Safety Reporting for Clinical Trials
Sponsors, via the local Principal Investigator (PI), will be required to provide the Research Ethics and Governance Office (REGO) with an annual safety report that supports trial oversight, includes a clear summary of the evolving safety profile of the trial and evidence that the sponsor is conducting its own ongoing safety monitoring appropriately. Should there be any new safety information the sponsor will be required to provide an updated participant information and consent form.
- Sponsors are required to review the Investigator Brochure at least annually and to provide updates to investigators and REGO.
- Sponsors must provide REGO with reports of Data Safety and Monitoring Boards.
PIs are obliged to review the safety information that is sent to them by the trial Sponsor and to act on all safety advice. The PI has primary responsibility to ensure that all investigators are up to date on all aspects of the safety of their protocol. Questions of product or protocol safety are relevant to the conduct of any clinical trial. Therefore, it is incumbent upon the investigator that they should be aware of, and act on, the latest available safety information and that this information should be discussed with participants as part of the ongoing assurance that consent is informed and remains valid.
Serious Adverse Event Reporting
Serious adverse events (SAEs) occurring at Canberra Health Services sites, including Canberra Hospital, or involving trial participants enrolled through Canberra Health Services are to be reported to REGO using the report form below.
Deviations from the approved protocol, occurring at Canberra Health Services sites, including Canberra Hospital, are to be reported to REGO using the template log below. Protocol deviation logs are to be submitted, one per trial, at least every six months. Where a trial has had no deviations in the reporting period, a protocol deviation log noting “nil deviations” and signed by the PI is to be submitted for REGO acknowledgment.