The National Clinical Trials Governance Framework – Response to the Consultation

This response to the Australian Commission on Safety and Quality in Health Care’s consultation on the draft National Clinical Trials Governance Framework follows Research Australia’s attendance at the Melbourne workshop on 21 February 2019. It welcomes the Framework and confines its comments to roles, site authorisation and reporting. It asks that the final Framework clarify whether the organisational culture outcomes on page 17 are intended as criteria for selecting clinical trials, and that it emphasise that organisations need people capable of performing the specified functions rather than new staff or positions, a concern raised by members. It submits that the Framework should recognise that site-specific assessment and site-specific authorisation can be delegated to different people, and that it should describe the role and functions of the site-specific authoriser, which it identifies as a significant omission from Standard 1 and the roles set out on pages 21 to 38. Finally, it recommends that Standard 1 assign clear responsibility for reporting on each trial to the governing body and for external reporting to state and territory health departments, in line with the Framework’s transparency principle.