmm/yyyy):
Patient Care Manager Clinical Services
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):
A Privacy and/or Security assessment may be required if you collect or generate direct or indirect identifiers from participants/substitute decision-makers, electronic or paper medical records, or in communications with participants.
Check ‘yes’ for all information collected or generated including for example, in Master Linking Logs, copies of source documents, emails with participants, etc.
Direct Identifiers Name Address Email Telephone number OHIP/health card number unique number that can identify a participant (e.g. student ID, CPSO #, community lab #) Mobile or medical device identifier IP address of a computer Videos, audio recording, photos or images that show or identify participants
Indirect Identifiers Medical record number (patient ID number ) or internal staff ID number Full visit, specimen, or accession number Specific location of an event (e.g. location of ambulance pickup) Diagnoses for rare diseases Videos, audio recording, photos or images that do not show or identify participants Combination of (a) full date of birth, (b) gender & (c) full postal code or city/town Whole genome sequence
Does the study involve: data about illegal activity (e.g. sex work, drug use) persons without status persons involved with the law/criminal justice system Indigenous persons Information from a registry, database, or biobank?
Will the study: Build a new registry, database, or biobank? Use a mobile app? Use a novel or wearable technology (e.g. a Fitbit, an electronic diary)? Collect biological samples? Conduct genetic testing? Conduct focus groups? Store direct or indirect identifiers in a cloud (i.e. Amazon Web Services, Google Cloud, Microsoft Azure), data centre, or other location outside of the Unity Health Toronto’s secure network? Transmit direct or indirect identifiers using a file sharing service that isn’t owned and operated by a hospital? (e.g. Dropbox, GoogleDocs, ShareFile)
June 14, 2018 _ last update February 2020Page 6
Date Privacy Approval Recieved (dd/mmm/yyyy):
PRIVACY INTAKE FORM
June 14, 2018 _ last update February 2020Page 7
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 although REB approval may have been issued, 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 Research Department, Department Chief, and for CTO Stream Clinical Ethics and Privacy).
Name: Principal Investigator Signature
Date (dd/mmm/yyyy)
Name: Site Investigator
Signature Date (dd/mmm/yyyy)
Name: Co-Investigator Signature
Date (dd/mmm/yyyy)
Name: Co-Investigator Signature
Date (dd/mmm/yyyy)
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 [email protected]
