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.

Protocol Deviations

Investigators must report to the REB any protocol deviations which:

  • impact the rights, safety or well-being of a research participant;(examples may include: incorrect dose of study medication, enrolment of subject that does not meet the inclusion/exclusion criteria of the protocol, consent violations, subject 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 10 days of their discovery. All other deviations must be reported to the applicable REB within 15 (fifteen) days of their discovery.

Protocol deviations should be submitted as an Email to REB Administrator within your specific REMO file and must include at least the following content:

  • A description of the deviation that occurred with an explanation of the circumstances that lead to the deviation and the resulting problem.
  • An explanation as to whether or not the deviation compromised the scientific integrity of the study
  • An explanation of whether or not the deviation increased the risk or the possibility of risk for the research participant;
  • A description of steps taken or that will be taken to correct / address the problem resulting from the deviation, and;
  • A plan for ensuring that a similar deviation does not occur in the future.

 Serious Adverse Events (SAEs)

  • 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 are to be reported to the REB (via Email in REMO to REB Coordinator) within 7 days of their discovery by the study site.  See Local SAE form.
  • Non-local SAEs may not need to be reported.  See SOP – non-local SAE.

Progress Reports or Safety Reports

Periodic Safety or Progress Reports and Data Safety Monitoring Board (DSMB) Letters/Reports from the sponsor should be submitted by email within the REMO system to the REB Coordinator as they are received.

Other

  • If an Investigator receives notice that their site will be audited (either by the study Sponsor, or by Health Canada or US FDA), the REB MUST be notified that the audit is being conducted.  A copy of the audit findings must also be sent to the REB when it is received by the site.
  • Interruptions to the study, notification of study closure/termination, new safety information are examples of other information that should be submitted to the REB.