CTO REB Qualification Program
The CTO REB Qualification Program provides research ethics boards (REBs) in Ontario, planning to participate in the CTO Streamlined Research Ethics Review System, a review of their operations, documentation, personnel and facilities with respect to regulations, standards and policies typically applicable to the conduct of clinical trials and health research in Ontario and Canada.
This is an important step as it promotes a high level of trust and allows institutions and REBs to feel confident delegating ethics review and oversight to each other.
We invite CTO REB Qualification requests! Please send an email to email@example.com or contact us for more information.
The requirements for Qualification reflected in the Manual have been informed by numerous sources including Food and Drugs Act and applicable regulations; Canadian General Standards Board (CGSB): Research Ethics Oversight of Biomedical Clinical Trials (CAN/CGSB-191.1-2013); Tri-Council Policy Statement 2 (TCPS2), the International Conference on Harmonization Good Clinical Practice guide (ICH GCP) and applicable US regulations.
The CTO REB Qualification Manual contains information on the CTO REB Qualification Program, along with the CTO REB Qualification Checklist (used during the Qualification review process) and the Preliminary Questionnaire, this assists in preparing both the REB and the CTO Qualification Review Team).
- An Auditor with specific training in reviewing REBs
- A CTO Program Coordinator
- Two individuals selected from the CTO College of Reviewers that consists of experienced members from the research ethics community (e.g., REB Chair/Vice-Chair, REB Director/Manager/Coordinator).
An REB must have written REB Standard Operating Procedures in place prior to the initiation of the Qualification process.
The primary components of the review process are:
- The Preliminary Questionnaire (completed by REBs prior to undergoing a Qualification review).
- A two-day on-site Qualification visit.
- REB Chair/Vice-Chair representative
- REB Operations Expert
Members representing each area are selected from the College of Reviewers for each Qualification visit.
If you are interested in joining the CTO College of Reviewers, please submit a cover letter specifying your experience and training related to research ethics review and clinical trials, along with your CV, to firstname.lastname@example.org.