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Reporting Safety Events or Unanticipated Problems

NOTICE:  Island Health Research Ethics office has moved.  Please refer to our revised contact information.

The following events/information must be reported to the Island Health REB through the Research Services Portal within 10 business days of the event.

Event Reporting Criteria Form in Portal
Local Serious Adverse Event (SAE)

An adverse event that is:

  • documented at the local study site,
  • serious,
  • unanticipated, and
  • related.
Local SAE Report
Major Protocol Deviation

Any change from REB-approved protocol that adversely affects the:

  • risk/benefit ration of the study, or
  • rights, safety, or welfare of participants or others, or
  • integrity of the study.
Protocol Deviation Report
Protocol Waiver/Exception Any prospective request for an intentional deviation from the REB approved protocol except when necessary to eliminate immediate hazard to a participant. Protocol Waiver/Exception Request
Other Unanticipated Problem/Info

Unanticipated problem/issue or additional study information that may adversely affect the:

  • risk/benefit ratio of the study, or
  • rights, safety, or welfare of participants or others, or
  • integrity of the study.
Unanticipated Problem/Info Report

Negative Inspections, Audit Findings or Enforcement Actions

All major audit, inspection, or other regulatory assessment findings that result in the issuance of a Corrective and Preventative Action (CAPA) must be reported to the REB. This includes enforcement actions taken against the local PI or research site.

Reports to the REB should be submitted within 10 working days. However, where there is any immediate risk to participants or integrity of data identified, notification should be made to the REB office within five (5) working days of the PI becoming aware of the situation. Form 503-02 Unanticipate Problem Report should be used in both cases.

How to report events occurring external to the local research site

Please submit the following information to the REB using the Non-Local Safety Information or Unanticipated Problem form in the Research Services Portal:

  • Summary or Listings of External SAE Reports (CIOMS, MedWatch, IND Safety reports, etc.)
  • Reports, publications, or interim results or findings (DSMB notifications, 'Dear Healthcare Professional' Letter, etc.)
  • New or updated study product safety information (Revised label/ Package Inserts, Device manuals, etc.)
  • Recalls / Withdrawals (Regulatory Agency or Sponsor Marketing withdrawal, etc.)

See Safety Information and Unanticipated Problems Reporting Guidelines.

Questions or Concerns?

Contact the Research Ethics Office: 250-519-6726.