Research Western

Post-Approval Events

These forms allow you to maintain your protocol.

How to Change Study Personnel - UPDATED September 2, 2014

Principal Investigator (PI) and Co-Investigator (Co-I)

Changes to PI and CoI require submission of a formal revision request in Romeo. The following documentation is required:

Study Personnel other than the PI and CoI

When the only revision is to change study personnel other than the PI or CoI, an email is sufficient. The email must come from the Principal Investigator, and must include the following:

Continuing Ethics Review (CER)

Western’s office of Human Research Ethics approves studies on an annual basis. If your study is on-going for more than one year, the ORE will issue an Annual Renewal Approval Notice for one year at a time. Depending on risk, continuing review may be required more than once per year; you will be informed if this is the case.

When your study has ended you are required to submit an End-of-Study Form.

The office will NOT accept CER Forms unless they are submitted by the PI, or have an accompanying Letter of Attestation authorizing this submission. If a Letter of Attestation is used, please see the ‘Letter of Attestation’ section above for more details, including Attestation Letter requirements)

To help facilitate compliance, the office will issue reminder notifications for when CER forms are due. This will occur two months and one month before the due date. If a CER form is not submitted by the due date the office will send a third and final notification just before your study will expire.  Should an Investigator fail to submit the CER form despite the reminder/follow-up notifications, a notice that REB approval has expired will be issued and the study will be suspended.  When suspended, the Investigator must suspend all study related activities as specified by the REB. If the CER form is still not submitted within two weeks of the study expiry date the REB may close the file and the Investigator will be required to submit a new study application.  If the CER form is submitted after the expiry date but before file closure this will result in a lapse in REB approval. The REB may also elect to pursue investigations for serious or continuing non-compliance.

Initiating or continuing the conduct of human participant research in the absence of REB approval does not conform to the Tri-Council Policy Statement 2 (TCPS 2) and for regulated studies, is contrary to Health Canada, FDA and OHRP regulations.

Protocol Revision

Any changes to a protocol must be done through a Non-Medical Revision Event Form in Romeo. It can be submitted at any time as deadlines do not apply for the review of these forms. This is a two-step process. The first step is to complete the Revision Form in Romeo. After it is reviewed, the second step will be to make the requested changes to your file in Romeo – an email will be sent by Ethics staff with instructions on this.

Please allow time for processing as the office often experiences a high volume of revision forms to process.

Required Documentation

Adverse Events

All local and non-local adverse events must be reported through our SAE system.

Protocol Deviations/Violations

Any unexpected events or issues which were not part of the originally approved protocol (i.e., data stored in a non-approved place or way, or over-enrollment) must be reported to the Non-Medical REB in a timely manner. Please use the Non-Medical Protocol Deviation/Violation Form in Romeo as soon as possible along with a summary of what the unexpected event or deviation/violation.

End of Study Report

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 Non-Medical End of Study Form in Romeo.