These forms allow you to maintain your protocol.
Continuing Ethics Review forms are due once a year for every active study. These forms are emailed to the Principal Investigator and if indicated in the protocol submission, the Administrative Contact for the study by the Office of Research Ethics. The form is not currently available online. The form in the email should be printed, the information filled in, and returned to the Office of Research Ethics by the deadline noted near the top of the form.
A brief report must be submitted with the progress of the study so far. Enrolment information is also collected.
The ONLY change to a protocol that can be made on a CER form is an end date extension. All other changes must be done using the Delegated Health Sciences Event Form in Romeo. Even if you are submitting a Revision Event Form, you must still submit your CER when it is due.
Any changes to a protocol must be done through the Delegated Health Sciences Revision Event Form in Romeo. It can be submitted at any time as deadlines do not apply for the review of these forms.
Please allow time for processing as the Office of Research Ethics often experiences a high volume of revision forms to process.
Any time the ethics approval has been violated (eg. data stored in a non-approved place or way, or over-enrolment) it must be reported as soon as possible. Please use the Delegated Health Sciences Deviation/Violation Form in Romeo as soon as possible along with a summary of what the deviation/ violation was and submit to the Office of Research Ethics for review by the Chair of the Board.
(2-I-003) Instructions and Definitions
(2-I-005) Decision Tree - SAE Follow-up Reporting
All local and non-local adverse events must be reported through our SAE system.
Please use the Health Sciences Updated Approval Event Form in Romeo only when the Sponsor requires that an annual renewal be issued for a study. DO NOT use this form for End Date Revisions
NB: Due to the increased volume in UDA submissions, our office now requires 6 weeks to process updated approval requests. Please ensure that you submit your request for an updated approval 6 weeks in advance of when it is needed.
For a list of deadline dates please refer to the schedule of submission and meeting dates.
When a study is completed and/or all data collection/patient contact completed, the Principle Investigator must inform the Office of Research Ethics of this and request that the study be closed using the Delegated End of Study Event Form in Romeo.
