The NHMRC published new safety monitoring and reporting guidelines for clinical trials in 2016 that substantially changed requirements in Australia. In 2018, the NHMRC published three more guidance documents: Reporting of Serious Breaches of GCP and the Protocol. Data Safety Monitoring Boards and Risk Based Management and Monitoring of Clinical Trials. These guidelines impact on a wide range of clinical trial stakeholders – Site staff, sponsors, ethics committees and research offices.