Definitions, Criteria and Submission Instructions
Examples of updated study safety information include, but are not limited to the following:
- Data Safety Monitoring (DSMB) report
- Audit or monitoring report
- Interim study results
- Health Canada, FDA or other regulatory agency study results
- Safety Alerts
- Publication in the literature or other findings
- Revised Investigators Brochures
- Notification of Sponsor suspension or termination of the study
- Changes in the Health Canada or FDA labeling or withdrawal from marketing of a drug, biologic or device used in a research protocol
- Use this form to summarize and submit any updated safety information listed above.
- Do not use this form to accompany an Investigator’s Brochure for a new application.
- Complete and submit one (1) copy of the Bannatyne Campus Updated Safety Reporting Form for each file along with one (1) copy of the sponsor generated report.
- Submissions will not be accepted without completion of the Bannatyne Campus Updated Safety Reporting Form. Acknowledgement of receipt will not be provided.
- Updated safety information which suggests increased risk and immediate safety concerns to participants should be reported to the REB promptly and no later than fifteen (15) days upon becoming aware of the information. All other updated safety information should be reported to the REB within thirty (30) days of becoming aware of the report (e.g. DSMB report that suggest trial may continue as planned, New Investigators Brochure that does not require an immediate notification of risks to participants, etc.)
- Any changes as result of the safety update information required to the protocol or consent form must be submitted using the Bannatyne Campus Amendment Form.
- Do not include a cover letter with the submission.
- Faxed or e-mail submissions are not accepted.