As part of the initiative to have quicker and more efficient research governance authorisation, NHMRC has developed the Good Practice Process for Site Assessment and Authorisation Phases of Clinical Trial Research Governance (the Good Practice Process). The Good Practice Process was developed and finalised, following extensive stakeholder consultation, by the NHMRC’s Research Governance Working Group. This group has broad representation from clinical trials sites, clinical trial sponsors and State/Territory health departments.
The Good Practice Process aims to streamline the site assessment and site authorisation of clinical trials by:
- Outlining a set of principles and critical success factors for site assessment and site authorisation;
- Detailing a set of planning and preparation activities that can made a site more responsive to commencing clinical trials; and
- Proposing a streamlined workflow for site assessment and authorisation.
NHMRC is currently piloting the Good Practice Process in 16 clinical trial sites across 7 states and territories. These sites are:
- The Canberra Hospital (ACT)
- Royal North Shore Hospital (NSW)
- Melbourne Health (VIC)
- Monash Health (VIC)
- Barwon Health (VIC)
- Peninsula Health (VIC)
- Royal Children’s Hospital Melbourne (VIC)
- St Vincent’s Hospital Melbourne (VIC)
- Princess Margaret Hospital (WA)
- Metro South Hospital and Health Service (QLD)
- Sunshine Coast Hospital and Health Service (QLD)
- Queensland University of Technology (QLD)
- Central Adelaide Local Health Network (SA)
- Northern Adelaide Local Health Network (SA)
- Women’s and Children’s Health Network (SA)
- The University of Tasmania/Royal Hobart Hospital/Launceston General Hospital (TAS)
The intended outcomes of the pilot studies are:
- Evidence of how implementing the Good Practice Process can positively impact timeframes; and
- The identification of any potential improvements to the Good Practice Process.
Once details on the effectiveness of the Good Practice Process have been collected, and any modifications made, it is expected that the Good Practice Process will be implemented at all clinical trials sites to facilitate a standardised approach to clinical trials research governance.
- Although the pilot studies are ongoing, with results expected in the first quarter of 2016, the Good Practice Process has been published to allow other institutions to review and implement as required, noting that some refinements following the pilot studies are expected.
- Exploring arrangements to facilitate expedited or streamlined governance arrangements for ‘lower risk’ clinical trials such as some comparative effectiveness clinical trials.
- Developing arrangements to support multi-centre trials conducted across academic institutions, public and private sector hospitals and local health services.
- Developing high level principles for the Good Practice Process to enable institutions to develop their own standard operating procedures.
- In September 2013 NHMRC held a National Forum on Clinical Trial Research Governance to discuss prospective solutions to the delays in commencing clinical trials in Australia.
- In December 2013 NHMRC held a Streamlined Research Governance meeting to progress the tasks identified during the Forum, including progressing a Good Practice Process model.
- In May 2014 NHMRC undertook a consultation on a good practice process (the Process) to seek views on whether the Process represented an approach that would be able to be implemented in Australia and any barriers to its implementation.
- In October 2014 NHMRC published the outcomes of the consultation and began to work with the Research Governance Working Group to finalise the Process.
- November 2015 NHMRC held a meeting of sites and with sponsor/ CRO representatives to determine mechanisms to further streamline the process.
Please contact the Clinical Trials section.