CTO Streamlined Research Ethics Review System (SRERS) at St. Michael’s

Clinical Trials Ontario (CTO) is an independent, non-profit organization established with support from the Government of Ontario. Their mandate is to work collaboratively with the clinical trials community, the public, and various partners to attract clinical trial investment to Ontario. The streamlined ethics review system aims to decrease the time to getting clinical trials started by having ethics review completed by a single, qualified research ethics board performing the review for all sites involved in a study. All other required institutional approvals must also be obtained prior to the conduct of the study at SMH (e.g. Privacy, Clinical Ethics, etc). Each institution’s approval groups may have questions/concerns about the approved Provincial Initial Application (PIA) protocol that a study team will need to direct to the Provincial Lead PI and the Board of Record.

CTO Process for Clinical Trials and Observational Studies

*Note: When St. Michael’s Hospital is the Provincial Applicant site, the research team should immediately create the Centre Initial Application for St. Michael’s Hospital – right after creating the Provincial Initial Application.

Submission of Clinical Trials Ontario (CTO) applications

Effective September 2021: The Unity Health Toronto Institutional Approval form and REB Submission checklist will replace all previous study impact forms including individual site-specific forms. This form must be submitted for all new Clinical Trials Ontario (CTO) submissions and new Unity Health REB applications.

Please be sure to re-visit this page often to download the form when starting new studies as the form is frequently updated

For questions regarding CTO, please contact Elizabeth Huggins Elizabeth.Huggins@unityhealth.to

While the online CTO Stream system provides a streamlined approach to research ethics review, researchers at St. Michael’s must ensure that all necessary institutional authorizations and contracts/agreements are in place prior to beginning the research. This information can be found in the SRERS Administration form for Unity Health Toronto. Please ensure you review the Documented Institutional Ethics Requirements for Unity Health Toronto to ensure your study is compliant with the hospital’s privacy policy and that the specific Informed Consent form requirements for a Catholic hospital are being properly incorporated. Questions? Please contact Elizabeth Huggins Elizabeth.Huggins@unityhealth.to. If you have technical issues or need help with your submission, contact streamline@ctontario.ca or 1-877-715-2700 (9 am to 5 pm).

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