Definitions, Criteria and Submission Instructions

Definitions:

Periodic Safety Update Reports:

• Periodic safety update reports are sponsor-generated compilations of suspected unexpected serious adverse reactions (SUSARs) and/or other unanticipated problems that occurred during a particular reporting period (typically quarterly, semi-annual, or annual), with a summary highlighting any main points of concern and the evolving safety profile of the investigational product.

Criteria for submission:

Periodic Safety Update Reports will be accepted provided:

• The report highlights the main points of concerns and the evolving safety profile of the investigational product.

Submitting Instructions:

• Upon receipt of the Periodic Safety Report from the sponsor, it is the Investigator’s responsibility to review each report to ensure it meets the reporting criteria outlined above.
• Complete and submit two (2) copies of the Bannatyne Campus External Adverse Event Form (EAE) for each file along with one copy of the sponsor generated report within fifteen (15) days of becoming aware of the unanticipated EAEs.  Include a self addressed (postage attached for external mail) returned envelope.
• Incomplete submissions/documents or submissions that do not meet the criteria listed above will not be processed and will be returned to the sender. Sponsor documents must meet the reporting criteria listed above or the Summary Report will not be accepted.
• Changes required to the protocol or consent as a result of the adverse events outlined in the Periodic Safety Report must be submitted on the Bannatyne Campus Amendment Form.
• Do not include a cover letter with the submission.
• Faxed or e-mail submissions are not accepted.