Development of a Good Practice Process for site assessment and authorisation of clinical trials

To improve clinical trial start-up times, following extensive stakeholder consultation and under the guidance and leadership of the NHMRC Research Governance Working Group, 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 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.

The Good Practice Process was piloted in 16 clinical trial sites around Australia. The pilot program demonstrated that through adopting the Good Practice Process and employing a Clinical Trial Liaison Officer the clinical trial start-up timeframe can be reduced by more than 100 days.

Good Practice Process Documents

Related Documents

Further information

If you would like to discuss how you could implement the Good Practice Process at your site, or have any other questions please contact the Clinical Trials section.