Any changes to a protocol must be done by submitting Form 2-F-004. 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.
The Continuing Ethics Review forms are sent annually, by email, for every active study. The email is sent to the Principal Investigator and, if applicable, to a designated administrative contact. The form should be printed and completed by the study site and returned to the Research Ethics office by the due date stated at the top of the page.
The ONLY change that can be done using the Continuing Ethics Review form is a revised end date. All other changes must be done using Revision Form 2-F-004.
Protocol Deviations must be reported to the REB within 7 days of implementation by using the Health Sciences REB Protocol Deviation Report. A copy of the sponsor protocol violation, deviation or waiver form should be appended to the Western University form. Other supporting documentation should be retained by the Investigator and be made available upon request.
Requests for a Protocol Exception (or Revision) should be made to the REB by using the Health Sciences REB Request for a Revision form prior to the implementation of the change.
(2-I-003) Instructions and Definitions
(2-I-005) Decision Tree - SAE Follow-up Reporting
Please use the adverse event system to enter and print copies for local SAE reporting. Please submit one signed copy of any LOCAL SAE print outs to the Office of Research Ethics.
For Local On-line registration assistance or for any other questions with the local on-line system please contact the Office of Research Ethics.
Serious, unexpected adverse events or reactions regardless of causality for subjects enrolled at the Local site.
Within 7 days of discovery of the event or reaction submit 1 hard copy of Western University Health Sciences REB Local Adverse Events Report that is generated through the On-Line Adverse Events Reporting system. Please ensure that YOU ALSO forward a hard copy of the event within 7 days (i.e. print copy for your records, sign and submit) at: https://grant3.vm.its.uwo.ca/sae/SAELogin.aspx
Serious, unexpected adverse reactions or events related to the study intervention that occur at all non-local or external sites.
Within 30 days of being notified of the event or reaction submit: An online Non-Local Adverse Events Report https://grant3.vm.its.uwo.ca/sae/SAELogin.aspx . Hard copies are no longer accepted.
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 Form 2-F-009.
Updates that do not necessitate a change to the approved Western University Protocol, informed consent(s) and approved study materials are submitted as FYI’s. Examples of such items are: updated Investigator Brochures, amendments that do not affect the local site and SUSAR reports.
Per article 11.7 A safety monitoring plan may (but need not) include the establishment of a data safety monitoring board (DSMB) or data safety committee (DSC).
A DSMB is normally a multidisciplinary, expert advisory group that is responsible for safeguarding the interests of participants, by reviewing emerging data, assessing the safety and efficacy of trial procedures, and monitoring the overall conduct of a trial. Researchers must indicate, in their proposal for REB review, whether they or a DSMB will be communicating any new information to the REB over the course of the trial. Researchers must ensure that DSMB reports are sent to REBs in a timely manner.
Please Use this form 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 before the HSREB that your file must be reviewed at.
