The Ontario Cancer Research Ethics Board (OCREB) is a central, expert oncology REB serving the hospitals/cancer centres in Ontario that conduct oncology clinical trials.

All OCREB studies have been transferred from O2 to Clinical Trials Ontario Stream (CTO Stream) and new studies and their follow-on/post-approval applications must be submitted in CTO Stream.

For more information about OCREB studies where the UHN reseach team is the Provincial or Centre Applicant, please contact BOR-CCRU@uhn.ca

When using an REB of Record model like CTO, it is important to note that each centre's institution will have additional review and/or approval requirements. These institutional requirements will change based on the nature of the study and structure of the organization. At UHN, these non-REB reviews and approvals must be obtained by submitting a CAPCR application. A complimentary CAPCR application is required for all studies submitted in CTO Stream to obtain approval from UHN's non-REB reviewers (e.g. Grants and Contracts Services, Research Quality Integration, Laboratory Medicine Program, etc.).

There are 2 things required before you may begin study activities at UHN:

1. CTO REB of Record (ethics) Approval for the UHN Centre
   • Note: The study team will be required to attach the UHN Site's CTO Centre Approval Letter to the initial CAPCR application, prior to Institutional Authorization being issued (the Approval Letter does not need to be attached to the 'submit' CAPCR, but is required for CAPCR to be authorized)
2. Study Granted Institutional Authorization (IA) in CAPCR

Q1. I am completing a UHN Participating Site Initial Application and need to include information for UHN's Primary Institution Rep- Who is this?

Title: Mr.
First Name: Alexander
Surname: Karabanow
Organization: University Health Network
Address: 700 University Avenue, 4th Floor North
City: Toronto
Province/State: Ontario
Postcode/Zip: M5G1Z5
Telephone: 
Email: alexander.karabanow@uhn.ca

The Secondary Institution Rep section should remain blank.

Q2. I have submitted a Participating Site Initial Application (PSIA) in CTO which requires UHN's Institution Rep's signature. The request has gone out but I am still waiting for them to sign - what's the hold up?

As Institution Rep for UHN, Alexander Karabanow must sign-off on the PSIA in CTO Stream before it can be submitted for review by the REB of Record. Before the Institution Rep will sign, the following has to be completed:

• CAPCR application submitted
• Department Head in PSIA and CAPCR must match
• The UHN Principal Investigator (PI) must sign in CTO stream

If you are waiting for a signature for the UHN Institution Rep, please contact boardofrecord@uhn.ca

Q3. When should you submit the CAPCR Application?

If there is a Participating Site Initial Application (PSIA) for UHN in CTO Stream, the UHN Centre PI is responsible for completing and submitting an application through CAPCR.

You can create and submit the initial application in CAPCR at any time so long as you understand study activities cannot begin at UHN until your study receives Institutional Authorization (IA) in CAPCR. You may submit as soon as the Clinical Trial / Observational Study Initial Application (CTIA/OSIA) for the study has been created in CTO Stream.

Q4. I am the Lead Applicant- When should I create / submit the Participating Site Initial Applications in CTO Stream?

A Participating Site Initial Application (PSIA) must be created and submitted for each site (including the Lead Applicant site). When the Clinical Trial / Observational Study Initial Application is created, research teams should immediately create the PSIAs for any known Participating Site (right after creating the CTIA/OSIA). When the PSIA is created for UHN, two things happen:

1. The UHN Institution Reps and Admins will automatically be tagged to the study.
2. One of the UHN Institution Reps will reach out to the UHN Site PI to guide them through the process of obtaining Institutional Authorization (IA) at UHN.

Q5. What do I need to start study activities at UHN?

• CTO REB of Record Approval for the UHN Site
• Institutional Authorization (IA) has been granted from the CAPCR system

Note: The CTO Participating Site Approval Letter is not required at the time of CAPCR submission, but is required for the CAPCR application to proceed to authorization.

Q6. I will be submitting an Amendment / Continuing Review / Reportable Event / Participating Site Closure in CTO Stream - Do I also need to submit a corresponding CAPCR application?

There are study-wide and site-level submissions in CTO Stream but not every submission needs a corresponding submission in CAPCR.

• Amendment – submission required in CAPCR if the CTO amendment would impact a new or existing service provider/impact assessment reviewer triggered to the study
• Participating Site Continuing Review – submission required in CAPCR to confirm the study continues to maintain ethical oversight
• Reportable Event – submission not required in CAPCR as it is overseen by the external Board of Record in CTO Stream
• Participating Site Completion/Termination/Suspension – submission required in CAPCR to inform all existing service providers/impact assessment reviewers are aware of the completion/termination/suspension

Q7. What is veritas IRB?

Veritas IRB: A central IRB that provides ethics review services for research studies conducted at UHN at the request of UHN REB. For more information, please contact reb@uhn.ca.

CTO Stream Contact
streamline@ctontario.ca
877-715-2700

Please also visit the CTO website: https://www.ctontario.ca/

As UHN has a large number of studies using CTO, there are 2 contacts for support. If research teams have questions about the process for CTO studies at UHN, please contact:

• Non-Oncology Studies: boardofrecord@uhn.ca
• Oncology or OCREB studies: BOR-CCRU@uhn.ca