Continuing review
Approval is limited to one year for all research projects. Requests for annual re-approval must be made by completing an annual renewal form and providing a status report to the REB. Beyond annual renewals and adverse event reporting, ongoing continuing review requirements are confirmed by the REB and implemented by the Clinical Research Monitors.
Continuing Review of Clinical Research
The Research Institute has implemented a formal oversight program for all clinical research. The Research Ethics Board (REB) is mandated by the Tri-Council Policy Statement to ensure continuing ethics review of ongoing research. The type of continuing review required by the study will be proportionate to the degree of potential risk to the research subject.
The initial priority for implementation of the Continuing Review Process will be clinical research studies of the highest risk to subjects i.e. Level III or Level IV clinical intervention trials, with no other monitoring (e.g. industry monitoring, DSMC, cooperative trial group auditing).
Velma Marzinotto, Clinical Research Monitor at 416-813-8924 or Rita Arseneault, Clinical Research Monitor 416-813-1966 can provide assistance in identifying an appropriate level of monitoring for your study.
Continuing Review Matrix
The following sample matrix and instructions are available for download in Adobe Acrobat format. This template is included in the standard application form and tissue application form for completion.
Level of continuing review matrix [Acrobat file]