This type of application applies when post-approval changes are required. A project amendment may be considered to be major or minor.
A Progress/Annual Report for each project must be submitted to the Office for Research every year. Annual Reports are due by the approval anniversary of each study.
It is a requirement that all updated insurance certificates throughout the life of a project be submitted to the Office for Research.
The Australian Government Department of Health Therapeutic Goods Administration (TGA) require notification of completion from the Sponsor, this should be made only after the trial has been completed at all sites.
When requesting a waiver of consent for an active study, Your waiver request will be reviewed by the full HREC and you will be notified of the outcome post meeting.
Austin Health requires all study participants to be registered and issued with an Austin Health UR number. This includes healthy volunteers, participating in research, who do not have an existing medical record.
Archiving of Research Records