National Clinical Trials Governance Framework
Sarah RathjenFull bio
Clinical Trials FacilitationLearn more
Murdoch Children’s Research Institute
Royal Melbourne Hospital, Austin Health, Northern Health, Western Health, Mercy Hospital, St Vincent’s Hospital, Peter MacCallum Cancer Centre. The Royal Victorian Eye and Ear Hospital, The Royal Women’s Hospital, The Royal Children’s Hospital
The Governance Framework is incorporated into the existing NSQHS Standards to the National Accreditation Standards and is intended to embed clinical trials into routine health service provision. Operationally, the intent is that – for health service organisations undertaking clinical trials – accreditation against the NSQHS Standards will extend to accreditation against the Governance Framework.
The MACH Clinical Trials committee saw the opportunity to coordinate the preparation and implementation of the Governance Framework to reduce the duplication of effort for the 10 MACH health service providers. A timely award of State government funding allowed the appointment of Senior Project Officers to assist with preparation for the implementation of the Governance framework.
A steering committee was appointed, chaired by Professor Andrew Davidson, as well as a working group for each of Standards 1 and 2. Initial funding of the Senior Project Officers is for 12 months and then will be reassessed as to the ongoing needs of the MACH health service providers.
- Embed clinical trials into clinical service.
- Harmonise the governance framework implementation of MACH health services.
- Identify gaps in compliance with the governance framework.
- Develop processes and policies as required to comply with the framework.
- Assist MACH health services to prepare for their next re-accreditation.