Reporting Requirements

As of November 2016 the Australian Health Ethics Committee (AHEC) has revised the requirements for safety reporting to HRECs.

In line with the AHEC statement ACT Health HREC no longer requires submission of individual Serious Adverse Events (SAEs), annual SUSARs or Line Listings.

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.

Investigators must provide the HREC with an annual progress report.

At completion of the research the investigator must provide HREC with a final report.