Reporting Requirements

Following initial REB approval of your application, any changes to the study or approved documentation must be reviewed and approved by REB before implementation, except where necessary to eliminate an immediate hazard(s) to study participants (see Protocol Deviations below). Otherwise, throughout the conduct of the study, the following is to be reported to the REB via Reportable Events in the online system (as of July 22, 2019).

Note: These reportable events typically apply to REB 4 studies, however they may be applicable to studies of the other REBs.

Category

Reporting Criteria/Description

Protocol Deviations / Violations

Investigators must report to the REB any protocol deviations/violations which:

  • impact the rights, safety or well-being of a research participant (examples may include: incorrect dose of study medication, enrollment of participant that does not meet the inclusion/exclusion criteria of the protocol, consent violations, participant visits which occur prior to study approval, or after expiry of study approval);
  • jeopardize the study efficacy or the data integrity (examples include significant variance from the protocol required study procedures, wrong diary or CRF in use, failure of sample storage conditions); OR
  • constitute a breach of privacy.

Deviations from or changes to the protocol to eliminate immediate hazards to the study participants must be reported to the REB within 7 calendar days of their discovery. All other deviations must be reported to the applicable REB within 15 calendar days of their discovery.

Complete the Protocol Violation Form and submit via Reportable Events in the systen.

Serious Adverse Events (SAEs) - Local

Local SAEs are adverse events experienced by research participants at the site(s) under the jurisdiction of the REB. Local SAEs must be reported to REB if the event is serious, unexpected, and considered to be related or possibly related to the study.

Local SAEs that are fatal or life threatening are to be reported to the REB within 7 calendar days of their discovery. All other local SAEs which are unanticipated problems must be reported within 15 calendar days of their discovery.

Complete the Local SAE Report and submit via Reportable Events in the system.

Serious Adverse Events (SAEs) - Non-Local

Non-local SAEs are adverse events experienced by research participants at centres/institutions outside the REB's jurisdiction. A non-local SAE is reportable if the local PI believes it is an unanticipated problem (unexpected, related or possibly related to participation in the research and places research participants or others at a greater risk of harm) AND requires a change to the protocol and/or informed consent form or immediate notifications to participants for safety reasons. Otherwise, non-local SAEs may not need to be reported to REB. See SOP: Non-Local SAE for more details.

Report within 15 calendar days of their receipt.

Progress Reports or Safety Reports

Written report or memorandum from study monitors or sponsors, such as Periodic Safety or Progress Reports and Data Safety Monitoring Board (DSMB) Letters/Reports.

Report within 15 calendar days of their receipt.

Audit

 Should your site be selected for an audit, inspection, or inquiry by a university, provincial or federal agency, the REB MUST be notified that the audit is being conducted. A copy of the audit findings must also be submitted to the REB within 15 calendar days of receipt.

Suspension

 Interruptions to the study or notification of study closure/termination by the sponsor, PI, REB or institution MUST be reported to the REB as information is received.

Participant Complaint

 Complaints made by participants or others affected by the research concerning their well-being (psychological or physical) and/or respectful and fair treatment from the researchers. Describe the participant complaint and what, if any, action was taken to address the participant complaint.

How to Submit Reportable Events in ARISE