CTO Stream: How It Works

The CTO Streamlined Research Ethics Review System can be used for multi-site health research being conducted at CTO Participating Sites in Ontario.

“Multi-site” means that your study must be taking place at a minimum of two sites. “CTO Participating Sites” are those institutions which have signed a Participation Agreement with CTO enabling them to use CTO Stream. A list of these sites can be found by clicking here. If you plan to work with a site that is not yet listed, please contact streamline@ctontario.ca.

CTO Stream can accommodate both Clinical Trials and Observational studies. You can view our application from templates on the Tools and Resources page.

CTO only charges ethics review fees for industry-sponsored or industry-supported studies. Invoices will be sent to directly to the sponsors listed in the application form.

For Sponsors/Contract Research Organizations (CROs) who require a service agreement in order to issue payments to CTO for REB fees, CTO has developed a Master Service Agreement template. The template can be downloaded on the Tools and Resources page.

For the provision of streamlined research ethics review services provided by CTO, the industry sponsor will be charged as follows:

Application Fees:

• $3,500 for each participating site for the first 5 sites.
• $2,500 for each of the next 5 sites (6-10).
• $2,000 for each additional site after 10.

Major Amendment Fees:

• $500 for each major amendment.

Renewal Fees (Provincial Continuing Review):

• $1,250 for each Provincial Continuing Review

CTO Streamlined Research Ethics Review Application Fees Structure Table (Download PDF Version)

* Prices are exclusive of HST

A breakdown of how fees are distributed for Industry-Sponsored/Supported studies can be found on the Tools and Resources page.

If you are a researcher from a CTO Participating Site, you can sign up for your own account to use CTO Stream. Individuals who are not affiliated with a CTO Participating Site (e.g., Sponsors or CRO users) can also sign up for an account if they plan to access the system.

To access CTO Stream, you will need an active account. Each research team member requiring access to the ethics submissions will require a CTO Stream account.

To create an account, go to the following link and use the green new user button:

https://apply.ctostream.ca.

We encourage new CTO Stream users to attend a training webinar. User manuals and quick guides are also available to help all of our users navigate through CTO Stream. You can find all of this information on the Training and Webinars page.

If you are a sponsor, please contact the CTO Help Desk to organize a sponsor training session:

Help desk email: streamline@ctontario.ca

The Provincial Initial Application (PIA) is the first application submitted for a study using the CTO Stream system.

This application is created by the Provincial Applicant Team, which will serve as the lead site for this project in Ontario. The Provincial Applicant Team is responsible for all ethics submissions that apply to the overall study.

Please note the Provincial Applicant (PA) listed in the PIA must be an investigator affiliated with one of CTO’s participating sites. The PA is usually the overall study lead/recipient of grant funding (investigator-initiated studies) or determined with input from the sponsor (industry-sponsored studies).

The PIA includes study-wide information that will apply to all sites within a project. This includes study risks and benefits, protocol, and the study-wide (provincial) consent form template.

The CTO Informed Consent Form Templates serve as the basis for the consent form for studies using CTO Stream. The appropriate template should be used when creating the study-specific consent form submitted with the initial study-wide application (the Provincial Initial Application) in CTO Stream. Please select the appropriate template(s) based on the type of research you are submitting. Please ensure you follow all of the instructions listed on the first page of the template as this will ensure a faster time to ethics approval. If you are submitting an oncology study through CTO Stream to be reviewed by the Ontario Cancer Research Ethics Board (OCREB) please use the OCREB Informed Consent Form Template, located on the OCREB website: https://ocreb.ca

Please note that as of May 1st 2019, all* studies being submitted through CTO Stream must use the CTO Informed Consent Template located on the Tools and Resources page.

*excluding studies being submitted to the Ontario Cancer Research Ethics Board (OCREB), which are required to use the OCREB templates on the OCREB website: https://ocreb.ca.

Before you begin working on your PIA in CTO Stream, you should first review your Streamlined Research Ethics Review System (SRERS) Administration form, which you can locate for your institution in the Participating Sites section of our website.  This form has information you will need to complete your PIA.

The PIA is created from your homepage within CTO Stream. For more information please see the “Getting Started” User Manual in the Webinars and Training section of our website.

Before your PIA can be submitted for review, it must be electronically signed off by the Provincial Applicant (PA) listed in the application form. For more information about how signatures work in CTO Stream, see the “Signing Applications” guide in the Webinars and Training section of our website.

Once your PIA is submitted, CTO will conduct a brief administrative screen of your application. This is to ensure that your study meets the CTO mandate (i.e., includes at least two CTO participating sites) and has used the appropriate Informed Consent Form template located on the Tools and Resources page.

CTO will also screen to ensure the appropriate individuals are listed and have signed your application.

If your study requires modification based on the elements described above, your application will be returned to you with a CTO review letter. Once these corrections are made, you can re-submit the application to CTO so the application can be assigned to your REB of Record.

Once your application passes CTO screening, it is assigned to a CTO Qualified REB. This REB will serve as the REB of Record for your study. This REB will review all submissions for this study.

The process of assigning the REB of Record will differ, depending on whether your project is industry sponsored/industry supported or an investigator-initiated study. For industry-sponsored research, CTO first considers whether your study could benefit from particular REB expertise before assigning a board of record to your project. For an investigator-initiated project, the provincial applicant’s (PA) local REB, if CTO qualified, is considered first to serve as the REB of Record. If the PA’s local REB is not CTO qualified, CTO will consider any beneficial expertise required before selecting a board.

Once your REB of Record has been selected, you can contact them directly using the correspondence feature within CTO Stream. For more information on how to contact the REB of Record please use see the “Correspondence” QuickGuide in the Webinars and Training section of our website. 

Following their review of an application, an REB may request additional information, clarification, or changes. All REB review and decision letters are accessible within CTO Stream. All queries from the REB of Record must be responded to directly in CTO Stream. Please see the “Finding an Approval Letter” QuickGuide in the Webinars and Training section of our website, for instructions on how to find the approval letter (or any letter sent by the REB) for your application.

Receiving PIA approval does not mean that you can begin the study at your site. Each participating site must submit a Centre Initial Application (CIA) in order to obtain ethics approval to conduct the study at their site. THIS INCLUDES THE PROVINCIAL APPLICANT SITE.

The Centre Initial Application (CIA) is the application each site (including the Provincial Applicant site) must submit to the REB of Record following the approval of the PIA for their study. The CIA contains details that are only specific to that site, such as the Principle Investigator’s contact information, the centre informed consent form (creating using the ICF Provincial Template), and details of how (if applicable) your site’s study conduct will differ from the protocol outlined with the PIA submission.

This application is created by the Provincial Applicant Team, who can share the form with members of the local site team.

For detailed guides on how to create a CIA and share an application with other team members, visit the Webinars and Training section of our website here.

Only once your project has PIA approval and your site has CIA approval, can you begin research at your site.

Once your CIA is submitted, CTO will conduct a brief administrative screen of your application. This is to ensure the appropriate individuals are listed and have signed your application, and to confirm that no changes have been made in the Provincial ICF template that are not outlined in your site’s Documented Institutional Ethics Requirements.

If your study requires modification based on the elements described above, your application will be returned to you with a CTO review letter. Once these corrections are made, you can re-submit the application to CTO so the application can be reviewed by your REB of Record.

Once your CIA passes the CTO screening process, it will be assigned to the same REB that reviewed your study’s PIA. You can contact them directly using the correspondence feature within CTO Stream. For more information on how to contact the REB of Record please see the “Correspondence” QuickGuide in the Webinars and Training section of our website.

Following their review of an application, an REB may request additional information, clarification, or changes. All REB review and decision letters are accessible within CTO Stream. All queries from the REB of Record must be responded to directly in CTO Stream. For more information about how to respond to a request for changes from the REB, please see the “Request for Changes from REB” QuickGuide in the Webinars and Training Section of our website.

After the approval of your initial application, the study team can submit post-approval submissions. Types of post-approval submissions include amendments, continuing review forms (ethics renewal), reportable events, and study closure forms.

These form types can be created at the provincial level (by the provincial study team) or at the centre level (by the site’s study team). Any post-approval changes affecting study-wide information or applicable to all sites must be done by the provincial team, while changes only applicable to a specific site must be submitted by that site’s study team. The diagram below outlines which submissions are the responsibility of the provincial team (on the left), and the site’s teams (on the right):

All submissions will go directly to your REB of Record to review your initial applications (i.e., post-approval applications are not screened by CTO). Please note that once a provincial post-approval is approved by your REB, this approval is applicable to all sites within your project.

Continuing Review Applications must be submitted to the REB of Record on a yearly basis in order to renew ethics approval for your study. These must be submitted at both the provincial and site level, including the site serving as the provincial applicant. Please note the there is a single ethics expiry date for the entire study and all participating sites. This date is based on the date of approval for the PIA.

For the Provincial Continuing Review (PCR), the Provincial Applicant (PA) will submit PCR by submission deadline for the full board meeting occurring prior to expiry. Please note a lapse in provincial ethics approval will simultaneously result in a lapse at all participating sites.

All Centre Continuing Review (CCR) forms must be created and submitted by each site by submission deadline for full board meeting occurring prior to expiry date. Centres can submit their CCR forms even if PCR form hasn’t been submitted. It is important to remember the Provincial Applicant must also submit a CCR for their own site (in addition to the PCR form).