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. 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.
| Fee per research site | Number of Research Sites | Total fee for Study Sponsor* |
|---|---|---|
| $3,500+ HST | 2 | $7,000 |
| $3,500+ HST | 3 | $10,500 |
| $3,500+ HST | 4 | $14,000 |
| $3,500+ HST | 5 | $17,500 |
| $2,500+ HST | 6 | $20,000 |
| $2,500+ HST | 7 | $22,500 |
| $2,500+ HST | 8 | $25,000 |
| $2,500+ HST | 9 | $27,500 |
| $2,500+ HST | 10 | $30,000 |
| $2,000 + HST | 11 | $32,000 |
| $2,000 + HST | 12 | $34,000 |
| $2,000 + HST | 13 | $36,000 |
| $2,000 + HST | 14 | $38,000 |
| $2,000 + HST | 15 | $40,000 |
| $2,000 + HST | 16 | $42,000 |
| $2,000 + HST | 17 | $44,000 |
| $2,000 + HST | 18 | $46,000 |
| $2,000 + HST | 19 | $48,000 |
| $2,000 + HST | 20 | $50,000 |
* Prices are exclusive of HST | Download PDF Version
| Fees Charged to Study Sponsor | Number of Research Sites | REB of Record Fee per Study | Total Site Participation Fees* ($500/site) | Fees Retained by CTO |
|---|---|---|---|---|
| $3,500 + HST | 2 | $5,750 | $1,000 | $250 |
| $3,500 + HST | 3 | $6,250 | $1,500 | $2,750 |
| $3,500 + HST | 4 | $6,750 | $2,000 | $5,250 |
| $3,500 + HST | 5 | $7,250 | $2,500 | $7,750 |
| $2,500 + HST | 6 | $7,750 | $3,000 | $9,250 |
| $2,500 + HST | 7 | $8,250 | $3,500 | $10,750 |
| $2,500 + HST | 8 | $8,750 | $4,000 | $12,250 |
| $2,500 + HST | 9 | $9,250 | $4,500 | $13,750 |
| $2,500 + HST | 10 | $9,750 | $5,000 | $15,250 |
| $2,000 + HST | 11 | $10,250 | $5,500 | $16,250 |
| $2,000 + HST | 12 | $10,750 | $6,000 | $17,250 |
| $2,000 + HST | 13 | $11,250 | $6,500 | $18,250 |
| $2,000 + HST | 14 | $11,750 | $7,000 | $19,250 |
| $2,000 + HST | 15 | $12,250 | $7,500 | $20,250 |
| $2,000 + HST | 16 | $12,750 | $8,000 | $21,250 |
| $2,000 + HST | 17 | $13,250 | $8,500 | $22,250 |
| $2,000 + HST | 18 | $13,750 | $9,000 | $23,250 |
| $2,000 + HST | 19 | $14,250 | $9,500 | $24,250 |
| $2,000 + HST | 20 | $14,750 | $10,000 | $25,250 |
* Site participation fees are intended to provide support for the ongoing operations of Research Ethics Boards (REBs) at institutions. Site participation fees will only be disbursed to sites that have an internal and/or institutional REB supported by their institution.
Note: Study sponsors will be charged an additional fee of $500 + HST per major amendment, and $1,250 + HST for each Provincial Continuing Review.
The Provincial Initial/CHEER Initial Application (PIA) is the first application submitted for a study using the CTO Stream system.
This application is created by the Leady Study Team, which will serve as the lead site for this project in Ontario. The Lead Study Team is responsible for all ethics submissions that apply to the overall study.
Please note the Provincial Applicant/CHEER 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 (PIA) in CTO Stream. Templates can be found on the Templates & Forms page.
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 on the Participating Sites page. 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 on the Manuals & Guides page.
The user who creates a new study in CTO Stream will automatically be given the role of Project Owner. The Project Owner has the ability to create/edit any application form and add or remove any roles or sharing privileges. It is recommended that the Sponsor, Provincial Applicant or study-wide research coordinator create the study in CTO Stream and act as the Project Owner.
The Project Owner is the ONLY user who can upgrade the study when CTO releases a new set of application forms into the system.
Please ensure that if the Project Owner is leaving the study, they transfer the ownership to a different user.
When a study is first created, only the project owner (the person who created the project) will be able to see and access the study. The project owner will need to use the collaboration features to give access and permissions to other research team members. Once other users have permission (e.g., through their new role or when the form is shared), they can also use the collaboration features to set up collaborators at their site.
The ‘Roles’ functionality is the most commonly used collaboration feature because it gives the user access and permissions for the entire study period. This means that, as new application forms are created, users with the appropriate role will automatically be given corresponding access and permissions. Similarly, if a user is given a role later in the life of the study, they will have access and permissions to currently existing forms and all previous forms based on their role.
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 on the Manuals & Guides page.
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 Templates & Forms 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/CHEER 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 on the Manuals & Guides page.
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 on the Manuals & Guides page, 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/CHEER 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.
Detailed guides on how to create a CIA and share an application with other team members can be found on the Manuals & Guides page.
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 on the Manuals & Guides page.
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 on the Manuals & Guides page.
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).
