National Clinical Trials Governance Framework project

The project set out to to provide advice, expertise and consumer input to development of the Clinical Trials Governance Framework.

Clinical Trials Steering Committee

A Clinical Trials Governance Framework Steering Committee (Steering Committee) was convened, comprising individuals with relevant expertise and experience in the clinical trials sector and the Australian health care system.

The Steering Committee set out to:

  • Support delivery of the project in line with the requirements of the Commission and the expectations of the Department of Health
  • Provide advice on development of the Clinical Trials Governance Framework and high level implementation plan
  • Facilitate engagement with peer groups about the project.

Development of Clinical Trials Governance Framework

The Commission undertook a review of the national and international literature on approaches to clinical trials governance, and carried out a mapping exercise of state and territory clinical trial policies and processes to  inform the development of the Clinical Trials Governance Framework and a high level implementation strategy.

Consultation on the draft Clinical Trials Governance Framework began in 2018.  

Contact

If you have any questions about the Clinical Trials Governance Framework project please contact Bernadette Aliprandi-Costa, Project Manager and the project team via email CTgovernance@safetyandquality.gov.au or phone 02 9126 3600.