Safety Reporting for Clinical Trials
Sponsors will be required to provide ACT Health HREC 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. Please include any outstanding safety reports from pre-November 2016 in the study's first annual safety report.
Sponsors are required to review the Investigator Brochure at least annually and to provide updates to investigators and the HREC.
Sponsors must provide the HREC with reports of Data Safety and Monitoring Boards.
Principal Investigators 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.
New NHMRC guidelines for safety monitoring and reporting in clinical trials involving therapeutic goods came into effect from March 2018.
In line with this guidance, ACT Health HREC no longer requires submission of individual Serious Adverse Events (SAEs), annual SUSARs or Line Listings.