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 during COVID-19

Effective September 2020: The Clinical Research Restart application for St. Michael’s Hospital or the Clinical Research Restart application for St. Joseph’s Health Centre will replace the CTO Study Impact Approval form until further notice.

1. Please complete a Clinical Research Restart application and submit to Elizabeth Huggins Elizabeth.huggins@unityhealth.to for review. Be sure to attach all [1] Service Area and Department Approvals and [2] the consent form to your application. Upon receipt, your submission will be forwarded to the Clinical Research Restart Review Committee (CR3C) for review.
2. CTO review will be conducted simultaneously with the Clinical Research Restart review. CR3C approval will need to be obtained prior to Institutional approval of a new CTO application. Once CR3C is granted, please forward the approval e-mail to Elizabeth Huggins. Please note CR3C approval may be conditional on successful completion of CTO requirements (e.g. Privacy review).

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

For questions regarding Clinical Research Restart, please contact Sabrina Aimola Sabrina.Aimola@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 St. Michael’s Hospital.

Please ensure you review the Documented Institutional Ethics Requirements for St. Michael’s Hospital 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 at Elizabeth.Huggins@unityhealth.to or 416-864-6060 x 77689.

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).