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)

Continuing Ethics Review forms are due once a year for every active study. A reminder that this form is due is 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 available through Romeo and the email will include instruction on how to complete it. The form should be filled in, and electronically submitted through Romeo by the deadline noted near the top of the form. The form will also ask for a brief summary on the progress to date.

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 Non-Medical Revision Event Form in Romeo. Even if you are submitting a Revision Event Form, you must still submit your CER when it is due.

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 ORE staff with instructions on this.

Please allow time for processing as the Office of Research Ethics 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.